Siemens receives FDA EUA for semi-quantitative COV2G test

5 August 2020 (Last Updated August 5th, 2020 11:06)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Siemens Healthineers' semi-quantitative SARS-CoV-2 IgG antibody test COV2G.

Siemens receives FDA EUA for semi-quantitative COV2G test
The SARS-CoV-2 IgG antibody test offers the first EUA-authorised semi-quantitative assay. Credit: Siemens Healthcare GmbH.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Siemens Healthineers’ semi-quantitative SARS-CoV-2 IgG antibody test COV2G.

COV2G is the first antibody test to secure authorisation with a semi-quantitative detection claim. It provides more than 99% sensitivity and specificity.

The test delivers a positive or negative result for IgG antibodies in the form of a numerical result expressed as an index value.

A positive or negative result for IgG antibodies provides information regarding an individual’s previous exposure to SARS-CoV-2 virus.

Siemens said that the test also obtained the European CE-mark and is available globally.

Siemens Healthineers Laboratory Diagnostics president Deepak Nath said: “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.

“Siemens Healthineers offers a robust portfolio of reliable tests to help support patient care and fight Covid-19.”

The company added that a semi-quantitative result helps clinicians to analyse the IgG antibodies levels in a patient’s blood sample. Clinicians can use this numerical value to determine a baseline and track the changes in the immune response to the virus.

Also, numerical results can be compared to investigate the development of SARS-CoV-2 antibodies over time in an individual.

The company’s SARS-CoV-2 Total antibody test identifies IgM and IgG antibodies present early and later during the immune response, while the COV2G test detects IgG antibodies that persist and aid long-term immune response.

Siemens expects the combination of these tests to offer complete insights into a patient’s serological status.

The COV2G antibody test can be used on analysers in the US and CE-Mark accepting countries, including the Atellica Solution and ADVIA Centaur XP and XPT analysers.