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Semi-quantitative detection of IgG antibodies

An important step in the global pursuit to understand immunity

Reliable and rapid SARS-CoV-2 antibody testing on a large scale for both reference laboratories and acute care settings

The SARS-CoV-2 IgG (COV2G) assay* is the first FDA EUA-authorized semi-quantitative assay to help clinicians assess the level of an individual's immune response.

This numerical value (index value) will enable detection of the level of IgG antibodies in a patient's blood sample. Clinicians will have a baseline and be better equipped to assess changes during the course of an individual's immune response to the SARS-CoV-2 virus.

Learn about the COV2G assay

*This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.

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