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Roche High-Throughput SARS-CoV-2 Antigen Test Gets CE Mark

NEW YORK – Roche announced Friday its Elecsys SARS-CoV-2 Antigen high-throughput test received CE marking and has launched in countries accepting the mark.

The automated immunoassay for the qualitative detection of the nucleocapsid antigen in SARS-CoV-2 runs on Roche's Cobas E analyzers, which can provide results in 18 minutes for one test and have a throughput of up to 300 tests per hour. Roche has also filed for Emergency Use Authorization from the US Food and Drug Administration, the firm said in a statement. 

The test, which uses nasopharyngeal and oropharyngeal swab samples, showed nearly 95 percent sensitivity and nearly 100 percent specificity in clinical studies. Roche said the test could be used as an alternative to or in conjunction with PCR testing, particularly in areas where laboratory PCR testing is limited or not available. Negative results may need to be confirmed with a PCR test.

The Basel, Switzerland-based company also said it will be able to ramp up its production capabilities to provide a double-digit million number of tests per month by early 2021. Earlier this month Roche received EUA for its Elecsys Anti-SARS-CoV-2 S antibody test, which also runs on the Cobas E line of analyzers.