Context.–
Serological tests on automated immunology analyzers are increasingly used to monitor the acquired immunity against SARS-CoV-2. The heterogeneity of assays raises concerns about their diagnostic performance and comparability.
Objective.–
To test sera from formerly infected individuals for SARS-Cov-2 antibodies utilizing six automated serology assays and a pseudoneutralization test (PNT).
Design.–
Six SARS-CoV-2 serology assays were utilized to assess 954 samples collected during a 12 months period from 315 COVID-19 convalescents. The tests determined either antibodies against the viral nucleocapsid (anti-NC) or spike protein (anti-S). Two assays did not distinguish between antibody classes whereas the others selectively measured immunoglubulins G (IgG) antibodies. PNT was used to detect the presence of neutralizing antibodies.
Results.–
Comparison of qualitative results showed only slight to moderate concordance between the assays (Cohen's kappa < 0.57). Significant correlations (P < .001) were observed between the antibody titers from all quantitative assays. However, titer changes were not detected equally. A total anti-S assay measured an increase in 128 out of 172 cases (74%) of a suitable subset, whereas all IgG anti-S tests reported decreases in at least 118 (69%). Regarding the PNT results, diagnostic sensitivities ≥89% were achieved with PPVs ≥93%. In contrast, specificity changed substantially over time varying from 20 to 100%.
Conclusions.–
Comparability of serological SARS-CoV-2 antibody tests is rather poor. Due to different diagnostic specificities, the tested assays were not equally capable of capturing changes in antibody titers. However, with thoroughly validated cut-offs, IgG-selective anti-S assays are a reliable surrogate test for SARS-CoV-2 neutralizing antibodies in former COVID-19 patients.
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