Demonstrates strong relationship between the Atellica IM sCOVG Assay index value and neutralization titer
The enhanced Atellica® IM SARS-CoV-2 IgG (sCOVG)*† Assay demonstrates analytical performance capable of measuring patient IgG antibody response to the S1 RBD antigen with accuracy and precision and is acceptable for quantifying an individual’s immune response, including production of neutralizing antibodies, and identifying an individual’s immunocompetence to the SARS-CoV-2 virus.†
Learn more about the sCOVG assay performance.
*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.
†Claims for correlation to neutralizing antibody titer have not been reviewed by the FDA and are not available in the U.S.