The new cobas SARS-CoV-2 and Influenza A/B test is designed for simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B infections
Roche has secured the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for cobas SARS-CoV-2 and Influenza A/B Test, performed on its cobas 6800/8800 Systems.
The Swiss healthcare company said that its new antibody test has been designed for simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected of having respiratory viral infection consistent with Covid-19.
Also, the company intends to commercialise its new cobas SARS-CoV-2 and Influenza A/B test in markets accepting the CE mark.
Roche Diagnostics CEO Thomas Schinecker said: “With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone.
“Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients. As a leader in diagnostics testing solutions, this launch demonstrates our ongoing commitment to stop the spread of serious infectious diseases by increasing access to accurate, reliable and efficient testing options.”
SARS-CoV-2 and Influenza A/B Test works on Roche’s cobas 6800/8800 Systems
The new SARS-CoV-2 and Influenza A/B Test works on the company’s fully-automated cobas 6800/8800 Systems, which results in less time with the high throughput and the long walk-away time compared to other automated molecular platforms.
The systems is capable of providing up to 96 results in around 3 hours, with 384 results using the cobas 6800 System and 1,056 results on the cobas 8800 System in an shift of 8 hours.
The cobas SARS-CoV-2 and Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay designed to simultaneously detect and differentiate SARS-CoV-2, Influenza A virus, and Influenza B virus using nasal or nasopharyngeal swab samples.
The cobas SARS-CoV-2 & Influenza A/B test is intended for individuals suspected of a respiratory infection, and is not intended for the detection of Influenza C virus. The test said to have a full-process negative control, positive control and internal control, said the company.
Also, the test is designed for use by trained clinical laboratory personnel, who are specifically instructed and trained in the techniques of real-time PCR and in-vitro diagnostic procedures.