Introduction Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests have been suggested as an additional diagnostic tool in highly suspected cases with a negative molecular test and determination of seroprevalence in population. We compared the diagnostic performance of eight commercial serological assays for IgA, IgM, and IgG antibodies to the SARS-CoV-2 virus. Materials and methods The comparison study was performed on a total of 76 serum samples: 30 SARS-CoV-2 polymerase chain reaction (PCR)-negative and 46 SARS-CoV-2 PCR-positive patients with asymptomatic to severe disease and symptoms duration from 3-30 days. The study included: three rapid lateral flow immunochromatographic assays (LFIC), two enzyme-linked immunosorbent assays (ELISA), and three chemiluminescence immunoassays (CLIA). Results Agreement between IgM assays were minimal to moderate (kappa 0.26 to 0.63) and for IgG moderate to excellent (kappa 0.72 to 0.92). Sensitivities improved with > 10 days of symptoms and were: 30% to 89% for IgM; 89% to 100% for IgG; 96% for IgA; 100% for IgA/IgM combination; 96% for total antibodies. Overall specificities were: 90% to 100% for IgM; 85% to 100% for IgG; 90% for IgA; 70% for IgA/IgM combination; 100% for total antibodies. Diagnostic accuracy for IgG ELISA and CIA assays were excellent (AUC ≥ 0.90), without significant difference. IgA showed significantly better diagnostic accuracy than IgM (P < 0.001). Conclusion There is high variability between IgM assays independently of the assay format, while IgG assays showed moderate to perfect agreement. The appropriate time for testing is crucial for the proper immunity investigation.
【저자키워드】 serological test, SARS-CoV-2, sensitivity, specificity, 【초록키워드】 severe acute respiratory syndrome coronavirus 2, CLIA, IgG, IgM, coronavirus, Immunity, Seroprevalence, diagnostic, SARS-CoV-2 virus, Symptom, severe acute respiratory syndrome Coronavirus, ELISA, lateral flow, polymerase chain reaction, serum, enzyme-linked immunosorbent assay, Diagnostic accuracy, IgG antibody, Serological tests, Serological assay, Asymptomatic, Accuracy, IgG antibodies, IgA, enzyme-linked immunosorbent assays, chemiluminescence immunoassay, agreement, immunochromatographic assay, respiratory, IgG ELISA, moderate, severe disease, AUC, Chain Reaction, acute respiratory syndrome, significant difference, acute respiratory syndrome coronavirus, serum samples, material, sensitivities, high variability, SARS-CoV-2 polymerase chain reaction, total antibodies, molecular test, polymerase chain, Result, significantly, eight, was performed, suggested, PCR-positive patient, the SARS-CoV-2 virus, 【제목키워드】 diagnostic, Diagnostic accuracy, Serological assay, Accuracy, eight,