Biochip Array Technology Katie Walker Biochip Array Product Specialist The Technology and Applications of Protein Biochip Array Technology Panels of tests, allowing for the simultaneous multi- analyte detection of a wide range of analytes, from a single undivided sample •81mm 2 Solid State Device •Assays contained in discrete reaction sites •Single patient sample per biochip •Multiple assays performed simultaneously
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Biochip Array Technology
Katie Walker
Biochip Array Product Specialist
The Technology and Applications of Protein Biochip Array
Technology
Panels of tests, allowing for the
simultaneous multi-analyte detection of
a wide range of analytes, from a single undivided
sample
•81mm2 Solid State Device
•Assays contained in discrete reaction sites
•Single patient sample per biochip
•Multiple assays performed simultaneously
Development of Biochip Array
• 1992 – 2003• Over 185 Scientists involved• $140,000,000.00 Investment• 45 new patents• Three main stages in Biochip development
• To assess the overall performance of drugs of abuse screening on the evidence immunoassay technology
• To compare the evidence performance to an alternate immunoassay system
• To compare the evidence performance to results obtained by GC/MS
Urine Evaluation
• More than 1300 clinical urine samples covering the entire range of possible test results for all ten drugs of abuse
• Comparison carried out by independent clinical toxicology laboratory in Texas
• 10% of samples fell within ±25% of the assay cut-off concentrations
82.1
3.2
96.8 96.7
17.93.3
0
20
40
60
80
100
evidence with CEDIA evidence with GC/MS CEDIA with GC/MS
% AGREEMENT% DISAGREEMENT
% Agreement Total number of samples Discrepant samples
evidence with CEDIA 96.8 1264 40
evidence with GC/MS 96.7 305 10
CEDIA with GC/MS 82.1 234 42
Amphetamines
Methamphetamine
82.2
3.3
96.7 97.0
17.8
3.0
0
20
40
60
80
100
evidence with CEDIA evidence with GC/MS CEDIA with GC/MS
% AGREEMENT% DISAGREEMENT
% Agreement Total number of samples Discrepant samples
evidence with CEDIA 96.7 1249 40
evidence with GC/MS 97.0 305 9
CEDIA with GC/MS 82.2 219 39
Cannabinoids
81.8
2.1
97.993.9
18.2
6.1
0
20
40
60
80
100
evidence with CEDIA evidence with GC/MS CEDIA with GC/MS
% AGREEMENT% DISAGREEMENT
% Agreement Total number of samples Discrepant samples
evidence with CEDIA 97.9 1335 28
evidence with GC/MS 93.9 231 14
CEDIA with GC/MS 81.8 231 42
Opiates
60.0
7.4
92.6 89.1
40.0
10.9
0
20
40
60
80
100
evidence with CEDIA evidence with GC/MS CEDIA with GC/MS
% AGREEMENT% DISAGREEMENT
% Agreement Total number of samples Discrepant samples
evidence with CEDIA 92.6 1334 99
evidence with GC/MS 89.1 320 35
CEDIA with GC/MS 60.0 320 128
Overall Summary
Evidence with CEDIA 96.9
Evidence with GC/MS 90.5
CEDIA with GC/MS 83.4
Total number of tests 11,750
% Agreement
User Defined Cut-off selection. Analysers and Software
Features
• Semi-automated• Based on Biochip Array Technology
– Multiple test sites per biochip• Fast Results
– 54 biochips ie. 540 Tests in 1 hour• Small sample volumes
– Urine – 3.5μl per test– Whole Blood - 6μl per test– Oral Fluid - 10μl per test
Features
• Quality of results– All Randox products are developed to ISO 13485,
diagnostic standards– Full trace-ability through manufacture– Antibody Specificity – Self sufficient antibody supply– Specific Methamphetamine and Lorazepam
assays
Features
• Cut-off selection– Cut-offs can be selected and reselected without
recalibration– Different cut-offs can be selected for the same
analyte during the same run, ie. Opiates sample A 25ng/mL, sample B 10ng/mL.
• Fully Quantitative Analysis– Identified as positive/negative – Concentration of compound also displayed
Features
• Software– Windows XP® based– Colour coding easy to follow– Multiple search formats– Easy export of results– Fully LIMS connectable– Extensive QC facilities
• Levy Jennings and Multi-point rules.
– Enhance trouble shooting
Features
• Fully Automated– Walk away system
• High throughput– 130 samples per hour x no.of tests per chip
• Chain of custody Features– Sample access doors lock once sample is loaded
• Password Protected
Features
• Retrospective Testing– Although only invoiced for tests reported, all assays
are carried out simultaneously– If certain assays are not reported they can be recalled
FitzGerald SP, Lamont JV, McConnell RI, Benchikh EO; Development of a high throughput automated analyser using biochip array technology; Clinical Chemistry; 51 (7) 1165-1176