Anti-SARS-CoV-2 Antibody Levels Measured by the AdviseDx SARS-CoV-2 Assay Are Concordant with Previously Available Serologic Assays but Are Not Fully Predictive of Sterilizing Immunity.
Anti-SARS-CoV-2 Antibody Levels Measured by the AdviseDx SARS-CoV-2 Assay Are Concordant with Previously Available Serologic Assays but Are Not Fully Predictive of Sterilizing Immunity.
复制标题
DOI：
10.1128/jcm.00989-21
复制
发表时间：
2021-08-18
影响因子：
9.4
通讯作者：
Greninger AL
中科院分区：
文献类型：
--
作者：
Bradley BT;Bryan A;Fink SL;Goecker EA;Roychoudhury P;Huang ML;Zhu H;Chaudhary A;Madarampalli B;Lu JYC;Strand K;Whimbey E;Bryson-Cahn C;Schippers A;Mani NS;Pepper G;Jerome KR;Morishima C;Coombs RW;Wener M;Cohen S;Greninger AL
随着 SARS-CoV-2 疫苗的广泛应用，高通量定量抗刺突蛋白血清学检测可能会变得越来越重要。在这里，我们研究了 FDA 最近授权的半定量抗尖峰蛋白 AdviseDx SARS-CoV-2 IgG II 检测方法与 FDA 授权的抗核衣壳蛋白 Abbott Architect SARS-CoV-2 IgG、Roche Elecsys 抗 SARS-CoV-2-S、EuroImmun 抗 SARS-CoV-2 酶联免疫吸附检测 (ELISA) 和 GenScript 替代病毒中和检测的性能特征并检查了与疫苗接种、自然保护和疫苗突破感染相关的体液反应。 AdviseDx 检测在症状出现后 14 天或 PCR 检测后 10 天时的临床敏感性为 95.6%（65/68；95% 置信区间 [CI]，87.8 至 98.8%），两个有差异的个体此后不久就出现了血清转化。 AdviseDx 检测结果显示，与使用相同症状发作或 PCR 检测截止值进行检查的其他四种检测方法的阳性率一致，为 100%。使用最近可用的 WHO 抗 SARS-CoV-2 抗体国际标准，我们为每个检查的测定提供国际单位的测定单位转换因子。我们对健康接种疫苗的个体进行了纵向调查，发现 AdviseDx 免疫球蛋白中值水平在首次疫苗接种后 7 周达到峰值，约为 4,000 IU/ml。有趣的是，在所检查的五项检测中，两名在先前描述的渔船疫情中免受 SARS-CoV-2 感染的血清反应阳性患者和五名经历过 SARS-CoV-2 感染疫苗突破的医护人员之间的抗原结合水平或中和活性没有显着差异，所有这些都带有令人担忧的变异。这些发现表明，目前不能仅使用针对野生型 SARS-CoV-2 刺突的体外抗体测定来预测对 SARS-CoV-2 感染的保护作用。需要进一步开展工作来建立 SARS-CoV-2 感染的保护相关性。
With the availability of widespread SARS-CoV-2 vaccination, high-throughput quantitative anti-spike protein serological testing will likely become increasingly important. Here, we investigated the performance characteristics of the recently FDA-authorized semiquantitative anti-spike protein AdviseDx SARS-CoV-2 IgG II assay compared to the FDA-authorized anti-nucleocapsid protein Abbott Architect SARS-CoV-2 IgG, Roche Elecsys anti-SARS-CoV-2-S, EuroImmun anti-SARS-CoV-2 enzyme-linked immunosorbent assay (ELISA), and GenScript surrogate virus neutralization assays and examined the humoral response associated with vaccination, natural protection, and vaccine breakthrough infection. The AdviseDx assay had a clinical sensitivity at 14 days after symptom onset or 10 days after PCR detection of 95.6% (65/68; 95% confidence interval [CI], 87.8 to 98.8%), with two discrepant individuals seroconverting shortly thereafter. The AdviseDx assay demonstrated 100% positive percent agreement with the four other assays examined using the same symptom onset or PCR detection cutoffs. Using a recently available WHO international standard for anti-SARS-CoV-2 antibody, we provide assay unit conversion factors to international units for each of the assays examined. We performed a longitudinal survey of healthy vaccinated individuals, finding that median AdviseDx immunoglobulin levels peaked 7 weeks after first vaccine dose at approximately 4,000 IU/ml. Intriguingly, among the five assays examined, there was no significant difference in antigen binding level or neutralizing activity between two seropositive patients protected against SARS-CoV-2 infection in a previously described fishing vessel outbreak and five health care workers who experienced vaccine breakthrough of SARS-CoV-2 infection, all with variants of concern. These findings suggest that protection against SARS-CoV-2 infection cannot currently be predicted exclusively using in vitro antibody assays against wild-type SARS-CoV-2 spike. Further work is required to establish protective correlates for SARS-CoV-2 infection.