Alliance for Pandemic Preparedness

May 10, 2021

Performance of Three SARS-CoV-2 Immunoassays, Three Rapid Lateral Flow Tests and a Novel Bead-Based Affinity Surrogate Test for the Detection of SARS-CoV-2 Antibodies in Human Serum

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  • A study comparing the performance of three commercial immunoassays to detect SARS-CoV-2 IgA and IgG antibodies (Euroimmun SARS-COV-2 IgA/IgG, Mikrogen recomWell SARS-CoV-2 IgA/IgG, and SERION ELISA agile SARS-CoV-2 IgA/IgG) and three rapid lateral flow tests (Abbott Panbio COVID-19 IgG/IgM, NADAL COVID-19 IgG/IgM, and Cleartest Corona 2019-nCOV IgG/IgM) to a gold standard plaque-reduction neutralization test (PRNT50) found that the sensitivity of the three immunoassays ranged from 32% to 91%, and the specificity from 86% to 100%. The lowest sensitivity among the immunoassays was a test for IgA. The lateral flow assays had a broader range of sensitivity (7-89%) and similar specificity (91-100%). Only the SERION IgG showed a sensitivity and specificity of >98%. The analysis was based on samples from 63 patients who recovered from COVID-19 up to seven months after symptom onset, and 50 samples from before the beginning of the pandemic.

Krone et al. (May 7, 2021). Performance of Three SARS-CoV-2 Immunoassays, Three Rapid Lateral Flow Tests and a Novel Bead-Based Affinity Surrogate Test for the Detection of SARS-CoV-2 Antibodies in Human Serum. Journal of Clinical Microbiology. https://doi.org/10.1128/JCM.00319-21