![]() ![]() (2020) Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays. Identification of these targets will be essential to improving assay performance.Ĭitation: Rikhtegaran Tehrani Z, Saadat S, Saleh E, Ouyang X, Constantine N, DeVico AL, et al. ![]() The causes of “false positivity” in pre-epidemic samples may be due to plasma antibodies apparently reacting with the corresponding antigen, or spurious reactivity may be directed against non-specific components in the assay system. Overall, there was wide variability in assay performance using our samples, with in-house tests exhibiting the highest combined sensitivity and specificity. In other cases, reactivity was consistently detected but not abrogated by the spiking, suggesting positive reaction was not attributed to the presence of antibodies against these antigens. In other cases, reactivity was abrogated by competitive inhibition (spiking the sample with the same antigen that was used for coating ELISAs prior to performing the assay), suggesting positive reaction could be attributed to the presence of antibodies against these antigens. In some cases, assays lacked reproducibility. The presumed causes of false positive results from pre-epidemic samples in commercial and in-house assays were mixed. The assays were evaluated using 300 pre-epidemic samples and 100 PCR-confirmed COVID-19 samples. Both sensitivity and specificity were evaluated and the probable causes of false-positive reactions were determined. We evaluated their performance along with four commercial ELISAs, EDI™ Novel Coronavirus COVID-19 ELISA IgG and IgM, Euroimmun Anti-SARS-CoV-2 ELISA IgG and IgA, and one lateral flow assay, DPP® COVID-19 IgM/IgG System (Chembio). We have developed 3 ELISA methods, trimer spike IgA, trimer spike IgG, and nucleocapsid IgG, for detecting anti-SARS-CoV-2 antibodies. ![]() There is an urgent need for an accurate antibody test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). ![]()
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