The performance of a laboratory-developed IgG/IgA flow cytometry-based immunoassay (FCI) using Jurkat T cells stably expressing full-length native S protein was compared against Elecsys electrochemiluminiscent (ECLIA) Anti-SARS-CoV-2 S (Roche Diagnostics, Pleasanton, CA, USA), and Liaison SARS-CoV-2 TrimericS IgG chemiluminiscent assay (CLIA) (Diasorin S.p.a, Saluggia, IT) for detection of SARS-CoV-2-specific antibodies. A total of 225 serum/plasma specimens from 120 acute or convalescent COVID-19 individuals were included. Overall, IgG/IgA-FCI yielded the highest number of positives (n = 179), followed by IgA-FCI (n = 177), Roche ECLIA (n = 175), IgG-FCI (n = 172) and Diasorin CLIA (n = 154). For sera collected early after the onset of symptoms (within 15 days) IgG/IgA-FCI also returned the highest number of positive results (52/72; 72.2%). Positive percent agreement between FCI and compared immunoassays was highest for Roche ECLIA, ranging from 96.1 (IgG/IgA-FCI) to 97.7% (IgG-FCI), whereas negative percent agreement was higher between FCI and Diasosin CLIA, regardless of antibody isotype. The data suggest that FCI may outperform Roche ECLIA and Diasorin CLIA in terms of clinical sensitivity for serological diagnosis of SARS-CoV-2 infection.
【저자키워드】 Infectious diseases, Microbiology, Virology, Infectious-disease diagnostics, 【초록키워드】 COVID-19, CLIA, SARS-CoV-2, IgG, S protein, antibody, Infection, immunoassay, T cell, sera, USA, convalescent, Roche, serological, SARS-CoV-2-specific antibodies, clinical sensitivity, individual, positive result, specimen, serum/plasma, positive, Roche Diagnostics, full-length, highest, collected, onset of symptom, expressing, returned, diagnosis of SARS-CoV-2, Elecsy, 【제목키워드】 immunoassay, SARS-CoV-2 spike protein, performance, antibodies binding,