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US FDA grants emergency use authorisation for Roche’s Covid-19 test

Roche has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for an Elecsys Anti-SARS-CoV-2 antibody test for the coronavirus (Covid-19).

The test is expected to help identify patients who have been exposed to Covid-19 and assess patients’ immune response to the SARS-CoV-2 virus. It is said to have specificity higher than 99.8% based on the measurement of 5,272 samples.

It also detected 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.