System Troubleshooting Guide Abbott Laboratories Abbott Park, IL 60064 94816-107—November 2004 ©1998, 2004 Abbott Laboratories AEROSET is a Registered Trademark of Abbott Laboratories
SystemTroubleshooting
Guide
Abbott LaboratoriesAbbott Park, IL 6006494816-107—November 2004
©1998, 2004 Abbott LaboratoriesAEROSET is a Registered Trademark of
Abbott Laboratories
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2 AEROSET® System Troubleshooting Guide94816-107—November 2004
NOTES
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AEROSET® System Troubleshooting Guide 394816-107—November 2004
Revision Status
Document Control Number(s)
Revision Date Section(s) Revised
Pages Revised and Added
30-0897/R1 9/98 Original Issue Original Issue
30-1762/R2 1/00 All Sections All Pages
94816-101 6/01 All Sections All Pages
94816-102 4/02 All Sections All Pages
94816-103 6/02 All Sections All Pages
94816-104 2/03 All Sections All Pages
94816-105 6/03 All Sections All Pages
94816-106 12/03 All Sections All Pages
94816-107 11/04 All Sections All Pages
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4 AEROSET® System Troubleshooting Guide94816-107—November 2004
Highlights of Changes from Previous AEROSET System Troubleshooting Guide (94819-106)
NOTE: This section is intended as a guide to highlight major and significant changes to this version of the AEROSET System Troubleshooting Guide, Part Number 94816-107. It is NOT intended to be a comprehensive description of all changes to the guide and/or AEROSET System functionality, hardware, and reagent applications.
Overview
• The organization of the Assays/Reagents section of the AEROSET System Troubleshooting Guide was updated; it is now divided into General Information and Assay-specific Information subsections.
1. If troubleshooting information for a specific assay is available, it is listed alphabetically in Assay-specific Information. If an assay-specific subsection does not exist, no additional troubleshooting information is currently available.
2. Previously, some assays, e.g., MULTIGENT® assays, included Assay-specific Questions sections. These Question and Answer sections were expanded and renamed Frequently Asked Questions (FAQ).
• The Question and Answer format of some sections in the Troubleshooting Guide was eliminated, with the exception of assay-specific Frequently Asked Questions (FAQ).
• Procedures to verify Limit of Detection (LOD) and Limit of Quantitation (LOQ) were consolidated into one subsection, Verification Procedures in Assays/Reagents, General Information.
• Assay-specific cross reactivity information for Drugs of Abuse (DOA) assays is now located in Assay-specific Information.
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AEROSET® System Troubleshooting Guide 594816-107—November 2004
• Some information previously included in the Troubleshooting Guide was eliminated because it duplicated information that is readily available to customers in other secondary labeling, e.g., Abbott Clinical Chemistry Package inserts or the AEROSET System Operations Manual. Major sections that were eliminated include:
1. Specific SmartWash™ parameters
2. Specific method comparison, interference, and limit of detection information for DOA assays
3. Specimen collection requirements for MULTIGENT® assays
Specific Changes and/or New Information
• Mercury warning symbol and information added.
• New information for the C-Reactive Protein and Rheumatoid Factor assays added to Assays/Reagents, Assay-specific Information.
• Information for the MULTIGENT Microalbumin assay added to Assays/Reagents, Assay-specific Information. The chemical reaction for MULTIGENT Microalbumin added to Chemical Reactions for Clinical Chemistry Assays.
• New information for the Specific Proteins assays added to both the Assays/Reagents, General Information and Assays/Reagents, Assay-specific Information sections.
• Product information for Abbott Clinical Chemistry calibrators added.
• A list of applicable assays for each control was added to the Bio-Rad Control Products information table.
• A general Specimen Collection and Handling section was created by consolidating various assay-specific information in the previous Troubleshooting Guide.
• Additional information for the Therapeutic Drug Monitoring (TDM) assays, including Frequently Asked Questions (FAQ), added to Assays/Reagents, General Information.
• CK assay—explanation of issues with FlexRate™ linearity.
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• Magnesium assay—new assay-specific information added to describe necessary parameter edits when converting units from mEq/L to mg/dL.
• Software section—new screen graphics with software version 1.03ER000. This includes:
– SYSTEM CONFIGURATION screen
– PAGE SETUP screen (Form 1 and Form 2)
– Log On screens (two)
– Assay Configuration screen, Rerun Rules page
– MAINTENANCE UTILITIES screen, SW Info page
– MAINTENANCE UTILITIES screen, Sampling page
– Pressure Monitor screen
• Updated Unit Configuration screen default settings in System Configuration.
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AEROSET® System Troubleshooting Guide 794816-107—November 2004
Table of Contents
Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Highlights of Changes from Previous AEROSET System Troubleshooting Guide (94819-106) . . . . . . . . . . . . . . . . . . 4
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Specific Changes and/or New Information . . . . . . . . . . . 5
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Pictorial Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Troubleshooting Guide Usage Disclaimers . . . . . . . . . . . . . . 16Master Table of Contents/Index Disclaimer . . . . . . . . . . . . . 17Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Assays/Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Assay Configuration/Installation . . . . . . . . . . . . . . . . . . . . . 21Drugs of Abuse (DOA) Assays . . . . . . . . . . . . . . . . . . . . . 21
Cutoff Calibrator Values . . . . . . . . . . . . . . . . . . . . . 21Qualitative Assay Configuration . . . . . . . . . . . . . . . 22Print Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Factor Mode—Numeric Results . . . . . . . . . . . . 23Example of Factor Mode—Numeric Results
Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Factor Mode—POS/NEG Results . . . . . . . . . . . 26Example of Factor Mode—POS/NEG Results
Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Absorbance Mode . . . . . . . . . . . . . . . . . . . . . . . 29Example of Absorbance Mode Results
Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Summary of Print Options . . . . . . . . . . . . . . . . 32
ICT™ Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32I-Index—Calibrator/Control Position 42 . . . . . . . . 32
Biohazardous Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Mercury Warning Symbol . . . . . . . . . . . . . . . . . . . . . . . . 33
Calculated Assay Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Recalculating Calculated Assay Results . . . . . . . . . . . . . 34
Calibration Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Drugs of Abuse (DOA) Assays . . . . . . . . . . . . . . . . . . . . . 35
Ethanol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Qualitative Assays. . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Enzyme Factor Calculation . . . . . . . . . . . . . . . . . . . 37Use Cal Factor From . . . . . . . . . . . . . . . . . . . . . . . . 38
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Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39Multiconstituent Calibrator (MCC), LN 1E65 . . . . . . . . .39Product Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Chemical Reactions for Clinical Chemistry Assays . . . . . . . .42Drugs of Abuse (DOA) Assays . . . . . . . . . . . . . . . . . . . . . . . . .60
Assay Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60Cross Reactivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65Method Comparison . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
MULTIGENT® Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66Manufacturer Information . . . . . . . . . . . . . . . . . . . . . . . .66
Plasma Claims for Gel Barrier Tubes . . . . . . . . . . . . . . . . . . .67Proficiency Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
AAB Reagent Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68CAP Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Serum Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69Urine Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71CSF Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71Therapeutic Drug Monitoring . . . . . . . . . . . . . . . . . .72Urine Drug Testing (Drugs of Abuse) . . . . . . . . . . . .72
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73Bio-Rad Control Products . . . . . . . . . . . . . . . . . . . . . . . . .73Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Bio-Rad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76Biochemical Diagnostics, Inc. . . . . . . . . . . . . . . . . . .76
Establishing Quality Control Limits . . . . . . . . . . . . . . . .77Temporary Quality Control Limits . . . . . . . . . . . . . .77Permanent Control Limits . . . . . . . . . . . . . . . . . . . .78Temporary Control Limits Worksheet . . . . . . . . . . .79
Reagent Test Count Tracking . . . . . . . . . . . . . . . . . . . . . . . . .80Reagent Test Counts . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Sample Blanking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81Self Blank vs. Non-Self Blank . . . . . . . . . . . . . . . . . . . . . .81
Self Blank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81Non-Self Blank . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Sample Interference Indices . . . . . . . . . . . . . . . . . . . . . . . . . .82SmartWash™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
SmartWash (Reagent Carryover) When Moving A and B-Line Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
SmartWash Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .84SmartWash for Non-Abbott Reagent Applications . . . . . .84
Specific Proteins Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85Imprecision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85Bar Code Read Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . .85Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . .86
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Specimen Collection and Handling . . . . . . . . . . . . . . . . . . . 88Therapeutic Drug Monitoring (TDM) Assays . . . . . . . . . . . . 89
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Troubleshooting Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . . 90
Verification Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Confirming the Limit of Detection (LOD) . . . . . . . 92
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Limit of Detection for Abbott Assays Data Sheet . . 94Limit of Detection for Abbott Assays Data
Sheet Example . . . . . . . . . . . . . . . . . . . . . . . . . . . 95Confirming the Limit of Quantitation (LOQ) . . . . 96
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Limit of Quantitation for Abbott Assays Data
Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98Limit of Quantitation for Abbott Assays Data
Sheet Example . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Assay-specific Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Acid Phosphatase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Method Comparison . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Albumin BCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Alkaline Phosphatase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
ALT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Ammonium Heparin Tube Not Acceptable . . . . . . . . . 104
ALT/AST Activated Versus ALT/AST . . . . . . . . . . . . . . . . . . 104Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
ALT Activated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Ammonium Heparin Tube Not Acceptable . . . . . . . . . 104
Amphetamine/Methamphetamine . . . . . . . . . . . . . . . . . . 105Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Amylase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Interference Information . . . . . . . . . . . . . . . . . . . . . . . 106Apolipoprotein A1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Apolipoprotein B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108AST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Ammonium Heparin Tube Not Acceptable . . . . . . . . . 109AST Activated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Ammonium Heparin Tube Not Acceptable . . . . . . . . . 109Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
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Barbiturates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110Benzodiazepines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112
Cross Reactivity Testing Performed on the AEROSET System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112
Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114
Cannabinoids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115Troubleshooting Imprecision . . . . . . . . . . . . . . . . . . . . .116
Cocaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117Complement C3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119Complement C4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120C-Reactive Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .121
Standard Material Recovery . . . . . . . . . . . . . . . . . . . . . .121Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .121
Creatine Kinase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125Digoxin (MULTIGENT®) . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Spironolactone/Canrenone Interference Results . . . . . .125Cross Reactivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126Sample Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .127
Direct LDL (MULTIGENT) . . . . . . . . . . . . . . . . . . . . . . . . . .128Sample Storage and Stability . . . . . . . . . . . . . . . . . . . . .128Reagent Storage and Stability . . . . . . . . . . . . . . . . . . . . .128Calibrator Storage and Stability . . . . . . . . . . . . . . . . . . .128Linearity Verifiers (80-5953-00, 2 x 3 mL) . . . . . . . . . . .129Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .131Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .131
Ethanol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132Specificity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132
GGT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132
Haptoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133
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Hemoglobin A1c (MULTIGENT®) . . . . . . . . . . . . . . . . . . . . 134Reaction Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134Pretreatment (Hemolysate Preparation) . . . . . . . . . . . . 135Accuracy by Recovery of Standards . . . . . . . . . . . . . . . 136Hemoglobin Denaturant Storage Conditions . . . . . . . 137Sample Mixing (Vortex Mixing vs. Pipet Mixing) . . . . 137
Vortex Mix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137Pipet Mix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Interference Information . . . . . . . . . . . . . . . . . . . . . . . 139Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . 141
ICT™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143L and H (Reference Range) Result Flags Display with
No Result when Error Log Message 351 or 352 Is Generated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Immunoglobulin A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Immunoglobulin G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Immunoglobulin M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Iron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148Interference Information . . . . . . . . . . . . . . . . . . . . . . . 148
Magnesium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149Units Conversion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Methadone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Microalbumin (MULTIGENT) . . . . . . . . . . . . . . . . . . . . . . . 152
Specimen Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . . 152
Opiates 300 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153Opiates 2,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Cross Reactivity Testing Performed on the AEROSET System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Phencyclidine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157Cross Reactivity Testing Performed on the AEROSET
System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157Prealbumin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159Propoxyphene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Cross Reactivity Testing Performed on the AEROSET System by SYVA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
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Rheumatoid Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162Standard Material Recovery . . . . . . . . . . . . . . . . . . . . . .162Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .163
Total Bilirubin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167Observed Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167
Total Protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167Interference Information . . . . . . . . . . . . . . . . . . . . . . . .167
Transferrin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .168Observed Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .168
Valproic Acid (MULTIGENT®) . . . . . . . . . . . . . . . . . . . . . . .169Accuracy by Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . .169Interference Information . . . . . . . . . . . . . . . . . . . . . . . .169Frequently Asked Questions (FAQ) . . . . . . . . . . . . . . . .170
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171Color Coding on the AEROSET System . . . . . . . . . . . . . . . .173Exporting Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174
Exported Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174Exported Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .174
Host Interface Trace Log . . . . . . . . . . . . . . . . . . . . . . . . . . . .175Observed Problems—Software . . . . . . . . . . . . . . . . . . . . . . .176QUALITY Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178
Interval QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178QC Rounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178QC Statistics—Decimal Places . . . . . . . . . . . . . . . . . . . .179
Rounding of Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . .180Sample Sequence/Smart Sampling . . . . . . . . . . . . . . . . . . . .180Screen Hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .181
Action Area of the Main Display . . . . . . . . . . . . . . . . . .181Information Access Area of the Main Display . . . . . . . .182
Screen Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183Main Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183REAGENTS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183REAGENTS (Supply Center Segment) Screen . . . . . . . . .184Reagent Supply Center Segment Details Screen . . . . . . .184DATABASE Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185Search Dialog Window . . . . . . . . . . . . . . . . . . . . . . . . . .185Patient Demographics Dialog Window . . . . . . . . . . . . .185Print Options Dialog Window—Order List/Loadlist . . .186Order Samples Screen . . . . . . . . . . . . . . . . . . . . . . . . . . .186PAGE SETUP Screen (Form 1) . . . . . . . . . . . . . . . . . . . . .187Form 1 Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187PAGE SETUP Screen (Form 2) . . . . . . . . . . . . . . . . . . . . .188Define Free Text Screen . . . . . . . . . . . . . . . . . . . . . . . . .188Form 2 Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .189On-line Data Transfer Dialog Window . . . . . . . . . . . . . .189
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RESULT Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190RESULT Screen—Viewing Rerun Result . . . . . . . . . . . . 190Reaction Graph Screen—Error Code . . . . . . . . . . . . . . 191Reaction Graph Screen—Rate Assay . . . . . . . . . . . . . . . 191Reaction Graph Screen—End-point Assay . . . . . . . . . . 192Absorbance Data Screen . . . . . . . . . . . . . . . . . . . . . . . . 192DATABASE Screen, Accept Results Dialog Window . . . 192CALIBRATOR/CONTROL Screen . . . . . . . . . . . . . . . . . 193CALIBRATOR/CONTROL Screen—Set 1 . . . . . . . . . . . . 193Position Dialog Window . . . . . . . . . . . . . . . . . . . . . . . . 194CALIBRATION SUMMARY Screen . . . . . . . . . . . . . . . . 194Calibration Details Screen . . . . . . . . . . . . . . . . . . . . . . 195QC SUMMARY Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 195Levey-Jennings Graph Screen . . . . . . . . . . . . . . . . . . . . 196Print Options (QC) Dialog Window . . . . . . . . . . . . . . . 196Levey-Jennings Graph Report . . . . . . . . . . . . . . . . . . . . 197QC Details Dialog Window . . . . . . . . . . . . . . . . . . . . . 197QC Data List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 197ASSAYS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198ASSAY STATUS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 198Assay Configuration Screen, Outline Page . . . . . . . . . . 199Assay Configuration Screen, Base Page
(End-point Assay) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199Assay Configuration Screen, Base Page (Rate Assay) . . 200Assay Configuration Screen, Calibration Page (Linear
Calibration Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . 200Assay Configuration Screen, SmartWash™ Page . . . . . 201Assay Configuration Screen, Rerun Rules Page . . . . . . 201RUN OPTIONS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 202SYSTEM CONFIGURATION Screen . . . . . . . . . . . . . . . . 202SELECT ASSAYS FOR STAT Screen . . . . . . . . . . . . . . . . . 203Pause Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203Unpause Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204START UP OPTIONS Screen . . . . . . . . . . . . . . . . . . . . . 204SHUTDOWN OPTIONS Screen . . . . . . . . . . . . . . . . . . . 205ERROR LOG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205MAINTENANCE UTILITIES Screen, System Page . . . . . 206MAINTENANCE UTILITIES Screen, SCC Page . . . . . . . 206MAINTENANCE UTILITIES Screen, Sampling Page . . . 207Pressure Monitor Screen . . . . . . . . . . . . . . . . . . . . . . . . 207MAINTENANCE UTILITIES Screen, Rgt Area 1 Page . . 208MAINTENANCE UTILITIES Screen, Rgt Area 2 Page . . 208MAINTENANCE UTILITIES Screen, Rxn Area Page . . . 209Cuvette Blank Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 209Cuvette Integrity Check Screen . . . . . . . . . . . . . . . . . . 210
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MAINTENANCE UTILITIES Screen, SW Info Page . . . . .210Printer A Configuration Window . . . . . . . . . . . . . . . . . .210ONLINE (HOST) CONFIGURATION Dialog Window . .211Run Progress Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .211Log On Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .211User Alert Dialog Window . . . . . . . . . . . . . . . . . . . . . . .211
System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .212FAC Limit % Field—Configuration . . . . . . . . . . . . . . . .212System Configuration Software Disk v3.0 . . . . . . . . . . .213Unit Configuration Default Screen . . . . . . . . . . . . . . . .215
Unit Configuration Screen, Default View Page 2 (Software Version 1.03ER000) . . . . . . . . . . . . . . .216
Startup/Shutdown Setting Default Screens . . . . . . . . . .217User Codes/Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221CPU Used with the AEROSET System . . . . . . . . . . . . . . . . .223Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .225
Cuvette Volumes—Minimum and Maximum . . . . . . . .225Cuvette Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .225Cuvette Identification . . . . . . . . . . . . . . . . . . . . . . . . . .225
GPIB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .226ICT™ Warranty Information . . . . . . . . . . . . . . . . . . . . . . . .226Noise Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .226Observed Problems—Hardware . . . . . . . . . . . . . . . . . . . . . .227Serial Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .230Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .231
Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .231USP Purified and WFI Requirements . . . . . . . . . . .231
Verification Procedures/Adjustments/Alignments . . . . . . .232Lamp Gain and A/D Check . . . . . . . . . . . . . . . . . . . . . .232
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . .232Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .232
Reagent Arm Adjustment . . . . . . . . . . . . . . . . . . . . . . . .234Materials Required . . . . . . . . . . . . . . . . . . . . . . . . .234R1A Probe Horizontal Adjustment . . . . . . . . . . . . .234Reagent Carousel Alignment . . . . . . . . . . . . . . . . .237R1A Probe Cuvette Alignment . . . . . . . . . . . . . . . .239R1A Probe Wash Cup Alignment . . . . . . . . . . . . . .242
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Troubleshooting Flowcharts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .245Abbott Assay—Basic Assay Troubleshooting . . . . . . . . . . . 247
Assay Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 248Instrument Troubleshooting . . . . . . . . . . . . . . . . . . . . 248
Non-Abbott Assay—Basic Assay Troubleshooting . . . . . . . 250Confirmation of Assay Parameter Settings (Illegal Configuration) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Erratic Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253QC Out of Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254Calibration Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257ICT™ Failed Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 259Bubbles in ICT Module Tubing . . . . . . . . . . . . . . . . . . . . . 261LIS/Communication Problems . . . . . . . . . . . . . . . . . . . . . . 262Water Issue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
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Proprietary StatementCopyright 1998, 2004, Abbott Laboratories, Abbott Park, Illinois. All rights reserved. No part of this document may be reproduced, stored, or transmitted in any form or by any means electronic, mechanical, photocopied, recorded, or otherwise without the prior written permission of Abbott Laboratories.
Pictorial DisclaimerAll samples (printouts, graphics, displays, screens, etc.) contained in the AEROSET System Troubleshooting Guide are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual patient names or test results. Abbott Laboratories makes no representations or warranties about the accuracy and reliability of the information in the graphics.
Troubleshooting Guide Usage DisclaimersInformation contained in this document was developed for use by trained Abbott Laboratories Field Service personnel, or by other persons knowledgeable or experienced with operation and service of the AEROSET System. The information should be used under direct supervision and cooperation with Abbott Laboratories technical sales and service representatives.
In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in connection with, or arising from use of information in this document by persons not fully trained by Abbott Laboratories as technical sales and service representatives. This limitation shall not apply to those persons knowledgeable or experienced with operation and service of the AEROSET System, who use this information under direct supervision of Abbott Laboratories technical sales and service representatives.
Any product information in this guide should be used in conjunction with the latest version of the AEROSET System Operations Manual, Operations Manual Addendum, or Product Information Letter. If any discrepancies in information exist within this guide or any other, the latest version of the Operations Manual, Operations Manual Addendum, or Product Information Letter takes precedence.
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Master Table of Contents/Index DisclaimerIncremental manual updates may cause the Master Table of Contents or Master Index page numbering to change.
Trademark StatementsAll Abbott Laboratories product names and trademarks are owned by or licensed to Abbott Laboratories, its subsidiaries, or affiliates. No use of any Abbott trademark, trade name, trade dress, or product name may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of Abbott Laboratories. All other trademarks, brands, product names, and trade names are the property of their respective companies. All rights reserved.
Except as permitted above, no license or right, express or implied, is granted to any person under any patent, trademark, or other proprietary right of Abbott Laboratories.
c 8000, AEROSET, ARCHITECT, AxSYM, IMx, MULTIGENT, Nembutal, and TDx are registered trademarks of Abbott Laboratories.
FastTrack, FlexRate, ICT, and SmartWash are trademarks of Abbott Laboratories.
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NOTES
AEROSET® System Troubleshooting Guide 1994816-107—November 2004
Assays/Reagents
Assays/Reagents
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NOTES
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General Information
Assay Configuration/InstallationRefer to the most current version of Technical Bulletin 1018-2003 when installing new assays.
Drugs of Abuse (DOA) Assays
The Abbott Clinical Chemistry Drugs of Abuse (DOA) menu includes Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Ethanol, Methadone, Opiates, Phencyclidine, and Propoxyphene.
Cutoff Calibrator Values
Cutoff calibrator levels used for each of the qualitative DOA assays are listed in the following table.
* Cutoff concentrations mandated by SAMHSA (Substance Abuse and Mental Health Services Administration) for Federal Workplace drug testing.
The Ethanol assay is a quantitative assay which is calibrated using two levels of calibrator, 0 mg/dL and 100 mg/dL.
Assay Level
Amphetamine/Methamphetamine 1,000 ng/mL*
Barbiturates 200 ng/mL
Benzodiazepines 200 ng/mL
Cocaine 300 ng/mL*
Cannabinoids (THC50) 50 ng/mL*
Methadone 300 ng/mL
Opiates 300 300 ng/mL
Opiates 2,000 2,000 ng/mL*
Phencyclidine (PCP) 25 ng/mL*
Propoxyphene 300 ng/mL
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Qualitative Assay Configuration
Use the following instructions to configure a qualitative assay in Absorbance mode.
1. Select <Assays> in the Information Access Area of the Main Display.
2. Select the desired assay button. The ASSAY STATUS screen displays.
3. Select <Config> in the right column of the screen. The Assay Configuration screen displays.
4. The Outline page is the default view.
5. Verify Quantitative Ranges is selected. This is the default setting.
6. Edit the L-Reference field from “-9999” to “0.0”.
7. Select the Calibration tab to access the Calibration page.
8. Select the list box icon next to the Calib Mode field. Select <Abs> then select the return arrow to close the list.
9. Select <OK>.
Refer to Print Options, Absorbance Mode in this section for additional information.
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Print Options
Results for the Drugs of Abuse (DOA) assays can be printed using one of the following options:
• Factor Mode—Numeric Results
• Factor Mode—POS/NEG Results
• Absorbance Mode
Factor Mode—Numeric ResultsWhen the system is selected for Quantitative Ranges on the Outline page of the Assay Configuration screen, results print a positive number for a value equal to or higher than the Multi DOA Cutoff calibrator, and a negative number for a value lower than the Multi DOA Cutoff calibrator. A positive number is interpreted as positive; the specimen contains drug. A negative number is interpreted as negative; the specimen does not contain drug, or drug present yields a response less than that of the cutoff concentration for the assay being tested.
NOTE: Positive and negative numeric response values do not represent drug concentrations.
Perform the following steps to configure an assay in Factor mode—Numeric.
1. Select <Assays> in the Information Access Area of the Main Display. The ASSAYS screen displays.
2. Select the desired assay button. The ASSAY STATUS screen displays.
3. Select <Config> in the right column of the screen. The Assay Configuration screen displays.
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4. The Outline page is the default view.
Figure 1: Assay Configuration Screen, Outline Page
5. Verify Quantitative Ranges is selected (�). This is the default setting.
6. Select the Calibration tab to access the Calibration page.
Figure 2: Assay Configuration Screen, Calibration Page
7. Verify the Factor option is selected in the Calib Mode field.
8. Verify 1000 is entered in the Factor field.
9. Select <OK> in the upper-right corner of the Assay Configuration screen. The Save dialog window displays.
10. Select <OK> to save the settings.
11. Repeat steps 1 through 10 for each DOA assay installed.
Select
Factor
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Example of Factor Mode—Numeric Results Printout
The Barbiturates assay in this example would be reported as positive.
Phencyclidine, Propoxyphene, Opiates 300, Methadone, Amphetamine/Methamphetamine, Cocaine, and Benzodiazepines would be reported as negative.
10/17/01 13:01 SN A7602220SID 007Name John DoePOS 5 ( 2) PIDDate/Time Run 10/17/01 13:01
ERR NAME L/H RESULT ERR NAME L/H RESULTPCP - 30 AmpM - 36Prpx - 52 Coc - 16Opi3 - 17 Benz - 24Meth - 30 Barb H 10
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Factor Mode—POS/NEG ResultsWhen the system is configured for Qualitative Ranges, results print as POS for a value equal to or higher than the Multi DOA Cutoff calibrator, and NEG for a value lower than the Multi DOA Cutoff calibrator. A POS result is interpreted as positive; the specimen contains drug. A NEG result is interpreted as negative; the specimen does not contain drug or drugs are present in concentrations below the cutoff level for the assay being tested.
Perform the following steps to configure an assay in Factor mode.
1. Select <Assays> in the Information Access Area of the Main Display. The ASSAYS screen displays.
2. Select the desired assay button. The ASSAY STATUS screen displays.
3. Select <Config> in the right column of the screen. The Assay Configuration screen displays.
4. The Outline page is the default view.
Figure 3: Assay Configuration Screen, Outline Page
5. Quantitative Ranges is the default setting. Select the checkbox (�) next to Qualitative Ranges.
Select
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6. Select the Calibration tab to access the Calibration page.
Figure 4: Assay Configuration Screen, Calibration Page
7. Verify the Factor option is selected in the Calib Mode field.
8. Verify 1000 is entered in the Factor field.
9. Select <OK> in the upper-right corner of the Assay Configuration screen. The Save dialog window displays.
10. Select <OK> to save the settings.
11. Repeat steps 1 through 10 for each DOA assay installed.
Factor
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Example of Factor Mode—POS/NEG Results Printout
The Barbiturates assay in this example would be reported as positive.
Phencyclidine, Propoxyphene, Opiates 300, Methadone, Amphetamine/Methamphetamine, Cocaine, and Benzodiazepines would be reported as negative.
NOTE: A result of “0” would be reported as a positive result.
10/17/01 13:01 SN A7602220SID 007Name John DoePOS 5 ( 2) PIDDate/Time Run 10/17/01 13:01
ERR NAME L/H RESULT ERR NAME L/H RESULTPCP NEG AmpM NEGPrpx NEG Coc NEGOpi3 NEG Benz NEGMeth NEG Barb POS
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Absorbance ModeWhen the system is in Absorbance mode, results print as absorbance values. A result equal to or higher than the Multi DOA Cutoff calibrator absorbance is considered positive for the assay tested and negative for a value lower than the Multi DOA Cutoff calibrator absorbance.
Perform the following steps to configure an assay in Absorbance mode.
1. Select <Assays> in the Information Access Area of the Main Display. The ASSAYS screen displays.
2. Select the desired assay button. The ASSAY STATUS screen displays.
3. Select <Config> in the right column of the screen. The Assay Configuration screen displays.
4. The Outline page is the default view.
Figure 5: Assay Configuration Screen, Outline Page
5. Verify Quantitative Ranges is selected (�). This is the default setting.
6. Edit the L-Reference field from “-9999” to “0.0”.
Select
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7. Select the Calibration tab to access the Calibration page.
Figure 6: Assay Configuration Screen, Calibration Page
8. Select the list box icon next to the Calib Mode field. Select <Abs> then select the return arrow to close the list.
9. Select <OK> in the upper right corner of the Assay Configuration screen. The Save dialog window displays.
10. Select <OK> to save the settings.
11. Repeat steps 1 through 10 for each DOA assay installed.
Abs
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Example of Absorbance Mode Results Printout
Each assay value in this example would be compared to its cutoff calibrator absorbance to determine if the result is positive or negative.
The following are examples only and do not demonstrate actual absorbance values.
The Barbiturates and Cannabinoids (THC50) assays in this example would be reported as positive.
Amphetamine/Methamphetamine, Benzodiazepines, Cocaine, Methadone, Opiates 300, Opiates 2,000, Phencyclidine, and Propoxyphene would be reported as negative.
