Serological Assays Estimate Highly Variable SARS-CoV-2 Neutralizing Antibody Activity in Recovered COVID-19 Patients.
Serological Assays Estimate Highly Variable SARS-CoV-2 Neutralizing Antibody Activity in Recovered COVID-19 Patients.
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DOI：
10.1128/jcm.02005-20
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发表时间：
2020-11-18
影响因子：
9.4
通讯作者：
Hatziioannou T
中科院分区：
文献类型：
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作者：
Luchsinger LL;Ransegnola BP;Jin DK;Muecksch F;Weisblum Y;Bao W;George PJ;Rodriguez M;Tricoche N;Schmidt F;Gao C;Jawahar S;Pal M;Schnall E;Zhang H;Strauss D;Yazdanbakhsh K;Hillyer CD;Bieniasz PD;Hatziioannou T
在感染或接种疫苗后，针对严重急性呼吸道综合征冠状病毒2型（SARS-CoV-2）的中和抗体（NAb）的发展可能对于发展足够的人群免疫力以推动2019冠状病毒病（COVID-19）大流行的停止至关重要。大量的血清学测试，平台和方法被用来确定人群中的血清阳性率，以选择恢复期血浆样本进行治疗试验，并指导重新开放的政策。在感染或接种疫苗后，针对严重急性呼吸道综合征冠状病毒2（SARS-CoV-2）的中和抗体（NAb）的发展可能对发展足够的人群免疫力以推动2019冠状病毒病（COVID-19）大流行的停止至关重要。大量的血清学测试，平台和方法被用来确定人群中的血清阳性率，以选择恢复期血浆样本进行治疗试验，并指导重新开放的政策。然而，这些测试在灵敏度和特异性方面有很大的差异，并且它们定量预测NAb水平的能力是未知的。我们收集了2020年4月至5月期间参加纽约血液中心恢复期血浆计划的370名独特供体。我们使用市售的SARS-CoV-2检测试验和内部酶联免疫吸附试验（ELISA）测量了恢复期血浆样本中的抗体水平，并将血清学测量与使用假型病毒颗粒测量的NAb活性相关联，这提供了对患者血清抗病毒感染的抗病毒活性的最有价值的评估。我们的数据表明，大部分的恢复期血浆样本具有适度的抗体水平，并且市售的测试在预测NAb活性方面具有不同程度的准确性。我们发现Ortho anti-SARS-CoV-2总IG和IgG高通量血清学检测试剂盒（HTSA）和Abbott SARS-CoV-2 IgG检测试剂盒定量的抗体水平与NAb检测试剂盒的结果密切相关，并且与金标准ELISA结果一致。这些发现提供了与血清学结果的直接临床相关性，可以等同于NAb活性，并可以作为指导SARS-CoV-2血清学检测的选择和解释的有价值的路线图。
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. 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.