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

• Published in: Journal of clinical microbiology Vol. 59; no. 8; p. e0031921
• Main Authors: Krone, Manuel, Gütling, Julia, Wagener, Johannes, Lâm, Thiên-Trí, Schoen, Christoph, Vogel, Ulrich, Stich, August, Wedekink, Florian, Wischhusen, Jörg, Kerkau, Thomas, Beyersdorf, Niklas, Klingler, Silvana, Backes, Simone, Dölken, Lars, Gasteiger, Georg, Kurzai, Oliver, Schubert-Unkmeir, Alexandra
• Format: Journal Article
• Language: English
• Published: United States American Society for Microbiology 19.07.2021
• Subjects: Antibodies, Viral; COVID-19; Humans; Immunoassay; Immunoassays; Immunoglobulin M; Pandemics; SARS-CoV-2; Sensitivity and Specificity; COVID-19; SARS-CoV-2; lateral flow assay; flow cytometry bead-based surrogate test; plaque-reduction neutralization test; ELISA
• ISSN: 0095-1137; 1098-660X; 1098-660X
• DOI: 10.1128/JCM.00319-21

For the control of immunity in COVID-19 survivors and vaccinated subjects, there is an urgent need for reliable and rapid serological assays. Based on samples from 63 COVID-19 survivors up to 7 months after symptom onset, and on 50 serum samples taken before the beginning of the pandemic, we compared the performances of three commercial immunoassays for the detection of SARS-CoV-2 IgA and IgG antibodies (Euroimmun SARS-COV-2 IgA/IgG, Mikrogen recom Well SARS-CoV-2 IgA/IgG, and Serion ELISA agile SARS-CoV-2 IgA/IgG) and three rapid lateral flow (immunochromatographic) tests (Abbott PanBio COVID-19 IgG/IgM, Nadal COVID-19 IgG/IgM, and Cleartest Corona 2019-nCOV IgG/IgM) with a 50% plaque-reduction neutralization test (PRNT50) representing the gold standard. For the control of immunity in COVID-19 survivors and vaccinated subjects, there is an urgent need for reliable and rapid serological assays. Based on samples from 63 COVID-19 survivors up to 7 months after symptom onset, and on 50 serum samples taken before the beginning of the pandemic, we compared the performances of three commercial immunoassays for the detection of SARS-CoV-2 IgA and IgG antibodies (Euroimmun SARS-COV-2 IgA/IgG, Mikrogen recom Well SARS-CoV-2 IgA/IgG, and Serion ELISA agile SARS-CoV-2 IgA/IgG) and three rapid lateral flow (immunochromatographic) tests (Abbott PanBio COVID-19 IgG/IgM, Nadal COVID-19 IgG/IgM, and Cleartest Corona 2019-nCOV IgG/IgM) with a 50% plaque-reduction neutralization test (PRNT50) representing the gold standard. Fifty-seven out of 63 PCR-confirmed COVID-19 patients (90%) showed neutralizing antibodies. The sensitivity of the seven assays ranged from 7.0% to 98.3%, and the specificity ranged from 86.0% to 100.0%. Only one commercial immunoassay showed a sensitivity and specificity of greater than 98%.