Cobas SARS-CoV-2 Test authorized for asymptomatic people

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August 2021—Roche’s Cobas SARS-CoV-2 has received FDA emergency use authorization for testing individuals without symptoms or reasons to suspect COVID-19. This authorization supports the guidance update from the CDC to expand SARS-CoV-2 testing to include people without symptoms and applies to pooled samples containing up to and including six individual samples. Asymptomatic testing with the Cobas SARS-CoV-2 test is also available in countries accepting the CE mark.

The test, for use on Cobas 6800/8800 systems, is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2.