5 August 2020 - - Germany-based medical technology company Siemens Healthineers has received FDA Emergency Use Authorization for the SARS-CoV-2 IgG (COV2G) antibody test, the company said.

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 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.

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 the Siemens Healthineers' 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 contiuum of care.

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, a key protein on the surface of the SARS-CoV-2 virus, within their focus.

Among the considerations for accelerated vaccine approval, according to most recent FDA guidance issued on June 30, validated serology testing in clinical trials may play a pivotal role in assessing surrogate endpoints such as immune response to a vaccine.

This requires additional understanding of SARS-CoV-2 immunology and, specifically, vaccine immune responses that might be reasonably likely to predict protection against COVID-19 and post-marketing studies to affirm predicted efficacy.

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.

This includes the Atellica Solution and ADVIA Centaur XP and XPT families of analyzers. Comparable tests for Siemens Healthineers Dimension Vista and Dimension EXL systems also are being pursued.

Siemens Healthineers AG (OTC: SMMNY) is headquartered in Erlangen, Germany.