Accuracy of serological testing for SARS‐CoV‐2 antibodies: First results of a large mixed‐method evaluation study
Allergy Oct 07, 2020
Brigger D, Horn MP, Pennington LF, et al. - Researchers conducted a mixed‐design evaluation study comparing the diagnostic performance of serological immunoassays that are based on various SARS‐CoV‐2 proteins and assessed the neutralizing activity of antibodies in patient sera. They prospectively followed consecutive patients admitted with confirmed SARS‐CoV‐2 infection alongside medical staff and biobank samples from winter 2018/2019. Development of an in‐house enzyme‐linked immunosorbent assay was done utilizing recombinant receptor‐binding domain (RBD) of the SARS‐CoV‐2 spike protein and its comparison was performed with three commercially available enzyme‐linked immunosorbent assays (ELISAs) targeting the nucleoprotein (N), the S1 domain of the spike protein (S1) and a lateral flow immunoassay (LFI) based on full‐length spike protein. Neutralization assays with live SARS‐CoV‐2 were carried out. Inclusion was performed of a total of 1,477 individuals; these comprised 112 SARS‐CoV‐2 positives (defined as a positive real‐time PCR result; prevalence 7.6%). Between day 0 and day 21, IgG seroconversion occurred. Findings suggest promising value of ELISAs targeting receptor‐binding domain (RBD) and the S1 domain of the spike protein (S1) protein of SARS‐CoV‐2; the ELISAs exhibited sensitivities of 88.4% for RBD, 89.3% for S1, and 72.9% for N protein and specificity above 94% for all tests.
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