ABSTRACT Serology is a crucial part of the public health response to the ongoing SARS-CoV-2 pandemic. Here, we describe the development, validation and clinical evaluation of a protein micro-array as a quantitative multiplex immunoassay that can identify S and N-directed SARS-CoV-2 IgG antibodies with high specificity and sensitivity and distinguish them from all currently circulating human coronaviruses. The method specificity was 100% for SARS-CoV-2 S1 and 96% for N antigen based on extensive syndromic (n=230 cases) and population panel (n=94) testing that also confirmed the high prevalence of seasonal human coronaviruses. To assess its potential role for both SARS-CoV-2 patient diagnostics and population studies, we evaluated a large heterogeneous COVID-19 cohort (n=330) and found an overall sensitivity of 89% (≥ 21 days post onset symptoms (dps)), ranging from 86% to 96% depending on severity of disease. For a subset of these patients longitudinal samples were provided up to 56 dps. Mild cases showed absent or delayed, and lower SARS-CoV-2 antibody responses. Overall, we present the development and extensive clinical validation of a multiplex coronavirus serological assay for syndromic testing, to answer research questions regarding to antibody responses, to support SARS-CoV-2 diagnostics and to evaluate epidemiological developments efficiently and with high-throughput.
【저자키워드】 COVID-19, SARS-CoV-2, serology, immune profiling, micro-array, 【초록키워드】 public health, coronavirus, antibody, SARS-CoV-2 pandemic, Symptom, diagnostics, Prevalence, Protein, immunoassay, sensitivity, specificity, Serological assay, clinical evaluation, SARS-CoV-2 IgG antibody, Patient, epidemiological, Severity of disease, multiplex, Quantitative, human coronaviruses, Support, SARS-CoV-2 antibody responses, heterogeneous, circulating, COVID-19 cohort, Research question, SARS-CoV-2 S1, responses, N antigen, identify, evaluate, evaluated, provided, subset, 【제목키워드】 multiplex, approach, human coronavirus,