FDA OKs emergency use of Bio-Rad’s COVID-19 blood test

The FDA has granted Emergency Use Authorization (EUA) for Bio-Rad Laboratories’ (NYSE:BIO) SARS-CoV-2 Total Ab test, an immunoassay that detects IgG, IgM and IgA antibodies to the COVID-19 coronavirus in the blood with 98% sensitivity (detecting true positives) and 99% specificity (detecting true negatives).

The test can be performed manually or on an automated platform like its EVOLIS system.

The test has also met the CE mark requirements for Europe.

https://seekingalpha.com/news/3567588-fda-oks-emergency-use-of-bio-rad-s-covidminus-19-blood-test