Independent Evaluation of SARS-CoV-2 Antibody Test Performance

Independent Evaluation of SARS-CoV-2 Antibody Test Performance

FDA Data, 2020-2021

Updated Mar. 10, 2021

*Data and charts updated monthly

Serology tests play an important role in assessing the immune response to a previous SARS-CoV-2 infection, the virus that causes COVID-19. Evaluation of serology tests with well-characterized clinical samples (serum or plasma) is critical to determine test performance.

In collaboration with National Cancer Institute (NCI), Centers for Disease Control and Prevention (CDC), and Biomedical Advanced Research and Development Authority (BARDA), the Food and Drug Administration (FDA) has developed a comprehensive dataset to compare the performance characteristics of different serological tests that were independently evaluated using well-characterized sample panels of positive and negative specimens for SARS-CoV-2 antibodies. This dataset is available for public use.

About the Data: This page is updated monthly. The serology tests were evaluated at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by NCI, by the Hemostasis Laboratory Branch, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, CDC or by the Department of Laboratory Medicine, Clinical Center, National Institutes of Health (NIH). Anti-SARS-CoV-2 antibody positive (n=30) and negative (n=80) serum and/or plasma samples were selected to establish three performance evaluation panels (PEVs) with similar overall antibody titer distribution.

Positive samples were from patients previously confirmed to have a SARS-CoV-2 infection using a nucleic acid amplification test. Negative samples were collected prior to 2020, before the SARS-CoV-2 pandemic. Each sample was characterized for presence/absence of SARS-CoV-2 IgM and IgG antibodies using a SARS-CoV-2 spike enzyme linked immunosorbent assay (ELISA) and a SARS-CoV-2 spike Receptor Binding Domain (RBD) IgG ELISA. Positive samples were assessed at multiple dilutions. Manufacturers submitted their serology assays for evaluation by this program. The sensitivity of each test was assessed for each antibody class (IgG and IgM) in a combined manner, where a positive result for either antibody was considered a positive result. For combined specificity, a negative result meant a sample was negative for both antibodies (IgG and IgM).

Learn more about serology tests

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