Quantitative and robust serology assays are critical measurements underpinning global COVID-19 response to diagnostic, surveillance, and vaccine development. Here, we report a proof-of-concept approach for the development of quantitative, multiplexed flow cytometry-based serological and neutralization assays. The serology assays test the IgG and IgM against both the full-length spike antigens and the receptor binding domain (RBD) of the spike antigen. Benchmarking against an RBD-specific SARS-CoV IgG reference standard, the anti-SARS-CoV-2 RBD antibody titer was quantified in the range of 37.6 µg/mL to 31.0 ng/mL. The quantitative assays are highly specific with no correlative cross-reactivity with the spike proteins of MERS, SARS1, OC43 and HKU1 viruses. We further demonstrated good correlation between anti-RBD antibody titers and neutralizing antibody titers. The suite of serology and neutralization assays help to improve measurement confidence and are complementary and foundational for clinical and epidemiologic studies.
【저자키워드】 IgG, IgM, spike, SARS-CoV-2 virus, Sensitivity and specificity, Neutralization assay, RBD, Cross reactivity, quantitative serology assays, monoclonal antibody reference standard, 【초록키워드】 COVID-19, viruses, Vaccine development, serology, SARS-CoV, diagnostic, MERS, anti-SARS-CoV-2, Receptor binding domain, Antigen, cross-reactivity, Surveillance, Antibody titer, correlation, serological, Quantitative, Critical, reference standard, OC43, HKU1, SARS1, Quantitative assays, Spike proteins, anti-RBD, complementary, IgG and IgM, Benchmarking, neutralizing antibody titers, help, serology assays, quantitative assay, neutralization assays, full-length, approach, robust, IMPROVE, the spike protein, demonstrated, quantified, serology assay, 【제목키워드】 COVID-19,