FDA Emergency Authorisation for Roche’s cobas SARS-CoV-2 test

Courtesy of Roche

Roche’s cobas SARS-CoV-2 test to detect the novel coronavirus that causes Covid-19 has received Emergency Use Authorisation from the FDA.

It is intended for the qualitative detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet Covid-19 clinical and/or epidemiological criteria for testing.

Hospitals and reference laboratories can run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are widely available in the US and around the world.

The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of Covid-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.

The cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results in three and half hours.

Upon authorisation Roche will have millions of tests a month available for use on the cobas 6800 and 8800 systems.

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