Roche’s cobas SARS-CoV-2 test gets EUA

April 4, 2020 0 By FM

The US FDA has issued an Emergency Use Authorization (EUA) for the cobas SARS-CoV-2 Test developed by Roche Diagnostics. 

The test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients. 

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.

Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results in three and half hours and offer improved operating efficiency, flexibility, and fastest time-to-results with the highest throughput providing up to 96 results in about three hours and a total of 1,440 results for the cobas 6800 System and 4,128 results for the cobas 8800 System in 24 hours. 

The test can be run simultaneously with other assays provided by Roche for use on the cobas 6800/8800 Systems, Roche said.