The Importance of Monitoring Emerging SARS-CoV-2 Variants to Ensure Antibody Assay Effectiveness
Understanding SARS-CoV-2 IgG Immunity Thresholds§ and the Process of Standardization§
Analytical Characterization of the SARS-CoV-2 JRC EURM-017 Reference Material
Evaluation of the Enhanced SARS-CoV-2 IgG (sCOVG) Assay* on the Atellica IM Analyzer
Publication: University of Innsbruck, Austria
Clinical Validation of the Quantitative Siemens SARS-CoV-2 Spike IgG Assay (sCOVG)* Reveals Improved Sensitivity and a Good Correlation with Virus Neutralization Titers§
Publication: The University of Maryland
Performance of Four Automated SARS-CoV-2 Serology Assay Platforms in a Large Cohort Including Susceptible COVID-19 Negative and COVID-19 Positive Patients*
Qualification of High Titer COVID-19 Convalescent Plasma
FDA has included the ADVIA Centaur SARS-CoV-2 IgG (COV2G)* in the EUA for Qualification of High Titer COVID-19 Convalescent Plasma
Diagnostic Outcomes with SARS-CoV-2 Serologic and Molecular Testing in a Symptomatic/Asymptomatic Population: Experience at a Regional Medical Center
Publication: NHS Lothian BioResource
Longitudinal analysis of clinical serology assay performance and neutralising antibody levels in COVID19 convalescents
Article: New York Times
Your Coronavirus Antibodies Are Disappearing. Should You Care?
Publication: Public Health England
Evaluation of Sensitivity and Specificity of Four Commercially Available SARS-CoV-2 Antibody Immunoassays*
*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, immunity thresholds and standardization have not been reviewed by the FDA and are not available in the U.S.