論文ID: JJID.2021.636
Comparative validation data and clinical performance data are essential for the reliable interpretation of SARS-CoV-2 antibody test results. This study aimed to assess the performance of six SARS-CoV-2 IgG immunoassays in different disease severity settings. Four automated chemiluminescence immunoassays Access (Beckman Coulter), Architect (Abbott), Atellica-IM (Siemens) and Elecsys (Roche) and two ELISA assays (SARS-CoV-2 IgG-S1-based and NCP IgG, Euroimmun) were evaluated in 143 patients and 50 pre-pandemic control sera. Accuracy and precision tests were performed for validation. Overall sensitivity differed between 73.38-88.65%, being higher in spike protein-based assays. Specificity was ≥ 98% in all immunoassays. IgG response was lower for the samples taken <20 days post-symptom onset (87.30%) than for the samples taken ≥20 days post-symptom onset (94.80%). Higher rate of antibody was detected in the clinically moderate disease group. In the asymptomatic and mild group more antibody positivity was detected with spike protein-based assays. Clinical performance of the immunoassays differs according to disease severity and antigen targeted; moderate disease leading to highest rate of IgG response. All the assays tested were eligible for the detection of SARS-CoV-2 IgG however, spike-based assays revealed relatively higher sensitivity than the nucleoprotein-based assays particularly in the asymptomatic and mild disease severity.
