Siemens receives FDA EUA authorization for COV2G

Semi-quantitative SARS-CoV-2 IgG antibody test

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COV2G
The SARS-CoV-2 IgG Antibody Test offers the first EUA-authorized semi-quantitative assay to help clinicians assess the level of an individual‘s immune response. Photo - Siemens

Siemens Healthineers announced that it received (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test. According to Siemens, 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%. The COV2G antibody test offers both a positive or negative result for IgG antibodies and reports a numerical result expressed as the index value. The test also attained the CE-mark and is now broadly available globally.

A positive or negative result for IgG antibodies provides insight into an individual’s prior exposure to the 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. A 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 establish IgG level that may be protective accurately, and Siemens Healthineer’s COV2G assay is well-positioned to support this global pursuit.

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, president of Laboratory Diagnostics for Siemens Healthineers. “Siemens Healthineers offers a robust portfolio of reliable tests to help support patient care and fight COVID-19.”

Antibody tests have multiple uses including:

  • As an adjunct to PCR tests to aid in clinical assessment
  • To help determine prior exposure to the virus, by detecting antibodies that may neutralize the virus
  • To potentially identify donors of convalescent plasma
  • For epidemiological purposes including establishing the prevalence of the disease in populations
  • To potentially help verify the effectiveness of vaccines as they become available

The company claims that the antibody tests from Siemens Healthineers are well-positioned to aid vaccine development efforts. The COV2G antibody test, and all SARS-CoV-2 antibody tests from Siemens Healthineers, detect antibodies to S1RBD. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein, specifically S1RBD—an essential protein on the surface of the SARS-CoV-2 virus—within their focus.

Among the considerations for accelerated vaccine approval, according to most recent issued on June 30, 2020, validated serology testing in clinical trials may play a pivotal role in assessing surrogate endpoints such as immune response to a vaccine. This requires further understanding of SARS-CoV-2 immunology and, precisely, vaccine immune responses that might be reasonably likely to predict protection against COVID-19 and post-marketing studies to affirm predicted efficacy. The COV2G test meets or exceeds FDA requirements, claims Siemens.

The COV2G antibody test is available on an expansive installed base of analyzers installed in the US and in countries that accept the CE mark worldwide. Siemens Healthineers has distinguished itself during the pandemic as a provider of quality antibody tests. For example, in a recent head-to-head of four commercial antibody tests conducted by Public Health England, in partnership with the University of Oxford, Siemens Healthineers’ COV2T assay was the only test that met both sensitivity and specificity targets.

As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare.

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