Abstract
A variety of serological tests have been developed to detect the presence of antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated the performance of 18 commercially available SARS-CoV-2 antibody assays. Early (6–8 days after the start of symptoms) and late sera (>14 days) from ICU patients (n=10 and n=16, respectively) and healthcare workers (n=5 and n=9, respectively) were included. Additionally, 22 sera were included to detect potential cross-reactivity. Test characteristics were determined for the 18 assays. In >14 days samples, the Vircell IgG and Wantai Ig ELISAs had superior sensitivity compared to the other ELISAs (96%). Furthermore, the Roche Ig, the Epitope Diagnostics IgM, Wantai IgM, Euroimmun IgG, and IgA all showed a specificity of 100%. The POCTs of Boson Biotech and ACRO Biotech showed the highest sensitivities: 100% and 96% (83.5–99.8), respectively. The POCT of Orient Gene Biotech, VOMED Diagnostics, and Coris-Bioconcept showed highest specificities (100%). For the IgM and IgA assays, the Euroimmun IgA test showed the highest sensitivity in early samples: 46.7% (23.5–70.9) to 53.3% (29.1–76.5). In general, all tests performed better in patients with severe symptoms (ICU patients). We conclude that the Wantai Ig and Vircell IgG ELISAs may be suitable for diagnostic purposes. The IgM/IgA tests performed poorer than their IgG/Ig counterparts but may have a role in diagnoses of SARS-CoV-2 in a population in which the background seroprevalence of IgG high, and IgM and/or IgA may distinguish between acute or past infection.
Highlights
A variety of serological tests have been developed to detect the presence of antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
We compared the sensitivity of ELISA/ElectroChemiLuminescence ImmunoAssay (ECLIA) kits of six different manufacturers, all of which had an Ig or IgG test, whereas four manufacturers had a separate IgM, IgA, or combined IgM/IgA test (Table 1)
For Roche Ig, Euroimmun IgG and IgA, Epitope Diagnostics IgM, and Wantai IgM, a specificity higher than 98% was found
Summary
We compared the sensitivity of ELISA/ECLIA kits of six different manufacturers, all of which had an Ig or IgG test, whereas four manufacturers had a separate IgM, IgA, or combined IgM/IgA test (Table 1). The sensitivity of the IgA/IgM tests was similar or lower than the sensitivity of the Ig/IgG test of the same manufacturer in the >14 days samples (Vircell IgM/IgA ranging from 88.0, 71.8–96.9, to 96.0%, 83.5–99.8; Euroimmun IgA 92.0%, 77.3–98.6; Wantai IgM 88.0%, 71.8–96.9; and Epitope Diagnostics ranging from 64.0, 44.5–80.8, to 80.0%, 61.8–92.3). Apart from the IgM test of Epitope Diagnostics (ranging from 87.5, 66.2–97.8, to 93.8%, 75.3– 99.6), the sensitivity of all tests for the >14 days sera from patients with severe disease was 100%. For patients with mild to moderate disease, the sensitivity in the >14 days sera was highest for Vircell IgG and Wantai Ig (88.9%, 59.5–99.3). For Roche Ig, Euroimmun IgG and IgA, Epitope Diagnostics IgM, and Wantai IgM, a specificity higher than 98% was found. The early samples include the samples 6 to 8 days after start of disease, whereas the late samples include the samples >14 days after start of disease a Two calculations were used for borderline results: the first one with borderline values counted as negative and the second with borderline values counted as positive
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