10/17/01 13:01 SN A7602220SID 007Name John DoePOS 5 ( 2) PIDDate/Time Run 10/17/01 13:01
ERR NAME L/H RESULT ERR NAME L/H RESULTPCP 0.3237 AmpM 0.2776Prpx 0.3870 Coc 0.3212Opi3 0.2341 Benz 0.2702Meth 0.3988 Barb 0.2926
Assay Sample Absorbance
Cutoff Absorbance Result
Amphetamine/Methamphetamine
0.2776 0.2778 Negative
Barbiturates 0.2926 0.2923 Positive
Benzodiazepines 0.2702 0.2705 Negative
Cannabinoids 50 0.3206 0.3206 Positive
Cocaine 0.3212 0.3232 Negative
Methadone 0.3988 0.3989 Negative
Opiates 300 0.2341 0.2378 Negative
Opiates 2,000 0.2781 0.2789 Negative
Phencyclidine 0.3237 0.3286 Negative
Propoxyphene 0.3870 0.3889 Negative
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Assays/Reagents Not for Customer Distribution
32 AEROSET® System Troubleshooting Guide94816-107—November 2004
Summary of Print OptionsThe following table summarizes the three print options for the DOA assays.
NOTE: For troubleshooting purposes, Absorbance mode is recommended.
ICT™ Configuration
I-Index—Calibrator/Control Position 42
I-Index is not currently used, but Calibrator/Control position 42 (I-Index) must have a concentration of zero defined for all ICT assays. If the concentrations are not defined:
• ICT buttons do not display on the SELECT ASSAYS FOR CALIBRATION screen.
• Calibration Summary report does not print the ICT Cal L values.
Print Options Description of Results Outline Page Configuration
Calibration Page Configuration
Factor Mode— Numeric Results
Positive or negative numbers will print; numbers are relative to the cutoff calibrator and do not represent actual concentration.
Select Quantitative Ranges
Calib Mode = FactorFactor = 1,000
Factor Mode—POS/NEG Results
Results will print POS or NEG relative to the cutoff calibrator.
Select Qualitative Ranges
Calib Mode = FactorFactor = 1,000
Absorbance Mode Results will print as absorbance values; results should be interpreted as positive or negative relative to the absorbance of the cutoff calibrator.
Select Quantitative RangesEdit the L-Reference field to 0.0
Calib Mode = Abs
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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AEROSET® System Troubleshooting Guide 3394816-107—November 2004
Biohazardous WasteBoth high and low-concentration waste contain reagent and sample and should be considered biohazardous.
Studies of the combined waste streams have shown the pH typically ranges from 5.5 to 7.
Dispose of waste in accordance with appropriate waste disposal regulations.
For additional environmental, health, and safety information, refer to Section 8, Hazards of the AEROSET System Operations Manual and the product-specific package insert.
Mercury Warning Symbol.
Because mercury is a persistent and toxic pollutant that bioaccumulates in the environment, several states have enacted legislation which impacts the marketing and labeling of products containing mercury or Thimerosal. Therefore, the above symbol was added to the following Abbott Clinical Chemistry products’ labeling due to mercury content.
• Albumin BCG
• Bilirubin Calibrators
• Urine/CSF Protein Calibrators
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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34 AEROSET® System Troubleshooting Guide94816-107—November 2004
Calculated Assay Results
Recalculating Calculated Assay Results
The assays included in a calculated assay must be performed during the same run for the calculation to take place. The result is calculated with the original assay results and does not automatically recalculate with an assay’s rerun data.
If a retest is necessary for one of the assays of a calculated result, retest all the assays included in the calculated result.
Use the following instructions to move an assay’s rerun data to the original data, and to perform recalculation of the ratio.
1. On the DATABASE screen, select the rerun sample (rerun sample has the Processing Code “L”).
2. Select <Result> in the right column of the DATABASE screen. The RESULT screen displays.
3. Display the desired rerun result.
4. Select <Select> in the right column of the RESULT screen.
5. Select <OK> on the Select Result dialog window. An “S” displays to the left of the assay name and the rerun result is copied over the original result for this assay.
6. Select <OK> to exit the RESULT screen.
7. On the DATABASE screen, select the original sample result.
8. Select <ReCalc> in the right column. The Recalc dialog window displays.
9. Select <Select Assay> then select the ratio to be recalculated on the SELECT ASSAYS screen.
10. Select <OK>. The ratio is calculated from the rerun assay data.
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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AEROSET® System Troubleshooting Guide 3594816-107—November 2004
Calibration Information
Drugs of Abuse (DOA) Assays
Ethanol
The Ethanol assay is a quantitative assay and uses the Ethanol 0 and 100 calibrators.
Qualitative Assays
Calibration of the qualitative DOA assays is performed by running the calibrators in duplicate. The Multi DOA Cutoff calibrator is configured as “0” (zero) in the Target Value field of the CALIBRATOR/CONTROL screen for the Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids (THC50), Cocaine, Methadone, Opiates 2,000, Phencyclidine, and Propoxyphene assays. The Opiates 300 calibrator is configured as “0” (zero) for the Opiates 300 assay.
For Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids (THC50), Cocaine, Methadone, Opiates 300, Opiates 2,000, Phencyclidine, and Propoxyphene assays, any result value equal to or greater than the Multi DOA Cutoff calibrator is positive; the specimen contains drug. Any result below the cutoff level for the assay being tested is interpreted as negative; the specimen does not contain drug, or drugs present yield a response less than that of the cutoff calibrator for the assay being tested.
The calibration is verified by running Multi DOA Verifiers I and II (recommended) and controls. Two levels of controls should also be run, with one control level 25% above the cutoff concentration and the other control level 25% below the cutoff concentration. Verifiers I and II and control results should show appropriate responses relative to one another, as shown:
Verifier I < – 25% Control < Cutoff Calibrator < + 25% Control < Verifier II
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36 AEROSET® System Troubleshooting Guide94816-107—November 2004
If any trends or sudden shifts in value of the verifiers occur, check the assay reagent cartridge for onboard dating and reagent expiration date. If necessary, replace the reagent cartridge and repeat calibration.
NOTE: The Opiates 300 calibrator contains methamphetamine. This does not interfere with the Opiates 300 assay.
Refer to the assay-specific package inserts for additional information on calibration, verifiers, and controls.
Assay DrugMulti DOA Verifier Ing/mL
Opiates 300 Calng/mL
Multi DOA Cutoff Cal
ng/mL
Multi DOA Verifier II
ng/mL
Amphetamine/ Methamphetamine
d-Methamphetamine 0 300 1,000 2,000
Barbiturates Secobarbital 0 200 800
Benzodiazepines Lormetazepam 0 200 1,000
Cannabinoids 11-nor-∆9-THC-9-COOH
0 50 200
Cocaine Benzoylecgonine 0 300 1,000
Methadone Methadone 0 300 1,000
Opiates Morphine 0 300 2,000 4,000
Phencyclidine Phencyclidine 0 25 100
Propoxyphene Propoxyphene 0 300 1,000
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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AEROSET® System Troubleshooting Guide 3794816-107—November 2004
Factor
The Factor option only displays if Factor is selected as the calibration mode. This method allows the operator to enter the factor used to calculate the result as a concentration.
The Factor math model can be used for any reaction that is linear and stable across all reagent lots. The calibration factor is defined at a fixed value and only the reagent blank is performed for calibration. No calibrators are required. It is ideal for use in measuring enzyme activity in a sample, because the enzyme reaction occurs at a predictable and steady rate that can be determined for the chromophore, wavelengths, and volume parameters used.
Enzyme Factor Calculation
The following formula is used to calculate enzyme factors.
Where:
Total Volume
Reagent 1 volume + Reagent 1 water volume + Reagent 2 volume + Reagent 2 water volume + Sample volume
(Extinction factor) established by measuring varying concentrations of the chromophore (NADH, PNP, etc.) on the system. The slope of the linear regression of the measured absorbance versus the concentration equals the extinction factor. The factor is specific for the AEROSET and c 8000® Systems, and optical characteristics of these systems.
Enzyme Factor
Entered in the Factor field on the Calibration page of the Assay Configuration screen.
TotalaVolumeaxa1000SampleaVolume
a1aε
a EnzymeaFactor=
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38 AEROSET® System Troubleshooting Guide94816-107—November 2004
*3-carboxy-4-nitroaniline
Use Cal Factor From
Use Cal Factor From option only displays if Use Factor/Blank is selected as the calibration mode. This method allows the operator to enter the name of the assay from which the calibration data are used.
This list includes all the assays configured on the system.
This method may be used when two assays use the same reagent and have the same sample-to-reagent volume ratios. Rather than calibrating both assays, only one of the assays is calibrated and the other assay is configured to refer to this calibration data for result calculation. For example, a urine application of an assay may use the calibration data generated for the serum application for the same assay, e.g., urine Amylase.
The assay selected as the reference assay must generate its own curve and cannot also be defined with the Use Factor/Blank calibration mode.
Assay Chromophore WavelengthTotal
Volume µL
Sample Volume
µL
Extinction Factor
Enzyme Factor
Acid Phosphatase
Alpha-naphthol-Fast
Red TR complex
412/660 162.0 12.0 12.9 1046.5
Alkaline Phosphatase
PNP 404/476 257.0 7.0 17.08 2150
Amylase CNP 404/476 204.8 4.8 12.44 3431
ALT NADH 340/380 205.3 5.3 4.76 8141
ALT Activated NADH 340/380 178.7 3.7 4.76 10151
AST NADH 340/380 205.3 5.3 4.76 8141
AST Activated NADH 340/380 182.4 7.4 4.76 5180
CK NADH 340/412 204.0 4.0 5.68 8974
GGT A PNA* 412/660 204.0 4.0 6.31 8077
LD NADH 340/380 203.2 3.2 4.76 13341
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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AEROSET® System Troubleshooting Guide 3994816-107—November 2004
Calibrators
Multiconstituent Calibrator (MCC), LN 1E65
Customers may observe differences among MCC calibrator lot numbers, within these specifications:
• Color—colorless to yellow
• Clarity—clear to opaque
Product Information
Calibrator Product Name List Number Configuration Assays
Multiconstituent 1E65-02 CAL 1: 3 x 5 mLCAL 2: 3 x 5 mL
AlbCaCholCreaCrea-UGluGlu-UPhos
Phos-UTPTrigUProUreaUrea-UUric
MCC DOA Cutoff 2G90-02 1 x 14 mL AmpMBarbBenzCocMeth
Opi2PCPPrpxTHC50
Apo Al/Apo B 6E54-02 1 x 1 mL ApoA ApoB
Bilirubin 1E66-03 CAL 1: 3 x 5 mLCAL 2: 3 x 5 mL
BilDBilN
BilT
C-Reactive Protein 8G68-02 CAL 1: 1 x 2 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL
CRP
Carbamazepine 6E90-02 CAL 1: 1 x 5 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL
Carb
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40 AEROSET® System Troubleshooting Guide94816-107—November 2004
Carbon Dioxide 1E64-02 CAL 1: 3 x 5 mLCAL 2: 3 x 5 mL
CO2
Digoxin 1E06-02 CAL 1: 1 x 4.8 mLCAL 2: 1 x 1.8 mLCAL 3: 1 x 1.8 mLCAL 4: 1 x 1.8 mLCAL 5: 1 x 1.8 mLCAL 6: 1 x 1.8 mL
Dig
Ethanol 9F59-02 (0 mg/dL)1G82-02 (100 mg/dL)
CAL 1: 1 x 3 mLCAL 2: 1 x 3 mL
ETOH
HDL 1E68-02 6 x 1 mL HDL
Hemoglobin A1c 2K96-02 CAL 1: 1 x 8 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL
HbA1c
ICT™ (Serum) 1E46-02 CAL 1: 5 x 10 mLCAL 2: 5 x 10 mL
NaK
Cl
ICT Urine 1E47-02 URINE CAL L:5 x 10 mLURINE CAL H:5 x 10 mL
Na-UK-U
Cl-U
Iron/Magnesium 1E69-02 CAL 1: 3 x 5 mLCAL 2: 3 x 5 mL
IronMg
TIBC
Lactic Acid 1E75-02 1 x 10 mL Lact
Lipase 3E16-02 2 x 3 mL Lip
Microalbumin 2K98-02 CAL 1: 1 x 2 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mL
uAlb
Opiates 300 2G92-02 1 x 14 mL Opi3
Calibrator Product Name List Number Configuration Assays
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AEROSET® System Troubleshooting Guide 4194816-107—November 2004
Phenobarbital 5F54-02 CAL 1: 1 x 5 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL
Pheno
Prealbumin 6E57-02 CAL 1: 1 x 1 mLCAL 2: 1 x 1 mLCAL 3: 1 x 1 mLCAL 4: 1 x 1 mLCAL 5: 1 x 1 mL
PAlb
Rheumatoid Factor 8G67-02 CAL 1: 1 x 1 mLCAL 2: 1 x 1 mLCAL 3: 1 x 1 mLCAL 4: 1 x 1 mLCAL 5: 1 x 1 mL
RF
Specific Proteins Multiconstituent
1E78-02 CAL 1: 1 x 1 mLCAL 2: 1 x 1 mLCAL 3: 1 x 1 mLCAL 4: 1 x 1 mLCAL 5: 1 x 1 mL
C3C4HaptIgA
IgGIgMTRF
Theophylline 6E89-02 CAL 1: 1 x 5 mLCAL 2: 1 x 2 mLCAL 3: 1 x 2 mLCAL 4: 1 x 2 mLCAL 5: 1 x 2 mLCAL 6: 1 x 2 mL
Theo
Urine/CSF Protein 1E71-02 CAL 1: 1 x 5 mLCAL 2: 1 x 5 mLCAL 3: 1 x 5 mLCAL 4: 1 x 5 mLCAL 5: 1 x 5 mL
UPro
Valproic Acid 1E13-02 CAL 1: 1 x 1 mLCAL 2: 1 x 1 mLCAL 3: 1 x 1 mLCAL 4: 1 x 1 mLCAL 5: 1 x 1 mLCAL 6: 1 x 1 mL
VPA
Calibrator Product Name List Number Configuration Assays
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42 AEROSET® System Troubleshooting Guide94816-107—November 2004
Chemical Reactions for Clinical Chemistry Assays
Assay Name
Reaction Tips
ACP
α-Naphthylphosphate α-Napthol + PO4-3
α-Napthol + Diazotized 2-amino-5-chlorotoluene Dye complex
Use fresh, nonhemolyzed, nonicteric, and nonlipemic serum samples. All specimens need to be stabilized with 50 µL Liquid Stabilizer for every 1 mL of serum. The acidified serum should be analyzed immediately, or stored at 2 to 8°C, or frozen. Calibration is stable for approximately five days and performed using a water blank. Sample Interference Indices may assist with determination of sample integrity.
AlbG (BCG)
Albumin + BCG Colored complex
BCG = Bromcresol green
Results are running high, due to non-specific protein binding. Recommend AlbP if more specificity needed.
AlbP (BCP)
Human Albumin + BCP Colored complex
BCP = Bromcresol purple
Human albumin specific.
AlkP p-Nitrophenylphosphate + H2O p-Nitrophenol + phosphate AlkP reagent contains AMP buffer.
ALT
L-Alanine + α-Ketoglutarate Pyruvate + L-glutamate
Pyruvate + NADH L-lactate + NAD+
LD = Lactate dehydrogenaseNADH = Nicotinamide adenine dinucleotide
Do not use plasma samples collected using ammonium heparin.
* MULTIGENT® assay
ACP
AlkP
Mg+2, Zn+2
ALT
LD
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AEROSET® System Troubleshooting Guide 4394816-107—November 2004
ALT-A
L-Alanine + α-Ketoglutarate Pyruvate + L-glutamate
Pyruvate + NADH L-lactate + NAD+
LD = Lactate dehydrogenaseNADH = Nicotinamide adenine dinucleotide
Activated reagent contains pyridoxal-5-phosphate (P-5-P).
Do not use plasma samples collected using ammonium heparin.
AmpM
Antibody to AmpM (R1) + G-6-PD-AmpM (R2) (Active)
G-6-PD-AmpM:Antibody complex (Inactive)
G-6-PD-AmpM:Antibody complex (Inactive) + AmpM G-6-PD-AmpM (Active) + AmpM:Antibody complex
G-6-PD-AmpM (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/CONTROL screen.
Amy10 CNPG3 9 CNP + 1 CNPG2
CNPG3 = 2-chloro-4 nitrophenyl-α D-maltotrioside
Chromophore is 2-chloro-4-nitrophenol (CNP), read at 404 nm.
ApoA
Apo-A1 + PEG/buffer (R1) + Antibody to Apo-A1 (R2) Turbidity due to Apo-A1:Antibody complex
PEG = Polyethylene glycol
ApoB
Apo-B + PEG/buffer (R1) + Antibody to Apo-B (R2) Turbidity due to Apo-B:Antibody complex
PEG = Polyethylene glycol
AST
L-Aspartate + α-Ketoglutarate Oxaloacetate + L-glutamate
Oxaloacetate + NADH L-Malate + NAD+
MD = Malate dehydrogenaseNADH = Nicotinamide adenine dinucleotide
Do not use plasma samples collected using ammonium heparin.
Assay Name
Reaction Tips
* MULTIGENT® assay
ALT, P-5-P
LD
α-amylase
AST
MD
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44 AEROSET® System Troubleshooting Guide94816-107—November 2004
AST-A
L-Aspartate + α-Ketoglutarate Oxaloacetate + L-glutamate
Oxaloacetate + NADH L-Malate + NAD+
NADH = Nicotinamide adenine dinucleotideMD = Malate dehydrogenase
Activated reagent contains pyridoxal-5-phosphate (P-5-P).
Do not use plasma samples collected using ammonium heparin.
Barb
Antibody to Barbiturates (R1) + G-6-PD-Barbiturates (R2) (Active) G-6-PD-Barbiturates:Antibody complex (Inactive)
G-6-PD-Barbiturates:Antibody complex (Inactive) + Barbiturates G-6-PD-Barbiturates (Active) + Barbiturates:Antibody complex
G-6-PD-Barbiturates (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/CONTROL screen.
Benz
Antibody to Benzodiazepines (R1) + G-6-PD-Benzodiazepines (R2) (Active) G-6-PD-Benzodiazepines:Antibody complex (Inactive)
G-6-PD-Benzodiazepines:Antibody complex (Inactive) + Benzodiazepines G-6-PD-Benzodiazepines (Active) + Benzodiazepines:Antibody complex
G-6-PD-Benzodiazepines (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/CONTROL screen.
Does not correlate well with AxSYM® Benzodiazepines assay.
Assay Name
Reaction Tips
* MULTIGENT® assay
AST, P-5-P
MD
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AEROSET® System Troubleshooting Guide 4594816-107—November 2004
BilD(LN 8G63-20)
Direct (Conjugated) Bilirubin + 2,4-Dichlorophenyl diazonium salt
Azobilirubin
The formation of azobilirubin is measured spectrophoto-metrically and is directly proportional to the concentration of bilirubin.
Avoid hemolysis during sample collection. Protect samples from light.
Same formulation as LN 2K59-20.
BilT(LN 8G62-20)
Total (Conjugated & Unconjugated) Bilirubin + 2,4-Dichlorophenyl
diazonium salt Azobilirubin
The formation of azobilirubin is measured spectrophoto-metrically and is directly proportional to the concentration of bilirubin.
Avoid hemolysis during sample collection. Protect samples from light.
Same formulation as LN 2K58-20.
C3
Complement C3 + PEG/buffer (R1) + Antibody to C3 (R2) Turbidity due to C3:Antibody complex
PEG = Polyethylene glycol
C4
Complement C4 + PEG/buffer (R1) + Antibody to C4 (R2) Turbidity due to C4:Antibody complex
PEG = Polyethylene glycol
Analyze fresh or refrigerate at 2 to 8°C no more than two days.
Ca 2 Arsenazo III + Ca+2 Ca-Arsenazo complex+2 (blue-purple)
Must not be on the same line as the Lipase assay.New reference range: 9.0 to 10.4 mg/dL.
Assay Name
Reaction Tips
* MULTIGENT® assay
Acid
Surfactant
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46 AEROSET® System Troubleshooting Guide94816-107—November 2004
Carb
Antibody to Carbamazepine (R1) + G-6-PD-Carbamazepine (R2) (Active) G-6-PD-Carbamazepine:Antibody complex (Inactive)
G-6-PD-Carbamazepine:Antibody complex (Inactive) + Carbamazepine G-6-PD-Carbamazepine (Active) + Carbamazepine:Antibody complex
G-6-PD-Carbamazepine (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Blank this assay with Carb CAL 1.
When either the R1 or R2 reagent cartridge is empty, replace both cartridges and validate the system by analyzing controls.
Chol
Cholesterol esters + H2O Cholesterol + fatty acids
Cholesterol + O2 Cholest-4-ene-3-one + H2O2
2H2O2 + HBA + 4-AAP Quinoneimine dye + 4H2O
CE = Cholesterol esteraseCO = Cholesterol oxidase4-AAP = 4-AminoantipyrineHBA = Hydroxybenzoic acidPOD = Peroxidase
According to the National Cholesterol Education Program (NCEP), patients need not be fasting.Assay certified against Cholesterol Reference Method Laboratory Network (CRMLN) reference method.Must not be on the same line as the Lipase assay.
CK
ADP + Creatine phosphate ATP + Creatine
ATP + Glucose ADP + Glucose-6-phosphate
G-6-P + NADP+ 6-phosphogluconate + NADPH
HK = HexokinaseG-6-PD = Glucose-6-phosphate dehydrogenase
R1 contains N-acetylcysteine; therefore, this is a “NAC” CK method.
Assay Name
Reaction Tips
* MULTIGENT® assay
CE
CO
POD
CK
HK
G-6-PD
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AEROSET® System Troubleshooting Guide 4794816-107—November 2004
CO2
Phospho(enol)pyruvate + HCO3- Oxaloacetate + H2PO4
-
Oxaloacetate + NADH + H+ Malate + NAD+
PEPC = Phospho(enol)pyruvate carboxylaseNADH = Nicotinamide adenine dinucleotideMD = Malate dehydrogenase
Must not be on the same line as the Lipase assay.
Perform a calibration with each CO2 reagent cartridge used and with each new reagent lot.
Run a minimum of two levels of control with each new CO2 reagent cartridge and at a minimum of eight hour intervals between calibrations.
Discard the CO2 reagent cartridge with 50 tests remaining.
Coc
Antibody to Cocaine (R1) + G-6-PD-Cocaine (R2) (Active) G-6-PD-Cocaine:Antibody complex (Inactive)
G-6-PD-Cocaine:Antibody complex (Inactive) + Cocaine G-6-PD-Cocaine (Active) + Cocaine:Antibody complex
G-6-PD-Cocaine (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/CONTROL screen.
Crea Creatinine + Picrate Creatinine-picrate complex
24 hour calibration requirement due to onboard refrigerated storage.
Based on traditional Jaffe reaction.
CRPCRP (Sample) + Buffer (R1) + Antibody to CRP adsorbed to latex particles (R2)
Turbidity due to agglutination of CRP:Antibody:Particle complex
This method is not suitable for high-sensitivity (HS) measurements.
Assay Name
Reaction Tips
* MULTIGENT® assay
Mg+2PEPC
MD
Alkaline pH
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48 AEROSET® System Troubleshooting Guide94816-107—November 2004
DBil(LN 7D59)
Bilirubin Biliverdin
CAP survey results show a 38.2% CV for 16 different chemistry methodologies. The AEROSET System produces higher biliverdin values than most other analyzers. A factor may be entered to adjust. Not intended for use with neonatal specimens.
Abbott reagent LN 8G63-20 is the same reagent formulation as DCL labeled product LN 2K59-20.
DIBIL(LN 2K59-20,DCL Label)
Direct Bilirubin + 2,4-Dichlorophenyl diazonium salt Azobilirubin
The formation of azobilirubin is measured spectrophoto-metrically and is directly proportional to the concentration of bilirubin.
Avoid hemolysis during sample collection. Protect samples from light.
Same formulation as LN 8G63-20.
Dig*
Digoxin + Antibody to Digoxin/BIS-TRIS buffer (R1) + Digoxin-coated
Microparticles (R2)
Digoxin:Antibody complex + Digoxin-coated Microparticle:Antibody complex
Digoxin concentration is inversely proportional to absorbance change. (High absorbance change = low digoxin concentration; low absorbance change = high digoxin concentration.)
Assay Name
Reaction Tips
* MULTIGENT® assay
Oxidation
Sodium Nitrite
Acid
Competition
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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AEROSET® System Troubleshooting Guide 4994816-107—November 2004
ETOH
ADHEthyl Alcohol + NAD NADH + acetaldehyde
ADH = Alcohol dehydrogenaseNADH = Nicotinamide adenine dinucleotide
Uses Ethanol 0 and 100 mg/dL calibrators for calibration.
Sample handling: ethanol is a volatile analyte. To prevent evaporation, ethanol sample containers must be kept tightly capped.
GGT
L-γ-glutamyl-3-carboxy-4-nitroanilide + glycylglycine
L-γ-glutamyl-glycylglycine + 3-carboxy-4-nitroaniline
The Roche GGT assay on the Roche/Hitachi 717 has approximately a 30% low bias compared to the AEROSET System. Abbott has documentation to support this bias and the accuracy of the AEROSET values. The AEROSET methodology utilizes the IFCC method.
Glu
Glucose + ATP Glucose-6-Phosphate + ADP
Glucose-6-phosphate + NADP+ 6-Phosphogluconate + NADPH
HK = HexokinaseG-6-PD = Glucose-6-phosphate dehydrogenase
Hapt
Haptoglobin + PEG/buffer (R1) + Antibody to haptoglobin (R2) Turbidity due to Haptoglobin:Antibody complex
PEG = Polyethylene glycol
Assay Name
Reaction Tips
* MULTIGENT® assay
GGT
HK
G-6-PD
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50 AEROSET® System Troubleshooting Guide94816-107—November 2004
HbA1c*
Total Hemoglobin:
Hemoglobin + Alkaline Non-ionic surfactant
Hematin (green solution)
Hemoglobin A1c:
HbA1c + Anti-HbA1c Antibody:Microparticle complex
HbA1c:Antibody:Microparticle complex
Remaining unbound Anti-HbA1c:Antibody:Microparticle complex +
HbA1c Hapten HbA1c Hapten:Antibody:Microparticle complex
HbA1c concentration is inversely proportional to absorbance change. (High absorbance change = low HbA1c concentration; low absorbance change = high HbA1c concentration.)
HDL
HDL, LDL, VLDL, Chylomicrons Stable complexes
HDL HDL Disrupted
HDL Cholesterol ∆4 Cholestenone + H2O2
H2O2 + DSBmT + 4-AAP Quinoneimine Dye + H2O
DSBmT = N,N-bis(4-sulphobutyl)-m-toluidine-disodium4-AAP = 4-Aminoantipyrine
Linearity and control material must be human-based material.
IgA
IgA + PEG/buffer (R1) + Antibody to IgA (R2) Turbidity due toIgA:Antibody complex
PEG = Polyethylene glycol
IgG
IgG + PEG/buffer (R1) + Antibody to IgG (R2) Turbidity due toIgG:Antibody complex
PEG = Polyethylene glycol
IgG may be very elevated due to an IgG monoclonal paraprotein.
IgM
IgM + PEG/buffer (R1) + Antibody to IgM (R2) Turbidity due toIgM:Antibody complex
PEG = Polyethylene glycol
Samples containing high IgM can have increased viscosity.
Assay Name
Reaction Tips
* MULTIGENT® assay
Detergent
Polyanion
Detergent
Cholesterol Esterase
Cholesterol Oxidase
Peroxidase
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET® System Troubleshooting Guide 5194816-107—November 2004
Iron
Fe-transferrin Fe+3 + transferrin
Fe+3 Fe+2
Fe+2 + FERENE Fe-FERENE complex
Serum only. Separate from red blood cells as soon after collection as possible.
Deferoxamine mesylate interferes with this assay.
Lact
Lactic Acid Pyruvate + H2O2
H2O2 + Chromogen Dye complex
LO = Lactate oxidase
Venous specimens should be obtained without the use of a tourniquet or immediately after the tourniquet is applied.
Specimen must be collected using a fluoride-oxalate tube, centrifuged as soon after collection as possible and immediately remove the plasma from the red blood cells.
Calibration is required each time a new reagent is reconstituted.
LD
L-lactate + NAD+ Pyruvate + NADH + H+
NADH = Nicotinamide adenine dinucleotide
When correlating, verify whether the comparison method is L � P or P � L, since AEROSET LD utilizes the forward reaction (L � P) which gives lower results (U/L).
Assay Name
Reaction Tips
* MULTIGENT® assay
pH 4.5
Hydroxylamine Hydrochlorided hl d
LO
Peroxidase
LD
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Assays/Reagents Not for Customer Distribution
52 AEROSET® System Troubleshooting Guide94816-107—November 2004
LDL*
HDL, LDL, VLDL, Chylomicrons LDL (non-LDL particlesconsumed in a non-color forming reaction)
LDL Cholesterol Cholesterone + H2O2
H2O2 + DSBmT + 4-AAP Quinoneimine dye + H2O
DSBmT = N,N-bis(4-sulphobutyl)-m-toluidine-disodium4-AAP = 4-Aminoantipyrine
MULTIGENT Direct LDL must not be on the same line as the Lipase assay.
Samples may be frozen one time at -80°C.
Lip
1,2 Diglyceride + H2O 2-Monoglyceride + fatty acid
2-Monoglyceride + H2O Glycerol + fatty acid
Glycerol + ATP Glycerol-3-phosphate + ADP
Glycerol-3-phosphate + O2 Dihydroxyacetone phosphate + H2O2
2H2O2 + 4-AAP + TOOS Quinoneimine dye + 4H2O
4-AAP = 4-Aminoantipyrine
TOOS = N-ethyl-N-(2-hydroxy)-3-sulfopropyl-m-toluidine
There are reports of interference by non-Abbott HDL methods. Correct SmartWash™ configuration is critical for some assays.
Serum only.
Must not be on the same line as Triglyceride, Calcium, Urine Calcium, Cholesterol, CO2, MULTIGENT LDL, and Uric Acid.
