The Clinical Laboratory Improvement Amendments (CLIA), passed in 1988, establishes quality standards for all laboratory testing to ensure the accuracy and reliability of patient test results, regardless of where the test is 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 |
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 |
| Zeptometrix | NATtrol BCID Control Panel | Coming Soon |
Table 3. QC Materials for FilmArray® Meningitis/Encephalitis (ME) Panel
| FilmArray® Meningitis/Encephalitis (ME) Panel | ||
| Vendor | Product Name | Part Number |
| Zeptometrix | NATtrol Meningitis/Encephalitis
|
NATMEC-BIO
|
| Zeptometrix | NATtrol Meningitis/Encephalitis Panel
|
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 Panel 2 (RP2) and Respiratory Panel 2
plus (RP2plus)
TECHNICAL
::: NOTE
| 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 QC Materials for 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 |
TECHNICAL
::: NOTE