Influenza A/B Test Receives CLIA Waiver

The first, real-time polymerase chain reaction (PCR) test to detect influenza A and B has received Clinical Laboratory Improvement Amendments (CLIA)-waiver.

Coupled with the CLIA waived Strep A test, the Influenza A/B test can now be used by healthcare providers in non-traditional testing sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.


The CLIA waiver was granted by the US Food and Drug Administration (FDA; Silver Springs, MD, USA). An estimated three to five million individuals develop influenza each year worldwide, and 250,000 to 500,000 die from the virus. Patients at highest risk include children, the elderly and pregnant women. The CLIA waived cobas Influenza A/B test (Roche Molecular Diagnostics; Pleasanton, CA, USA) for the cobas Liat PCR System offers an effective, new diagnostic tool to clinicians for the upcoming flu season and provides faster diagnosis and treatment for patients in primary and urgent care settings.

The Influenza A/B test uses real-time PCR technology to detect and differentiate Influenza A virus and Influenza B virus RNA in about 20 minutes. It targets highly conserved regions of the influenza A and B genomes to provide broad strain coverage of over 30 commonly found strains of influenza A and B. The cobas Liat System fully automates the testing process, simplifies workflow and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability and minimal training. Real-time PCR is widely recognized as the gold standard for molecular testing. It is highly accurate and offers a low limit of detection (LOD) to detect viruses in patients with low viral load, such as some adults with influenza infection.

Related Links:
US Food and Drug Administration 
Roche Molecular Diagnostics