Meth
Antibody to Methadone (R1) + G-6-PD-Methadone (R2) (Active) G-6-PD-Methadone:Antibody complex (Inactive)
G-6-PD-Methadone:Antibody complex (Inactive) + Methadone G-6-PD-Methadone (Active) + Methadone:Antibody complex
G-6-PD-Methadone (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/CONTROL screen.
Assay Name
Reaction Tips
* MULTIGENT® assay
Detergent 1
COCE
POD
Detergent 2
Peroxidase
Lipase
MGLP
GK
GPO
POD
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET® System Troubleshooting Guide 5394816-107—November 2004
Mg Arsenazo III + Mg+2 Mg-Arsenazo III complex
Perform calibration with each reagent cartridge used.
24 hour calibration requirement due to onboard refrigerated storage.
Reagent contains chelating agents to prevent calcium interference.
NBil Bichromatic spectrophotometric absorbance only; no chemical reaction
Valid only in neonates, due to low concentration of carotenes in serum.
Opi
Antibody to Opiates (R1) + G-6-PD-Opiates (R2) (Active) G-6-PD-Opiates:Antibody complex (Inactive)
G-6-PD-Opiates:Antibody complex (Inactive) + Opiates G-6-PD-Opiates (Active) + Opiates:Antibody complex
G-6-PD-Opiates (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Opiates 300: Use Opiates 300 calibrator in duplicate for calibration.
Calibrator value is zero on CALIBRATOR/CONTROL screen for both Opiates 300 and Opiates 2,000 assays.
Opiates 2,000: Use Multi DOA Cutoff calibrator in duplicate for calibration.
PAlb
Prealbumin + PEG/buffer (R1) + Antibody to prealbumin (R2) Turbidity due to prealbumin:Antibody complex
PEG = Polyethylene glycol
Serum samples only. Alternate test method: nephelometry.
Assay Name
Reaction Tips
* MULTIGENT® assay
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Assays/Reagents Not for Customer Distribution
54 AEROSET® System Troubleshooting Guide94816-107—November 2004
PCP
Antibody to Phencyclidine (R1) + G-6-PD-Phencyclidine (R2) (Active) G-6-PD-Phencyclidine:Antibody complex (Inactive)
G-6-PD-Phencyclidine:Antibody complex (Inactive) + Phencyclidine G-6-PD-Phencyclidine (Active) + Phencyclidine:Antibody complex
G-6-PD-Phencyclidine (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/ CONTROL screen.
Pheno
Antibody to Phenobarbital (R1) + G-6-PD-Phenobarbital (R2) (Active) G-6-PD-Phenobarbital:Antibody complex (Inactive)
G-6-PD-Phenobarbital:Antibody complex (Inactive) + Phenobarbital G-6-PD-Phenobarbital (Active) + Phenobarbital:Antibody complex
G-6-PD-Phenobarbital (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Blank this assay with Pheno CAL 1.
When either the R1 or R2 reagent cartridge is empty, replace both cartridges and validate the system by analyzing controls.
Pheny
Antibody to Phenytoin (R1) + G-6-PD-Phenytoin (R2) (Active) G-6-PD-Phenytoin:Antibody complex (Inactive)
G-6-PD-Phenytoin:Antibody complex (Inactive) + Phenytoin G-6-PD-Phenytoin (Active) + Phenytoin:Antibody complex
G-6-PD-Phenytoin (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Blank this assay with Pheny CAL 1.
When either the R1 or R2 reagent cartridge is empty, replace both cartridges and validate the system by analyzing controls.
Phos Phosphate + molybdate Heteropolyacid complex
Assay Name
Reaction Tips
* MULTIGENT® assay
H+
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET® System Troubleshooting Guide 5594816-107—November 2004
Prpx
Antibody to Propoxyphene (R1) + G-6-PD-Propoxyphene (R2) (Active) G-6-PD-Propoxyphene:Antibody complex (Inactive)
G-6-PD-Propoxyphene:Antibody complex (Inactive) + Propoxyphene G-6-PD-Propoxyphene (Active) + Propoxyphene:Antibody complex
G-6-PD-Propoxyphene (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/ CONTROL screen.
RFRF (Sample) + Buffer (R1) + Antibody to RF adsorbed to latex particles (R2)
Turbidity due to agglutination of RF:Antibody:Particle complex
TBil(LN 7D60)
Conjugated & Unconjugated Bilirubin Biliverdin
Abbott reagent LN 8G62-20 is the same reagent formulation as DCL labeled product LN 2K58-20.
Assay Name
Reaction Tips
* MULTIGENT® assay
Detergent
Solubilizer
Sodium Nitrite
Oxidation
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Assays/Reagents Not for Customer Distribution
56 AEROSET® System Troubleshooting Guide94816-107—November 2004
THC50
Antibody to THC (R1) + G-6-PD-THC (R2) (Active) G-6-PD-THC:Antibody complex (Inactive)
G-6-PD-THC:Antibody complex (Inactive) + UC G-6-PD-THC (Active) + UC:Antibody complex
G-6-PD-THC (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
THC = ∆9-TetrahydrocannabinolG-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceUC = Urine cannabinoidsNADH = Nicotinamide adenine dinucleotide
Use Multi DOA Cutoff calibrator in duplicate for calibration. Cutoff calibrator value is zero on CALIBRATOR/CONTROL screen.
Certain types of plastics adsorb cannabinoids (THC) from solutions, decreasing the concentration. To prevent adsorbtion:
• Fill AEROSET sample cups with 600 µL to minimize surface-to-volume ratio.
• Do not use disposable polyethylene transfer pipettes to dispense urine specimens, calibrator, or controls.
• Do not redispense solutions from a pipette into a calibrator, controls, or specimen container (includes redispensing after wetting pipette tip).
• Immerse pipette tip below surface of the liquid only far enough to aspirate the needed volume.
Assay Name
Reaction Tips
* MULTIGENT® assay
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET® System Troubleshooting Guide 5794816-107—November 2004
Theo
Antibody to Theophylline (R1) + G-6-PD-Theophylline (R2) (Active) G-6-PD-Theophylline:Antibody complex (Inactive)
G-6-PD-Theophylline:Antibody complex (Inactive) + Theophylline G-6-PD-Theophylline (Active) + Theophylline:Antibody complex
G-6-PD-Theophylline (Active) + NAD + Glucose-6-phosphate NADH + 6-phosphogluconate
G-6-PD = Glucose-6-phosphate dehydrogenase from bacterial sourceNADH = Nicotinamide adenine dinucleotide
Blank this assay with Theo CAL 1.
When either the R1 or R2 reagent cartridge is empty, replace both cartridges and validate the system by analyzing controls.
TIBC
Apotransferrin + excess Fe+3 Fe-transferrin + Fe+3
Fe+3 + Fe-transferrin + alumina Eluent of Fe-transferrin;analyzed using Iron Reagent (LN 7D68)
Serum only.
TOBIL (LN 2K58-20,DCL Label)
Total (Conjugated & Unconjugated) Bilirubin + 2,4-Dichlorophenyl
diazonium salt Azobilirubin
The formation of azobilirubin is measured spectrophoto-metrically and is directly proportional to the concentration of bilirubin.
Avoid hemolysis during sample collection. Protect samples from light.
Same formulation as LN 8G62-20.
TPCu+2 Cu+2-Protein Nitrogen complex
(Biuret reaction)
Dextran interferes with the Total Protein assay, a biuret method. Plasma values are generally 0.3 to 0.5 g/dL higher than serum values, due to the presence of fibrinogen.
Assay Name
Reaction Tips
* MULTIGENT® assay
Saturating Solution
AdsorbentColumns
Surfactant
OH-
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Assays/Reagents Not for Customer Distribution
58 AEROSET® System Troubleshooting Guide94816-107—November 2004
TRF
Transferrin + PEG/buffer (R1) + Antibody to transferrin (R2) Turbidity due to transferrin:Antibody complex
PEG = Polyethylene glycol
Trig
Triglyceride + 3H2O Glycerol + 3 Fatty Acids
Glycerol + ATP Glycerol-3-phosphate + ADP
Glycerol-3-phosphate + O2 DAP + H2O2
H2O2 + 4-AAP + 4-CP Quinoneimine dye + 2H2O
ATP = Adenosine triphosphateGK = Glycerol kinaseGPO = Glycerol phosphate oxidaseDAP = Dihydroxyacetone phosphate4-AAP = 4-Aminoantipyrine4-CP = Chlorophenol
The expected range for Triglyceride stated in the package insert is < 200 mg/dL. The low reference value configured on the Assay Configuration screen is defined as 1 because the software does not allow for a “<” sign reference value. Must not be on the same line as the Lipase assay.
Hyperlipemic samples require a dilution to be performed to ensure accurate results.
uAlb*Microalbumin + Good’s buffer (R1) + TRIS buffer (R2) + Anti-human albumin
(goat) antibody (R2) Turbidity due to Microalbumin:Anti-human albumin (goat) antibody complex (Insoluble)
The degree of turbidity is proportional to albumin concentration in the specimen.
UProNative Protein + Benzethonium Chloride Denatured protein precipitate
(detected turbidimetrically)
This is a non-specific method that does not detect many proteins in urine and CSF.
Urea
Urea + H2O 2NH3 + CO2
NH3 + α-Ketoglutarate + NADH Glutamate + NAD+ + H2O
NADH = Nicotinamide adenine dinucleotideGLD = Glutamate dehydrogenase
Assay Name
Reaction Tips
* MULTIGENT® assay
Lipase
GK
GPO
Peroxidase
Urease
GLD
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET® System Troubleshooting Guide 5994816-107—November 2004
Uric
Uric Acid + O2 + H2O Allantoin + CO2 + H2O2
2H2O2 + 4-AAP + TBHB Quinoneimine + H2O
TBHB = 2,4,6 Tribromo-3-hydroxy benzoic acid4-AAP = 4-Aminoantipyrine
Calibrate each reagent cartridge. Run a minimum of two levels of control with each new reagent cartridge.
Ascorbate interferes with this method.
Currently, Sigma linearity standards recover at approximately 50% for the highest level on the AEROSET System. The same is seen with Roche assays run on the Roche/Hitachi. Verichem linearity was able to recover at 100%.
VPA*
Valproic Acid + Antibody to Valproic Acid/BIS-TRIS buffer (R1) +
Valproic Acid-coated Microparticles (R2)
Valproic Acid:Antibody complex + Valproic Acid-coated Microparticle:Antibody complex
Valproic acid concentration is inversely proportional to absorbance change. (High absorbance change = low valproic acid concentration; low absorbance change = high valproic acid concentration.)
Assay Name
Reaction Tips
* MULTIGENT® assay
Uricase
Peroxidase
Competition
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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60 AEROSET® System Troubleshooting Guide94816-107—November 2004
Drugs of Abuse (DOA) AssaysAssay Details
Trade/Alternate Name Street Name Physical
Description
Major Compounds/Metabolites
Amphetamine/Methamphet-amine
Dexedrine, Ritalin, Adderall,N-Methylamphetamine
Bennies, Dexies, Uppers, Meth, Doe, Crystal, Ice
Capsules, tablets, liquid
Amphetamine, Methamphet-amine, and hydroxy metabolites
Barbiturates Amytal (amobarbital sodium), Nembutal® (pentobarbital sodium), Seconal (secobarbital sodium), Fiorinal (butalbital), Butisol
Blues, Blue Dolls, Rainbows, Yellows, Yellow Jackets, Nebbies, Reds, Red Devils, M&M’s, Barbs, Downers
Capsules, tablets
Parent compounds of each with hydroxy metabolite
Benzodiazepines Valium (diazepam), Tranxene (clorazepate), Librium(chlordiazepoxide), Serax (oxazepam), Dalmane (flurazepam), Ativan (lorazepam) Xanax (alprazolam), Versed, Halcion,Restoril
Benzos, mellow, “Mickey Finn” (when used with alcohol)
Powder, capsules, tablets
Oxazepam (for diazepam and chlordiazepoxide)
Cannabinoids Marinol (dronabinol) THC, Mary Jane, Weed, Grass, Pot, Hash, Reefer, Ganja, Dope
Capsules; plant material—flowering tops, leaves and seeds, small stems coated with resinous oil
11-nor-∆9-THC-9-carboxylic acid and other marijuana metabolites
Cocaine Cocaine hydrochloride Coke, Rock, Snow, Flake, Blow, Crack
• Free base form—rocks (“dime rocks”)
• White powder
Benzoylecgonine, 3-Methyl-ecgononine, Ecgonine
Ethanol Ethanol, beer, wine, liquor, Everclear
Booze, Hooch, Sauce Liquid, flavorings added for taste
Acetaldehyde, acetic acid
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AEROSET® System Troubleshooting Guide 6194816-107—November 2004
Methadone Dolophine, Amidone Methadose Tablets Methadone (EDDP) and metabolites
Opiates Heroin: DiacetylmorphineMorphine: Duramorph, Oramorph, MSContinOther: Meperidine (Demerol, Mepergan), Hydromorphone (Dilaudid), Oxycodone (OxyContin, Percodan, Percocet), Codeine
• Heroin: Smack, Horse, White Lady, Skag, “H”
• Morphine: Junk, White Stuff, Morpho, “M”
• Other: analgesics, anti-tussives
• Heroin: brown to white powder
• Morphine: small white tablets or powder, injectable form
• Other: tablets, liquid, powder, and injectable forms
• Heroin: Morphine
• Morphine: Morphine
• Other: Codeine to morphine parent compound
Phencyclidine None Angel Dust, Hog, Killer Weed (when used on marijuana)
Fine white powder
PCP and metabolites
Propoxyphene Darvon, Darvocet-N Yellow Footballs Capsules, tablets
Propoxyphene and norpropoxyphene
Assay Details (Continued)
Trade/Alternate Name Street Name Physical
Description
Major Compounds/Metabolites
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62 AEROSET® System Troubleshooting Guide94816-107—November 2004
Assay Details (Continued)
UseNormal
Detection Time in Urine
Symptoms of Abuse Possible Dangers
Amphetamine/Methamphetamine
Taken orally, injected, inhaled
Dependent on urine pH: 3 to 5 days
Insomnia, psychosis, anorexia, euphoria, tachycardia
High blood pressure, loss of appetite and weight
Barbiturates Taken orally • Phenobarbital: up to 30 days
• Amobarbital, pentobarbital, butabarbital, secobarbital: 4 to 6 days
Drowsiness, slurred speech, irritability
• Acute: respiratory collapse, loss of consciousness
• Chronic: addiction• Abstinence:
seizures, death• Deadly when
combined with alcohol
Benzodiazepines Taken orally • Flurazepam: 1 to 2 days
• Oxazepam, etc.: 2 to 7 days
“Laid back,” mellow personality, mental confusion
• Acute: intoxication, loss of inhibitions
• Chronic: addiction, involuntary muscle movements of the face, limbs, and trunk (tardive dyskinesia)
Cannabinoids • Smoked as cigarette or in a pipe
• Eaten as part of other food (brownie, salad)
• Occasional user: 3 to 5 days
• Chronic user: up to 14 days
• Large person, chronic user: up to 30 days (based on 25 ng/mL detection limit)
Indifference (lethargy), confusion, lazy (amotivational syndrome), slow mental activity
• Acute: intoxication similar to alcohol
• Chronic: amotivational syndrome, decreased emotional development, increased susceptibility to disease
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AEROSET® System Troubleshooting Guide 6394816-107—November 2004
Cocaine • Free base: vaporized then smoked
• White power: intravenously, nasal insuffulation (“snorting” or “sniffing”)
2 to 3 days Extreme euphoria, insomnia, psychosis, anorexia, rapid heart rate (transient tachycardia)
High blood pressure, abnormal heartbeat pattern (cardiac arrhythmia), elevated temperature, stroke, heart failure, psychosis
Ethanol Taken orally Dose dependent: up to 24 hours
Mental confusion, vomiting, blackouts, personality change when drinking
• Acute: intoxication, hangover, vomiting, death
• Chronic: abstinence—seizures, addiction, inflammation of stomach lining (gastritis), inflammation of liver (hepatitis), inflammation of pancreas (pancreatitis), death
Methadone Taken orally 14 days • Acute: abnormal sense of well-being (euphoria)
• “Good sick”: nauseous but it feels pleasurable
• “Nod”: central nervous system (CNS) depression, drowsiness
• Withdrawal: watery eyes, salivation, GI symptoms, discomfort, agitation
Addiction, but less than morphine or heroin
Assay Details (Continued)
UseNormal
Detection Time in Urine
Symptoms of Abuse Possible Dangers
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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64 AEROSET® System Troubleshooting Guide94816-107—November 2004
Opiates Intravenously, orally
• Heroin: rapidly metabolizes to morphine, 72 hours
• Morphine: 3 days
• Other: 2 to 4 days
• Acute: Abnormal sense of well-being (euphoria)
• “Good sick”: nauseous but it feels pleasurable
• “Nod”: central nervous system (CNS) depression, drowsiness
• Withdrawal: watery eyes, salivation, GI symptoms, discomfort, agitation
Addiction, overdose, death
Phencyclidine Smoked on marijuana, taken intravenously or orally
Up to 10 days Aggressive behavior, combativeness, involuntary rhythmic movements of eyes (nystagmus), uncoordinated movement (ataxia)
Aggressive and dangerous behavior, persistently elevated blood pressure (hypertension), seizures, involuntary muscle contractions (spasms)
Propoxyphene Orally, intravenously
7 days • Acute: abnormal sense of well-being (euphoria), drowsiness, slurred speech
• Withdrawal: agitation, seizures
Addiction, overdose, death
Assay Details (Continued)
UseNormal
Detection Time in Urine
Symptoms of Abuse Possible Dangers
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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AEROSET® System Troubleshooting Guide 6594816-107—November 2004
Cross Reactivity
Refer to Assay-specific Information in this section for additional assay-specific cross reactivity information. Each DOA assay includes a table which lists cross reactivity testing performed on the AEROSET System by SYVA; this information is not included in the Abbott Clinical Chemistry Drugs of Abuse package inserts.
Method Comparison
For the qualitative drug of abuse assays Amphetamine/Methamphetamine, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Opiates, Phencyclidine, and Propoxyphene, urine samples known to be free from interfering substances or other drugs should be used. Run 40 positive and 40 negative specimens. The concentration of drug should cover the entire assay range, with particular emphasis at the cutoff concentration. All discrepant data points between the AEROSET DOA assay and comparative method should be investigated further by GC/MS to confirm the results.
Because the Ethanol assay is a quantitative assay, routine method comparison studies should be performed. Serum and urine samples known to be free from interfering substances or other drugs should be used. Run 40 positive and 40 negative specimens. The concentration of drug should cover the entire assay range.
For the c 8000® System, the package insert describes rate results between the cutoff rate and ± 25% rate, also the ± 50% rate. For the AEROSET System, only results between the cutoff rate and ± 25% rate are discussed, not the ± 50% rate. This is because of the new Guidance for Industry and FDA staff document, Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests, released December 2, 2003. AEROSET method comparison rate results were completed before the guidance document was updated.
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66 AEROSET® System Troubleshooting Guide94816-107—November 2004
MULTIGENT® Assays
General Information
MULTIGENT assays are supplied to Abbott from Original Equipment Manufacturers (OEM) and include Abbott Laboratories as the distributor on all MULTIGENT labeling. The MULTIGENT assay menu, including OEM supplier information, is listed in the following table.
Manufacturer Information
Seradyn, Inc.7998 Georgetown Road, Suite 1000Indianapolis, IN 46268(800) 428-4072(317) 610-3828www.seradyn.com
Genzyme DiagnosticsOne Kendall SquareCambridge, MA 02139-1562(800) 332-1042(617) 252-7500www.genzymediagnostics.com
Wako Chemicals USA, Inc.1600 Bellwood RoadRichmond, VA(877) 714-1924(804) 271-7677www.wakousa.com
MULTIGENT Assay OEM Supplier
Digoxin Seradyn
Direct LDL Genzyme
Hemoglobin A1c Seradyn
Microalbumin Wako
Valproic Acid Seradyn
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AEROSET® System Troubleshooting Guide 6794816-107—November 2004
Plasma Claims for Gel Barrier TubesFor assays that allow plasma as a suitable specimen, the following statement appears in the package insert: “Use plasma collected by standard venipuncture techniques in glass or plastic tubes without gel barrier”.
Clarification—plasma tubes with a gel barrier were not tested; therefore, no claim is made for these types of tubes.
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68 AEROSET® System Troubleshooting Guide94816-107—November 2004
Proficiency Testing
AAB Reagent Codes
Analyte Code Methodology
Albumin BCG 130 Abbott bromcresol green
Albumin BCP 146 Abbott bromcresol purple
Alkaline Phosphatase 146 Abbott no DEA 37°C
ALT 147 Abbott no P5P 37°C
Amylase 135 Abbott CNPG3 substrate
AST 147 Abbott no P5P 37°C
Bicarbonate (CO2) 146 Abbott UV/serum blanks
Bilirubin, Total (LN 7D60)
147 Abbott oxidation
Calcium 135 Abbott arsenazo III
Chloride 135 Abbott diluted ISE
Cholesterol, Total 146 Abbott
Creatine Kinase (CK) 146 Abbott NAC 37°C
Creatinine 135 Abbott nonenzymatic rate
GGT 146 Abbott IFCC substrate 37°C
Glucose 142 Abbott hexokinase 340 nm
HDL Cholesterol 135 Abbott direct (homogeneous)
Iron 146 Abbott FERENE-based
Lactate Dehydrogenase (LD)
135 Abbott L-P 37°C
Magnesium 135 Abbott arsenazo
Phosphorus 147 Abbott UV-bichrom smp blk
Potassium 135 Abbott diluted ISE
Sodium 135 Abbott diluted ISE
Total Protein 142 Abbott bichromatic-no SB
Triglyceride 135 Abbott gly-unc/GPO
Urea 135 Abbott GLDH-rate
Uric Acid 135 Abbott enzymatic-uncorrected
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AEROSET® System Troubleshooting Guide 6994816-107—November 2004
CAP Codes
Serum Survey
Analyte CAP Code Methodology
Acid Phosphatase 1518 Abbott/37°C
Albumin BCG 1099 Bromcresol green/dye binding
Albumin BCP 1101 Bromcresol purple/dye binding
Alkaline Phosphatase 1518 Abbott/37°C
ALT 1518 Abbott/37°C
ALT Activated 1526 Abbott pyridoxal phosphate activated reagent/37°C
Amylase 1518 Abbott/37°C
Apolipoprotein A1 1241 Immunoturbidimetric
Apolipoprotein B 1241 Immunoturbidimetric
AST 1518 Abbott/37°C
AST Activated 1526 Abbott pyridoxal phosphate activated reagent/37°C
Bilirubin, Direct (LN 7D59)
1764 Oxidation
Bilirubin, Direct(LN 2K59, DCL)
1114 Diazo-caffeine/benzoate coupling (Jendrassik-Grof) with blank
Bilirubin, Neonatal 1120 Spectrophotometric, without blank
Bilirubin, Total (LN 7D60)
1764 Oxidation
Bilirubin, Total(LN 2K58, DCL)
1114 Diazo-caffeine/benzoate coupling (Jendrassik-Grof) with blank
Calcium 1138 Arsenazo III dye
Carbon Dioxide (CO2) 1160 Enzymatic
Chloride 1227 Ion-selective/diluted (indirect)
Cholesterol 1154 Enzymatic
Creatine Kinase (CK) 1518 Abbott/37°C
Creatinine 1161 Kinetic alkaline picrate
GGT 1518 Abbott/37°C
Glucose 1172 Hexokinase, UV* MULTIGENT® assay
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70 AEROSET® System Troubleshooting Guide94816-107—November 2004
Hemoglobin A1c* 1055 Abbott AEROSET
HDL, Direct 1757 Liquid selective detergent (enzymatic)
Iron 1207 FERENE without a protein removal step
Lactate Dehydrogenase (LD)
1518 Abbott/37°C
Lactic Acid 1321 Oxidation of lactate to pyruvate (automated)
LDL, Direct* 1757 Liquid select detergent (Equal, Genzyme, Pointe, ThermoTRACE)
Lipase 1518 Abbott/37°C
Magnesium 1763 Arsenazo
Phosphorus 1216 Phosphomolybdate UV
Potassium 1227 Ion-selective/diluted (indirect)
Prealbumin 3254 Abbott AEROSET
Protein, Total 1217 Biuret
Sodium 1227 Ion-selective/diluted (indirect)
TIBC 1018 Alumina adsorption
Transferrin 3254 Abbott AEROSET
Triglyceride 1685 Enzymatic (glycerol phosphate oxidase)
Urea 1253 Urease with GLDH (coupled enzyme)
Uric Acid 1262 Uricase
Analyte CAP Code Methodology
* MULTIGENT® assay
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AEROSET® System Troubleshooting Guide 7194816-107—November 2004
Urine Survey
CSF Survey
Immunology
Analyte CAP Code Methodology
Amylase 1518 Abbott/37°C
Calcium 1138 Arsenazo III dye
Chloride 1227 Ion-selective electrode/diluted (indirect)
Creatinine 1161 Kinetic alkaline picrate
Glucose 1172 Hexokinase, UV
Magnesium 1763 Arsenazo
Microalbumin* 1637 Turbidimetric/immunoturbidimetric
Phosphorus 1216 Phosphomolybdate, UV
Potassium 1227 Ion-selective electrode/diluted (indirect)
Sodium 1227 Ion-selective electrode/diluted (indirect)
Urea 1253 Urease with GLDH (coupled enzyme)
Uric Acid 1262 Uricase
Urine/CSF Protein 0010 Other method, specify on result form
* MULTIGENT® assay
Analyte CAP Code Methodology
Glucose 1172 Hexokinase, UV
Urine/CSF Protein 0010 Other method, specify on result form
Analyte CAP Code Methodology
C-Reactive Protein 1637 Turbidimetric/immunoturbidimetric
Complement C3 1637 Turbidimetric/immunoturbidimetric
Complement C4 1637 Turbidimetric/immunoturbidimetric
Haptoglobin 1637 Turbidimetric/immunoturbidimetric
Immunoglobulin A 1637 Turbidimetric/immunoturbidimetric
Immunoglobulin G 1637 Turbidimetric/immunoturbidimetric
Immunoglobulin M 1637 Turbidimetric/immunoturbidimetric
Rheumatoid Factor 1637 Turbidimetric/immunoturbidimetric
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72 AEROSET® System Troubleshooting Guide94816-107—November 2004
Therapeutic Drug Monitoring
Urine Drug Testing (Drugs of Abuse)
Analyte CAP Code Methodology
Carbamazepine 3254 Abbott AEROSET
Digoxin* 3254 Abbott AEROSET
Phenobarbital 3254 Abbott AEROSET
Phenytoin 3254 Abbott AEROSET
Theophylline 3254 Abbott AEROSET
Valproic Acid* 3254 Abbott AEROSET* MULTIGENT® assay
Analyte CAP Code Methodology
Amphetamine/ Methamphetamine
1031 EIA (EMIT)
Barbiturates 1031 EIA (EMIT)
Benzodiazepines 1031 EIA (EMIT)
Cannabinoids 1031 EIA (EMIT)
Cocaine 1031 EIA (EMIT)
Methadone 1031 EIA (EMIT)
Opiates 300 1031 EIA (EMIT)
Opiates 2,000 1031 EIA (EMIT)
Phencyclidine 1031 EIA (EMIT)
Propoxyphene 1031 EIA (EMIT)
Ethanol (quantitative) 1031 EIA (EMIT)
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AEROSET® System Troubleshooting Guide 7394816-107—November 2004
Quality Control
Bio-Rad Control Products
NOTE: Information in tables is subject to change; refer to vendor for latest information
Control Product Name Catalog Number Configuration Assays
Lyphochek Assayed Chemistry Control
L-1: C-310-5L-2: C-315-5
12 x 5 mL12 x 5 mL
ACPAlbAlkPALTAmyApoAApoBASTBilDBilTC3C4CaCarbChol
CKClCO2CreaDigGGTGluHaptIgAIgGIgMIronKLactLD
LipMgNaPhenoPhenyPhosTheoTIBCTPTRFTrigUreaUricVPA
Liquid Assayed Multiqual Chemistry Control
L-1: 694L-2: 695L-3: 696
12 x 3 mL12 x 3 mL12 x 3 mL
ACPAlbAlkPALTAmyApoAApoBASTBilDBilNBilTC3C4CaCarbCholCK
ClCO2CreaDigETOHGGTGluHaptHDLIgAIgGIgMIronKLactLD
LDLLipMgNaPAlbPhenoPhenyPhosTheoTIBCTPTRFTrigUreaUricVPA
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74 AEROSET® System Troubleshooting Guide94816-107—November 2004
Liquichek Pediatric Control L-1: 354L-2: 355
6 x 4 mL6 x 4 mL
BilDBilNBilTCa
ClGluK
MgNaTheo
Liquichek Ethanol/Ammonia Control
L-1: 544L-2: 545L-3: 546
6 x 3 mL6 x 3 mL6 x 3 mL
ETOH
Liquichek Spinal Fluid Control
L-1: 751L-2: 752
6 x 3 mL6 x 3 mL
AlbClGlu
IgAIgGIgM
LDNaTP
Liquichek Immunology Control
L-1: 591L-2: 592L-3: 593L-1: 594L-2: 595L-3: 596
6 x 1 mL6 x 1 mL6 x 1 mL6 x 3 mL6 x 3 mL6 x 3 mL
AlbApoAApoBC3C4
CRPHaptIgAIgGIgM
PAlbRFTPTRF
Liquichek Urine Chemistry Control
L-1: 397L-2: 398
12 x 10 mL12 x 10 mL
AmyCaClCreaGlu
KMgNaPhos
TPuAlbUreaUric
Lyphochek Quantitative Urine Control
L-1: 376L-2: 377
12 x 10 mL12 x 10 mL
BarbCaClCreaGlu
IronMgNaPhos
TPuAlbUreaUric
Liquichek Rheumatoid Factor Control
L-1: 501L-2: 502L-3: 503
6 x 2 mL6 x 2 mL6 x 2 mL
RFNOTE: Control means may shift at the end of shelf life and control ranges may need to be reestablished. Control Level 1 varies in concentration.
