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.

血清学是应对持续发生的 SARS-CoV-2 大流行的公共卫生反应的重要组成部分。在这里，我们描述了蛋白质微阵列作为一种定量多重免疫分析的开发、验证和临床评估，它可以以高特异性和灵敏度识别 S 和 N 导向的 SARS-CoV-2 IgG 抗体，并将它们与所有目前流行的人类区分开来。冠状病毒。根据广泛的综合征（n = 230 例）和人群面板（n = 94）测试，该方法对 SARS-CoV-2 S1 的特异性为 100%，对 N 抗原的特异性为 96%，这也证实了季节性人类冠状病毒的高流行率。为了评估其在 SARS-CoV-2 患者诊断和人群研究中的潜在作用，我们评估了一个大型异质 COVID-19 队列（n = 330），发现总体敏感性为 89%（≥ 21 天后出现症状 (dps) ), 根据疾病的严重程度，从 86% 到 96% 不等。对于这些患者的一个子集，提供高达 56 dps 的纵向样本。轻度病例显示不存在或延迟，并且 SARS-CoV-2 抗体反应较低。总体而言，我们介绍了用于综合征检测的多重冠状病毒血清学检测的开发和广泛的临床验证，以回答有关抗体反应的研究问题，支持 SARS-CoV-2 诊断，并有效且高通量地评估流行病学发展。