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FDA Permits Wider Use of Real-Time Test for Influenza A and B
The FDA has authorized wider use of a test that can detect influenza A and B in approximately 20 minutes, providing faster diagnosis and treatment for patients in primary and urgent care settings.
Roche announced that the FDA has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the cobas Influenza A/B test for use on the cobas Liat System. This is the first CLIA-waived, real-time polymerase chain reaction (PCR) test to detect influenza A and B so quickly.
The cobas Influenza A/B test can now be used by health care providers in nontraditional testing sites, including physicians’ offices, emergency rooms, health department clinics, pharmacy clinics, and other health care facilities.
An estimated three to five million people 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 offers a new diagnostic tool to clinicians for the upcoming flu season.
The cobas Influenza A/B test is the second assay on the cobas Liat System to receive a CLIA waiver. The cobas Strep A test received a CLIA waiver in May 2015. The cobas Liat Analyzer is also CLIA-waived.
Source: Roche; September 22, 2015.