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. Supplementary Information The online version contains supplementary material available at 10.1007/s10096-021-04220-7.
【저자키워드】 SARS-CoV-2, Antibody testing, serology, ELISA, ECLIA, POCT, 【초록키워드】 serological test, IgG, IgM, coronavirus, Healthcare workers, Infection, Test, diagnostic, severe acute respiratory syndrome Coronavirus, Symptoms, healthcare worker, cross-reactivity, sensitivity, specificity, Serological tests, Characteristics, SARS-CoV-2 antibody, IgA, sera, Patient, POCT, ICU Patients, respiratory, IgG ELISA, epitope, Roche, diagnose, acute respiratory syndrome, supplementary material, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, diagnoses, severe symptoms, Orient, ACRO, Boson, ICU patient, highest, performed, detect, assays, evaluated, variety, presence of antibody, severe symptom, 【제목키워드】 antibody, Serological assay, serum sample,