Department of Medical Microbiology, Stavanger University Hospital, 4068 Stavanger, Norway.
Department of Research, Section of Biostatistics, Stavanger University Hospital, 4068 Stavanger, Norway.
Viruses. 2022 Oct 5;14(10):2196. doi: 10.3390/v14102196.
The aim of this study was to evaluate the performances of three commercially available antibody assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies at different time points following SARS-CoV-2 infection. Sera from 536 cases, including 207 SARS-CoV-2 PCR positive, were tested for SARS-CoV-2 antibodies with the Wantai receptor binding domain (RBD) total antibody assay, Liaison S1/S2 IgG assay and Alinity i nucleocapsid IgG assay and compared to a two-step reference ELISA (SARS-CoV-2 RBD IgG and SARS-CoV-2 spike IgG). Diagnostic sensitivity, specificity, predictive values and Cohen's kappa were calculated for the commercial assays. The assay's sensitivities varied greatly, from 68.7% to 95.3%, but the specificities remained high (96.9-99.1%). The three tests showed good performances in sera sampled 31 to 60 days after PCR positivity compared to the reference ELISA. The total antibody test performed better than the IgG tests the first 30 days and the nucleocapsid IgG test showed reduced sensitivity two months or more after PCR positivity. Hence, the test performances at different time points should be taken into consideration in clinical practice and epidemiological studies. Spike or RBD IgG tests are preferable in sera sampled more than two months following SARS-CoV-2 infection.
本研究旨在评估三种市售抗体检测试剂盒在 SARS-CoV-2 感染后不同时间点检测严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 抗体的性能。检测了来自 536 例病例的血清,包括 207 例 SARS-CoV-2 PCR 阳性病例,这些病例使用万泰受体结合域(RBD)总抗体检测试剂盒、Liaison S1/S2 IgG 检测试剂盒和 Alinity i 核衣壳 IgG 检测试剂盒进行 SARS-CoV-2 抗体检测,并与两步参考 ELISA(SARS-CoV-2 RBD IgG 和 SARS-CoV-2 刺突 IgG)进行比较。计算了商业检测试剂盒的诊断敏感性、特异性、预测值和 Cohen's kappa。检测试剂盒的敏感性差异很大,从 68.7%到 95.3%不等,但特异性仍然很高(96.9-99.1%)。与参考 ELISA 相比,三种检测试剂盒在 PCR 阳性后 31 至 60 天采集的血清中表现出良好的性能。总抗体检测在 PCR 阳性后前 30 天的 IgG 检测中表现更好,核衣壳 IgG 检测在 PCR 阳性后两个月或更长时间表现出敏感性降低。因此,在临床实践和流行病学研究中应考虑不同时间点的检测性能。在 SARS-CoV-2 感染后两个月以上采集的血清中,刺突或 RBD IgG 检测更为可取。