Recommendation: Do not use Level 1 if < 15 IU/mL.
Control Product Name Catalog Number Configuration Assays
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AEROSET® System Troubleshooting Guide 7594816-107—November 2004
Liquichek Qualitative Urine Toxicology Control
Negative: 454Positive: 455
6 x 3 mL6 x 3 mL
AmpMBarbBenz
CocETOHMeth
PCPPrpxTHC
Liquichek Immunology Plus Control
Trilevel: 360L-1: 361L-2: 362L-3: 363
12 x 5 mL (4 ea.)12 x 5 mL12 x 5 mL
CarbDigIron
PhenoPheny
TheoVPA
Liquichek Therapeutic Drug Monitoring Control
Trilevel: 724L-1: 725L-2: 726L-3: 727
12 x 5 mL12 x 5 mL12 x 5 mL
CarbDig
PhenoPheny
TheoVPA
Control Product Name Catalog Number Configuration Assays
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76 AEROSET® System Troubleshooting Guide94816-107—November 2004
Ordering Information
Commercial controls are available from several vendors.
NOTE: Analyte concentrations in commercial controls can vary from vendor to vendor and lot to lot.
Bio-Rad
Clinical Diagnostics(800) 2-BIORAD [(800) 224-6723]
Information(888) 5-BIORAD [(888) 524-6723]
Worldwide Webwww.bio-rad.com
NOTE: The Bio-Rad package insert includes the following statement for assignment of control values:
“The mean values printed in this insert were derived from replicate analyses and are specific for this lot of control. The tests listed were performed by the reagent manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of control. Individual laboratory means should fall within the corresponding acceptable range; however, the values listed may vary during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation, and reagents, or by manufacturer test method modifications. It is recommended that each laboratory establish its own means and acceptable range, and use those provided only as guides.”
Biochemical Diagnostics, Inc.
East Coast(800) 223-4835 or (631) [email protected]
West Coast(800) [email protected]
Worldwide Webwww.biochemicaldiagnostics.com
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AEROSET® System Troubleshooting Guide 7794816-107—November 2004
Establishing Quality Control Limits
Use the following instructions to establish quality control limits for Abbott Clinical Chemistry assays.
Temporary Quality Control Limits
1. Enter the assay parameters for the appropriate new assay.
2. Calibrate and run three replicates each of a multi-level control in a single run. Record the results on the Temporary Control Limits Worksheet at the end of this section. Do not discard any result unless it was generated by operator error or instrument malfunction, or results can be rejected as a statistical outlier.
3. Repeat the calibration and controls two more times for a total of three calibration and control runs (nine values for each control). Add fresh calibrators and controls to each analyzer cup for each new run.
4. Calculate the mean for each control level and record it on the worksheet. Multiply each mean by 0.20 and record the result (20% of the mean) on the worksheet.
5. Determine the temporary control limits for each control level (± 20% of each mean control concentration). For example, if the mean control concentration of Theophylline is 10 µg/mL, the control limits are 8 µg/mL (– 20%) and 12 µg/mL (+ 20%).
6. Use these temporary control limits when running patient samples. Test at least two levels of control every 24 hours, or more often as specified by the laboratory’s quality control program.
7. Use the following rules to determine if the run can be accepted.
a. If controls are within the temporary control limits, accept the run.
b. If any control is not within its control limits, rerun the control. If the control is within the control limits, accept the run.
c. If the control is still not within its control limits, reject the run. Recalibrate the assay. After recalibration, if the controls are within their control limits, test patient samples.
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78 AEROSET® System Troubleshooting Guide94816-107—November 2004
d. After calibration, if any control is not within its control limits, check control, calibrator, and reagent handling, then rerun the control. If the control is within its control limits after retesting, test patient samples.
8. Use the temporary limits until permanent control limits are established. Record and plot all routine control results on Levey-Jennings charts. These control results are used to determine the permanent control limits.
Permanent Control Limits
1. Start on the first testing day after temporary control limits were established; assay one aliquot each of two or more controls in a single run.
2. Use the following rules to determine if the run can be accepted.
a. If controls are within the temporary control limits, test patient samples.
b. If the control is still not within its control limits, reject the run and recalibrate. Run controls again. After recalibration, if the controls are within their control limits, accept the run.
c. If the control is still not within its control limits, reject the run then recalibrate. Run controls again. After recalibration, if the controls are within their control limits, accept the run.
d. If after recalibration the control is not within its control limits, check the control, calibrator, and reagent handling, then rerun the control. If the control is within its control limits after retesting, test patient samples.
3. Evaluate control results for 30 calendar days (a minimum of 20 values for control level) to determine the permanent control limits. Recalibrate whenever a control fails or every 14 calendar days. Record control results. Do not discard any result unless it was generated by operator error or instrument malfunction, or results can be rejected as a statistical outlier.
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AEROSET® System Troubleshooting Guide 7994816-107—November 2004
Temporary Control Limits Worksheet
Assay Name:_______________________________________________ Lot#: _______________________Exp. Date: _________________________________________________ Lot#: _______________________Control 1: _________________________________________________ Lot#: _______________________Control 2: _________________________________________________ Lot#: _______________________Control 3: _________________________________________________ Lot#: _______________________
Temporary control limits accepted by:
Name: ____________________________________________________ Date: _______________________
Calibration/Accepted by Replicate Control 1 Control 2 Control 3
1 1
by: 2
3
2 1
by: 2
3
3 1
by: 2
3
Mean (x)
20% of Mean(x) (0.20)
Lower Limit(x – 20%)
Upper Limit(x + 20%)
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80 AEROSET® System Troubleshooting Guide94816-107—November 2004
Reagent Test Count Tracking
Reagent Test Counts
The AEROSET System performs a level sense in the reagent cartridge and calculates the remaining volume of reagent. The dead volume (based on the height of the low aspiration limit) and the configured reagent volume plus over-aspiration is subtracted from the reagent volume; remaining volume is calculated as the number of tests remaining.
When a reagent cartridge is configured for two different assays, the number of tests is divided by two and the volume displays for both assays. For example, assays with both a serum and urine application, such as Glucose and Creatinine, use the same reagent cartridge but have different assay numbers. The total number of tests is divided by two—half for the serum assay and half for the urine assay.
In-house studies have validated the number of estimated tests per kit, included in the assay-specific Abbott Clinical Chemistry Package Inserts. However, the test count displayed on the REAGENTS screen is not always correct.
Example: the Glucose package insert claims an estimated tests per kit of 3,770 (3,770 divided by 10 kits = 377 tests per cartridge). In our studies, the number of tests left per cartridge after the first calibration showed R1 = 223 and R2 = 176 when both should have been 368 [377 – 9 (3 calibrator levels at 3 replicates)]. Despite the displayed volume, 377 tests were performed before an empty reagent error was generated.
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AEROSET® System Troubleshooting Guide 8194816-107—November 2004
Sample Blanking
Self Blank vs. Non-Self Blank
Self Blank
The blank is done in the same cuvette as assay measurement. It is typically done with R1 and sample immediately before R2 is added. On the Base page of the Assay Configuration screen, in the Sample Blank Test field, you must select the same assay name as the assay you are configuring, then a Blank Read Time must be defined. The absorbance value measured during the Blank Read Time is corrected for the sample/reagent dilution ratio, then is subtracted from the absorbance value measured during the Main Read Time. If the Blank Read Time is defined after the addition of R2, the absorbance value is not corrected for the dilution ratio.
Non-Self Blank
A separate assay parameter file is defined to measure the blank reading. All parameters must be defined as if it was a “stand-alone” assay. This stand-alone blank assay should have nothing selected in the Sample Blank Test field or in the Blank Read Time field. For example, for the blank test, you could use saline or water, and sample. On the Base page of the Assay Configuration screen of the assay to be blanked, you must select the assay name of the configured blank assay in the Sample Blank Test field. The Blank Read Time fields must remain zero. When the assay is ordered, the AEROSET System dispenses the sample and reagent defined in the assay configuration into one cuvette and dispenses the sample and reagent defined in the blank configuration into another cuvette. They are treated as two separate tests to be dispensed and measured. When measurement is completed, the system subtracts the absorbance value measured during the Main Read Time of the blank assay from the absorbance value measured during the Main Read Time of the assay.
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82 AEROSET® System Troubleshooting Guide94816-107—November 2004
Sample Interference IndicesThe Sample Interference Indices Protocol is available on the AEROSET Assay Disk, Assays > 50 (LN 2K15 and 2K16). This feature allows semi-quantitative or qualitative estimates (index values) for the presence of hemolysis, icterus, or lipemia (turbidity) in serum or plasma samples.
The AEROSET System uses specific wavelength combinations to measure absorbance of hemolysis, icterus, and lipemia. The absorbance data are converted to semi-quantitative values according to the specific formulas defined in the assay parameters. The operator can choose between semi-quantitative (i.e., Index units) or qualitative (0, 1+, 2+, 3+, 4+) results format.
To estimate hemolysis, icterus, and lipemia on a sample, a reference photometric assay file must be configured. To configure this file, the operator must define which reagent (saline, ALT, or AST) to use for the analysis.
Package inserts are available for both the Saline and the ALT/AST Protocols to run the Sample Interference Indices.
Sample Interference Indices are used to observe the color of a sample that is due to hemolysis, icterus, and lipemia. The indices measurement is performed on each sample, not each assay.
Sample Interference Indices report the presence of hemolysis, icterus, and lipemia. These values are not used to correct results, but to indicate when assay results should be evaluated. To correct results for interferences, the Self or Non-Self Blank options are used.
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AEROSET® System Troubleshooting Guide 8394816-107—November 2004
SmartWash™
SmartWash (Reagent Carryover) When Moving A and B-Line Assays
When the AEROSET Assay/Configuration Disks are loaded, A and B-Line definition is complete. Throughput is maximized while minimizing the possibility of reagent carryover when defining the A and B-Line assays.
If an operator needs to change the assay configuration and move an A-Line assay to the B-Line (or B to A) to improve throughput, they must consider how this would affect the reagent carryover (SmartWash).
Things to consider:
1. When an assay is defined in the B-Line, the SmartWash page only allows selection of a reagent probe wash with other assays in the B-Line. These reagent probe washes are defined for the Abbott assays. If the assay is moved to the A-Line, the assay may be affected by carryover from an assay in the A-Line. Refer to the assay-specific or Abbott Clinical Chemistry Package Inserts and the following table to define any probe washes needed for A-Line and B-Line assays.
2. Some assays should not be configured for the same line; it is not possible to ensure sufficient washing to eliminate reagent carryover.
The following assays should not be positioned on the same line as Lipase:
• Calcium
• Urine Calcium
• Cholesterol
• CO2
• Triglyceride
• Uric Acid
• MULTIGENT® Direct LDL
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84 AEROSET® System Troubleshooting Guide94816-107—November 2004
SmartWash™ Parameters
When a SmartWash is configured for the reagent probe, the AEROSET System attempts to schedule the assay so the two assays are separated by another reagent, maximizing throughput and eliminating need for the wash.
NOTE: If the interfering and affected assays are both two-reagent assays (R1 and R2) and the assay that separates the interfering and affected assay uses one reagent (R1) only:
• SmartWash is not performed for the R2 reagent
• An extra “routine” water rinse is performed for R2
If the interfering assay is followed by the affected assay, the reagent probe aspirates the required volume of wash solution to clean the probe between the assays, and dispenses wash solution into an empty cuvette to also clean the mixer(s). An extra cuvette is used for this procedure.
When a SmartWash is configured for the reaction cuvette, wash solution is added to the cuvette to minimize reagent interference. This decreases the assay throughput from extra time spent washing the reaction cuvette.
When a SmartWash is configured for the sample probe, the probe is washed immediately before aspirating the sample, delaying throughput by one cycle.
SmartWash for Non-Abbott Reagent Applications
It is the customer’s responsibility to determine possible reagent carryover and SmartWash required for non-Abbott reagent applications. Refer to Reagent Carryover in Section 2, Installation Requirements and Special Procedures of the AEROSET System Operations Manual.
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AEROSET® System Troubleshooting Guide 8594816-107—November 2004
Specific Proteins AssaysThe Abbott Clinical Chemistry Specific Proteins menu includes Apolipoprotein A1 and B; Complement C3 and C4; Haptoglobin; Immunoglobulin A, G, and M; Prealbumin; and Transferrin.
Imprecision
• The R2 component of two-reagent assay contain the active ingredient
• R2 dispense and mixing drives the reaction
• When troubleshooting precision concerns, verify R2 mixer alignment and function, R2 reagent probe dispense and position, and proper installation of R2 reagent syringe seal tips and O-ring.
Bar Code Read Errors
• Round bottles may rotate slightly in adapters when the Reagent Carousel rotates, moving the bar code label and affecting the ability of the bar code scanner to read the bar code label.
– Turn the reagent bottle toward the center of the Reagent Carousel to allow the bar code scanner to read the bar code label.
– Insert the bottle from the bottom of the adapter so the bar code label is not scraped.
• Reagent bottles may fit tightly in some adapters. Frequent reloading and removal of bottles may damage the bar code label.
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86 AEROSET® System Troubleshooting Guide94816-107—November 2004
)
Frequently Asked Questions (FAQ)
Question Response
Why are linearity claims only up to the highest calibrator?
• Non-linear assays (C3, C4, Hapt, IgA, IgG, IgM, and TRF): accuracy by recovery cannot be guaranteed beyond the highest calibrator. The AEROSET System uses %EXT to prevent extrapolation.
• Linear assays (ApoA, ApoB, and PAlb): accuracy above the highest calibrator is dependant on calibrator concentrations, which vary from lot to lot. The AEROSET System uses %EXT to prevent extrapolation. Although R&D testing supports linearity beyond the highest calibrator, linearity was defined up to the high calibrator. Data from a large cohort of samples indicate very few samples will exceed the highest calibrator concentration.
Why are calibration modes for ApoA, ApoB, and PAlb linear if the calibration curves are not straight?
Although the graphs appear non-linear for these assays, the calibrations approximate a linear response close enough to ensure accurate results across the calibration range. Therefore, the calibration modes were defined as linear for each of these assays.
When the Specific Proteins assays were originally launched for the AEROSET System, only two levels of controls were run for precision. Why are three levels of controls now included for precision?
• Commercial trilevel controls were used for the ARCHITECT® c 8000® precision testing. The Level 3 control is approximately the same concentration as the Level 2 control used in original AEROSET testing.
• The revised package inserts now include a combination of AEROSET and/or c 8000 data. The data were selected based on the highest total %CV for each control level, independent of the instrument on which they were tested.
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AEROSET® System Troubleshooting Guide 8794816-107—November 2004
When a manual dilution is performed for the IgA and IgM assays, what value should be entered for the sample dilution?
Enter the manual dilution factor only. The system automatically adjusts for use of a standard sample dilution.Example: a manual 1:4 dilution is prepared and tested using the standard sample dilution (1:5). Enter 4 for the manual dilution; the system automatically multiplies the measured concentration by 20 (manual dilution × standard sample dilution) to determine the result.
Why are the linear low and LOQ different values?
• LOQ is the lowest analyte concentration at which %CV = 20.
• Some Specific Proteins assays become increasingly inaccurate as analyte concentrations drop below the lowest calibrator and approach the LOQ. For this reason, the linear low limits for these assays are based on accuracy by recovery studies, not LOQ studies.
When running the IgA or IgM assay, and an LH Result Error Code occurs, what should the customer do?
The sample should be diluted and rerun. An automated dilution can be performed using Dil 2.
When running the IgA or IgM assay, and an LL Result Error Code occurs, what should the customer do?
The sample should be rerun undiluted. An automated dilution can be performed using Dil 1.
Frequently Asked Questions (FAQ) (Continued)
Question Response
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88 AEROSET® System Troubleshooting Guide94816-107—November 2004
Specimen Collection and HandlingIn the SPECIMEN COLLECTION AND HANDLING section of the package inserts, many state: “Separate from red blood cells as soon after collection as possible”.
To clarify a reasonable time period for “as soon as possible”, Tietz Textbook of Clinical Chemistry, 2nd ed. uses the same verbiage but adds “..., and certainly within two hours”.
Reference: Laessig RH, et al. Changes in serum chemical values as a result of prolonged contact with the clot. Am J Clin Pathol 1986 Mon;66(#):598–604.
Serum should be separated within two hours of collection, and prolonged contact of serum with the clot will affect potassium, glucose, and ammonia results.
Reference: McClatchey KD, editor. Clinical Laboratory Medicine, 1st ed. Philadelphia, PA: Lippincott, Williams, and Wilkins, 1994:85.
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AEROSET® System Troubleshooting Guide 8994816-107—November 2004
Therapeutic Drug Monitoring (TDM) AssaysThe Abbott Clinical Chemistry Therapeutic Drug Monitoring (TDM) menu includes Carbamazepine, Phenobarbital, Phenytoin, and Theophylline.
Calibration
• A full calibration is required with each reagent cartridge change and each change in reagent lot number.
• CAL 1 must always be used as the blank. Do not use water to calibrate.
• A Blank Adjustment calibration using CAL 1 is required once each day of assay use, unless a full calibration is performed.
• To obtain recommended volume requirements for the Abbott TDM calibrators, hold the bottles vertically and dispense two drops (50 µL) of each calibrator into each respective sample cup.
Troubleshooting Tips
The following issues may impact TDM assay results:
• Crimped tubing
• Flared tubing—reagent probes
• Wash flow rates for reagent and sample probes
• Cuvette dryer tip tubing disconnected
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90 AEROSET® System Troubleshooting Guide94816-107—November 2004
Frequently Asked Questions (FAQ)
Question Response
Why are Phenytoin precision data from only two instruments included in the package insert?
Because of instrument issues, data from only two instruments will be included in the package insert but additional studies are being performed for inclusion at a later date.
Why are AEROSET precision data different than the c 8000® precision data presented?
Precision was performed for all four TDM assays at the same time on both the c 8000 and AEROSET Systems. Testing was repeated on the AEROSET for all four assays because of additional requirements for a daily blank calibration and calibration with each new wedge.
Why is it now necessary to calibrate with each new reagent cartridge?
It is necessary to recalibrate with each new cartridge to optimize performance, and to achieve 28 days reagent onboard stability and 14 days calibration stability. Also, this eliminates the need to recap reagent cartridges and place them back in the refrigerator, which is necessary with other vendor products, such as Olympus.
How is Abbott’s precision claim determined? Abbott’s package insert claim for total precision is CV < 7% for Carbamazepine and Phenobarbital, and CV < 8% for Phenytoin and Theophylline. These are based on initial product requirements used in product development. The validation and verification testing demonstrated total precision of less than 7%. Representative data are included in the package insert.
What is the benefit of running a blank calibration (using CAL 1) once each day of assay use?
It provides an additional level of robustness to assay performance.
Why was the method comparison data changed from the previous package insert?
Slope, correlation coefficient, and Y-intercept were recalculated using least squares regression; this aligns with the method used to calculate c 8000 data.
Was there a change to the TDM onboard stability?
Yes, changes were made to provide an additional level of robustness to onboard stability.
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AEROSET® System Troubleshooting Guide 9194816-107—November 2004
Why is Phenytoin compared to high-performance liquid chromatography (HPLC) methodology, but not the other TDM assays?
HPLC is commonly considered the gold standard in immunoassay. Phenytoin is extensively metabolized and the major pathway is para-hydroxylation of the phenyl ring. The resulting metabolite, p-hydroxyphenytoin (HPPH) is inactive and present largely as a glucuronide conjugate (HPPG). Both metabolites are structurally similar to phenytoin, and may interfere with immunoassays. This is especially true in renal insufficiency, where HPPG clearance is decreased and plasma levels of HPPG may be increased 10 times the phenytoin concentration.
Frequently Asked Questions (FAQ) (Continued)
Question Response
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92 AEROSET® System Troubleshooting Guide94816-107—November 2004
Verification Procedures
Confirming the Limit of Detection (LOD)
The Limit of Detection (LOD) represents the noise associated with the analytical system in the absence of analyte. The LOD is determined by analyzing a zero concentration sample (saline or equivalent zero level material and adding two standard deviations (SD) to the mean of the results. The LOD is the mean concentration of an analyte-free sample + 2 SD, where SD equals the pooled, within-run standard deviation of the analyte-free sample.
Before performing the study, the following conditions must be met:
• Maintenance procedures are up to date.
• Reagent and samples are available in sufficient quantity.
• Assays are calibrated.
• All control levels are in range.
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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AEROSET® System Troubleshooting Guide 9394816-107—November 2004
Procedure1. Prepare one blank level for each assay to be tested.
2. Select <Database> in the Information Access Area of the Main Display. The DATABASE screen displays.
3. Select <Order> in the right column of the screen. The Order Samples screen displays. If this is not the first sample ordered, select <New>.
4. Enter the following information:
• Name or SID
• C/P
• Replicates (5)
5. Select the assay(s) to be evaluated.
6. Select <Copy> in the right column of the Order Samples screen. The Copy Order dialog window displays.
7. Enter 1 in the How Many Copies? field to request one copy (N = 10, 2 samples × 5 replicates) then select <OK>. The Order Samples screen displays.
8. Load the sample(s) in the designated C/P.
9. Select <OK> in the right column of the screen.
10. Select <RUN> in the Action Area of the Main Display. The RUN OPTIONS screen displays.
11. Select the Patient option (�).
12. Select <Start> in the right column of the RUN OPTIONS screen to initiate the run.
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94 AEROSET® System Troubleshooting Guide94816-107—November 2004
Limit of Detection for Abbott Assays Data Sheet
Date: _____________ Analyte: ___________________________________________________________Instrument: ___________________________________________ Serial No.: ______________________
Record the values for the zero concentration sample replicates.
Calculate the limit of detection.
Comments: ____________________________________________________________________________________________________________________________________________________________________Technologist: _____________________________________________ Date: _______________________ Reviewed by: _____________________________________________ Date: _______________________
Lot Number Expiration Date
Reagent Kit
Calibrators
Replicate Value
1
2
3
4
5
6
7
8
9
10
A. Determine the mean of the replicates: Mean* = __________________
B. Determine the SD of the replicates: SD = __________________
C. Multiply the SD by 2: 2 × SD = __________________
D. Add line A and line C: Mean + (2 × SD) = __________________
* If the calculated mean is � 0, enter 0 as the mean.
Data Summary Calculated Value Expected Value
Limit of Detection
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AEROSET® System Troubleshooting Guide 9594816-107—November 2004
Limit of Detection for Abbott Assays Data Sheet Example
Date: 3/11/03 Analyte: ABC Instrument: AEROSET System Serial No.: 1243
Record the values for the zero concentration sample replicates.
Calculate the limit of detection.
Comments: Confirmed limit of detection _______________________________________________________________________________________
Technologist: (Name) Date: 3/11/03 Reviewed by: (Name) Date: 3/11/03
Lot Number Expiration Date
Reagent Kit 334455MB 07/07/03
Calibrators 50383 05/01/03
Replicate Value
1 0.05
2 0.05
3 0.03
4 0.04
5 0.02
6 0.06
7 0.03
8 0.02
9 0.10
10 0.02
A. Determine the mean of the replicates: Mean* = 0.04
B. Determine the SD of the replicates: SD = 0.02
C. Multiply the SD by 2: 2 × SD = 0.04
D. Add line A and line C: Mean + (2 × SD) = 0.08
* If the calculated mean is � 0, enter 0 as the mean.
Data Summary Calculated Value Expected Value
Limit of Detection 0.08 0.12
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96 AEROSET® System Troubleshooting Guide94816-107—November 2004
Confirming the Limit of Quantitation (LOQ)
The Limit of Quantitation (LOQ) represents the analyte concentration corresponding to a coefficient of variation (CV) of 20%. This is considered the functional sensitivity of an assay.
Before performing the study, the following conditions must be met:
• Maintenance procedures are up to date.
• Reagent and samples are available in sufficient quantity.
• Assays are calibrated.
• All control levels are in range.
Procedure1. Prepare the low analyte sample for each assay to be tested.
Review the reagent package insert for the LOQ. Dilute the first or second non-zero calibrator to the approximate concentration of the LOQ stated in the insert. For example, the LOQ for AEROSET Carbamazepine is 0.5 µg/mL. The Level 2 calibrator (first non-zero calibrator) contains 2.0 µg/mL of analyte. The following dilution can be prepared:
1:4 dilution of the Level 2 calibrator, resulting in a 0.5 µg/mL sample for testing
2. Select <Database> in the Information Access Area of the Main Display. The DATABASE screen displays.
3. Select <Order> in the right column of the screen. The Order Samples screen displays. If this is not the first sample ordered, select <New>.
4. Enter the following information:
• Name or SID
• C/P
• Replicates (5)
5. Select the assay(s) to be evaluated.
6. Select <Copy> in the right column of the Order Samples screen. The Copy Order dialog window displays.
7. Enter 1 in the How Many Copies? field to request one copy (N = 10, 2 samples × 5 replicates) then select <OK>. The Order Samples screen displays.
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AEROSET® System Troubleshooting Guide 9794816-107—November 2004
8. Load the sample(s) in the designated C/P.
9. Select <OK> in the right column of the screen.
10. Select <RUN> in the Action Area of the Main Display. The RUN OPTIONS screen displays.
11. Select the Patient option (�).
12. Select <Start> in the right column of the RUN OPTIONS screen to initiate the run.
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98 AEROSET® System Troubleshooting Guide94816-107—November 2004
Limit of Quantitation for Abbott Assays Data Sheet
Date: _____________ Analyte: ___________________________________________________________Instrument: ___________________________________________ Serial No.: ______________________
Record the values for the low analyte sample replicates.
Calculate the limit of quantitation.
Comments: ____________________________________________________________________________________________________________________________________________________________________Technologist: _____________________________________________ Date: ________________________Reviewed by: _____________________________________________ Date: _______________________
Lot Number Expiration Date
Reagent Kit
Calibrators
Replicate Value
1
2
3
4
5
6
7
8
9
10
A. Determine the mean of the replicates: Mean = __________________
B. Determine the SD of the replicates: SD = __________________
C. Determine the %CV of the replicates: %CV = __________________
Data Summary Calculated Value Expected Value
Limit of Quantitation
SD
Mean× 100%CV =
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AEROSET® System Troubleshooting Guide 9994816-107—November 2004
Limit of Quantitation for Abbott Assays Data Sheet Example
Date: 3/11/03 Analyte: ABC Instrument: AEROSET System Serial No.: 1243
Record the values for the low analyte sample replicates.
Calculate the limit of quantitation.
Comments: Confirmed limit of quantitation _______________________________________________________________________________________
Technologist: (Name) Date: 3/11/03 Reviewed by: (Name) Date: 3/11/03
Lot Number Expiration Date
Reagent Kit 334455MB 07/07/03
Calibrators 50383 05/01/03
Replicate Value
1 0.25
2 0.25
3 0.25
4 0.23
5 0.20
6 0.26
7 0.24
8 0.35
9 0.35
10 0.25
A. Determine the mean of the replicates: Mean = 0.26
B. Determine the SD of the replicates: SD = 0.0481
C. Determine the %CV of the sample: %CV = 18.5
Data Summary Calculated Value Expected Value
Limit of Quantitation 18.5% 20.0%
SD
Mean× 100%CV =
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100 AEROSET® System Troubleshooting Guide94816-107—November 2004
NOTES
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AEROSET® System Troubleshooting Guide 10194816-107—November 2004
Assay-specific Information
Acid Phosphatase
Method Comparison
The Abbott Clinical Chemistry Acid Phosphatase (ACP) assay compares well to some other assays and not as well to others. Review of CAP proficiency testing survey results indicates the degree of comparability that can be expected. For two survey specimens, the mean values are listed in the following table.
Array and AEROSET values for ACP agree with each other, as do the Vitros and Paramax, but the Array/AEROSET do not agree with Vitros/Paramax. ACP values for three other CAP specimens tested by Paramax and AEROSET demonstrate similar disparity (1.93, 10.85, and 7.73 U/L by Paramax; 5.67, 40.39, 29.19 U/L by AEROSET).
Method comparison data for AEROSET and Paramax yielded the following least squares equation:
AEROSET = 3.61 (Paramax) - 2.96, r = 0.992, N = 78
When the same data were analyzed using Passing-Bablok, the equation was:
AEROSET = 2.86 (Paramax) - 1.59, r = 0.992, N = 78
Instrument Specimen 1 (U/L) Specimen 2 (U/L)
Array 1.55 19.78
AEROSET 1.66 21.70
Paramax 0.44 5.57
Vitros 0.65 5.55
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102 AEROSET® System Troubleshooting Guide94816-107—November 2004
Although Paramax and AEROSET assays definitely correlate (as shown by the r value), a specimen tested on the AEROSET will yield a value approximately three times greater than that obtained by the Paramax System. The Paramax uses alpha-naphthylphosphatase as the substrate for the ACP reaction, as does the AEROSET and Vitros (Array substrate unavailable). Despite the use of the same substrate and generally similar reaction schemes, different reagents do not yield similar results. The Paramax employs a solid tablet reagent format, the Vitros a unique dry (damp) slide format, and the Array and AEROSET both use liquid reagents. The exact content of all of these reagents is not known, this is proprietary information. Given the many factors affecting ACP analysis, such as heterogeneity of the enzyme (different isozymes are found in liver, spleen, erythrocytes, prostate, etc.), differences in conditions for optimal activity of these isozymes (pH, inhibitors, etc.), need to maintain an acidic environment to stabilize and preserve ACP activity (addition of an acidifying solution to serum specimens after collection), and the variety of different reagent formulations that exists, it is not surprising that roughly equivalent results are not obtained when the same specimens are tested using kits from different vendors.
