InDevR Inc. 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
InDevR Inc. 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.
J Virol Methods. 2021 May;291:114111. doi: 10.1016/j.jviromet.2021.114111. Epub 2021 Feb 25.
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.
在候选 COVID-19 疫苗开发期间，快速、敏感和精确的血清学分析多重检测将简化临床试验。VaxArray 冠状病毒（CoV）血清学分析在 2 小时内使用自动化结果分析定量测定 IgG 抗体与 9 种大流行、潜在大流行和地方性人类 CoV 刺突抗原的结合。血清中的 IgG 抗体与以微阵列形式打印的 CoV 刺突蛋白捕获抗原结合，并被荧光抗物种 IgG 二级标签标记。该测定法显示出出色的定量下限，范围从 0.3 到 2.0ng/mL，线性动态范围为 76 到 911 倍。在 216 个重复实验中（代表 3 天和 3 个微阵列批次），所有捕获抗原的平均精密度为 11%CV，准确性（%回收率）为 92.5%。在 263 个人类血清样本上的临床性能（根据供体匹配的 RT-PCR 和/或采集日期，132 个 SARS-CoV-2 阴性和 131 个阳性）产生了 98.5%的阳性预测值和 100%的阴性预测值。
