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Abstract
We evaluated the performance of 11 SARS-CoV-2 antibody tests using a reference set of heat-inactivated samples from 278 unexposed persons and 258 COVID-19 patients, some of whom contributed serial samples. The reference set included samples with a variation in SARS-CoV-2 IgG antibody titers, as determined by an in-house immunofluorescence assay (IFA). The five evaluated rapid diagnostic tests had a specificity of 99.0% and a sensitivity that ranged from 56.3 to 81.6% and decreased with low IFA IgG titers. The specificity was > 99% for five out of six platform-based tests, and when assessed using samples collected ≥ 22 days after symptom onset, two assays had a sensitivity of > 96%. These two assays also detected samples with low IFA titers more frequently than the other assays. In conclusion, the evaluated antibody tests showed a heterogeneity in their performances and only a few tests performed well with samples having low IFA IgG titers, an important aspect for diagnostics and epidemiological investigations.
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Details
1 Public Health Agency of Sweden, Department of Microbiology, Solna, Sweden (GRID:grid.419734.c) (ISNI:0000 0000 9580 3113)
2 Public Health Agency of Sweden, Department of Microbiology, Solna, Sweden (GRID:grid.419734.c) (ISNI:0000 0000 9580 3113); Karolinska Institutet, Department of Medicine Huddinge, Stockholm, Sweden (GRID:grid.4714.6) (ISNI:0000 0004 1937 0626)
3 Karolinska Institutet, Department of Laboratory Medicine, Stockholm, Sweden (GRID:grid.4714.6) (ISNI:0000 0004 1937 0626)
4 Umeå University, Department of Clinical Microbiology, Umeå, Sweden (GRID:grid.12650.30) (ISNI:0000 0001 1034 3451)
5 Region Västmanland, Västerås, Sweden (GRID:grid.12650.30)
6 Karolinska University Hospital, Stockholm, Sweden (GRID:grid.24381.3c) (ISNI:0000 0000 9241 5705)
7 County Hospital of Västernorrland, Region Västernorrland, Sundsvall, Sweden (GRID:grid.24381.3c)
8 Centralsjukhuset, Region Värmland, Karlstad, Sweden (GRID:grid.413655.0) (ISNI:0000 0004 0624 0902)
9 Public Health Agency of Sweden, Department of Microbiology, Solna, Sweden (GRID:grid.419734.c) (ISNI:0000 0000 9580 3113); Karolinska Institutet, Department of Laboratory Medicine, Stockholm, Sweden (GRID:grid.4714.6) (ISNI:0000 0004 1937 0626)