The US Food and Drug Administration (FDA) has granted 510(k) clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver for Roche's cobas influenza A/B & RSV test for use on the cobas Liat System.
Roche is the first manufacturer to extend the value of highly accurate CLIA-waived molecular testing beyond flu A/B and strep A to include Respiratory Syncytial Virus (RSV), a cause of more than 80% of acute lower respiratory tract infections in infants under one year of age.
"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," said Uwe Oberlaender, head of Roche Molecular Diagnostics. "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."
In the US, an average of 58,000 hospitalizations and 2.1 million outpatient visits in children under five years are attributed to RSV. A significant number is also seen in adults over 65 years with 177,000 hospitalizations and 14,000 deaths per year. A quick detection and discrimination of flu and RSV enables clinicians to optimize patient management and antiviral treatment.
The cobas influenza A/B & RSV test is the third assay on the cobas Liat System to receive CLIA waiver, following the cobas Strep A and cobas influenza A/B tests, which received CLIA waiver in May and September 2015, respectively. The cobas Liat Analyser and all three assays are FDA cleared and CLIA waived.
The cobas influenza A/B & RSV test uses real-time PCR (polymerase chain reaction) technology to detect 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 over 40 commonly found strains of influenza A and B and seven commonly found strains of RSV.
Utilizing PCR technology, the cobas Liat System fully automates the testing process, simplifies workflow and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability and minimal training. Definitive results are generated in 20 minutes or less to aid a treatment decision. In addition to the existing tests for influenza A/B, strep A and influenza A/B & RSV, assays for other infectious diseases are in development.
Real-time PCR is widely recognized as the gold standard for molecular testing. It is highly accurate and offers a low limit of detection (LOD) to detect viruses in patients with low viral load, such as some adults with influenza infection. PCR is also extremely versatile, offering capabilities with high multiplex testing (e.g. influenza A, influenza B and RSV in the same test), quantification (viral load count), and detection. Additionally, compared to physician clinical management, rapid antigen testing and other point-of-care testing methods, real-time PCR has demonstrated improved detection of influenza.