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

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

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

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

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

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

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

Table 8. QC Materials for FilmArray® MERS

Table 9. Other QCMaterialsfor FilmArray®