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."
