Siemens gets EUA for semi-quantitative antibody test

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November 2020—Siemens Healthineers received FDA emergency use authorization for the SARS-CoV-2 IgG antibody test. It is the first antibody test authorized with a semiquantitative detection claim.

The test offers a positive or negative result for IgG antibodies and reports a numerical result expressed as index value. With this numerical value, clinicians can establish a baseline and be better equipped to assess changes of an individual’s immune response to the SARS-CoV-2 virus, the company said in a statement. Comparison of numerical results will help determine how SARS-CoV-2 antibodies develop in an individual and persist over time.