Siemens wins EUA for semiquantitative SARS-CoV-2 antibody test

2019 02 13 19 24 5396 Fda Logo V2 400

Siemens Healthineers has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COV2G semiquantitative SARS-CoV-2 immunoglobulin G (IgG) antibody test.

The antibody test is the first with a semiquantitative claim to receive an EUA from the FDA, according to Siemens. COV2G offers both a positive or negative result for IgG antibodies and reports a numerical result expressed as index value. It has been shown to offer 100% sensitivity and 99.9% specificity, Siemens said.

The test has also received the CE Mark and is now broadly available around the world.

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