Department of Microbiology Quality Manual Policy # MI_MD_CDAR Page Version: 0 CURRENT 1 of 14 Section: Molecular Diagnostics Procedures Subject Title: Clostridium difficile PCR by Luminex Aries Prepared by QA Committee Issued by: Laboratory Manager Revision Date: 9/30/2017 Approved by Laboratory Director: Microbiologist-in-Chief Annual Review Date: 11/1/2018 Uncontrolled When Printed UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked against the document (titled as above) on the server prior to use. Management System\UHN_Mount Sinai Hospital Microbiology\Standard Operating Procedures\Molecular Diagnostics Procedures\ Introduction The ARIES ® C. difficile Assay uses Multi-Code ® real-time PCR chemistry in combination with ARIES ® Systems. ARIES ® Systems are capable of automated nucleic acid extraction and purification, real-time PCR detection of nucleic acid sequences, and data analysis. The ARIES ® C. difficile Assay detects the C. difficile toxin A gene (tcdA) and toxin B gene (tcdB). Specimen Collection and Transport Collect unformed stool specimen in a clean Starplex container Stool collected in Enteric Transport Medium, or in SAF is not suitable for this assay. Specimens can be stored at 15°C to 30°C (room temperature) for up to 8 hours or 2°C to 8°C (refrigerated) for up to 15 days. If the specimen cannot be tested within the indicated durations at the specified temperatures, then the specimen can be stored at ≤ -70°C for up to three months. Reagents/Materials/Media The ARIES ® C. difficile Assay Complete Kit includes 24 assay cassettes and the ARIES ® Stool Resuspension Kit. The assay protocol file, package insert, and ARIES ® Quick Guide ship separately on a USB as part of the ARIES ® C. difficile Assay Protocol File Kit Luminex ® ARIES ® Systems and accessories ARIES ® magazines ARIES ® Sample Prep Tray Hand-held barcode reader Appropriately sized pipettor Microcentrifuge Variable volume Ranin Pipette: 1000uL Aerosol Resistant Tips (ART) Powder free gloves Biological Safety Cabinet
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
against the document (titled as above) on the server prior to use.
UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
against the document (titled as above) on the server prior to use.
UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
against the document (titled as above) on the server prior to use.
UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked
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