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Siemens Healthineers obtains first FDA EUA for SARS-CoV-2 IgG antibody test

Siemens Healthineers announced that it received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test. This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent. The COV2G antibody test offers both a positive or negative result for IgG antibodies and reports a numerical result expressed as index value. The test also attained the CE-mark and is now broadly available globally.

Siemens Healthineers’ SARS-CoV-2 Total antibody assay [COV2T] that detects both IgM and longer-lasting IgG antibodies is available in India since June 2020. It is currently being used by several reputed clinical laboratories and institutions on company’s reliable high throughput automated chemiluminescence analyzers including Atellica Solution, ADVIA Centaur and Dimension EXL series for sero-surveillance.

MB Bureau

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