Quality Control Materials for use with FilmArray® Panels

Introduction

The Clinical Laboratory Improvement Amendments (CLIA), passed in1988, establishes quality standards for all laboratory testing to ensure the accuracy and reliability of patient test results, regardless of where the testis performed. CLIA regulations require a laboratory to have quality control(QC) procedures to monitor the accuracy and precision of the complete testing process.

This document provides a listing of QC materials that have been tested at BioFire and are compatible with the FilmArray Panels indicated. The information in this document is meant to be a guideline and may not be inclusive.

For guidelines to assist your laboratory in developing a protocol for establishing daily quality control equivalence for FilmArray® Systems, please refer to FLM1-PRT-0215.

Note:The QC materials listed are appropriate for use with the panel described and may not be compatible with other FilmArray panels.


Quality Control Resources


Table 1.QC Materials for FilmArray® Blood Culture Identification (BCID) Panel

FilmArray® Blood Culture Identification (BCID) Panel
Vendor         Product Name          Part Number
Zeptometrix         NATtrol BCID Verification Panel          NATBCP-BIO
Zeptometrix         NATtrol BCID2 Panel          NATBCP2-BIO
Zeptometrix             NATtrol BCID Control Panel           Coming Soon

Table 2. QC Materials for FilmArray® Gastrointestinal (GI) Panel

FilmArray® Gastrointestinal (GI) Panel
Vendor         Product Name         Part Number
Zeptometrix         NATtrol GI Controls         NATGIC-BIO
Zeptometrix         NATtrol GI Panel         NATGIP

Table 3.QC Materials for FilmArray® Meningitis/Encephalitis (ME) Panel

FilmArray® Meningitis/Encephalitis (ME) Panel
Vendor          Product Name            Part Number
Zeptometrix

Zeptometrix

         NATtrol Meningitis/Encephalitis

         NATtrol Meningitis/Encephalitis Panel

           NATMEC-BIO

            NATMEP-BIO



Table 4. QC Materials for FilmArray® Respiratory Panel (RP)

FilmArray® Respiratory Panel (RP)
Vendor           Product Name            Part Number
Zeptometrix           NATtrol™ RP Multimarker Controls            MDZ001


Table 5. QC Materials for FilmArray® Respiratory Panel (RP)EZ

FilmArray® Respiratory Panel (RP) EZ
Vendor            Product Name            Part Number
Zeptometrix            NATtrol™ RP Multimarker Controls            MDZ001


Table 6. QC Materials for FilmArray® Respiratory Panel2 (RP2) and Respiratory Panel 2 plus (RP2 plus)

FilmArray® Respiratory Panel 2 (RP2) and Respiratory Panel 2 plus (RP2plus)
Vendor            Product Name         Part Number
Zeptometrix            NATtrol™ Respiratory Panel 2 (RP2) Controls         NATRPC2-BIO
Zeptometrix            NATtrol Respiratory Verification Panel 2         NATRVP2-BIO
Zeptometrix            NATtrol Respiratory Verification Panel RVP         NATRVP-IDI


Table 7. QC Materials for FilmArray® SARS-CoV-2

FilmArray® SARS-CoV-2
Vendor          Product Name        Part Number
Zeptometrix          NATtrol SARS-Related Coronavirus 2 SARS-CoV-2 External Run Control        NATSARS(COV2)-ERC
Zeptometrix         NATtrol SARS-Related Coronavirus 2 SARS-CoV-2 Negative Control       NATSARS(COV2)-NEG


Table 8. QC Materials for FilmArray® MERS

Other FilmArray® QC Materials
Vendor           Product Name          Part Number
Zeptometrix           NATtrol Pneumonia Panel-Atypical Bacteria & Viruses          NATMEC-BIO
Zeptometrix           NATtrol Pneumonia Panel-Quantifiable Bacteria          NATMEP-BIO


Table 9. Other QCMaterialsfor FilmArray®

Other FilmArray® QC Materials
Vendor          Product Name         Part Number
Zeptometrix          NATtrol MERS Recombinant Pack         NATMR-BIO
Zeptometrix          NATtrol MERS-S. cerevisiae Recombinant        NATCOV(MR)-BIO
8th Jun 2021 Zeptometrix

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