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Roche's point-of-care Flu/RSV test gets FDA 510(k) clearance

MDBR Staff Writer Published 02 August 2016

Roche has received 510(k) clearance from the US Food and Drug Administration and Clinical Laboratory Improvement Amendments (CLIA) waiver for a point-of-care molecular test to identify and distinguish influenza A, influenza B, and respiratory syncytial virus.

The first CLIA-waived, real-time PCR test that differentiates flu and RSV in 20 minutes is available for use in physician offices and urgent care settings.

The cobas Influenza A/B & RSV test is the third assay on the cobas Liat System to secure CLIA waiver, following the cobas Strep A and cobas Influenza A/B tests.

Roche said The cobas Liat Analyser and all three assays are FDA cleared and CLIA waived.

The cobas Influenza A/B & RSV test uses real-time polymerase chain reaction technology to identify and differentiate influenza A virus RNA, influenza B virus RNA and respiratory syncytial virus (RSV) RNA in about 20 minutes.

It targets well-conserved regions of influenza A, influenza B and RSV RNA to provide broad strain coverage and has been validated on more than 40 commonly found strains of influenza A and B and seven commonly found strains of RSV.

The cobas Liat System automates the testing process, simplifies workflow and allows healthcare professionals to carry out molecular testing in a variety of settings with speed, reliability and minimal training.

Roche Molecular Diagnostics Head Uwe Oberlaender said: "For young children and the elderly, it is essential to have a differential diagnosis for RSV and flu to ensure appropriate treatment within a short time frame after symptoms strike.

"This can be challenging with current turnaround times for lab-based test results. The cobas Influenza A/B & RSV test provides lab-quality PCR results for flu and RSV in about 20 minutes, supporting a prompt, confident diagnosis to patients."