Roche's influenza A and B tests get federal permission to be used at the point-of-care

An article from FierceDiagnostics
September 23, 2015

Roche's real-time polymerase chain reaction tests for the detection of influenza A and B can now be used in settings such as the emergency room, pharmacies and physicians' offices, thanks to a CLIA waiver exempting it from a set of regulations on large diagnostic laboratories carried out by the federal Centers for Medicare & Medicaid Services.

"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," said Roche Diagnostics COO Roland Diggelmann in a statement. "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."
The cobas Influenza A/B test is used in conjunction with the cobas Liat PCR System. It detects and differentiates between the RNA of influenza A and B virus in about 20 minutes.
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