Rapid, sensitive, and precise multiplexed assays for serological analysis during candidate COVID-19 vaccine development would streamline clinical trials. The VaxArray Coronavirus (CoV) SeroAssay quantifies IgG antibody binding to 9 pandemic, potentially pandemic, and endemic human CoV spike antigens in 2 h with automated results analysis. IgG antibodies in serum bind to the CoV spike protein capture antigens printed in a microarray format and are labeled with a fluorescent anti-species IgG secondary label. The assay demonstrated excellent lower limits of quantification ranging from 0.3 to 2.0 ng/mL and linear dynamic ranges of 76 to 911-fold. Average precision of 11 % CV and accuracy (% recovery) of 92.5 % over all capture antigens were achieved over 216 replicates representing 3 days and 3 microarray lots. Clinical performance on 263 human serum samples (132 SARS-CoV-2 negatives and 131 positives based on donor-matched RT-PCR and/or date of collection) produced 98.5 % PPA and 100 % NPA.
【저자키워드】 COVID-19, SARS-CoV-2, serology, immunoassay, VaxArray, human coronavirus, 【초록키워드】 IgG, pandemic, clinical trials, RT-PCR, Spike protein, Antigen, serum, IgG antibody, Accuracy, clinical, Microarray, Rapid, CoV, automated, quantification, human serum, binding, Endemic, Analysis, Streamline, Precision, COVID-19 vaccine development, serological analysis, fluorescent, positive, human CoV, limit, produced, replicate, linear, demonstrated, representing, capture antigen, 【제목키워드】 coronavirus, antibody, Serological assay,