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.
Technical Support Contact Information
BioFire is dedicated to providing the best customer support available. If you have any questions or concerns about this process, please contact the FilmArray Technical Support team for assistance.