The SARS-CoV-2 IgG (sCOVG) assay*†§ measures neutralizing IgG antibodies to SARS-CoV-2 in the blood to help clinicians assess the level of an individual's immune response over time.
A correlation study using a viral neutralizing test demonstrated a strong relationship between index values from the Atellica® IM and sCOVG assay*†§ and neutralizing antibody titers. This allows clinicians to be able to assess and monitor patients’ neutralizing antibody levels. This strong correlation is critical for potential convalescent donor identification as well as future determination of vaccine response and monitoring post-vaccination neutralizing antibody levels.
Comparison of numerical results will help determine how the immune response develops in an individual and persists over time. The combination of these assays provides a more complete picture of a patient’s serological status for the most accurate results throughout his or her continuum of care.
* 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 he 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 by country and is subject to varying regulatory requirements.
† Claims for detection of neutralizing antibodies, correlation to PRNT, detection of immune response following vaccination, and correlation to reference materials have not been reviewed by the FDA and are not available in the U.S. Availability of these claims varies from country to country and is subject to varying regulatory requirements.
§ Assays are for semi-quantitative use in the U.S.