Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) has been identified as the causative agent for causing the clinical syndrome of COVID -19. Accurate detection of SARS-CoV-2 infection is not only important for management of infected individuals but also to break the chain of transmission. South Africa is the current epicenter of SARS-CoV-2 infection in Africa. To optimize the diagnostic algorithm for SARS-CoV-2 in the South African setting, the study aims to evaluate the diagnostic performance of the EUROIMMUN Anti-SARS-CoV-2 assays. This study reported the performance of EUROIMMUN enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgA and IgG antibodies in serum and plasma samples targeting the recombinant S1 domain of the SARS-CoV-2 spike protein as antigen. Samples were collected from 391 individuals who had tested positive for SARS-CoV-2 and 139 SARS CoV-2 negative controls. Samples were stratified by number of days’ post-PCR diagnosis and symptoms. The sensitivity of EUROIMMUN IgG was 64.1% (95% CI: 59.1–69.0%) and 74.3% (95% CI: 69.6–78.6%) for IgA and the specificity was lower for IgA [84.2% (95% CI: 77–89.2%)] than IgG [95.2% (95% CI: 90.8–98.4%)]. The EUROIMMUN Anti-SARS-CoV-2 ELISA Assay sensitivity was higher for IgA but low for IgG and improved for both assays in symptomatic individuals and at later timepoints post PCR diagnosis.
【초록키워드】 SARS CoV-2, SARS-CoV-2, IgG, SARS-COV-2 infection, diagnostic, Diagnosis, Transmission, Symptoms, ELISA, Spike protein, Antigen, COVID, sensitivity, specificity, South Africa, IgG antibody, PCR, IgA, management, African, Algorithm, respiratory, Euroimmun, negative controls, infected individual, individual, syndrome, South, positive, serum and plasma, S1 domain, enzyme-linked immunosorbent, tested, collected, Sample, evaluate, reported, assays, semi-quantitative, stratified, symptomatic individual, the SARS-CoV-2, timepoint, 【제목키워드】 ELISA, South Africa, IgG antibody, IgA, performance, Euroimmun,