Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies Against SARS-CoV-2

J Clin Microbiol. 2020 Jun 8;JCM.01243-20. doi: 10.1128/JCM.01243-20. Online ahead of print.

Abstract

The role of serologic testing for SARS-CoV-2, both in the clinical and public health settings, will continue to evolve as we gain increasing insight into our immune response to the virus. Here, we evaluated four high throughput serologic tests for detection of anti-SARS-CoV-2 IgG antibodies, including assays from Abbott Laboratories (Abbott Park, IL), Epitope Diagnostics Inc. (San Diego, CA), Euroimmun (Lubeck, Germany), and Ortho-Clinical Diagnostics (Rochester, NY), using a panel of serially collected serum samples (N=224) from 56 patients with confirmed COVID-19, healthy donor sera from 2018 and a cross-reactivity serum panel collected in early 2020. Sensitivity of the Abbott, Epitope, Euroimmun and Ortho-Clinical IgG assays in convalescent serum samples collected more than 14 days post symptom onset or initial positive RT-PCR result was 92.9% (78/84), 88.1% (74/84), 97.6% (82/84) and 98.8% (83/84), respectively. Among unique convalescent patients, sensitivity of the Abbott, Epitope, Euroimmun and Ortho-Clinical anti-SARS-CoV-2 IgG assays was 97.3% (36/37), 73% (27/37), 94.6% (35/37) and 97.3% (36/37), respectively. Overall assay specificity and positive predictive values based on a 5% prevalence rate are 99.6%/92.8%, 99.6%/90.6%, 98.0%/71.2% and 99.6%/92.5%, respectively, for the Abbott, Epitope, Euroimmun and Ortho-Clinical IgG assays. In conclusion, we show high sensitivity in convalescent sera and high specificity for the Abbott, Euroimmun and Ortho-Clinical anti-SARS-CoV-2 IgG assays. With the unprecedented influx of commercially available serologic tests for detection of antibodies against SARS-CoV-2, it remains imperative that laboratories thoroughly evaluate such assays for accuracy prior to implementation.