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AEROSET® System Troubleshooting Guide 10394816-107—November 2004
Albumin BCG
Calibrators
Do not use Multiconstituent Calibrator CAL 1 (MCC 1) for calibration. Use MCC 2 for both CAL 1 and 2. The AEROSET System automatically dilutes MCC CAL 2 for CAL 1.
Observed Problem
Alkaline Phosphatase
Observed Problem
Illegal assay configuration
Probable Cause(s) Corrective Action(s)
Diluent not configured. Ensure new assay parameters are installed. (Diluent is now necessary for calibration; refer to Revision 3 or greater of the package insert.) Refer to Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual.
RL% Result Error Code
Probable Cause(s) Corrective Action(s)
R2 reagent probe is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
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104 AEROSET® System Troubleshooting Guide94816-107—November 2004
ALT
Ammonium Heparin Tube Not Acceptable
Ammonium heparin was removed from the list of approved anticoagulants for ALT, ALT-A, AST, and AST-A. The reference used to support this recommendation is Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 2nd ed. Philadelphia, PA: WB Saunders, 1994:795.
This reference states:
“Elevated levels of L-GLD (EC 1.4.1.3) may be encountered in some sera from patients with parenchymal liver disease. If ammonia is also present in the serum specimen or in one of the reagents, the GLD reaction will proceed and interfere with the AST determination by consuming oxoglutarate and NADH. Thus, use of ammonia-free reagents is recommended.”
ALT/AST Activated Versus ALT/AST
Differences
ALT Activated and AST Activated assays contain the coenzyme (activator) pyridoxal-5-phosphate (P-5-P); ALT and AST assays do not contain P-5-P. Most laboratories in the U.S. prefer non-activated formulations, while use of activated assays is prevalent in European laboratories. The IVD Directive is encouraging laboratories to use activated forms of the reagent.
There is no difference in reaction, and there are minimal differences with most patient results. The activated reagent is useful in patients with nutritional deficiencies, where the coenzyme P-5-P level may be decreased with resultant decreased enzyme activity. With these patients, the activated reagent provides an advantage because it activates enzymes that may not otherwise be fully active if the patient has a P-5-P deficiency.
However, ALT Activated and AST Activated assays require reconstitution, and have shorter onboard stability than the non-activated assays—seven days vs. 27 days.
ALT Activated
Ammonium Heparin Tube Not Acceptable
Refer to ALT in this section for details.
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AEROSET® System Troubleshooting Guide 10594816-107—November 2004
Amphetamine/Methamphetamine
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table yielded a negative result at 1,000 ng/mL d-methamphetamine (Multi DOA Cutoff calibrator) when tested at the concentration listed.
Compound SYVA Package Insert µg/mL
Acetaminophen 1,000
Acetylsalicylic acid 1,000
Alpha-acetyl-N, N-dinormethadol (dinor LAAM)
25
l-Alpha-acetylmethodol (LAAM) 25
Buprenorphine 100
Caffeine 1,000
Clomipramine 2.5
Clonidine 1,000
Codeine 500
Cotinine 100
Cyclobenzaprine 28
Doxepin 10
Glutethimide 500
Ketamine 100
Lysergic acid diethylamide (LSD) 10 ng/mL
Meperidine 1,000
Phenytoin 1,000
Tramadol 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
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106 AEROSET® System Troubleshooting Guide94816-107—November 2004
Amylase
Interference Information
Icodextrin, a complex carbohydrate contained in some fluids used for peritoneal dialysis, has been reported to interfere with amylase assays. Low amylase values may be obtained due to inhibition of amylase activity by icodextrin. No testing has yet been conducted for the specific amylase method used on the AEROSET System. In addition, the mechanism of the reported amylase inhibition may not affect all amylase assays. Until specific information is available for the AEROSET, amylase results from patients receiving peritoneal dialysis must be assessed in relation to their clinical condition and exposure to icodextrin.
Wang G, Leesch V, Turner P, Moberly JB, Martis L. Kinetic analysis of icodextrin interference with serum amylase assays, Adv Perit Dial 2002;18:96–99.
Anderstam B, Garcia-Lopez E, Heimburger O, Lindholm B. Determination of alpha-amylase activity in serum and dialysate from patients using icodextrin-based peritoneal dialysis fluid, Perit Dial Int 2003;23:146–50.
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AEROSET® System Troubleshooting Guide 10794816-107—November 2004
Apolipoprotein A1
Observed Problems
Falsely lowered results near the concentration of CAL 1
Probable Cause(s) Corrective Action(s)
Apo Al/Apo B calibrator not prepared correctly.
Prepare calibrators correctly:• Reconstitute with 1.0 mL Type II water.• Allow to stand for 10 minutes.• Dissolve by swirling—do not shake.• Prepare the four calibrator dilutions using
the reconstituted calibrator and diluent.
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
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108 AEROSET® System Troubleshooting Guide94816-107—November 2004
Apolipoprotein B
Observed Problems
Falsely lowered results near the concentration of CAL 1
Probable Cause(s) Corrective Action(s)
Apo Al/Apo B calibrator not prepared correctly.
Prepare calibrators correctly:• Reconstitute with 1.0 mL Type II water.• Allow to stand for 10 minutes.• Dissolve by swirling—do not shake.• Prepare the four calibrator dilutions using
the reconstituted calibrator and diluent.
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
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AEROSET® System Troubleshooting Guide 10994816-107—November 2004
AST
Ammonium Heparin Tube Not Acceptable
Refer to ALT in this section for details.
AST Activated
Ammonium Heparin Tube Not Acceptable
Refer to ALT in this section for details.
Observed Problem
Results within normal range are flagged with LL Result Error Code
Probable Cause(s) Corrective Action(s)
The L-Linear Range parameter was edited in the updated assay parameter file, from the Limit of Detection (LOD) value of 2.8 U/L to the Limit of Quantitation (LOQ) value of 7.8 U/L. The LOQ value is rounded up to the number of decimal places defined in the Decimal Places field, and results with a value < 8 U/L are flagged with a LL Result Error Code.
NOTE: LOQ was chosen as the lower limit because it represents the lowest limit at which quantitative information is reliable (%CV = 20), rather than using the LOD which represents the noise associated with the analytical system in the absence of analyte. An in-house normal range study is planned.
If a report with a result < 8 U/L (no LL Result Error Code) is desired, an alternate method should be used.
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110 AEROSET® System Troubleshooting Guide94816-107—November 2004
Barbiturates
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table yielded a negative result at 200 ng/mL secobarbital (Multi DOA Cutoff calibrator) when tested at the concentration listed.
Compound SYVA Package Insert µg/mL
Acetaminophen 1,000
N-Acetylprocainamide (NAPA) 400
Acetylsalicylic acid 1,000
Alpha-acetyl-N, N-dinormethadol (dinor LAAM)
25
l-Alpha-acetylmethodol (LAAM) 25
Amitriptyline 1,000
Buprenorphine 100
Caffeine 1,000
Cimetidine 1,000
Clomipramine 2.5
Clonidine 1,000
Codeine 500
Cotinine 100
Cyclobenzaprine 28
Desipramine 800
Diphenhydramine 1,000
Doxepin 10
2-Ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)
1,000
Fluoxetine 500
Ibuprofen 1,000
Ketamine 100
Ketorolac tromethamine 1,000
Lysergic acid diethylamide (LSD) 10 ng/mL
Meperidine 1,000
Naproxen 1,000
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AEROSET® System Troubleshooting Guide 11194816-107—November 2004
Nortriptyline 750
Promethazine 1,000
Ranitidine 900
Scopolamine 500
Tramadol 100
Tyramine 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
Compound SYVA Package Insert µg/mL
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112 AEROSET® System Troubleshooting Guide94816-107—November 2004
Benzodiazepines
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table yielded a result approximately equivalent to the Multi DOA Cutoff calibrator (200 ng/mL lormetazepam).
Compounds listed in the following table yielded a negative result at 200 ng/mL lormetazepam (Multi DOA Cutoff calibrator) when tested at the concentration listed.
Compound Concentration Calculated ng/mL
SYVA Package Insert ng/mL
7-aminoflunitrazepam 341 295
CompoundSYVA Package Insert
µg/mL (Tested at 150 ng/mL Cutoff)
Acetaminophen 1,000
N-Acetylprocainamide (NAPA) 400
Acetylsalicylic acid 1,000
Alpha-acetyl-N, N-dinormethadol(dinor LAAM)
25
l-Alpha-acetylmethodol (LAAM) 25
Amitriptyline 1,000
Buprenorphine 100
Caffeine 1,000
Cimetidine 1,000
Clomipramine 2.5
Clonidine 1,000
Codeine 500
Cotinine 100
Cyclobenzaprine 28
Desipramine 800
Diphenhydramine 1,000
Doxepin 10
2-Ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)
1,000
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AEROSET® System Troubleshooting Guide 11394816-107—November 2004
Fluoxetine 500
Glutethimide 500
Ketamine 100
Ketorolac tromethamine 1,000
Lysergic acid diethylamide (LSD) 10 ng/mL
Meperidine 1,000
Nortriptyline 750
Phenytoin 1,000
Promethazine 1,000
Ranitidine 900
Scopolamine 500
Thioridazine 100
Tramadol 100
Tyramine 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
CompoundSYVA Package Insert
µg/mL (Tested at 150 ng/mL Cutoff)
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114 AEROSET® System Troubleshooting Guide94816-107—November 2004
Calcium
Observed Problem
LOD/LOQ claim not duplicated by customer
Probable Cause(s) Corrective Action(s)
Reagent cross contamination.NOTE: Creatinine contaminates Calcium at very low levels, even with SmartWash™ configured. The contamination is not clinically significant.
Run Calcium in batch mode for LOD/LOQ testing.
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AEROSET® System Troubleshooting Guide 11594816-107—November 2004
Cannabinoids
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table yielded a negative result at 50 ng/mL 11-nor-∆9-THC-9-carboxylic acid (Multi DOA Cutoff calibrator) when tested at the concentration listed.
Compound SYVA Package Insert µg/mL
Acetaminophen 1,000
N-Acetylprocainamide (NAPA) 400
Alpha-acetyl-N, N-dinormethadol(dinor LAAM)
25
l-Alpha-acetylmethodol (LAAM) 25
Buprenorphine 100
Caffeine 1,000
Cimetidine 1,000
Clomipramine 2.5
Clonidine 1,000
Codeine 500
Cotinine 100
Cyclobenzaprine 28
Desipramine 800
Diphenhydramine 1,000
Doxepin 10
2-Ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)
1,000
Fluoxetine 500
Glutethimide 300
Ibuprofen 1,000
Ketamine 100
Ketorolac tromethamine 1,000
Lysergic acid diethylamide (LSD) 10 ng/mL
Naproxen 1,000
Nortriptyline 750
Phenytoin 1,000
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116 AEROSET® System Troubleshooting Guide94816-107—November 2004
Troubleshooting Imprecision
Imprecision on the Cannabinoids assay can be the result of:
• Crimped tubing, especially at the cuvette wash station
• Incomplete cuvette wash
Certain types of plastics adsorb cannabinoids (THC) from solutions, decreasing the concentration. Observe the following guidelines to prevent adsorption.
• AEROSET sample cups should be filled with 600 µL of calibrator, control, or specimen to minimize the surface-to-volume ratio.
• Do not use disposable polyethylene transfer pipettes to dispense calibrators, controls, or specimens.
• Do not redispense solutions from a pipette back into a calibrator, control, or specimen container (includes redispensing after wetting a pipette tip).
• Immerse the pipette tips below the surface of the liquid only far enough to aspirate the needed volume; this minimizes contact of the pipette tip with calibrator, control, or specimen.
Ranitidine 900
Scopolamine 500
Thioridazine 100
Tramadol 100
Tyramine 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
Compound SYVA Package Insert µg/mL
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AEROSET® System Troubleshooting Guide 11794816-107—November 2004
Cocaine
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table yielded a negative result at 300 ng/mL benzoylecgonine (Multi DOA Cutoff calibrator) when tested at the concentration listed.
CompoundSYVA Package Insert
µg/mL (Tested at 150 ng/mL Cutoff)
N-Acetylprocainamide (NAPA) 400
Alpha-acetyl-N, N-dinormethadol(dinor LAAM)
25
l-Alpha-acetylmethodol (LAAM) 25
Buprenorphine 100
Caffeine 1,000
Cimetidine 1,000
Clomipramine 2.5
Clonidine 1,000
Codeine 500
Cotinine 100
Cyclobenzaprine 28
Desipramine 800
Diphenhydramine 1,000
Doxepin 10
2-Ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)
1,000
Fluoxetine 500
Glutethimide 500
Ibuprofen 1,000
Ketamine 100
Ketorolac tromethamine 1,000
Lysergic acid diethylamide (LSD) 10 ng/mL
Meperidine 1,000
Naproxen 1,000
Nortriptyline 750
Phenytoin 1,000
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Promethazine 1,000
Ranitidine 900
Scopolamine 500
Thioridazine 100
Tramadol 100
Tyramine 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
CompoundSYVA Package Insert
µg/mL (Tested at 150 ng/mL Cutoff)
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AEROSET® System Troubleshooting Guide 11994816-107—November 2004
Complement C3
Observed Problems
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
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120 AEROSET® System Troubleshooting Guide94816-107—November 2004
Complement C4
Observed Problems
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
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AEROSET® System Troubleshooting Guide 12194816-107—November 2004
C-Reactive ProteinBefore troubleshooting the CRP assay, ensure the assay parameters were configured correctly. Do not install the CRP assay using assay parameters on the Import Disk—Serum Proteins Version 1.0.
Standard Material Recovery
Recovery accuracy results of the standard material are summarized in the following table.
Assay Standard Material N Units Expected
ValueRecovered
(Mean) Value %Recovery
CRP (LN 8G65)
CRM 470 4 IU/mL 203.72 213.14 104.62
4 IU/mL 105.73 115.62 109.35
4 IU/mL 50.93 52.47 103.02
4 IU/mL 26.43 27.19 102.87
Frequently Asked Questions (FAQ)
Question Answer
The LOQ claim is 0.50 mg/dL in the CRP package insert. The insert also states that a study was performed on the AEROSET and ARCHITECT® c 8000® Systems, which resulted in an LOQ of 0.25 mg/dL. Where did the LOQ claim of 0.50 mg/dL originate?
The LOQ study yielded representative data of 0.25 mg/dL (worst case result observed). The claim of 0.50 mg/dL is the Product Requirement, minimum acceptable performance, which was determined before performing the LOQ study.Product claims are based on product requirements which Abbott Laboratories determines from literature, customer feedback, and other sources of information. Actual product performance “typical results” may perform better than the claim.
In the package insert, why is there is a serum reference range but not a plasma reference range?
The reference range study was performed with only serum specimens to confirm the literature reference, which also used only serum specimens.A separate reference study with plasma specimens was not performed.
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The CRP R2 reagent contains latex microparticles. Is inversion of R2 reagent required before every run to ensure the particles do not settle?
Inversion is not required before running the test. The latex microparticles are very small and remain suspended after the R2 cartridge is initially inverted and placed on the Reagent Carousel.Although a specific study was not performed, we suspect the carousel movement keeps the microparticles suspended.
How much control variability should be observed between reagent lots of the CRP assay?
The CRP assay was tested with a minimum of three lots. These lots included freshly prepared reagent, and one nearing the expiration date. Minimal variability in controls was observed. Control ranges (also called Action Limits) were not reset with a change in reagent lot.
How would results be affected if reagent kits are inadvertently frozen during delivery? The package insert does not address this issue.
The customer should check QC performance. Freeze/thaw studies by the OEM supplier support acceptable performance with frozen material.
Will customers have an issue if there are not enough Abbott assay users when results from a proficiency survey are compared to other manufacturers’ CRP assays?
OPEN QUESTION – Under evaluation.We do not have data for this. However, CAP Proficiency Survey specimens were recently run at Abbott, as they are for all on-market products. We will review the results and communicate them internally when published by CAP.
Were gel barrier tubes tested for use with the CRP assay?
A study has not yet been performed with gel barrier tubes. However, this will be considered for a future study.
If CRP is not inverted before use, what errors are observed?
A specific study has not been performed. However, if latex particles have settled to the bottom of the reagent cartridge and are not pipetted, it is possible that low absorbance values could be observed.
Is the Hitachi method for CRP a turbidimetric method?
Boehringer Mannheim reagents for use on Hitachi instruments are described in the BM package inserts as “immunological agglutination” which is a turbidimetric method.
Frequently Asked Questions (FAQ) (Continued)
Question Answer
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AEROSET® System Troubleshooting Guide 12394816-107—November 2004
Is the assay number for the new CRP assay the same as the original CRP assay?
Yes. However, this it not an issue because the “original” CRP assay was never released to customers.A new Import Disk—Serum Proteins Version 2.0 was released with the new CRP assay.
Conv Units SI UnitsOld Import Disk LN 4E43-03 4E43-06New Import Disk LN 2K89-02 2K90-02
Why does the RF assay have a Reaction Check programmed but the CRP assay does not?
The shape of the RF progress curve allows for use of the Reaction Check feature. At concentrations > 30 mg/dL, the CRP progress curve does not demonstrate enough difference in Read Times A & B for the Reaction Check flag to detect each occurrence. However, it was verified that the EXT and High flags work appropriately with CRP.
Why do AEROSET CRP control means listed in the Precision section of the package insert not match those for c 8000®?
Precision studies for the AEROSET and c 8000 Systems were done at different times with different lots of control material. The lots are referenced as Lots A and B in the package insert to note this difference.
Does the milky composition of the CRP R2 reagent have any impact on instrument dispense components?
No impact was observed over several years of internal product evaluation.
Did the CRP assay cause any build-up in the high-concentration waste pump manifold tubing?
No impact was observed over several years of internal product evaluation.
If a reagent kit was not mixed properly before use then discovered after the fact, would it be acceptable to mix and run controls to determine whether to continue use? The amount of volume used for testing prior to mixing would have some impact on the suitability for use, but is it correct that we have only control performance to use in evaluating that?
It would be acceptable to continue if only a small quantity of reagent was used. You would not want the ratio of liquid reagent and concentration of the microparticles to change in the R2 cartridge. The cartridge should be mixed by gentle inversion, then evaluate controls.
Frequently Asked Questions (FAQ) (Continued)
Question Answer
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As the lamp ages and performance diminishes, should we assume that results will increase for this assay? Logically, less lamp intensity would translate as additional turbidity, and therefore higher concentration. Were any study data generated with a diminished lamp?
A specific study has not been performed to evaluate diminished lamp intensity.
Frequently Asked Questions (FAQ) (Continued)
Question Answer
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Creatine KinaseFlexRate™ linearity is not stated in the Linearity section of the CK package insert; however, Flex Read times (22 – 25) and Abs Limits (0 – 2.8) are configured in the assay parameters.
The Flex Read Time is used if less than three data points fall within the absorbance range during the Main Read Time. However, because of the nature of the CK assay, this condition does not occur, and the Flex Read Time is never utilized by the AEROSET System for the CK assay. Linearity of CK is 4,267 U/L. To obtain a higher value than 4, 267, the result can be auto diluted 1:2 or 1:10 using the dilution protocols defined for the CK assay.
Digoxin (MULTIGENT®)
Spironolactone/Canrenone Interference Results
A case report by Steimer et al has shown that a negative bias in the determination of digoxin results may be observed when the aldosterone inhibitor spironolactone or canrenone is present in serum. A sample containing 2.0 ng/mL of digoxin was spiked separately with 800 µg/L spironolactone and 3,000 µg/L canrenone and analyzed with the MULTIGENT Digoxin assay. The following results demonstrate no significant interference.
Reference: Steimer W, Muller C, Eber B, et al. Intoxication due to negative canrenone interference in digoxin drug monitoring. Lancet 1999;354:1176–7.
SampleControl
Concentration Recovered
Compound (ng/mL Digoxin)
(nmol/L Digoxin)
(ng/mL Digoxin)
(nmol/L Digoxin)
Spironolactone 1.98 2.53 1.98 2.53
Canrenone 2.07 2.65 2.12 2.71
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Cross Reactivity
The following digoxin cross reactivity data are not included in the package insert.
NOTE: Test results were obtained with an alternate assay configuration with the same antibody as MULTIGENT® Digoxin.
Compound
Conc. of Cross Reactant Spiked
(ng/mL)
Digoxin Reported
Value (ng/mL)
% Cross Reactivity
Acetaminophen 1,000,000 0.0 0.0%
Cortisol(hydrocortisone)
10,000 0.0 0.0%
Cortisone 10,000 0.0 0.0%
Dehydroisoandrosterone 10,000 0.0 0.0%
D(+)-Digitoxose 10,000 0.0 0.0%
Estriol 10,000 0.0 0.0%
Furosemide 50,000 0.0 0.0%
Gitoxin 150 0.7 0.5%
Hydrochlorothiazide 100,000 0.0 0.0%
11α-Hydroxyprogesterone 10,000 0.1 0.001%
17α-Hydroxyprogesterone 10,000 0.0 0.0%
Lidocaine HCl 100,000 0.0 0.0%
Ouabain octahydrate 150 2.8 1.9%
Phenytoin 100,000 0.0 0.0%
Prednisolone 10,000 0.0 0.0%
Prednisone 10,000 0.0 0.0%
Procainamide 100,000 0.0 0.0%
Progesterone 10,000 0.0 0.0%
Propanolol HCl 100,000 0.0 0.0%
Quinidine sulfate dihydrate
100,000 0.0 0.0%
Salicylate 1,000,000 0.0 0.0%
Secobarbital 100,000 0.0 0.0%
Testosterone 5,000 0.0 0.0%
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AEROSET® System Troubleshooting Guide 12794816-107—November 2004
Sample Carryover
No sample carryover effects were observed when testing samples with high digoxin concentration (4.0 to 5.0 ng/mL) immediately before samples with low digoxin concentration (0.3 to 0.8 ng/mL).
Frequently Asked Questions (FAQ)
Question Response
MULTIGENT® Digoxin results do not match another method. Why?
MULTIGENT Digoxin is a competitive binding method, in which lowest levels of digoxin concentration produce highest signal levels. In addition, the reading wavelength of 700 nm minimizes interference from HAMA (human anti-mouse antibodies), hemolysis, bilirubin, and lipemia. The disagreement between methods may be due to cross reactivity and interference differences.
Which controls are recommended? Which controls have AEROSET assay values?
Bio-Rad Liquichek TDM control has been used successfully with this method, although system-specific assay values are not provided in the package insert. Onboard stability and 20 day precision testing were done with this product.
Why am I getting negative calibration rates? Is this normal?
This is normal. The competitive binding method provides a curve in which the signal is inversely proportional to concentration, i.e., low sample values produce the highest rates. The zero calibrator rate (highest rate) is used as a blank and is subtracted from the rates of all other calibrators, causing them to be negative.
How does this assay perform with DLIS (digoxin-like immunoreactive substances)?
Refer to the Interfering Substances section of the Digoxin package insert.
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Direct LDL (MULTIGENT®)
Sample Storage and Stability
• Samples should not be frozen at -20°C.
• Samples stored at -25°C for 1 month showed a – 14% bias.
• Samples stored at -80°C for 3 months showed a 2% bias.
Reagent Storage and Stability
• Do not freeze reagents.
• Protect reagents from light.
Calibrator Storage and Stability
• Do not refreeze calibrator.
• The calibrator should not be frozen at -20°C.
• The calibrator concentration changes with each lot number and is listed on the label.
• The calibrator is reconstituted with 1 mL DI water, allowed to stand for 5 minutes, and swirled until dissolved. Due to the low volume of the calibrator (1 mL), a 1 mL Class A volumetric pipette should be used.
• Do not shake the calibrator. Shaking can cause calibration inconsistencies due to bubbles in the vial.
• The calibrator is traceable to the National Reference System for Cholesterol, NRS/CHOL.
• The calibrator is supplied with the reagent, and cannot be ordered separately.
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AEROSET® System Troubleshooting Guide 12994816-107—November 2004
Linearity Verifiers (80-5953-00, 2 x 3 mL)
The Linearity Verifiers are Genzyme products and should be ordered from Genzyme. Verifiers are stable for 7 days when stored at 2 to 8°C.
Perform the following steps to confirm linearity of the assay.
1. Reconstitute with 3 mL of DI water, swirl, and let stand for 30 to 60 minutes at room temperature. Invert gently and let stand for an additional 15 minutes.
2. Make admixtures* from the high and low level verifiers, and run in quadruplicate.
* Admixtures are additional levels created by diluting the high and low level verifiers. Refer to the following table.
3. Graph the admixtures using 40% as the theoretical value. The 40% dilution is considered truth to calculate the remaining admixture’s theoretical values.
a. Calculate the mean value of the replicates for each dilution.
b. Calculate the theoretical value of each sample using the value determined for the 40% sample.
c. Plot the results: theoretical (x axis), mean values of the samples (y axis).
d. Inspect the plot for linearity and make a visual determination as to the acceptable reportable range.
e. Calculate the %recovery for each sample: %recovery = (mean result/theoretical result) × 100.
f. Each sample value should be within ± 10% of the theoretical value. If not, evaluate the clinical significance.
% Sample Volume High Verifier (µL)
Volume Low Verifier (µL)
0 0 500
20 100 400
40 200 300
60 300 200
80 400 100
100 500 0
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g. Document findings.
% Sample Mean Result
Theoretical Result %Recovery
0 0.5 0 N/A
20 175 174 (= 40% Mean Result × 0.5)
101%
40 347 347 100%
60 80 694 (= 40% Mean Result × 1.5)
102%
80 704 694 (= 40% Mean Result × 2.0)
101%
100 886 868 (= 40% Mean Result × 2.5)
102%
The reportable range has been verified up to 868 mg/dL.
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AEROSET® System Troubleshooting Guide 13194816-107—November 2004
Observed Problem
Frequently Asked Questions (FAQ)
Question/Comment Response
MULTIGENT® Direct LDL does not match the Friedewald (calculated) LDL.
• As the triglyceride level rises above 400 mg/dL, the Friedewald calculation underestimates the true LDL concentration.
• In the Friedewald, an erroneously calculated LDL result can be compounded by an error measuring total cholesterol, triglyceride, or HDL.
On a proficiency survey, the peer comparison looks OK—but the comparison to the reference method (ultracentrifugation) has a significant bias.
• Matrix effects are not uncommon with proficiency material, especially lipids.
• Results should be evaluated against the peer group for LDL.
• Comparison of the homogeneous LDL to ultracentrifugation should be performed using fresh serum samples.
The doctor is questioning the LDL result (high or low).
• Was the test repeated on the original serum or plasma sample?
• Are other lipid results available? Is the triglyceride level greater than 1,293 mg/dL?
• Sample integrity—verify the serum/plasma sample was stored at 2 to 8°C if not analyzed immediately.
• Was plasma used? Plasma in citrate tubes is not acceptable; use plasma in EDTA, sodium, or lithium heparin tubes.
A bias (negative or positive) is seen with CAP proficiency survey results.
Verify the customer is reporting under CAP Code 225: Liquid Selective Detergent.
Imprecision
Probable Cause(s) Corrective Action(s)
Problem with sample probe (e.g., not aligned, bent, etc.).
1. Run multiple reps of sample to confirm the problem exists.
2. If problem still exists, troubleshoot the sample probe. Refer to Section 10, Troubleshooting and Diagnostics of the AEROSET System Operations Manual.
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Ethanol
Specificity
Ethanol (ethyl alcohol) specificity was tested by conducting studies on specific compounds; refer to the package insert for additional information. An ethanol-free aqueous matrix was used. Levels tested exceeded toxic concentrations. Therefore, cross reactivity is not considered clinically significant, with the exception of n-propanol which showed a cross reactivity of approximately 10% in the Ethanol assay.
GGT
Observed Problem
Imprecision
Probable Cause(s) Corrective Action(s)
R2 reagent probe is not centered over the cuvette. If R2 reagent is dispensed down the side of the cuvette, complete reagent/sample mixing does not occur.
Adjust the R2 reagent arm over the cuvette. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
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AEROSET® System Troubleshooting Guide 13394816-107—November 2004
Haptoglobin
Observed Problem
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
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134 AEROSET® System Troubleshooting Guide94816-107—November 2004
Hemoglobin A1c (MULTIGENT®)
Reaction Diagram
Step 1
Step 2
Hemoglobin A1c concentration is inversely proportional to absorbance change. High absorbance change = low HbA1c concentration; low absorbance change = high HbA1c concentration.
HbA1c (Sample) Anti-HbA1c
Antibody:Microparticle Complex (Reagent 1)
HbA1c:Antibody:Microparticle Complex (lower rate of agglutination—increased
absorbance rate)
Remaining Unbound Anti-HbA1c
Antibody:Microparticle Complex (Reagent 1)
HbA1c Hapten (Reagent 2)
HbA1c:Antibody:Microparticle Complex (higher rate of agglutination—decreased
absorbance rate)
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AEROSET® System Troubleshooting Guide 13594816-107—November 2004
Pretreatment (Hemolysate Preparation)
1. Using a calibrated positive displacement micropipette, dispense 400 µL Hemoglobin Denaturant into a microcentrifuge tube.
NOTE: Dispense Hemoglobin Denaturant directly to the bottom of the tube; do not allow the denaturant to drip down the inside of the tube.
2. Using another calibrated positive displacement micropipette, withdraw exactly 10 µL of the well-mixed whole blood patient specimen or control.
3. Insert the pipette into the microcentrifuge tube containing the Hemoglobin Denaturant, allowing the tip of the pipette to barely make contact with the surface of the denaturant. Dispense the specimen (1:41 dilution).
4. Withdraw and redispense the mixture two times, keeping the tip of the pipette in constant contact with fluid in the tube.
