The development of neutralizing antibodies (NAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) following infection or vaccination is likely to be critical for the development of sufficient population immunity to drive cessation of the coronavirus disease of 2019 (COVID-19) pandemic. A large number of serologic tests, platforms, and methodologies are being employed to determine seroprevalence in populations to select convalescent plasma samples for therapeutic trials and to guide policies about reopening. However, the tests have substantial variations in sensitivity and specificity, and their ability to quantitatively predict levels of NAbs is unknown. We collected 370 unique donors enrolled in the New York Blood Center Convalescent Plasma Program between April and May of 2020. We measured levels of antibodies in convalescent plasma samples using commercially available SARS-CoV-2 detection tests and in-house enzyme-linked immunosorbent assays (ELISAs) and correlated serological measurements with NAb activity measured using pseudotyped virus particles, which offer the most informative assessment of antiviral activity of patient sera against viral infection. Our data show that a large proportion of convalescent plasma samples have modest antibody levels and that commercially available tests have various degrees of accuracy in predicting NAb activity. We found that the Ortho anti-SARS-CoV-2 total Ig and IgG high-throughput serological assays (HTSAs) and the Abbott SARS-CoV-2 IgG assay quantify levels of antibodies that strongly correlate with the results of NAb assays and are consistent with gold standard ELISA results. These findings provide immediate clinical relevance to serology results that can be equated to NAb activity and could serve as a valuable roadmap to guide the choice and interpretation of serological tests for SARS-CoV-2.

中文翻译：

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血清学分析估计在恢复的COVID19患者中高度可变的SARS-CoV-2中和抗体活性。

感染或接种疫苗后针对严重急性呼吸系统综合症冠状病毒2（SARS-CoV-2）的中和抗体（NAbs）的开发可能对于开发足够的人群免疫力以推动2019年冠状病毒疾病的戒断至关重要（COVID- 19）大流行。大量的血清学检测，平台和方法被用于确定人群中的血清阳性率，以选择恢复期的血浆样品进行治疗性试验并指导有关重新开放的政策。但是，这些测试在敏感性和特异性方面存在很大差异，并且尚无法定量预测NAb的水平。在2020年4月至5月之间，我们收集了370名独特的捐赠者，他们参与了纽约血液中心康复血浆计划。我们使用市售的SARS-CoV-2检测测试和内部酶联免疫吸附测定（ELISA）测量了恢复血浆样品中的抗体水平，并使用伪型病毒颗粒测量了血清学测量值与NAb活性的相关性，这提供了最有价值的评估血清抗病毒感染的抗病毒活性 我们的数据表明，大部分恢复性血浆样品的抗体水平适中，而市售测试在预测NAb活性方面具有不同程度的准确性。我们发现Ortho抗SARS-CoV-2总Ig和IgG高通量血清学检测（HTSA）和Abbott SARS-CoV-2 IgG检测可量化与NAb检测结果密切相关且一致的抗体水平具有金标准ELISA结果。