Department of Pathology
Amino Acids, Peptides, and Proteins | Enzymes and Coenzymes | Immunology of Infectious Disease | Immunopathology | Infectious Disease | Pathology | Virus Diseases
Background: Several serological assays have been developed to detect anti-SARS-CoV-2 IgG antibodies, but evidence about their comparative performance is limited. We sought to assess the sensitivity of four anti-SARS-CoV-2 IgG enzyme-linked immunosorbent assays (ELISA) in individuals with evidence of prior SARS-CoV-2 infection.
Methods: We obtained sera from 36 individuals with PCR-confirmed SARS-CoV-2 infection between March and May 2020. We evaluated samples collected at around 21 days (±14 days) after their initial PCR test using 3 commercially available ELISA assays, two anti-spike (Ortho-Clinical Diagnostics Vitros, and Euroimmun) and one anti-nucleocapsid (Abbott Architect), and a Yale-developed anti-spike ELISA test. We determined the sensitivity of the tests and compared their results. The Euroimmun and Yale ELISA had an equivocal and indeterminate category, which were considered as both negative and positive.
Results: Among the 36 individuals with SARS-CoV-2 infection, mean age was 43 (±13) years and 19 (53%) were female. The sensitivities of the tests were not significantly different (Abbott Architect, Ortho Vitros, Euroimmmun, and Yale assays: 86% (95% confidence interval [CI], 71-95), 94% (95% CI, 81-99), 86% (95% CI, 71-95), and 94% (95% CI, 81-99), respectively; p-value=0.464). The sensitivities of the Euroimmun and Yale ELISA tests increased when the equivocal/indeterminate results were considered positive (97% [95% CI, 85-100] and 100% [95% CI, 90-100], respectively), but were not significantly different from other tests (p=0.082). The cross-correlation coefficient ranged from 0.85-0.98 between three anti-spike protein assays (Ortho Vitros, Euroimmun, Yale) and was 0.58-0.71 between the three anti-spike protein assays and the anti-nucleocapsid assay (Abbott).
Conclusion: The sensitivities of four anti-SARS-CoV-2 protein assays did not significantly differ, although the sample size was small. Sensitivity also depended on the interpretation of equivocal and indeterminate results. The strongest correlations were present for the three anti-spike proteins assays. These findings suggest that individual test characteristics and the correlation between different tests should be considered when comparing or aggregating data across different populations studies for serologic surveillance of past SARS-CoV-2 infection.
infectious diseases, COVID-19, past SARS-CoV-2 infection, antibodies, serological testing, antibody testing, assays, sensitivity
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DOI of Published Version
medRxiv 2020.07.29.20164343; doi: https://doi.org/10.1101/2020.07.29.20164343. Link to preprint on medRxiv
Mahajan S, Redlich CA, Wisnewski AV, Fazen LE, Rao LV, Kuppusamy K, Ko AI, Krumholz HM. (2020). Performance of Abbott Architect, Ortho Vitros, and Euroimmun Assays in Detecting Prior SARS-CoV-2 Infection [preprint]. University of Massachusetts Medical School Faculty Publications. https://doi.org/10.1101/2020.07.29.20164343. Retrieved from https://escholarship.umassmed.edu/faculty_pubs/1734
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