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

进行三种 SARS-CoV-2 免疫测定、三种快速横向流动检测和一种新型基于珠子的亲和力替代检测,以检测人类血清中的 SARS-CoV-2 抗体

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作者:Manuel Krone, Julia Gütling, Johannes Wagener, Thiên-Trí Lâm, Christoph Schoen, Ulrich Vogel, August Stich, Florian Wedekink, Jörg Wischhusen, Thomas Kerkau, Niklas Beyersdorf, Silvana Klingler, Simone Backes, Lars Dölken, Georg Gasteiger, Oliver Kurzai, Alexandra Schubert-Unkmeir

Abstract

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 recomWell 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%.

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