Roche has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 & Influenza A/B Test for use on the the cobas 6800/8800 systems.
The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay.
It is designed for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, and Influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory infection.
The cobas 6800/8800 systems of Roche run the test to quickly detect Covid-19 infection
The FDA EUA status enables the healthcare provider to use the test for individuals suspected of a respiratory viral infection such as Covid-19.
With a full-process negative control, positive control and internal control, the cobas 6800/8800 systems run the test to quickly detect Covid-19 infection.
Roche’s fully automated cobas 6800/8800 systems hold the capacity to deliver up to 96 results in around three hours. The cobas 6800 system offers 384 results and cobas 8800 system provides 1,056 results in an eight-hour shift.
Roche is already offering various Covid-19 diagnostic tests for the identification of antibodies in patients who have been exposed to the virus, as well as focused on evaluating treatments from its existing portfolio to better understand their potential to treat Covid-19 patients.
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.”
In May this year, Roche secured FDA EUA status for its new Elecsys Anti-SARS-CoV-2 antibody test, which is an immunoassay for the in-vitro qualitative detection of antibodies to severe acute SARS-CoV-2 in human serum and plasma.
