The test uses real-time PCR technology for identifying and separating influenza A virus and influenza B virus RNA in 20 minutes.
Highly conserved regions of the influenza A and B genomes will be targeted to offer strain coverage of more than 30 commonly identified strains of both the types.
Roche said the test provides a new diagnostic tool to clinicians for the upcoming flu season with rapid diagnosis and treatment for patients in primary and urgent care settings.
The cobas Influenza A/B test is the second assay on the cobas Liat system to secure CLIA waiver. The cobas Strep A test received CLIA waiver in May this year.
The system includes the cobas Liat Analyzer, a small, benchtop analyzer safeguarded by an array of instrument controls, and a portfolio of assays, including cobas Influenza A/B, cobas Influenza A/B and RSV, and cobas Strep A. Roche is also developing assays for other infectious diseases.
Roche Diagnostics COO Roland Diggelmann said: "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.
"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."
Influenza is an acute respiratory illness caused by infection with the influenza virus. It is expected that three to five million individuals develop influenza each year globally, and 250,000 to 500,000 die from the virus.
Image: cobas 6000: analysis module (for clinical chemistry parameters). Photo: courtesy of F. Hoffmann-La Roche Ltd.