Temporal Analysis of Serial Donations Reveals Decrease in Neutralizing Capacity and Justifies Revised Qualifying Criteria for Coronavirus Disease 2019 Convalescent Plasma.
Temporal Analysis of Serial Donations Reveals Decrease in Neutralizing Capacity and Justifies Revised Qualifying Criteria for Coronavirus Disease 2019 Convalescent Plasma.
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DOI：
10.1093/infdis/jiaa803
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发表时间：
2021-03-03
期刊：
影响因子：
--
通讯作者：
McDonough KA
中科院分区：
文献类型：
--
作者：
Girardin RC;Dupuis AP;Payne AF;Sullivan TJ;Strauss D;Parker MM;McDonough KA
2019 冠状病毒病 (COVID-19) 恢复期血浆 (CCP) 获得美国食品和药物管理局 (FDA) 的紧急使用授权。使用 Ortho VITROS 严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 免疫球蛋白 G (IgG) 检测 (OVSARS2IgG) 时，信号截止比 ≥12 的 CCP 可以标记为“高效价”。关于 OVSARS2IgG 比率与血浆/血清针对真正 SARS-CoV-2 的中和能力之间的关系知之甚少。对来自 196 名重复 CCP 捐献者的初次捐献后 0-119 天 (DPID) 的 981 个样本进行了分析。使用金标准空斑减少中和试验 (PRNT) 评估感染性病毒减少 50% (PRNT50) 和 90% (PRNT90) 的中和能力。通过 OVSARS2IgG 评估了 91 份捐赠的子集，并与 PRNT 滴度进行比较以确保诊断准确性。在捐赠中，32.7%/79.5% (PRNT90/PRNT50) 最初达到 1:80 滴度，但只有 14.0%/48.8% (PRNT90/PRNT50) 达到此截止值 ≥85 DPID。 OVSARS2IgG 结果与中和能力的相关性允许推断 CCP 治疗结果。 OVSARS2IgG 比率相当于治疗有益组的 CCP 的中和滴度为 ≥1:640 (PRNT50) 和/或 ≥1:80 (PRNT90)。 OVSARS2IgG 对于鉴定高度中和 CCP 的特异性和阳性预测价值是最佳的，使用的比率显着大于 FDA 的临界值。该信息为完善用于治疗 COVID-19 的 CCP 的推荐特性提供了基础。对 COVID-19 恢复期血浆重复捐献者的中和能力的分析显示，在初次捐献后 4 个月内，中和抗体显着下降。美国食品和药物管理局唯一批准的合格 COVID-19 恢复期血浆检测的性能支持修订后的截止标准。
Coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) received an Emergency Use Authorization by the US Food and Drug Administration (FDA). CCP with a signal-to-cutoff ratio of ≥12 using the Ortho VITROS severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) test (OVSARS2IgG) is permitted to be labeled “high titer.” Little is known about the relationship between OVSARS2IgG ratio and neutralizing capacity of plasma/sera against genuine SARS-CoV-2. Nine hundred eighty-one samples from 196 repeat CCP donors 0–119 days post–initial donation (DPID) were analyzed. Neutralizing capacity was assessed for 50% (PRNT50) and 90% (PRNT90) reduction of infectious virus using the gold standard plaque reduction neutralization test (PRNT). A subset of 91 donations was evaluated by OVSARS2IgG and compared to PRNT titers for diagnostic accuracy. Of donations, 32.7%/79.5% (PRNT90/PRNT50) met a 1:80 titer initially but only 14.0%/48.8% (PRNT90/PRNT50) met this cutoff ≥85 DPID. Correlation of OVSARS2IgG results to neutralizing capacity allowed extrapolation to CCP therapy results. CCP with OVSARS2IgG ratios equivalent to a therapeutically beneficial group had neutralizing titers of ≥1:640 (PRNT50) and/or ≥1:80 (PRNT90). Specificity and positive predictive value of the OVSARS2IgG for qualifying highly neutralizing CCP was optimal using ratios significantly greater than the FDA cutoff. This information provides a basis for refining the recommended properties of CCP used to treat COVID-19. Analyses of neutralizing capacity of COVID-19 convalescent plasma repeat donors reveal a significant decrease in neutralizing antibodies within 4 months of the initial donation. Performance of the only US Food and Drug Administration–approved assay for qualifying COVID-19 convalescent plasma supports revised cutoff criteria.
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发表时间：
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期刊：
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影响因子：
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发表时间：
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