5. Mix by gently vortexing at medium speed 5 to 10 seconds. Avoid foaming.
6. Prior to testing, allow the hemolysate to incubate for at least 5 minutes at 15 to 30°C.
7. Transfer hemolysate to a sample cup and place on the instrument.
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Accuracy by Recovery of Standards
Six midpoint samples were prepared by mixing 1:1 proportions of each calibrator with the next highest calibrator. In the following table, the shaded “theoretical” values are normal calibrator concentrations. The other values were prepared from these standards to yield the midpoint standards. An additional standard was created to test the very low end of the curve. Each midpoint sample was tested in triplicate; results are listed below.
The spline method of calibration matches the theoretical calculation value at the midpoints of the curve.
Theoretical g/dL
Recovered g/dL
Variation%
Variation g/dL
0.00 0.00 0 0
0.094 0.12 27.7 0.026
0.24 0.26 8.3 0.02
0.47 0.48 2.1 0.01
0.63 0.65 3.2 0.02
0.78 0.79 1.3 0.01
0.89 0.89 0 0
0.99 1.00 1.0 0.01
1.27 1.23 3.1 -0.04
1.54 1.57 1.9 0.03
1.80 1.85 2.8 0.05
2.06 2.06 0 0
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Hemoglobin Denaturant Storage Conditions
The recommended storage temperature for the Hemoglobin Denaturant is 2 to 8°C. A study was performed to evaluate the effect of room temperature storage of Hemoglobin Denaturant. The study used the same lot of Hemoglobin Denaturant, with one bottle stored at 4°C and another stored at room temperature (22°C). One normal and one high sample were used for the evaluation. Results are listed in the following table.
There is little to no apparent difference between the HbA1c result for the room temperature (22°C) and 4°C denaturant solutions.
Sample Mixing (Vortex Mixing vs. Pipet Mixing)
A study was performed to evaluate effects of vortex mixing and pipet mixing on sample results. Procedures to perform this study are included below.
Vortex Mix
1. 400 µL denaturant was added to plastic tubes, using the same tip for three tubes.
2. Blood sample was pipetted by rinsing the tip once with blood.
3. The pipet tip was wiped clean on the outside, with precautions taken to not wick any sample.
4. Blood was dispensed into denaturant and the tip was rinsed two times.
5. The treated sample was vortexed at medium speed approximately five seconds.
Room Temp 2 to 8°C
HbA1c g/dL
THb g/dL
HbA1c %
HbA1c g/dL
THb g/dL
HbA1c %
Level 1, Rep 1 0.75 15.2 4.9 0.73 14.1 5.2
Level 1, Rep 2 0.75 15.3 4.9 0.73 14.7 5.0
Level 2, Rep 1 1.62 14.1 10.7 1.52 13.8 11.0
Level 2, Rep 2 1.61 14.9 10.8 1.50 13.9 10.8
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Pipet Mix
1. 400 µL denaturant was added to plastic tubes.
2. Blood sample was pipetted by rinsing the tip once with blood.
3. The pipet tip was wiped clean on the outside, with precautions taken to not wick any sample.
4. Blood was dispensed into denaturant and the tip was rinsed two times.
5. The pipet tip used to dispense denaturant was used to mix the treated sample by pipetting and dispensing the sample five times.
The following data were observed.
There is no difference in the final HbA1c result based on mixing method.
Vortex Mix Pipet Mix
Prep 1, Rep 1 8.4 8.2
Prep 1, Rep 2 8.3 8.2
Prep 2, Rep 1 8.6 8.3
Prep 2, Rep 2 8.4 8.2
Prep 3, Rep 1 8.2 8.3
Prep 3, Rep 2 8.4 8.4
Mean 8.4 8.3
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Interference Information
Any condition that shortens RBC survival, e.g., hemolytic anemia or hemolytic diseases, pregnancy, and recent significant blood loss, results in decreased HbA1c.
Samples containing hemoglobin variants S and C may result in up to a 40% increase in apparent HbA1c result.
Samples containing > 10% HbF may give lower results.
Samples containing HbE were shown to not interfere.
The following table was obtained from the National Glycohemoglobin Standardization Program (NGSP) website; it lists effects of frequently encountered hemoglobin variants and derivatives on HbA1c (GHB) measurement. A list of references can be found on the website, http://web.missouri.edu/~diabetes/ngsp.html. All of these methods, with the exception of Beckman Diatrac and Helena Glyco-Tek, were NGSP certified as of March 2002.
Method
Interference (Yes/No)
HbC Trait
HbSTrait
HbE Trait
Elevated HbF
Carbamyl-Hb
Axis-Shield Nycocard (Primus Nycocard)
No No — — —
Bayer DCA 2000 No No No — No
Beckman Diatrac Yes Yes — Yes Yes
Beckman Synchron CX7 No No — — —
Bio-Rad Variant A1c No Yes No — Yes
Bio-Rad Variant GHb No No — — —
Bio-Rad Variant II A1c
No Yes/No Conflicting
data in literature
— No � 24%
HbF
No
Helena Glyco-Tek Yes No — — —
Menarini HA8140
No Yes Yes No Yes/No Conflicting
data in literature
Primus CLC 330/385 No No No — No
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Provalis Glycosal (Bio-Rad MicroMat)
Yes No — — —
Roche Cobas Integra Yes Yes — — —
Roche Tina-quant IINo No No No
� 30% HbF
No
Roche Unimate Yes Yes — — No
Tosoh A1c 2.2 Plus
No No Yes — Yes/No Conflicting
data in literature
Method
Interference (Yes/No)
HbC Trait
HbSTrait
HbE Trait
Elevated HbF
Carbamyl-Hb
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Frequently Asked Questions (FAQ)
Question Response
MULTIGENT® Hemoglobin A1c results do not match another method. Why?
MULTIGENT Hemoglobin A1c is an indirect method, in which lower HbA1c concentrations produce higher signal levels. This may provide less imprecision at these lower concentrations. The reading wavelength of 604 nm minimizes interference from HAMA (human anti-mouse antibodies), hemolysis, bilirubin, and lipemia.
Which controls are recommended? Which controls have AEROSET assay values?
MULTIGENT Hemoglobin A1c controls, LN 2K96-10, are recommended for the Hemoglobin A1c assay. Refer to the MULTIGENT Hemoglobin A1c Control value sheet for control ranges.
Why am I getting negative calibration rates? Is this normal?
This is normal. The indirect assay method provides a curve in which the signal is inversely proportional to concentration, i.e., low sample values produce the highest rates. The zero calibrator rate (highest rate) is used as a blank and is subtracted from the rates of all the other calibrators, causing them to be negative.
How does this assay perform with specific hemoglobin variants, e.g., HbA2, HbF, HbS?
Refer to the Interfering Substances section of the Hemoglobin A1c package insert.
The Reaction Mode for Total Hemoglobin is listed as END UP in the package insert. Why does the Reaction Graph appear to show an END DOWN reaction?
• This occurs because sample and reagent are added and mixed at Read Time 1. However, it takes time for the reaction mixture to settle. Bubbles and swirling of the mixture in the cuvette cause absorbance of the sample to start at a higher number than when the final read is taken.
• The reaction is classified as END UP because absorbance increases with increasing analyte concentration within the main read window.
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The Reaction Mode for HbA1c is listed as RATE UP in the package insert. Why does the Reaction Graph appear to show an END DOWN reaction?
• The reaction is defined as RATE UP because the change in absorbance per minute increases over time as agglutination occurs in the main read window.
• The appearance of the Reaction Graph is because the assay is based on competitive inhibition. When there is a small amount of HbA1c in the sample, the HbA1c hapten (agglutinator) in the R2 reagent binds with the HbA1c antibody-coated microparticles in the R1 reagent. The resultant agglutination causes increased absorbance.
• When HbA1c concentration in the sample is high, there is less agglutination because there are fewer binding sites available for the agglutinator. This results in a lower absorbance change over time.
Does Abbott have microcentrifuge tubes? Abbott TDx® centrifuge tubes, LN 9527-40 can be ordered. There are 100 tubes per box.
There is no sample probe SmartWash™ in assay configuration. Was hemolysate build-up on the sample probe an issue during assay testing?
Studies were run on assays most sensitive to hemolysis, and there was no evidence of hemoglobin interference. Also, calculations were done based on maximum sample probe carryover and the worst case of carryover was lower than hemoglobin interference claims for the assays most sensitive to it.
Why are four reagent cartridges provided for THb, and only two cartridges provided for HbA1c?
Reagent volume requirements are 200 µL for THb and 100 µL for HbA1c.
Besides MULTIGENT® HbA1c controls, have other vendor controls from been tested?
No.
Was sodium fluoride tested as an anticoagulant for the HbA1c assay?
No.
Frequently Asked Questions (FAQ) (Continued)
Question Response
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AEROSET® System Troubleshooting Guide 14394816-107—November 2004
ICT™
L and H (Reference Range) Result Flags Display with No Result when Error Log Message 351 or 352 Is Generated
When the Error Log Message “351 - ICT Reference Solution Cup Not Filling” or “352 - ICT Reference Solution Not Aspirated” is generated, the ICT result is masked but the L and H result flags display.
Resolution: There is no corrective action to mask the L and H flag. Refer to Error Log Messages—Supplemental Information in Section 10, Troubleshooting and Diagnostics of the AEROSET System Operations Manual for initial recovery from Error Log Messages 88, 351, and 352.
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Immunoglobulin A
Observed Problems
Assay button text is black
Probable Cause(s) Corrective Action(s)
Diluent not loaded and/or configured in assay parameters.
Configure correctly and/or load diluent.
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
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AEROSET® System Troubleshooting Guide 14594816-107—November 2004
Immunoglobulin G
Observed Problems
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
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Immunoglobulin M
Observed Problems
Assay button text is black
Probable Cause(s) Corrective Action(s)
Diluent not loaded and/or configured in assay parameters.
Configure correctly and/or load diluent.
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
Issues with the source lamp. Check the lamp:• Normal lamp function: flat line between
reads 2 and 16, and a smooth line bending from vertical to horizontal between reads 17 and 33.
• Lamp degeneration: progress curve not smooth (exhibits an erratic sawtooth appearance).
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
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AEROSET® System Troubleshooting Guide 14794816-107—November 2004
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
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Iron
Interference Information
Desferal is the brand name for deferoxamine mesylate or desferoxamine; it is an iron chelating substance indicated for the treatment of acute iron intoxication and chronic iron overload. Desferal prevents iron from entering into further chemical reactions and readily chelates iron from ferritin and hemosiderin, but not readily from transferrin. It does not combine with iron from cytochromes and hemoglobin. Young states that Desferal (desferoxamine) chelates iron, making it unavailable to react with most chromagens thereby giving falsely low iron concentrations. Young also states, “At concentrations of 250 mg/dL and higher iron concentration reduced when measured by method on Kodak Ektachem systems”. In addition, the Vitros uses ascorbic acid as a reducing agent. Ascorbic acid is unique in its property not only to reduce but also chelate iron. Iron methodologies containing ascorbic acid are prone to over-recovery of serum iron liberated from non-transferrin sources. In one study, ascorbic acid significantly and selectively increased iron concentrations and iron recovery measured on the Ektachem.
Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed. Washington, DC: AACC Press, 1995:3-361–3-364.
Letter to Editor, Underestimation of serum iron with automated methods, Clin Chem 1995;41:1199–1201.
Physicians’ Desk Reference 54th Edition, Montvale, NJ, Medical Economics Company, 2000;54:2012–2013.
Kempinaire A, Laureys M, Goedhuys W, et al. Spuriously low concentrations of serum iron measured with Generation 14 Kodak Ektachem slides: prevalence, possible causes, and partial improvement with Generation 16 slides, Clin Chem 1992; 38:2457–64.
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AEROSET® System Troubleshooting Guide 14994816-107—November 2004
Magnesium
Units Conversion
Current assay configuration settings for the Magnesium assay provide mEq/L as conventional units and mmol/L as international (SI) units. If magnesium values will be reported in mg/dL units, edits to assay configuration parameters and Magnesium calibrator values are required. Editing the reporting units does not automatically convert the appropriate parameters.
In the Abbott Clinical Chemistry Iron/Magnesium calibrator package insert, calibrator values for the Magnesium assay are provided in mEq/L and mmol/L units. The calibrator vial lists Magnesium units in mEq/L only, due to limited area available on the vial label. Package inserts will be revised at a later date to include values for mg/dL; these values are listed in the following table.
When converting units for an assay, the following parameters must be edited, if applicable, using the appropriate conversion factor.
• Calibrator Values
• Panic Range
• Min and Max Values
• Reference Range
• Linear Range
• Qualitative Range
• Control Means
mEq/L mmol/L mg/dL
Magnesium Calibrator Value CAL 1
1.0 0.50 1.2
Magnesium Calibrator Value CAL 2
4.0 2.00 4.9
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Perform the following steps to convert Magnesium results from mEq/L to mg/dL.
1. Multiply existing values by the conversion factor, 1.215.
2. Edit the following parameters as described in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual. The following example uses values listed in the Abbott Clinical Chemistry Magnesium package insert, Commodity No. 30-3348/R6, March 2004.
3. On the Base page of the Assay Configuration screen, edit the Units field from mEq/L to mg/dL.
4. Edit control mean values on the CALIBRATOR/CONTROL screen.
5. Verify all edits are saved.
6. Calibrate the Magnesium and/or Magnesium Urine assays as appropriate.
7. Run two levels of controls to verify the calibration.
Parameters Requiring Edits Serum/Plasma Values in mg/dL
Urine Values in mg/dL
L-Reference 2.1 User defined value × 1.215, rounded to one significant digit
Reference-H 2.8 User defined value × 1.215, rounded to one significant digit
L-Linear Range 0.7 0.4
Panic-L User defined value × 1.215, rounded to one significant digit
User defined value × 1.215, rounded to one significant digit
Panic-H User defined value × 1.215, rounded to one significant digit
User defined value × 1.215, rounded to one significant digit
Linear Range-H 9.5 5.2
Magnesium Calibrator Value CAL 1
1.2 1.2
Magnesium Calibrator Value CAL 2
4.9 4.9
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AEROSET® System Troubleshooting Guide 15194816-107—November 2004
Methadone
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table yielded a negative result at 300 ng/mL methadone (Multi DOA Cutoff calibrator) when tested at the concentration listed.
Compound SYVA Package Insert µg/mL
N-Acetylprocainamide (NAPA) 400
l-Alpha-methadol 2
Buprenorphine 100
Caffeine 1,000
Cimetidine 1,000
Clomipramine 2.5
Clonidine 1,000
Cotinine 100
Cyclobenzaprine 28
Desipramine 800
Diphenhydramine 500
Doxepin 10
2-Ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)
1,000
Fluoxetine 500
Glutethimide 500
Ibuprofen 1,000
Ketamine 100
Ketorolac tromethamine 1,000
Lysergic acid diethylamide (LSD) 10 ng/mL
Naproxen 1,000
Phenytoin 1,000
Ranitidine 900
Scopolamine 500
Tramadol 100
Tyramine 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
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Microalbumin (MULTIGENT®)
Specimen Storage
If specimens cannot be analyzed immediately, they should be stored observing the following guidelines:
• Up to two weeks at 4°C
• Up to five months at -70°C
• Repeated freeze/thaw cycles should be avoided
• Frozen specimens must be adequately mixed prior to testing; if not, reduced values could be observed
Frequently Asked Questions (FAQ)
Question Response
Can I use another vendor’s controls, or is use of MULTIGENT Microalbumin controls required?
Bovine or other sourced control material, e.g., Bio-Rad controls, do not work with the MULTIGENT Microalbumin assay. The control must be a human-sourced control.Use MULTIGENT Microalbumin controls, LN 2K98-10.
If controls are out of range, what troubleshooting should be performed?
1. Check the dryer tip. If the dryer tip is not perfectly aligned, residual water or excess protein can remain in the cuvettes.
2. Inspect the sample probe for protein build-up.
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AEROSET® System Troubleshooting Guide 15394816-107—November 2004
Opiates 300
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table yielded a negative result at 300 ng/mL morphine (Opiates 300 calibrator) when tested at the concentration listed.
Compound SYVA Package Insert µg/mL
Acetaminophen 1,000
N-Acetylprocainamide (NAPA) 400
Acetylsalicylic acid 1,000
Alpha-acetyl-N, N-dinormethadol(dinor LAAM)
25
l-Alpha-acetylmethodol (LAAM) 25
Amitriptyline 500
Buprenorphine 100
Caffeine 1,000
Cimetidine 1,000
Clomipramine 2.5
Clonidine 1,000
Cotinine 100
Cyclobenzaprine 28
Desipramine 800
Diphenhydramine 1,000
Doxepin 10
2-Ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)
1,000
Fluoxetine 500
Glutethimide 500
Ibuprofen 1,000
Ketamine 100
Ketorolac tromethamine 1,000
Lysergic acid diethylamide (LSD) 10 ng/mL
Naproxen 1,000
Nortriptyline 750
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NOTE: Therapeutic doses of ofloxacin (Floxin) or levofloxacin (Levaquin), non-opiates, may produce positive results with this assay. A positive result from an individual taking ofloxacin or levofloxacin should be interpreted with caution and confirmed by another method.
Phenytoin 1,000
Promethazine 143
Ranitidine 900
Scopolamine 500
Thioridazine 100
Tramadol 100
Tyramine 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
Compound SYVA Package Insert µg/mL
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AEROSET® System Troubleshooting Guide 15594816-107—November 2004
Opiates 2,000
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table below yielded a negative result at 2,000 ng/mL morphine (Multi DOA Cutoff calibrator) when tested at the concentration listed.
Compound SYVA Package Insert µg/mL
Acetaminophen 1,000
N-Acetylprocainamide (NAPA) 400
Acetylsalicylic acid 1,000
Alpha-acetyl-N, N-dinormethadol(dinor LAAM)
25
l-Alpha-acetylmethodol (LAAM) 25
Amitriptyline 1,000
Buprenorphine 100
Caffeine 1,000
Cimetidine 1,000
Clomipramine 2.5
Clonidine 1,000
Cotinine 100
Cyclobenzaprine 28
Desipramine 800
Diphenhydramine 1,000
Doxepin 10
2-Ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)
1,000
Fluoxetine 500
Glutethimide 500
Ibuprofen 1,000
Ketamine 100
Ketorolac tromethamine 1,000
Lysergic acid diethylamide (LSD) 10 ng/mL
Naproxen 1,000
Nortriptyline 750
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156 AEROSET® System Troubleshooting Guide94816-107—November 2004
NOTE: Therapeutic doses of ofloxacin (Floxin) or levofloxacin (Levaquin), non-opiates, may produce positive results with this assay. A positive result from an individual taking ofloxacin or levofloxacin should be interpreted with caution and confirmed by another method.
Phenytoin 1,000
Promethazine 1,000
Ranitidine 900
Scopolamine 500
Thioridazine 100
Tramadol 100
Tyramine 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
Compound SYVA Package Insert µg/mL
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AEROSET® System Troubleshooting Guide 15794816-107—November 2004
Phencyclidine
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table yielded a negative result at 25 ng/mL phencyclidine (Multi DOA Cutoff calibrator) when tested at the concentration listed.
Compound SYVA Package Insert µg/mL
Acetaminophen 1,000
N-Acetylprocainamide (NAPA) 400
Acetylsalicylic acid 1,000
l-Alpha-acetylmethodol (LAAM) 25
Buprenorphine 100
Caffeine 1,000
Cimetidine 1,000
Clomipramine 2.5
Clonidine 1,000
Codeine 500
Cotinine 100
Cyclobenzaprine 28
Desipramine 800
Diphenhydramine 1,000
Doxepin 10
2-Ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)
1,000
Fluoxetine 500
Glutethimide 500
Ibuprofen 1,000
Ketorolac tromethamine 1,000
Lysergic acid diethylamide (LSD) 10 ng/mL
Naproxen 1,000
Nortriptyline 750
Phenytoin 1,000
Ranitidine 900
Scopolamine 500
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Tramadol 100
Tyramine 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
Compound SYVA Package Insert µg/mL
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AEROSET® System Troubleshooting Guide 15994816-107—November 2004
Prealbumin
Observed Problems
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
Issues with the source lamp. Check the lamp:• Normal lamp function: flat line between
reads 2 and 16, and a smooth line bending from vertical to horizontal between reads 17 and 33.
• Lamp degeneration: progress curve not smooth (exhibits an erratic sawtooth appearance).
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
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Propoxyphene
Cross Reactivity Testing Performed on the AEROSET System by SYVA
Compounds listed in the following table yielded a negative result at 300 ng/mL propoxyphene (Multi DOA Cutoff calibrator) when tested at the concentration listed.
Compound SYVA Package Insert µg/mL
Acetaminophen 1,000
N-Acetylprocainamide (NAPA) 400
Acetylsalicylic acid 1,000
Alpha-acetyl-N, N-dinormethadol(dinor LAAM)
25
l-Alpha-acetylmethodol (LAAM) 25
Buprenorphine 100
Cimetidine 1,000
Clomipramine 2.5
Clonidine 1,000
Cotinine 100
Diphenhydramine 1,000
Doxepin 10
Fluoxetine 500
Glutethimide 500
Ibuprofen 1,000
Ketamine 100
Ketorolac tromethamine 1,000
Lysergic acid diethylamide (LSD) 10 ng/mL
Meperidine 1,000
Naproxen 1,000
Phenytoin 1,000
Ranitidine 900
Scopolamine 500
Thioridazine 100
Tramadol 100
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AEROSET® System Troubleshooting Guide 16194816-107—November 2004
Tyramine 100
Zidovudine (AZT) 2 mg/mL
Zolpidem 100
Compound SYVA Package Insert µg/mL
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Rheumatoid FactorBefore troubleshooting the RF assay, ensure the assay parameters were configured correctly. Do not install the RF assay using assay parameters on the Import Disk—Serum Proteins Version 1.0.
NOTE: At the end of control shelf life, means may shift and control ranges may need to be reestablished. Bio-Rad Liquichek RF Control Level 1 varies in concentration.
Recommendation: Do not use Level 1 if < 15 IU/mL.
Standard Material Recovery
Recovery accuracy results of the standard material are summarized in the following table.
Assay Standard Material N Units Expected
ValueRecovered
(Mean) Value %Recovery
RF (LN 8G66)
WHO 64/2 4 mg/dL 3.92 3.8513 98.25
4 IU/mL 105.73 115.62 109.35
4 IU/mL 50.93 52.47 103.02
4 IU/mL 26.43 27.19 102.87
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AEROSET® System Troubleshooting Guide 16394816-107—November 2004
Frequently Asked Questions (FAQ)
Question Response
How much shift is observed for the RF Bio-Rad Liquichek control toward the end of shelf life?
The Bio-Rad Liquichek Immunology control package insert states, “Variation over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents or by manufacturer test method modifications.”For the Abbott Clinical Chemistry RF assay application, we used control ranges of approximately 15%. In one case, the control ranges needed to be reset for controls near expiration. In one other case, controls possibly stored inappropriately required reevaluation after control ranges were established.Based on our experience, however, the need to reevaluate control ranges should be infrequent.
The RF R2 reagent contains latex microparticles. Is inversion of R2 reagent required before every run to ensure the particles do not settle?
Inversion is not required before running the test. The latex microparticles are very small and remain suspended after the R2 cartridge is initially inverted and placed on the Reagent Carousel.Although a specific study was not performed, we suspect the carousel movement keeps the microparticles suspended.
How much control variability should be observed between reagent lots of the RF assay?
The RF assay was tested with a minimum of three lots. These lots included freshly prepared reagent, and one nearing the expiration date. Minimal variability in controls was observed. Control ranges (also called Action Limits) were not reset with a change in reagent lot.
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Were plasma specimens evaluated for use with the RF assay?
Yes. Initially, it was the project development team’s goal to develop a plasma claim for the RF assay application. Acceptable performance was observed with the majority of plasma specimens.However, there is a small population of plasma specimens that will generate a falsely elevated result. Therefore, it was not possible to generate a reliable plasma claim and customers should not use plasma specimens with the RF assay.
How would results be affected if reagent kits are inadvertently frozen during delivery? The package insert does not address this issue.
The customer should check QC performance. Freeze/thaw studies by the OEM supplier support acceptable performance with frozen material.
Will customers have an issue if there are not enough Abbott assay users when results from a proficiency survey are compared to other manufacturers’ RF assays?
CAP surveys do not work with RF and should not be used. The cause for this is under investigation. The RF assay cannot be used with plasma specimens, and CAP survey sample is based on plasma as well as other processing which makes it a very artificial matrix.
Were gel barrier tubes tested for use with the RF assay?
A study has not yet been performed with gel barrier tubes. However, this will be considered for a future study.
Frequently Asked Questions (FAQ) (Continued)
Question Response
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AEROSET® System Troubleshooting Guide 16594816-107—November 2004
During RF precision studies on the AEROSET and c 8000®, how many points were below the LOQ of 10, and excluded for the Level 1 control?
None. Excluding data points from the precision study would have prevented achieving the correct number of test results per the NCCLS protocol.Before performing any studies that involved a control (either for testing or assay validity check), a lot of Bio-Rad Liquichek Immunology controls requires setting Action Limits. If a specific control lot had a result for the Level 1 control that was too low, it was not assigned an Action Limit or used in subsequent studies. In those cases, only Level 2 and 3 materials were used.The frequency of obtaining a Level 1 control with a concentration too small is dependent on Bio-Rad manufacturing processes.
If RF is not inverted before use, what errors are observed?
A specific study has not been performed. However, if latex particles have settled to the bottom of the reagent cartridge and are not pipetted, it is possible that low absorbance values could be observed.
Is the Hitachi method for RF a turbidimetric method?
Boehringer Mannheim reagents for use on Hitachi instruments are described by the BM package inserts as “immunological agglutination” which is a turbidimetric method.
Is the assay number for the new RF assay the same as the original RF assay?
Yes. However, this it not an issue because the “original” RF assay was never released to customers.A new Import Disk—Serum Proteins Version 2.0 was released with the new RF assay.
Conv Units SI UnitsOld Import Disk LN 4E43-03 4E43-06New Import Disk LN 2K89-02 2K90-02
Frequently Asked Questions (FAQ) (Continued)
Question Response
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Why does the RF assay have a Reaction Check programmed but the CRP assay does not?
The shape of the RF progress curve allows for use of the Reaction Check feature. At concentrations > 30 mg/dL, the CRP progress curve does not demonstrate enough difference in Read Times A & B for the Reaction Check flag to detect each occurrence. However, it was verified that the EXT and High flags work appropriately with CRP.
Why do AEROSET RF control means listed in the Precision section of the package insert not match those for c 8000®?
Precision studies for the AEROSET and c 8000 Systems were performed at different times with different lots of control material. The lots are referenced as Lots A and B in the package insert to note this difference.
Does the milky composition of the RF R2 reagent have any impact on instrument dispense components?
No impact was observed over several years of internal product evaluation.
Did the RF assay cause any build-up in the high-concentration waste pump manifold tubing?
No impact was observed over several years of internal product evaluation.
If a reagent kit was not mixed properly before use then discovered after the fact, would it be acceptable to mix and run controls to determine whether to continue use? The amount of volume used for testing prior to mixing would have some impact on the suitability for use, but is it correct that we have only control performance to use in evaluating that?
It would be acceptable to continue if only a small quantity of reagent was used. You would not want the ratio of liquid reagent and concentration of the microparticles to change in the R2 cartridge. The cartridge should be mixed by gentle inversion, then evaluate controls.
As the lamp ages and performance diminishes, should we assume that results will increase for this assay? Logically, less lamp intensity would translate as additional turbidity, and therefore higher concentration. Were any study data generated with a diminished lamp?
A specific study has not been performed to evaluate diminished lamp intensity.
Frequently Asked Questions (FAQ) (Continued)
Question Response
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AEROSET® System Troubleshooting Guide 16794816-107—November 2004
Total Bilirubin
Observed Problem
Total Protein
Interference Information
Dextran has been reported to negatively interfere with the Abbott Clinical Chemistry Total Protein assay, a biuret method.
The following summary is from the Methods in Clinical Chemistry, 1987, by Laurence A. Kaplan.
“Low molecular weight dextrans interfere with the biuret assay. The dextrans, used as plasma volume expanders for the treatment of low blood pressure, complex with copper and tartrate in the reaction mixture and form a precipitate. The degree of the resulting interference varies greatly with the concentration of dextran and the composition of the biuret reagent. The percent interference can range from 3% to 5% at usually encountered dextran levels. Although the interference is usually a positive one, a negative interference was reported for the bichromatic DuPont ACA procedure.”
Direct Bilirubin result exceeds Total Bilirubin result
Probable Cause(s) Corrective Action(s)
Total bilirubin concentration of 0.2 mg/dL (3.4 µmol/L) or less; observed when nearly all reacting bilirubin is direct bilirubin.
For information only. In this situation, individual laboratories should establish reporting guidelines.
Hemolyzed sample. Obtain a new sample.
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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168 AEROSET® System Troubleshooting Guide94816-107—November 2004
Transferrin
Observed Problems
LH Result Error Code observed when result is less than the highest calibrator
Probable Cause(s) Corrective Action(s)
Linear Range-H field not edited to high calibrator concentration.
Edit the Linear Range-H field to the high calibrator concentration (as stated in the calibrator value sheet).
Poor precision or erroneous results
Probable Cause(s) Corrective Action(s)
R2 reagent arm is out of alignment. Adjust the R2 reagent arm. Refer to Reagent Arm Adjustment in the Hardware section of this guide.
R2 reagent is not dispensed correctly. • Check R2 dispense components (sample or reagent probe, syringes, wash, mixer, tubing).
• Check the reagent cartridge for bubbles or foam. If present, remove with an applicator stick; use a new applicator stick for each cartridge.
• Check reagent adapters to verify they are seated properly.
Reagent container bar code label not read
Probable Cause(s) Corrective Action(s)
Bar code label not positioned correctly.
Check positioning of the R1 and R2 reagent bottles; verify the bar code label is facing the center of the carousel.
