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Siemens Healthineers bags first US FDA EUA for semi-quantitative SARS-CoV-2 IgG antibody test

Siemens Healthineers

Siemens Healthineers receives FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test.2 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.

COV2G 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.

“A positive or negative result for IgG antibodies provides insight into an individual’s prior exposure to SARS-CoV-2 virus. Importantly, a semi-quantitative result enables clinicians to gauge the level of IgG antibodies in a patient’s blood sample. 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. Comparison of numerical results will help determine how SARS-CoV-2 antibodies develop in an individual and persist over time. A semi-quantitative result is necessary to accurately establish the level of IgG that may be protective, and Siemens Healthineers COV2G assay is well positioned to support this global pursuit,” a statement said.

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Further added that when an individual is infected with the SARS-CoV-2 virus, unique antibodies will develop at different stages of the infection. Whereas the Siemens Healthineers SARS-CoV-2 Total antibody test detects antibodies to IgM and IgG that are present both early and later during the immune response, the COV2G antibody test specifically detects IgG antibodies that persist, and are the basis for an individual’s longer term immune response. The combination of these tests provides a complete picture of a patient’s serological status for the most accurate results throughout his or her continuum of care.

“Our high-quality antibody test helps clinicians assess the level of a person‘s immune response, which is an important tool to have at this stage of the pandemic,” said Deepak Nath, PhD, President of Laboratory Diagnostics for Siemens Healthineers.

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