June 3, 2020—Siemens Healthineers announced the FDA has issued an emergency use authorization for its laboratory-based total antibody test, which is designed to detect the spike protein receptor binding domain on the surface of the SARS-CoV-2 virus. Test data demonstrated 100 percent sensitivity and 99.8 percent specificity.
The total antibody test SARS-CoV-2 Total (COV2T) is available on the Atellica IM immunoassay analyzer, which can run up to 440 tests per hour and enables a result in 10 minutes, and on the Advia Centaur XP and XPT analyzers, which can test up to 240 samples per hour with a result in 18 minutes. The company is ramping up production, with capacity exceeding 50 million tests per month across its testing platforms.