Introduction: Few data on the diagnostic performance of serological tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are currently available. We evaluated sensitivity and specificity of five different widely used commercial serological assays for the detection of SARS-CoV-2–specific IgG, IgM, and IgA antibodies using reverse transcriptase-PCR assay in nasopharyngeal swab as reference standard test. Methods: A total of 337 plasma samples collected in the period April–June 2020 from SARS-CoV-2 RT-PCR positive ( n = 207) and negative ( n = 130) subjects were investigated by one point-of-care lateral flow immunochromatographic assay (LFIA IgG and IgM, Technogenetics) and four fully automated assays: two chemiluminescence immunoassays (CLIA-iFlash IgG and IgM, Shenzhen YHLO Biotech and CLIA-LIAISON ® XL IgG, DiaSorin), one electrochemiluminescence immunoassay (ECLIA-Elecsys ® total predominant IgG, Roche), and one enzyme-linked immunosorbent assay (ELISA IgA, Euroimmune). Results: The overall sensitivity of all IgG serological assays was >80% and the specificity was >97%. The sensitivity of IgG assays was lower within 2 weeks from the onset of symptoms ranging from 70.8 to 80%. The LFIA and CLIA-iFlash IgM showed an overall low sensitivity of 47.6 and 54.6%, while the specificity was 98.5 and 96.2%, respectively. The ELISA IgA yielded a sensitivity of 84.3% and specificity of 81.7%. However, the ELISA IgA result was indeterminate in 11.7% of cases. Conclusions: IgG serological assays seem to be a reliable tool for the retrospective diagnosis of SARS-CoV-2 infection. IgM assays seem to have a low sensitivity and IgA assay is limited by a substantial rate of indeterminate results.
【저자키워드】 COVID-19, CLIA, SARS-COV-2 infection, Sensitivity and specificity, LFIA, SARS-CoV-2 RT-PCR, SARS-CoV-2-specific antibodies, ECLIA and ELISA, 【초록키워드】 serological test, CLIA, SARS-CoV-2, IgG, IgM, coronavirus, SARS-COV-2 infection, Infection, diagnostic, severe acute respiratory syndrome Coronavirus, RT-PCR, ELISA, lateral flow, Nasopharyngeal swab, point-of-care, sensitivity, specificity, enzyme-linked immunosorbent assay, Serological tests, Serological assay, IgA, chemiluminescence immunoassay, automated, LFIA, SARS-CoV-2 RT-PCR, immunochromatographic assay, respiratory, Roche, reference standard, lateral flow immunochromatographic assay, retrospective, LIAISON, IgG and IgM, reverse transcriptase, retrospective diagnosis, acute respiratory syndrome, acute respiratory syndrome coronavirus, Shenzhen, acute respiratory syndrome coronavirus 2, subject, DiaSorin, IgA antibodies, plasma samples, PCR assay, iFlash, positive, electrochemiluminescence immunoassay, Elecsys, FIVE, enzyme-linked immunosorbent, plasma sample, collected, investigated, evaluated, onset of symptom, predominant, IgA antibody, diagnosis of SARS-CoV-2, 【제목키워드】 SARS-CoV-2, advance, recent,