To support the deployment of serology assays for population screening during the COVID-19 pandemic, we compared the performance of three fully automated SARS-CoV-2 IgG assays: Mindray CL-900i ® (target: spike [S] and nucleocapsid [N]), BioMérieux VIDAS ® 3 (target: receptor-binding domain [RBD]) and Diasorin LIAISON ® XL (target: S1 and S2 subunits). A total of 111 SARS-CoV-2 RT-PCR- positive samples collected at ≥ 21 days post symptom onset, and 127 pre-pandemic control samples were included. Diagnostic performance was assessed in correlation to RT-PCR and a surrogate virus-neutralizing test (sVNT). Moreover, cross-reactivity with other viral antibodies was investigated. Compared to RT-PCR, LIAISON ® XL showed the highest overall specificity (100%), followed by VIDAS ® 3 (98.4%) and CL-900i ® (95.3%). The highest sensitivity was demonstrated by CL-900i ® (90.1%), followed by VIDAS ® 3 (88.3%) and LIAISON ® XL (85.6%). The sensitivity of all assays was higher in symptomatic patients (91.1–98.2%) compared to asymptomatic patients (78.4–80.4%). In correlation to sVNT, all assays showed excellent sensitivities (92.2–96.1%). In addition, VIDAS ® 3 demonstrated the best correlation (r = 0.75) with the sVNT. The present study provides insights on the performance of three fully automated assays, which could help diagnostic laboratories in the choice of a particular assay according to the intended use.
【저자키워드】 COVID-19, SARS-CoV-2, Neutralizing antibodies, serology, sensitivity, specificity, surrogate virus neutralization test (sVNT), 【초록키워드】 COVID-19 pandemic, Population screening, diagnostic, RT-PCR, Laboratory, cross-reactivity, nucleocapsid, automated, SARS-CoV-2 RT-PCR, correlation, SARS-CoV-2 IgG, asymptomatic patient, bioMérieux, LIAISON, Support, symptom onset, sVNT, domain, help, subunits, positive sample, Mindray, control sample, highest, S1 and S2, collected, assays, addition, investigated, provide, demonstrated, virus-neutralizing, serology assay, symptomatic patient, viral antibody, 【제목키워드】 Test, novel, individual, surrogate,