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Assays/Reagents
AEROSET® System Troubleshooting Guide 16994816-107—November 2004
Valproic Acid (MULTIGENT®)
Accuracy by Recovery
Five midpoint samples were prepared by mixing 1:1 proportions of each calibrator with the next highest calibrator.
For example: 100 µL CAL 1 (0 µg/mL) + 100 µL CAL 2 (12.5 µg/mL) yields a 6.25 µg/mL standard.
Each midpoint sample was tested in triplicate and results are listed in the following table.
Interference Information
Any assay using mouse antibodies has potential for interference from human anti-mouse antibodies (HAMA) in the patient sample. To test this, we obtained a normal human serum pool (control) and two types of human anti-mouse antibodies, HAMA type 1 and HAMA type 2. We then spiked them with identical amounts of valproic acid. Each sample was assayed in duplicate on the AEROSET System using the MULTIGENT Valproic Acid assay. The means of both duplicate HAMA samples were compared to the mean of the control normal human serum. Test results show a recovery of 100 + 10%.
Expected Average Diff
Midpoint # (µg/mL) (µg/mL) %Recovery (µg/mL)
1 6.25 5.61 89.8 -0.64
2 18.75 19.10 101.9 0.35
3 37.50 37.60 100.3 0.10
4 75.00 78.41 104.5 3.41
5 125.00 122.52 98.0 -2.48
N Mean(µg/mL) %Recovery
Control 2 98.24 —
HAMA 1 2 90.96 92.6
HAMA 2 2 94.2 95.9
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170 AEROSET® System Troubleshooting Guide94816-107—November 2004
Frequently Asked Questions (FAQ)
Question Response
MULTIGENT® Valproic Acid results do not match another method. Why?
MULTIGENT Valproic Acid is an indirect method, in which lower valproic acid concentrations produce higher signal levels. The reading wavelength of 604 nm minimizes interference from HAMA (human anti-mouse antibodies), hemolysis, bilirubin, and lipemia. The disagreement between methods may be due to cross reactivity and interference differences.
Which controls are recommended? Which controls have AEROSET assay values?
Bio-Rad Immunoassay Plus controls have been used successfully with this method, although system-specific assay values are not provided in the package insert.
Why am I getting negative calibration rates? Is this normal?
This is normal. The competitive binding method provides a curve in which the signal is inversely proportional to concentration, i.e., low sample values produce the highest rates. The zero calibrator rate (highest rate) is used as a blank and is subtracted from the rates of all other calibrators, causing them to be negative.
AEROSET® System Troubleshooting Guide 17194816-107—November 2004
Section 10: Software
System Troubleshooting Guide
Software
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NOTES
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AEROSET® System Troubleshooting Guide 17394816-107—November 2004
Color Coding on the AEROSET System
Assay OK(Green)
Reagent Low/Cal error(Yellow)
Reagent expiredor empty/calibrationexpired orunusable
(Pink)
Illegal assay(Black)
Database Running(Brown)
Pending(Pink)
Complete/not validated
(Blue)
Incomplete/not validated
(Blue)
Validated(Black)
Run Progress Patient Sample(Gray)
STAT Sample(Pink)
Calibrator(Green)
Control(Yellow)
Water Bath Hot(Pink)
OK(Green)
Cold(Blue)
ControlsLevey-Jennings
Graph
2 SD(Yellow)
1 SD(Green)
3 SD(Red)
Outside 3 SD(Blue)
Cal SummaryPending/
Cal expired(Pink)
OK(Black)
Failed(Brown)
START UPSHUTDOWN
Bulk solutionslow
(Red)
Bulk solutionsOK
(Green)
Reagent Expired/empty(Pink)
OK(Green)
Reagent low(Brown)
Reagentscanned
(Brown text)
Reagentmanually
configured(Black text)
Assay Status Previous curve(grey)
Current curve(blue)
Stored curve(pink)
Error Log Level 1(Red)
No error(Gray)
Level 2(Pink)
Level 3(Yellow)
(Gray)(Blue) (Pink)
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174 AEROSET® System Troubleshooting Guide94816-107—November 2004
Exporting Files
Exported Data
A change was made to the name of the folder to which data are exported. In software v1.00ER005 and v1.00ER005.2, the folder was named USR. In software v1.02ER000, the folder is named EXTERNAL.
This change does not impact file names (which are user defined) and does not impact the export function.
Exported Files
Due to an anomaly associated with the Export function, when exported files are imported into a PC spreadsheet (.csv format), certain characters may not appear correctly on the spreadsheet. The following are some examples of this anomaly:
• French character é appears as “,”
• Spanish character ú appears as “£”
To correct the problem, manually edit the affected characters on the spreadsheet.
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Software
AEROSET® System Troubleshooting Guide 17594816-107—November 2004
Host Interface Trace LogWhen transmission errors occur, the system generates an Error Log Message. The message in the Display Area no longer appears.
Use the following instructions to enable the Host Interface Trace log.
1. Log On with the “extra” or “guest” level user code and password.
2. Hold down the [Alt] key on the keyboard and press [Print Scrn]. The CONTROL BOX dialog window displays.
3. Select <Special> in the drop-down list box. The c:\ prompt appears in the Display Area.
4. Type dbgmode at the c:\ prompt then press [Enter].
5. In the drop-down list box next to Online, select <Printer>.
6. Select <OK>.
7. Type exit at the c:\ prompt to return to the Main Display.
When the Host communication error “Illegal Message: Text Error” is generated, ensure the Host is configured to resend the sample.
Use the following instructions to disable the Host Interface Trace log.
1. Log On with the “extra” or “guest” level user code and password.
2. Hold down the [Alt] key on the keyboard and press [Print Scrn]. The CONTROL BOX dialog window displays.
3. Select <Special> in the drop-down list box. The c:\ prompt appears in the Display Area.
4. Type dbgmode at the c:\ prompt then press [Enter].
5. In the drop-down list box next to Online, select <NONE>.
6. Select <OK>.
7. Type exit at the c:\ prompt to return to the Main Display.
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176 AEROSET® System Troubleshooting Guide94816-107—November 2004
Observed Problems—Software=
Auto Rerun is not performed on replicate samples
Probable Cause(s) Corrective Action(s)
System functionality. Manually order the rerun. Dil 1 or Dil 2 must be selected manually, if required.
CLT Result Error Code falsely generated for a diluted sample
Probable Cause(s) Corrective Action(s)
The following sample aspiration sequence occurred:1. A sample that requires a dilution is
aspirated from the sample cup.2. A clotted sample is aspirated and a
CLT Result Error Code is generated.
3. The sample probe moves to the wash cup to attempt removal of clot.
4. The diluted sample cannot be dispensed into a new cuvette and is flagged with a CLT Result Error Code.
After the clot or clotted sample is removed from the system, rerun the diluted sample.
<START> is selected on the RUN OPTIONS screen to begin a run, but the run is not initiated; system status is READY
Probable Cause(s) Corrective Action(s)
<START> was selected when the system status was changing from SUSPEND to READY.
1. Select <RUN> in the Action Area of the Main Display. The RUN OPTIONS screen displays.
2. Select <START> to initiate the run.
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AEROSET® System Troubleshooting Guide 17794816-107—November 2004
<START> is selected on the SELECT ASSAYS FOR STAT screen to begin a run, but the run is not initiated; system status is RUN
Probable Cause(s) Corrective Action(s)
<START> was selected when the system status was changing from SUSPEND to READY.
1. Select <STAT> in the Action Area of the Main Display. The SELECT ASSAYS FOR STAT screen displays.
2. Select <START> to initiate the run.
Unresolved Host communications error, including but not limited to Error Log Message 339 Time Out, Order Not Received from SCC
Probable Cause(s) Corrective Action(s)
Communication failure between the AEROSET system and Host interface.
Cycle power on both the AEROSET system and Host computer.
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Quality Control
Interval QC
Interval QC is not based on the actual number of samples for an assay, but is based on the number of samples aspirated on the FastTrack™ or Sample Carousel. When the “As Needed” option is selected, QC will not run for an assay if samples were not run for that assay. When “As Needed” is not selected, the QC will run for every defined control at the set interval, whether or not samples are ordered for the assay.
Interval QC for all assays is reset by the instrument being powered off or when the interval occurs on a different day. In this example, the system was powered off as part of SHUTDOWN and the interval for the QC was reset.
QC Rounding
For a QC result to be flagged with an “L” or “H” Result Flag, the mean concentration and SD must be considered. A result is rounded to the reporting number of decimals for an assay after comparing the result to the QC range.
The range in the following example is 90 to 100.
When the result is 90, it is not known if the actual value was 90.001 (no Flag) or 89.999 (L Flag).
Actual Result Rounded Results Result Flag
90 90.0 L or No Flag
89.15 89.2 L
99.49 99.5 No Flag
99.89 99.9 No Flag
99.91 99.9 No Flag
99.95 100.0 No Flag
100 100.0 H or No Flag
100.34 100.3 H
100.45 100.5 H
100.56 100.6 H
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AEROSET® System Troubleshooting Guide 17994816-107—November 2004
QC Statistics—Decimal Places
The decimal places used for QC statistics are based on the value configured in the Decimal Places field on the Base page of the Assay Configuration screen.
Mean = Decimal places value + 1 additional decimal place
SD = Decimal places value + 1 additional decimal place
CV = 2 Decimal places (fixed)
Range = Decimal places value
Decimal Places Value (Base Page
of Assay Configuration
Screen)
Decimal Places of Mean Values
Decimal Places of SD Values
Decimal Places of CV Values
Decimal Places of Range Values
1 2 2 2 1
2 3 3 2 2
3 4 4 2 3
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180 AEROSET® System Troubleshooting Guide94816-107—November 2004
Rounding of NumbersThe AEROSET System allows only 7 digits, one of which may be a decimal. When the last digit is 5 or greater, the number rounds up. If the last digit is less than 5, the number rounds down. For example, 1.15 rounds to 1.2 and 1.14 rounds to 1.1.
Sample Sequence/Smart Sampling
Smart Sampling Selected Smart Sampling Deselected
Sample Sequence Defined
Only acknowledges ICT™ assays defined in Sample Sequence. Aspirates photometric assays using Smart Sampling scheduling. Iron* is always aspirated last.
Runs assays as defined in Sample Sequence, except Iron. Then runs assays in the order of buttons on the ASSAYS screen (left to right). Iron* is last, independent of button placement.
Sample Sequence Not Defined
Aspirates using Smart Sampling scheduling. ICT assays are run later in the run. Iron* is always aspirated last.
Aspirates in the order of buttons on the ASSAYS screen (left to right). Iron* is last, independent of button placement.
* Iron special handling is due to 2-cycle sample aspiration requirements.
• Sample Sequence—will run first defined A-Line assay with first defined B-Line assay, etc.• Does run a B-Line assay in cuvette pair where ICT assays are run as A-Line.
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
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AEROSET® System Troubleshooting Guide 18194816-107—November 2004
Screen Hierarchy
Act
ion
Are
a o
f th
e M
ain
Dis
pla
y
RU
N O
PT
ION
S
SE
LEC
T A
SS
AY
S F
OR
ST
AT
ST
AR
T U
P O
PT
ION
S
SH
UT
DO
WN
OP
TIO
NS
ER
RO
R L
OG
HO
ST
CO
MM
UN
ICA
TIO
N
Prin
ter
Con
figur
atio
n
Log
On
Sys
Cfg
Bee
p O
FF
Sm
plS
eq
Sam
plin
g
ON
LIN
E
CO
NF
IGU
RA
TIO
N
Res
etE
rr
Sys
tem
SC
C
Rgt
Are
a 2
Rgt
Are
a 1
QC
Rul
e
Rxn
Are
a
SW
Info
MA
INT
EN
AN
CE
U
TIL
ITIE
S
Prin
t
ST
OP
RE
AG
EN
T S
CA
N
RU
N O
PT
ION
SS
ysC
fgS
mpl
Seq
QC
Rul
e
Can
cel
Sav
e
Sta
rt
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Info
rmat
ion
Acc
ess
Are
a o
f th
e M
ain
Dis
pla
y
Ord
erP
rint
AS
SA
YS
Del
Pre
v
RE
SU
LT
Prin
t Opt
ions
Pag
e S
etup
Ord
er S
ampl
es
LJ G
raph
Ass
ay S
tatu
s
Res
ult
CA
LIB
RA
TIO
N
SU
MM
AR
Y
QC
SU
MM
AR
Y
CA
LIB
RA
TO
R/
CO
NT
RO
L
Dat
esD
etai
lA
vera
ge
Con
figC
alib
Exp
ort
Dat
alis
tD
etai
ls
QC
Rep
lace
Cle
arW
izar
dE
xpor
tIm
port
Fre
eTex
t
ReC
alc
Edi
tR
erun
Rea
ctio
n G
raph
Acc
ept
Cal
ibra
tion
Bas
eO
utlin
e
Add
Del
ete
Leve
y-Je
nnin
gs
Gra
ph
Cal
Det
ails
Rer
un R
ules
Sm
artW
ash
QC
Err
or S
tatu
s
Set
2S
et 1
C/C
Crs
l
Abs
Dat
aE
xpor
t
Sav
eE
xpor
tIm
port
Prin
t
Set
3
Exp
ort
Dat
alis
tD
etai
ls
Del
ete
R1-
DR
1-C
R1-
BR
1-A
Vie
w
R2-
BR
2-A
R2-
CR
2-D
Cle
ar A
llR
epor
t
Opt
ions
For
m1/
2P
rint
Prin
tA
djus
ted/
Fre
e/N
orm
al
Prin
t
Sta
tus
Prin
t
Prin
t
Cle
ar A
llA
llS
tore
dP
rint
All
Exp
ort
Prin
t
D. R
ange
Del
ete
Del
ete
Rec
alc
Exp
ort
Rer
unR
xnG
raph
Acc
ept
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AEROSET® System Troubleshooting Guide 18394816-107—November 2004
Screen Navigation
Main Display
REAGENTS Screen
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REAGENTS (Supply Center Segment) Screen
Reagent Supply Center Segment Details Screen
DILUENT
Bar Code Scanned (Reagent name text is BROWN)
Manually Configured (Reagent name text is BLACK)
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AEROSET® System Troubleshooting Guide 18594816-107—November 2004
DATABASE Screen
Search Dialog Window
Patient Demographics Dialog Window
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Print Options Dialog Window—Order List/Loadlist
Order Samples Screen
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PAGE SETUP Screen (Form 1)
Form 1 Report
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PAGE SETUP Screen (Form 2)
Define Free Text Screen
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AEROSET® System Troubleshooting Guide 18994816-107—November 2004
Form 2 Report
On-line Data Transfer Dialog Window
5/21/98 13:10 Instrument #: 0001
Address 1Address 2Address 3Address 4Address 5
Sample ID: Age:Name: Nelson ,Harry Sex:Patient ID: Doctor:Carrier/Pos: 1(4) Date/Time Run: 5/21/98 11:32Comment:
ASSAY LOW/HIGH RESULT REFERENCE RANGES
Na-S L 135 mmol/L 136.0 - 145.0CO2 25 mEq/L 22.0 - 29.0Urea 12 mg/dL 7.0 - 18.0ALT 12 U/L 10.0 - 35.0Crea H 1.4 mg/dL 0.7 - 1.3Ca H 12.3 mg/dL 8.4 - 10.2Phos L 2.6 mg/dL 2.7 - 4.5TBil 0.8 mg/dL 0.2 - 1.0
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RESULT Screen
RESULT Screen—Viewing Rerun Result
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AEROSET® System Troubleshooting Guide 19194816-107—November 2004
Reaction Graph Screen—Error Code
Reaction Graph Screen—Rate Assay
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Reaction Graph Screen—End-point Assay
Absorbance Data Screen
DATABASE Screen, Accept Results Dialog Window
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AEROSET® System Troubleshooting Guide 19394816-107—November 2004
CALIBRATOR/CONTROL Screen
CALIBRATOR/CONTROL Screen—Set 1
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Position Dialog Window
CALIBRATION SUMMARY Screen
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Calibration Details Screen
QC SUMMARY Screen
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Levey-Jennings Graph Screen
Print Options (QC) Dialog Window
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Levey-Jennings Graph Report
QC Details Dialog Window
QC Data List Screen
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ASSAYS Screen
ASSAY STATUS Screen
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Assay Configuration Screen, Outline Page
Assay Configuration Screen, Base Page (End-point Assay)
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200 AEROSET® System Troubleshooting Guide94816-107—November 2004
Assay Configuration Screen, Base Page (Rate Assay)
Assay Configuration Screen, Calibration Page (Linear Calibration Mode)
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Assay Configuration Screen, SmartWash™ Page
Assay Configuration Screen, Rerun Rules Page
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RUN OPTIONS Screen
SYSTEM CONFIGURATION Screen
NOTE: The Sample Barcodes, Reagent Barcodes, External Robotics, and ICT™ fields can only be edited using guest Log On.
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SELECT ASSAYS FOR STAT Screen
Pause Function
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Unpause Function
START UP OPTIONS Screen
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SHUTDOWN OPTIONS Screen
ERROR LOG Screen
Level 1 (Red)
Level 2 (Pink)
Level 3 (Yellow)
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MAINTENANCE UTILITIES Screen, System Page
NOTE: Zero Set is only visible with guest Log On.
MAINTENANCE UTILITIES Screen, SCC Page
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MAINTENANCE UTILITIES Screen, Sampling Page
NOTE: Step Edit is visible only with guest Log On.
Pressure Monitor Screen
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MAINTENANCE UTILITIES Screen, Rgt Area 1 Page
MAINTENANCE UTILITIES Screen, Rgt Area 2 Page
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MAINTENANCE UTILITIES Screen, Rxn Area Page
Cuvette Blank Screen
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Cuvette Integrity Check Screen
MAINTENANCE UTILITIES Screen, SW Info Page
Printer A Configuration Window
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ONLINE (HOST) CONFIGURATION Dialog Window
Run Progress Area
Log On Screen
User Alert Dialog Window
With Optional Clot Detection and Sample Carryover Reduction Installed
Without Optional Clot Detection and Sample Carryover Reduction Installed
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System Configuration
FAC Limit % Field—Configuration
The FAC Limit % field was added to the Calibration page of the Assay Configuration screen with software version 1.02ER000. Acceptable entries in the FAC Limit % field range from 0 to 99. After installation of software v1.02ER000, the default setting is 10. If set to zero, the FAC Limit check is not performed.
For those assays configured on the AEROSET System at the time of software installation, the default setting for the FAC Limit % field is 10.
Any assays imported (from the Import Disks listed below) after upgrade to software v1.02ER000 will have a FAC Limit % default setting of 0 and must be edited to 10.
The FAC Limit % was defined as 10 (%) in all versions of AEROSET software prior to v1.02ER000, but this was not an editable field. This value was used in validation testing for all currently released Abbott assays and was applied to any non-Abbott assays configured on the system prior to v1.02ER000.
For non-Abbott assays or manually configured assays—the default setting will be 10 for the FAC Limit % field.
Refer to Assay Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual for instructions on editing the FAC Limit % field.
• 4E43-02/4E43-05 Import Disk 1–50/Import Disk >50
• 4E43-08/4E43-09 Import Disk Drugs of Abuse v5.00
• 4E43-03/4E43-06 Import Disk Serum Proteins v3.0
• 4E43-04/4E43-07 Import Disk TDMs v4.00
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System Configuration Software Disk v3.0
The AEROSET System Configuration Software Disk v3.0 can only be used with AEROSET software v1.00ER005.0 or v1.00ER005.2.
Do not use System Configuration Software Disk v3.0 with AEROSET software v1.02ER000 or greater. Installation of the System Configuration Software Disk v3.0 on a v1.02ER000 AEROSET System adversely affects system parameters on the Unit Configuration and automatic Startup/Shutdown Setting screens.
NOTE: AEROSET System software version 1.03ER000 prevents restoration of System Configuration parameters using a System Configuration disk created from a different version of system software.
The Unit Configuration and automatic Startup/Shutdown Setting screens should only be accessed by Abbott personnel. Perform the following steps to access these screens.
1. Log On with the “extra” or “guest” level user code and password.
2. Perform the steps below to access the Unit Configuration or automatic Startup/Shutdown Setting screens.
a. Press [Alt] + [Print Screen] on the keyboard at the same time. The CONTROL BOX dialog window displays.
b. Press [�] on the keyboard to highlight the Special option then press [Enter] to select. A DOS window with the c:\prompt displays.
c. Type the appropriate entry to access the desired screen:
• Type unitconf then press [Enter] to access the Unit Configuration screen.
• Type setups then press [Enter] to access the automatic Startup/Shutdown Setting screen.
3. Edit the appropriate fields back to the default settings listed in the following sections. These screens should match exactly, except those fields noted as customer defined.
4. Select <OK> to save the settings and exit.
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5. For the Unit Configuration screen only: select <OK> on the Save Parameters confirmation dialog window to return to the c:\ prompt.
6. Type exit then press [Enter].
7. Select the Exit icon in the Action Area of the Main Display to Log Off the system.
8. On the Log On screen, type bye in the User Code field.
9. Perform the Power OFF Procedure; wait 15 seconds then Power ON the system.
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Unit Configuration Default Screen
The default view of the AEROSET software v1.02ER000 Unit Configuration screen is shown below. Also included is a table that describes fields on the Unit Configuration screen which can be affected if the System Configuration Software Disk v3.0 is loaded after upgrade to software v1.02ER000.
Figure 7: Unit Configuration Screen, Default View
Figure 8: Unit Configuration Default Screen, Default View Page 2 (Software Version 1.02ER000)
NOTE: For software v1.03ER000, refer to the following page for default settings on the Unit Configuration screen, Page 2.
1 24 3
5
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* Customer defined at v1.02ER000 installation. Refer to the Installation Configuration Questionnaire included in the most recent revision of TSB 125-022.
** Not customer defined. These fields should not be changed from the default settings.
Unit Configuration Screen, Default View Page 2 (Software Version 1.03ER000)
Figure 9: Unit Configuration Default Screen, Default View Page 2 (Software Version 1.03ER000)
NOTE: The New Sample Wash Cup option should only be selected if the optional hardware upgrade was installed. Review the Log On screen to determine if this hardware was installed.
Unit Configuration Screen
Field Default Setting
1. Priority on Rgt Bar Code* Deselected
2. Multiple Rgt Ctgs* Deselected
3. Reagent Link* Deselected
4. Area/20mlW** 305
5. ICT™ reference cup check**
Selected
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Startup/Shutdown Setting Default Screens
Default views of the AEROSET software v1.02ER000 automatic Startup/Shutdown Setting screen are shown below. Also included is a table that describes fields on the Startup/Shutdown Setting screen which can be affected if the System Configuration Software Disk v3.0 is loaded after upgrade to software v1.02ER000.
Figure 10: Startup/Shutdown (Startup-1) Settings Screen, Default View
* None of the Automatic START UP Options are customer defined. Each of these settings should match the defaults listed in this table.
Automatic START UP Options
Option Startup-1 Startup-2 Startup-3
Change Bath-water X X X
Wash Cuvettes X X X
Wash Probes by: Water Alk Water
• Water• Alk (Wash)• Acid (Wash)• Alk + Acid
Wash ISE by: ICAL EW + ICAL
• ICAL (IRef)• EW (I-Clean)• EW + ICAL
Change MCC(Drain & Fill IRef Cup)
X X
Probe Air Purge(Flush Water Lines)
X X X
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Figure 11: Startup/Shutdown (Shutdown-1) Setting Screen, Default View
Automatic SHUTDOWN Options
Option Shutdown-1 Shutdown-2 Shutdown-3
Change Bath-water X X X
Wash Cuvettes X X X
Fill with Dtg
Wash Probes by:
• Water• Alk (Wash)• Acid (Wash)• Alk + Acid
Alk Water Alk
Wash ISE by:
• ICAL (IRef)• EW (I-Clean)• EW + ICAL
EW + ICAL
Change MCC(Drain & Fill IRef Cup)
X
Clear Database:• Cal, QC• All Results• All Records• Cal, QC, QC Clo• All Res., QC Clo• All Rec., QC Clo
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User Codes/PasswordsA new user code/password was created to give customers access to “extra” level functions. The password changes daily, so the customer does not have permanent or ongoing access. The new user code is “guest” and the password is the same daily number used for IMx® and AxSYM®.
1 0507 21 0729
2 0128 22 0321
3 0908 23 1128
4 0816 24 0701
5 1006 25 0603
6 0222 26 0808
7 0524 27 0418
8 1026 28 0922
9 0130 29 1102
10 0817 30 0221
11 1107 31 0702
12 0513 32 0220
13 0616 33 1207
14 0202 34 0315
15 1016 35 0405
16 0728 36 1216
17 0614 37 0810
18 0416 38 1126
19 1119 39 0717
20 0924 40 0521
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NOTES
AEROSET® System Troubleshooting Guide 22194816-107—November 2004
Section 10: Hardware
Hardware
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NOTES
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CPU Used with the AEROSET SystemThe following table describes units used with the AEROSET System.
.
Figure 11: AEROSET CPU, Rear View (133/233 MHz)
CPU Memory (RAM)
ETM10-AD Pentium 133 MHz 16 MB
Pentium MMX 233 MHz 64 MB
Celeron 566 MHz 256 MB
KeyboardPort
Printer Port
125649
Host Port
PowerReceptacle
Monitor Port Touchscreen GPIBPort
Alignment Pin
Port
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Figure 12: AEROSET CPU, Rear View (566 MHz)
Power Receptacle Printer Port
Monitor Port Touchscreen Port
GPIB Port
Keyboard Port Host Port
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Cuvettes
Cuvette Volumes—Minimum and Maximum
Volumes (Min and Max) for the reaction cuvettes:
• Minimum volume in cuvette to achieve adequate mixing = 100 µL
• Minimum volume to achieve photometric reads = 160 µL
• Maximum volume of cuvette = 360 µL
Cuvette Warranty
The AEROSET cuvette warranty is one year post-installation.
Cuvette Identification
New cuvettes (type H) are shipped dry; however, cuvettes have been shipped dry since cuvette type G. That remains a valid way to identify “good” cuvettes, but type G cuvettes are also acceptable.
The only exact way to identify cuvettes is on the cuvette segment itself. The letter designation is located on the underside of the cuvette segment. In the following illustration, note the YC at the bottom. The C indicates this is a cuvette type C. There is no way to identify individual cuvette cells.
Figure 13: Cuvette Segment, Underside
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GPIBGPIB is the acronym for General Purpose Interface Bus.
ICT™ Warranty InformationThe ICT module is warranted for whichever occurs first:
• A period of two months after installation on the AEROSET System, or
• 15,000 ICT samples, or• Until the expiration date on the package label.
Before troubleshooting the ICT module, verify it is within the stated usage period. The ICT module expiration date is on the label of the ICT module box. The expiration date can also be calculated by adding seven months to the date of manufacture coded in the ICT module lot number.
The customer should receive the ICT module a minimum of 90 days before the expiration date.
Noise SpecificationsWhen the instrument is running, continuous noise is 64 decibels (dB); non-continuous noise is 68 dB. For example, non-continuous noise is caused by an additional pump or degasser running that normally does not run the entire time a sample test is processing.
EXAMPLE: AA80717002
Month
Year
Day
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Observed Problems—Hardware
Figure 14: Clot Detection Pressure Sensors
Erroneous Error Log Messages related to the Clot Detection system:341 Invalid Status Was Received from PM Board342 Sample Aspiration Error Occurred (A-Line)343 Sample Aspiration Error Occurred (B-Line)344 Unable to Remove Sample Probe Obstruction (A-Line)345 Unable to Remove Sample Probe Obstruction (B-Line)
NOTE: Refer to the following illustrations for details.
Probable Cause(s) Corrective Action(s)
Sample probe is obstructed or damaged.
Clean or replace sample probe.
Sample arm tubing is crimped. Replace the sample arm tubing.
Pressure sensor tubing is loose or crimped.
Reseat or replace the pressure sensor tubing.
Pressure sensor is defective. Contact your Abbott Reprepresentative to replace the pressure sensor.
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Figure 15: Clot Detection Pressure Sensors (Close-up)
Fatal Error: GPIB Error Log Message X (X equals 1 through 11)
Probable Cause(s) Corrective Action(s)
• GPIB cable is loose or defective.• CPU printed circuit board is
defective.• Flash memory data are corrupt.• SCC previously configured in
Demo mode and software reloaded.
1. Reseat the GPIB cable.2. Reset error in the Error Log.3. Cycle power to the analyzer.4. Flash memory.5. Reconfigure SCC to Demo mode.
Cable to PCB
Tubing to Probe
Sensor
Tubing to Syringe
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Reagent Supply Centers have no water
Probable Cause(s) Corrective Action(s)
Water evaporated. Ensure Reagent Supply Center covers are securely in place.
Flush Water Lines option of the START UP Procedure was not performed.
Perform the Flush Water Lines option of the START UP Procedure.• Ensure water is present in the Reagent
Supply Center.• If still unresolved, contact your Abbott
Representative.
Cuvette wash pump valve failure or crimped tubing.
Contact your Abbott Representative.
System DI water source is not functioning.
1. Check the DI water system.2. Perform the Flush Water Lines option of the
START UP Procedure. Refer to Section 9, Service and Maintenance of the AEROSET System Operations Manual.
3. Check for water delivery to the Reagent Supply Centers.
Bellows pump failure/valve failure. Contact your Abbott Representative.
Refrigerator condensation pan contains bluish water
Probable Cause(s) Corrective Action(s)
A bluish tint in the water originating from the Reagent Supply Centers’ refrigerated condensation units is caused by a coating within the unit. This observation is normal. The length of time of this situation varies, relative to the daily amount of condensation generated by the instrument. Under normal conditions, the bluish water should not persist longer than one month post-installation.
None required.
