FDA Clears First Real-time PCR Test for Influenza A/B

Megan Brooks

September 23, 2015

The US Food and Drug Administration (FDA) has cleared the cobas Influenza A/B test for use on the cobas Liat System, according to manufacturer Roche.

It is the first Clinical Laboratory Improvement Amendments (CLIA)-waived, real-time polymerase chain reaction (PCR) test to detect and differentiate influenza A virus and influenza B virus in RNA in nasopharyngeal swab specimens in about 20 minutes or less, the company notes in a September 22 news release.

"Today's CLIA waiver for the cobas Influenza A/B test allows real-time PCR technology, the gold standard in molecular testing, to be utilized at the point of care to accurately and quickly detect and differentiate influenza A and B," Roland Diggelmann, chief operating officer of Roche Diagnostics, said in the release.

"Effective management of influenza relies on accurate detection within 48 hours of onset, which can be challenging with current turnaround times for lab-based test results. The cobas Influenza A/B test provides lab-quality PCR results in ~20 minutes, enabling health care providers in all settings to give prompt and confident diagnosis and treatment to patients," he added.

According to the company, the test "provides broad strain coverage of over 30 commonly found strains of influenza A and B."

The cobas Influenza A/B test is the second assay on the cobas Liat System to receive CLIA waiver. Roche's cobas Strep A test received CLIA waiver in May 2015. The cobas Liat Analyzer, cobas Influenza A/B test, and cobas Strep A test are CE Marked, cleared by the FDA and CLIA waived, the company notes.


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