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Serial NumbersInterpretation of AEROSET serial numbers:
A = AEROSET
3 = 2003, 2 = 2002, 1 = 2001, 0 = 2000, 9 = 1999, 8 = 1998, 7 = 1997
51 = January, 52 = February, 53 = March, 54 = April, 55 = May, 56 = June, 57 = July, 58 = August, 59 = September, 60 = October, 61 = November, 62 = December
2 = Space holder
001 = Sequence Number
For example A0542236 means AEROSET, April 2000, Sequence Number 236.
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Specifications
Water
USP Purified and WFI Requirements
Purified Water Water for Injection
Conductivity Not greater than 2.1 mS/cm at 25°C*
Not greater than 2.1 mS/cm at 25°C*
pH 5.0 to 7.0 5.0 to 7.0
Total Organic Carbon Not greater than 500 ppb Not greater than 500 ppb
Total Bioburden Does not exceed 10,000 CFU/100 mL
Does not exceed 10,000 CFU/100 mL
Endotoxin N/A Not more than 0.25 Endotoxin Unit per mL
Coliform Level Zero per 100 mL Zero per 100 mL
* Refer to USP 24/NF19 Monograph <645> “Water Conductivity” if conductivity meter is not temperature compensated, or conductivity value exceeds 2.1 mS/cm at 25°C.
NOTE: The above USP specifications are derived from the ASTM Type III Specification.
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Verification Procedures/Adjustments/Alignments
Lamp Gain and A/D Check
Perform the following procedure to check lamp gains and A/D reads. This will determine if the lamp should be replaced or if additional troubleshooting is necessary.
Materials Required
None
Procedure
1. Ensure the system status is READY.
2. Remove one cuvette segment.
3. Select the Maintenance Utilities icon in the Action Area of the Main Display. The MAINTENANCE UTILITIES screen displays.
4. Select the Rxn Area tab. The Rxn Area page displays.
Figure 16: MAINTENANCE UTILITIES Screen, Rxn Area Page
5. Using the Rxn Crsl buttons, rotate the Reaction Carousel to place the empty position in the optics light path.
6. Select Shutter <ON> to open the shutter.
Rxn Crsl
Shutter
Data
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7. Select <Data>. The Photometer and ICT™ A/D Data screen displays.
Figure 17: Photometer and ICT A/D Data Screen
8. Observe the displayed Gain and A/D values. Ensure the Gain values are � 2.6 AND A/D readings are > 35,000, with a range of < 300.
NOTE: If the Gain value is 2.6 AND A/D reading is � 35,000, or if the Gain value is 4.0, replace the lamp. Refer to Source Lamp Replacement in Section 9, Service and Maintenance of the AEROSET System Operations Manual. After lamp replacement, recheck the Gain and A/D values; verify all Gain values are � 2.6 and A/D readings are > 35,000. If not resolved, contact your Abbott Representative.
9. Print the screen for reference. Select <OK>. The Rxn Area page of the MAINTENANCE UTILITIES screen displays.
10. Select Shutter <OFF> to close the shutter.
11. Using the Rxn Crsl buttons, rotate the Reaction Carousel to replace the cuvette segment.
12. Select Rxn Crsl <Home>.
13. Select <OK> to exit the Rxn Area page.
14. Select <Cancel>.
Gain and A/D Values
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Reagent Arm Adjustment
NOTE: Ensure the reagent probe is not bent or damaged before performing any of the following adjustment procedures.
NOTE: The following procedures can be used for both the R1 and R2 probe reagent arm adjustment.
Materials Required
Empty reagent cartridge, large size
R1A Probe Horizontal Adjustment
NOTE: Any robotic position can be adjusted using the Adj (Adjust) button, clockwise or counterclockwise, after moving the robotic arm to that particular position.
1. Select the Maintenance Utilities icon in the Action Area of the Main Display. The MAINTENANCE UTILITIES screen displays.
2. Select the Rgt Area 1 tab. The Rgt Area 1 page displays.
3. Install a clean, empty reagent cartridge in position A1 of the Reagent Supply Center.
Figure 18: MAINTENANCE UTILITIES Screen, Rgt Area 1 Page
A-LIne (Outer)A <Adj>
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4. Select A-Line (Outer) A <Adj> to position the empty cartridge in the R1A adjustment position.
5. Select Rgt Arm A Horz Rgt <Adj>.
CAUTION: The R1A reagent probe moves over the Reagent Carousel.
6. Verify the reagent probe is centered over the cartridge in position A1.
7.
8. Select <Adjust> on the right side of the screen.
If... Then
Reagent probe is not centered over the cartridge
Proceed to step 8.
Reagent probe is centered over the cartridge
Proceed to step 16.
!
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9. Select <CW> (clockwise) or <CCW> (counterclockwise) as needed to center the probe over the reagent cartridge.
10. When the probe is centered, select <OK> to save the position.
11. Verify the probe position.
12. Select Rgt Arm A Vert Down <Adj>. Verify the probe is centered in the cartridge.
13. Select Rgt Arm A Vert Home/Up <Adj>.
NOTE: Proceed to step 14 if additional adjustment is needed.
14.
NOTE: If unable to center the probe front to back, proceed to Reagent Carousel Alignment.
15. When the probe is centered, select <OK> to save the position.
16. Select <OK> on the MAINTENANCE UTILITIES screen then select <OK> on the Home All Robotics dialog window.
If... Then
Reagent probe is not centered in the cartridge
Repeat steps 7 through 12.
Reagent probe is centered in the cartridge
Proceed to step 15.
CounterclockwiseClockwise
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Reagent Carousel Alignment
NOTE: This procedure is performed after R1A Probe Horizontal Adjustment.
1. Install a clean, empty reagent cartridge in position A1 of the Reagent Supply Center.
2. Select the Maintenance Utilities icon in the Action Area of the Main Display. The MAINTENANCE UTILITIES screen displays.
3. Select the Rgt Area 1 tab. The Rgt Area 1 page displays.
4. Select Rgt Arm A Horz Rgt <Adj>.
5. Select A-Line (Outer) A <Adj>.
Figure 19: MAINTENANCE UTILITIES Screen, Rgt Area 1 Page
NOTE: Steps 1 through 5 position the empty cartridge in the R1A adjustment position.
A-Line (Outer)A <Adj>
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6. Verify reagent probe alignment over the reagent cartridge.
7. Select <Adjust> on the right side of the screen.
8. Select <CW> (clockwise) or <CCW> (counterclockwise) as needed to center the probe over the reagent cartridge.
9. Select <OK> to save the position.
10. Select Rgt Arm A Vert Down <Adj>.
11. Verify the reagent arm position.
12.
13. Select Rgt Arm A Vert Home/Up <Adj>.
14. Repeat steps 4 through 12.
If... Then
Reagent probe is not aligned over the reagent cartridge
Proceed to step 13.
Reagent probe is aligned over the reagent cartridge
Select <OK> on the MAINTENANCE UTILITIES screen then select <OK> on the Home All Robotics dialog window.
CounterclockwiseClockwise
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R1A Probe Cuvette Alignment
1. Select the Maintenance Utilities icon in the Action Area of the Main Display. The MAINTENANCE UTILITIES screen displays.
2. Select the Rgt Area 1 tab. The Rgt Area 1 page displays.
Figure 20: MAINTENANCE UTILITIES Screen, Rgt Area 1 Page
3. Select Rgt Arm A Cuv <Adj>.
Rgt Arm ACuv <Adj>
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4. Verify the R1A probe is centered over the A-Line cuvette in the Reaction Carousel.
5.
6. Select <Adjust> on the right side of the screen.
If... Then
R1A probe is not centered over the cuvette
Proceed to step 6.
R1A probe is centered over the cuvette
Proceed to step 9.
A-Line Cuvette
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7. Select <CW> (clockwise) or <CCW> (counterclockwise) as needed to center the probe over the reagent cartridge.
NOTE: If unable to align the reagent probes, contact your local Abbott Representative.
8. Select <OK> to save the position.
9. Select <OK> on the MAINTENANCE UTILITIES screen then select <OK> on the Home All Robotics dialog window.
Clockwise
Counterclockwise
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R1A Probe Wash Cup Alignment
1. Select the Maintenance Utilities icon in the Action Area of the Main Display. The MAINTENANCE UTILITIES screen displays.
2. Select the Rgt Area 1 tab. The Rgt Area 1 page displays.
Figure 21: MAINTENANCE UTILITIES Screen, Rgt Area 1 Page
3. Select Rgt Arm A WCup <Adj>.
NOTE: The reagent arm may not move if it is centered over the wash cup.
Rgt Arm AWCup <Adj>
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4. Verify the R1A probe is centered over the wash cup.
5.
6. Select <Adjust> on the right side of the screen.
If... Then
R1A probe is not centered over the wash cup
Proceed to step 6.
R1A probe is centered over the wash cup
Proceed to step 9.
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7. Select <CW> (clockwise) or <CCW> (counterclockwise) as needed to center the probe over the wash cup.
8. Select <OK> to save the position.
9. Select Rgt Arm A Vert Down <Adj>.
10. Verify the R1A probe is centered in the wash cup.
11.
12. Select Rgt Arm A Vert Home/Up <Adj>.
13. Repeat steps 3 through 12.
NOTE: If the probe fails to align in the wash cup, contact your Abbott Representative.
14. Select <OK> on the MAINTENANCE UTILITIES screen then select <OK> on the Home All Robotics dialog window.
If... Then
Reagent probe is not centered in the wash cup
Proceed to step 12.
Reagent probe is centered in the wash cup
Proceed to step 14.
CounterclockwiseClockwise
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Flowcharts
TroubleshootingFlowcharts
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NOTES
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Abbott Assay—Basic Assay Troubleshooting
Customerperceive assayis performingas expected?
Canperformance
change be tracedto a certain
event or date?
Yes
Text for assayon ASSAYS
screen green?Yes Stop
Investigate thefollowing
bullet points(next page)
Troubleshootevent, or
investigateimplementationof different lots/
shipments ofreagent or
calibrator fordate in question
Yes
No
NoNo
Yes
No
Proceed toQC OOR
FlowchartQC OOR?
Proceed toIllegal
Configuration orCalibration
ErrorsFlowchart
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Abbott Assay—Basic Assay Troubleshooting, Continued
Assay Characteristics
If multiple assays are affected, look for similar characteristics such as:
• Same line
• Assays using R1 only vs. assays using R1 and R2
• Similar wavelengths
• Same calibrators
• Same sample and reagent volumes
• Rate vs. end-point reaction
If the issue affects one assay:
• Verify assay parameters with the assay-specific package insert
• Was a different bottle of reagent, calibrator, or control used, and was it handled correctly?
• Was a different lot of calibrator or reagent used?
• Are there any non-Abbott assays on the original line? If so, were carryover studies performed between those assays and the affected assay?
• Move the assay to an alternate line. If the issue is not resolved, proceed to step 2 of Instrument Troubleshooting.
Instrument Troubleshooting
1. Is the issue on both lines? If yes, troubleshoot common items, including:
• Lamp
• Cuvette washer
• Water
• Bulk solution use
• Maintenance
• Probe/mixer wash flow
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2. If issue is only on one line, troubleshoot:
• Sample probes for damage, obstruction, and alignment
• Reagent probes for damage, obstruction, and alignment
• All probe tubing for crimps or leaks
• Sample, reagent, and wash solution syringes
• Mixers
• Maintenance
• Probe/mixer wash flow
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Non-Abbott Assay—Basic Assay Troubleshooting
System ErrorLog Messages
NoOnly affected
assay?
What isconcern?
Illegal assayconfiguration:
noteassay-specific
error.Abbott Dist.
OEM reagents?
Followrecommended
troubleshooting inOperations
Manual
Yes
QC in range?
Canperformance
change betraced to a
certain eventor date?
Customertried freshreagent &
calibrators?
Open freshreagent &
calibrators;recalibrate.Resolved?
Yes
Was this aninstrumentevent? (e.g.,service call,
maintenance)
Abbott assayswith similar
characteristicsperforming as
expected?
Troubleshootevent
Investigateenvironment,operator, &
Refer toVendor
Yes
Instrumentmaintenanceup to date?
YesCarryover
studiesperformed?
Refer toVendor
Performcarryoverstudies
NoNo
No
Performmaintenance,recalibrate, &rerun controls
Yes
No
Yes
Refer toVendor
Yes
No
Patient issue?Sample
handlingcorrect?
No
Yes
Correct &repeat.
Resolved?
No
Stop
All calibratortargets entered
correctly?Yes
Calibrationconcern?
No No
Correctvalues &
recalibrate.Resolved?
No
No
Yes
Yes
Obtain fax ofcustomer
parameters.Verify assay
configurationparameters.
Correct?
Yes
Correctconfiguration& rerun assay
No
Obtain fax ofcustomer TPF &
vendorconfiguration.
Correct?
No
Yes
YesRefer toVendor
Yes
No
QC concern?
Recalibrate &rerun QC. OK?
QC prep &handling OK?
Preparefresh
controls &rerun QC.
OK?
AcceptData
Yes
YesNo
No
Yes
No
Yes
Yes
Yes
Start
Yes
Yes
Refer toVendor
Was event anew lot ofreagent orcalibrator?
No
Proceed toAbbott Assay—
Basic TSFlowchart
Proceed toIllegal
ConfigurationFlowchart
Proceed toAbbott Assay—
Basic TSFlowchart
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Flowcharts
AEROSET® System Troubleshooting Guide 25194816-107—November 2004
Confirmation of Assay Parameter Settings (Illegal Configuration)
Check ifreagent ordiluent is
onboard. OK?
Reagent ordiluent
manuallyconfigured?
If black—assayparameter is
definedincorrectly
Select the assaybutton; select<STATUS> on
ASSAY STATUSscreen
Reagent oncorrect line?
No
Replace cartridge& touch newcartridge on
Reagent SupplyCenter SegmentDetails screen
Check individualAssay button &verify buttoncolor is black
Start
Load reagents thenperform reagent
scan or load diluent& configuremanually
No
Yes
Yes
Cartridgeempty or
low?
Move reagent tocorrect line &
rescan reagentsNo
Yes
Bar codelabel facingoutward?
Yes
Labeldamaged?
No
Readjustcartridges thenperform reagent
scan
YesManuallyconfigurereagent
No
Select tab onREAGENTS
screen matchingthe position;
reagent present?
No
Access Base pageon Assay
Configurationscreen; may needto pull in correct
position forreagent name/
position
Clear position& rescanreagents
Proceedto #2
(next page)Yes
Is Assay-specificError Message 10,11, or 12 visible?
Verify correctreagent & positionare on Base page
configuration. OK?
Yes
Bar codereader
windowclean?
Yes
No
Clean bar codereader windowthen performreagent scan
Yes
Yes
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Flowcharts Not for Customer Distribution
252 AEROSET® System Troubleshooting Guide 94816-107—November 2004
Confirmation of Assay Parameter Settings (Illegal Configuration), Continued
If everything is OK, and assay is still illegally configured (assay text still black), verify the following:
1. Assay name is in range 1 to 9999.
2. If a calibrator is defined, it must be placed in the specified position.
3. If a Use Factor calibration method is specified, the assay for the referred calibration curve must be configured.
4. If a diluent is defined, it must be placed in the specified position.
5. Sample Interference Indices—photometric assays to be run must be specified and configured.
6. Calculation Assays—all assays used for the calculation must be configured.
7. If a non-self (user defined assay file) blank is defined, the specified test must be configured.
8. Multiple Rgt Ctgs option is ON and R2 and/or R2 reagent is empty.
2
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Flowcharts
AEROSET® System Troubleshooting Guide 25394816-107—November 2004
Erratic Results
Multipleassays?
Probesdripping?
Probescentered?
No
Yes
No
No
Edit assay
Recalibrate
Edit setpoints
Reagentexpired?
All maintenanceup to date?
Yes NoYes
QC & patientsamples?
Linespecific? No
Incubatordirty?
No
Patientonly?
NoQConly?
No
Probedamaged/
obstructed?
Replace poppetvalve. Dripping
resolved?
Check QChandling
No
Bubbles insyringes?
Yes
Assay configcorrect?
Calibrationcurrent?
Cal setpoints
correct?
Yes
YesNo
No
Yes
No
No
Quarterlymaintenance Yes
No
Non-Abbottassays?
No
SmartWashesconfigured?
Mixers OK?
Replace/styletprobe(s)
Yes
Yes
Carryoverstudy Yes
Replace mixers
Yes
No
No
No
Replace syringeseal tips &
O-rings.Drippingresolved?
Lamponboard
> 2 months?
ReplacelampYes
Drain & fillwater bath
Yes
Cuvettesegments
loose?Yes
Wash nozzlesdripping ormisaligned?
No
No
Yes
Cuvetteoverfill?
Dryer tipsdiscolored?
No
ConfigureSmartWashes™
Tighten
Styletnozzles
Yes
Replacetips
CuvetteIntegrity
pass?
Cuvetteoverfill?
HC wasteblocked?
Washcuvettes
manually
No
Yes
No
Replacereagent
Performmaintenance
Service
Yes
Yes
Yes
No
No
Yes
Yes
No
Yes
Yes
Yes
Performprecision runon selectedassays. OK?
Yes
No
No
Yes
No
Service
Stop
Replacepoppet
valves oralign
cuvettewasher
Yes
Precisionrun. OK?
Service
Stop
Yes
No
Precisionrun
Realignprobes
Replacetubing
Tubingkinked?
Check samplehandling
Precisionrun. OK?
Address any error codes. Refer to specific Troubleshooting in AEROSET System Operations Manual
Multiple reagent cartridgesin use with Rgt Link ON
(in SW v1.02ER000)?
Verfy emptycartridge is replaced
after changeover,before Reagent Scan
Yes
Yes
No
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Flowcharts Not for Customer Distribution
254 AEROSET® System Troubleshooting Guide 94816-107—November 2004
QC Out of Range
Multiple assays?
Verifycalibration.Check calvalues, cal
prep, &expiration. OK?
Verify system.OK?
Yes
Observed Problem:QC Out of Range
Recalibrate/reblank.
Rerun QC.OK?
Yes
QC prephandling OK?
Yes
Yes
Correct errors.OK?
Prepare freshreagent.
Rerun QC.OK?
No
Accept data
Yes
No
Verify properreagent
handling. OK?
Yes
Service
No
No
Prepare freshcontrols &rerun QC.
OK?
No
Yes
Recalibrate &rerun QC.
OK?
Yes
No
1.
2.
3.
4.
5.
No
No
No
No
Accept data
Yes
Yes
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Flowcharts
AEROSET® System Troubleshooting Guide 25594816-107—November 2004
QC Out of Range, Continued1. Check for the following:
• Involved assays on same line?
• Involved assays using similar wavelengths?
• Is the reagent kit make up the same for all assays involved? R1 vs. R2?
2. Multiple assays? Check for the following:
• Test file parameters are correct
• Recent QC or reagent lot changes
• Recent shifts or trends in QC data
• Is QC material assayed or unassayed?
• Manufacturer claims for analyte stability
• Are ranges appropriate to assess system performance?
• Peer group statistics
3. Verify reagent handling:
• Prepared correctly, if preparation required
• Reagent loaded in correct Reagent Carousel and position
• Expiration date
• Date reagent was opened and placed onboard
• Pipettes—disposable or washed?
• Workload pattern
4. Check calibrators for the following:
• Correct values entered
• Dates opened
• Placed onboard in correct positions
• Length of time calibrators have been onboard
5. Verify instrument:
• Check when source lamp was installed
• Ensure all scheduled maintenance is current
• Check for damaged probes, drips, or drops
• Check cuvette washer performance
• Check for instrument leaks, e.g., pumps and syringes
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Flowcharts Not for Customer Distribution
256 AEROSET® System Troubleshooting Guide 94816-107—November 2004
• Check robotic training for sample and reagent arms, mixer, and ICT™ module
• Check for incubator temperature errors
• Ensure reagent carousels are cold and have puddles of water in compartments
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Flowcharts
AEROSET® System Troubleshooting Guide 25794816-107—November 2004
Calibration Errors
Calibration errorgenerated? QC OOR?No Yes
ICT™calibration
failed?
No
Yes
No
Check calibratorconcentration,
carousel location,calibrator handling &expiration, & reagent
open & expirationdates. OK?
Yes
NoCorrect &recalibrate.
OK?
1. Did onlyone assay fail?
No
Verify assayconfiguration.
OK?
Correct &recalibrate.
OK?
Same calibratorsused for all
assays?
Verify assayconfiguration.
OK?
Start
Nocalibration
Open freshcalibrators &
recalibrate. OK?Yes
Yes
2. All assays onthe same line?
3. Move toopposite line &recalibrate. OK?
Yes
No
Yes
Yes
Proceed to #4(next page)
Proceed to #3
Review RunOptions
calibrationcheckbox. OK?
Correct &recalibrate.
OK?
Yes
NoYes
Yes
NoCorrect &recalibrate.
OK?
Yes
Verify caltargets on
CALIBRATOR/CONTROLscreen. OK?
No
No
Correct calibratortarget &
recalibrate. OK?
Cycle power &calibrate. OK?
Yes
No
Delete & reinstallassay & calibrate.
OK?
Service
No
Proceedto QCOOR
Flowchart
No
No
No
No
Proceed toICT FailedCalibrationFlowchart
Troubleshoot perOperations Manual.
Resolved?
No
Open freshreagent &recalibrate.
OK?
Open freshcalibrators &recalibrate.
OK?
No
Yes
Stop
No
Yes
Yes
StopNo
Yes
Yes
No
NoYes
Stop
Proceedto QCOOR
Flowchart
Proceedto QCOOR
Flowchart
Yes
Yes
Stop
Yes
Run QC.OK?
Run QC.OK?
Run QC.OK?
Proceed to #5(next page)
No
No
Run QC.OK?
Yes
Yes
Yes
Yes No
No
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Flowcharts Not for Customer Distribution
258 AEROSET® System Troubleshooting Guide 94816-107—November 2004
Calibration Errors, Continued
No
Yes
No
6. Replace lamp& recalibrate.
OK?
Service
5. Checkdispense
components. OK?No
Adjust, replace, or cleanaffected component(s)
& calibrate. OK?
Yes
Yes
Open new lot ofreagent &
recalibrate. OK?(If already done,proceed to #6.)
4. Open new lotof reagent &
recalibrate. OK?
Stop
Open new lot ofcalibrators &
recalibrate. OK?Yes
No
No
Yes
No
Is cuvette washerdripping or
overflowing cuvettes?Yes
Replace poppetvalve or look for
obstruction in HCwaste tubing.
Resolved?
No
No Service
Yes
Yes
No
Stop
No
Open new lot ofcalibrators &
recalibrate. OK?(If already done,proceed to #6.)
No
Yes
Yes
No
Yes
Proceedto QCOOR
Flowchart
Proceedto QCOOR
Flowchart
Proceedto QCOOR
Flowchart
Run QC.OK?
Run QC.OK?
Recalibrate.OK?
Run QC.OK?
Run QC.OK?
Yes
Yes
Yes
Run QC.OK?
Yes Stop
No
Proceedto QCOOR
Flowchart
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Flowcharts
AEROSET® System Troubleshooting Guide 25994816-107—November 2004
ICT™ Failed Calibration
Review error codes &troubleshoot per Operations
Manual. Resolved?
Bubbles in ICTmodule tubing or
1 mL syringe?
No
Determine whether Serum and/or Urine ICT failed calibration
Verify ICT module lotnumber & installation
date
No
Yes
Replace ICTmodule
Yes
Yes
ICT module:1 Onboard > two months?2 More than 15,000 samples?3 Past expiration date?
Proceedto Bubbles
in ICTFlowchart
Error Log Message with1.02ER000 software
Error Log Message with1.02ER000 software
Remove bubbleswith applicator stick& recalibrate. OK?
Verify calibrator positions,target values, correct calsused, open & exp. dates.
All OK?
Bubbles in calibratorsample cup?
1 Verify ICT Dil lot number& onboard date.
2 Verify cartridge location.3 Verify reagent loadlist.OK?
Yes Stop
No
No Correct &recalibrate. OK?
Yes
YesNo
No
Stop
No
B No
Yes
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Flowcharts Not for Customer Distribution
260 AEROSET® System Troubleshooting Guide 94816-107—November 2004
ICT™ Failed Calibration, Continued
B
ICT diluent cartridgeempty or expired?
No
Replace ICTdiluent cartridge
Yes
Bubbles in IRefsolution bottle
tubing?Yes
IRef tubing not insolution?Twisted?
NoReposition/untwist
tubing into IRefsolution bottle
Replace IRef solutionfilter at end of tubing
(QuarterlyMaintenance)
IRef cup draining& filling
correctly?
Perform preheatertestNo
Yes
Inspect Sample Aprobe: Bent?Damaged?Build-up?
YesClean/replace
Sample A probe
No
Inspect R1Aprobe: Bent?Damaged?Build-up?
Service
Replace R1Aprobe
Yes
Verify IRef solution lotnumber & open date
Yes Replace IRefsolution bottle
IRef bulk solutionbottle empty or
expired?
No
No
No
Yes
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Flowcharts
AEROSET® System Troubleshooting Guide 26194816-107—November 2004
Bubbles in ICT™ Module Tubing ICT reference solutionempty, or volume too
low for the filter toreach?
ICT reference solutiontubing all the way
down in the bottle?
Correct positioning thenperform the Wash ICT with
IRef and Drain & Fill IRef Cupof the START UP Procedure.
Bubbles gone?
ICT probe damaged,blocked, and/or
positionedincorrectly?
Seals present & seatedcorrectly in the ICTmodule at the top &
bottom?
If missing, replace seals. Verify seals areseated correctly; do not overtighten
connections. Perform the Wash ICT withIRef option of the START UP Procedure.
Bubbles gone?
Connections at theICT module loose ?
Connection at the1 mL aspiration
syringe or aspirationpump valve loose?
Reconnect and/or replace syringe ifneeded. Perform the Wash ICT with IRefand Drain & Fill IRef Cup options of theSTART UP Procedure. If the 1 mL syringe
is replaced, refer to the 1 mL SyringeReplacement Procedure in Section 9 of
the Operations Manual.Bubbles gone?
Other Possibilities:ICT aspiration tubing damagedICT aspiration pump defectiveIRef solution filter needs to bechangedPreheater check
Yes
Yes
Yes
Yes
No
Yes
No
No
YesStart Yes
No
Yes
Lift IRef bottle toverify functioning of
weight platform.Correct?
No
No
Yes
No
No
Yes Stop
Yes
Yes
No
No
Yes
Replace solution then performthe ICT Reference Solution
Loading Procedure in Section 9of Operations Manual.
Bubbles gone?
Access module &tighten top &
bottomconnections. Donot overtighten.
Perform the Wash ICTwith IRef and Drain & FillIRef Cup options of theSTART UP Procedure.
Bubbles gone?
Correct probe position. Referto the ICT Probe/ModuleReplacement Procedure in
Section 9, Operations Manual.Bubbles gone?
No
No
No
Service
Service
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Flowcharts Not for Customer Distribution
262 AEROSET® System Troubleshooting Guide 94816-107—November 2004
LIS/Communication ProblemsCycle power in this orderto establish handshake:Host down/AEROSET
down/Host up/AEROSETup
Yes
Error LogMessage?
Bar code facingcorrectly?
1.
2.
3.
Configurationchanges?
Bar code errors?
Yes
Yes
Check systemconfiguration. Bar
codes selected?
Powercycled?
YesCorrect sample
position
Bar codedamaged?
No
YesSelect bar
codes (guestlog on)
Cyclepower toAEROSET
No
Yes
Power?
Bar codeconfiguration
OK?
Make new barcode or runmanually
No
NoEdit Barcode
Length-Skip-IDfield
Cyclepower
Yes
No
Attemptrun.
Resolved?
Yes
YesNo
Yes
YesNo
No
Contact LISsupport Stop
Stop
Proceed to #4(next page)
Proceed to #4(next page)
No
Proceed to #4(next page)
No
No
Cyclepower
Power issuesor Error LogMessages?
Run.Resolved?
No
Attemptrun.
Resolved?
Run.Resolved?
Run.Resolved?
StopYes .
Troubleshoot perOperations
Manual. Resolved?
Yes
No
Yes
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Not for Customer Distribution Flowcharts
AEROSET® System Troubleshooting Guide 26394816-107—November 2004
LIS/Communication Problems, Continued
4.Host icon
with green linethrough it (or not
BLUE)?
Host cableconnected?
Connectcable
Cyclepower
Verifyconfiguration
matches on Host &AEROSET
Changesrequired?
Make changes& cycle power
Run.Resolved?
Yes
Run debug
Change toAEROSET
configurationrequired?
YesCyclepower
No
No
Yes
Contact LISVendor
Evaluate debug;consult LIS
support
Yes5.
NoYes
No
No
Stop
Service
No YesRun.Resolved?
Run.Resolved?
No
Hostsuspended?
Yes
No
Yes"Resume" Hostcommuniction
PROPRIETARY INFORMATIONCONFIDENTIAL MATERIAL
Flowcharts Not for Customer Distribution
264 AEROSET® System Troubleshooting Guide 94816-107—November 2004
Water Issue
Stop
Service
1 Plug in2 Turn on3 Use another outletLight on?
Check externalwater carboy;water present?
Yes
Error Log Messages99, 100, 240-248
Air in tubing?
Yes
Verify:1 Cap plugged
in?2 Switch on?3 Outlet has
power?
Yes
1 Check tubingconnections &crimps
2 Clean & replacefilter, if necessary
3 Cycle power toAnalyzer
4 Flush lines onSTART UP screen
Service
External waterprior tocarboy?
Yes
Air stillpresent?
Carboyoverflow?
Check inputpressure: 30 to 40psi desired. Adjust
if necessary
Pull up cap.Does water
flow?
Yes
Yes
NoCheck
external watersupply. OK?
Yes
Service
Proceed toB
No
Flush waterlines. Resolved?
No
Yes
No
Yes
No
No
Yes
Contactwater vendor
Can customerresolve?
No
No
Yes
No
1 Cycle power2 Perform flush
water linesResolved?
A
B
Yes
Yes
Stop
No