SARS-CoV-2 IgG antibodies in COVID-19 convalescent plasma and conventional plasma units.

IF 2 3区医学 Q2 HEMATOLOGY Transfusion Pub Date : 2025-03-01 Epub Date: 2025-01-22 DOI:10.1111/trf.18139

Andrew Sulaiman, Isabella Sengsouk, Jodie L White, Christi Marshall, Reinaldo E Fernandez, Andrew D Redd, Yolanda Eby, Arturo Casadevall, David Sullivan, Kelly Gebo, Shmuel Shoham, Oliver Laeyendecker, Herleen Rai, Evan M Bloch, Elizabeth P Crowe, Aaron A R Tobian

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Abstract

Background: The Association for the Advancement of Blood and Biotherapies guidelines recommend the use of high-titer COVID-19 convalescent plasma (CCP) for patients with SARS-CoV-2 at high risk of disease progression, including those who are immunocompromised. We hypothesized that conventional plasma units have comparable neutralizing antibody levels to CCP.

Study design and methods: Conventional plasma and CCP units were obtained from blood suppliers. Quantitatively measured antibodies to SARS-CoV-2 were assessed using the MesoScale Discovery multiplex electrochemiluminescence immunoassay. Binding antibody distributions were compared with Wilcoxon rank-sum tests. SARS-CoV-2 neutralizing antibodies were analyzed using the GeneScript ELISA-based neutralization assay. The proportion of conventional and CCP units with a percent signal inhibition of ≥80% (as defined by the United States Food and Drug Administration for CCP in 2021) and exact binomial confidence intervals (CIs) were calculated.

Results: Among 218 conventional plasma units and 74 CCP units collected between September 2023 and July 2024, the distribution of total antibody binding levels largely overlapped between conventional plasma and CCP, though statistically significant differences in median nucleocapsid and spike Omicron variant concentrations were observed. Median percent signal neutralization was 97.5% (range 3.4%-98.6%) among conventional plasma units and 97.7% (range 95.4%-98.6%) among CCP units. For conventional plasma, 95.0% (95% CI = 91.2%-97.5%) met the neutralization antibody threshold for high-titer CCP. For CCP, 100% (95% CI = 95.1%-100.0%) met the neutralization threshold for high-titer CCP.

Conclusion: Conventional plasma units demonstrate similar median antibody concentration to CCP units. In countries or regions where licensed CCP is unavailable and titers are unknown, transfusion of multiple conventional plasma units may be of clinical utility.

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新冠肺炎恢复期血浆和常规血浆中SARS-CoV-2 IgG抗体的检测。

背景：血液和生物治疗促进协会指南推荐对疾病进展高风险的SARS-CoV-2患者（包括免疫功能低下的患者）使用高滴度COVID-19恢复期血浆（CCP）。我们假设传统血浆单位具有与CCP相当的中和抗体水平。研究设计和方法：从血液供应商处获得常规血浆和CCP单位。使用MesoScale Discovery多重电化学发光免疫分析法对定量测量的SARS-CoV-2抗体进行评估。结合抗体分布与Wilcoxon秩和检验比较。使用基于GeneScript elisa的中和试验分析SARS-CoV-2中和抗体。计算信号抑制率≥80%（按照美国食品和药物管理局2021年对CCP的定义）的常规和CCP单位的比例和精确的二项置信区间（CIs）。结果：在2023年9月至2024年7月采集的218个常规血浆单位和74个CCP单位中，常规血浆和CCP之间的抗体总结合水平分布基本重合，但中位核衣皮和尖刺Omicron变异浓度存在统计学差异。在传统等离子装置中，信号中和的中位数百分比为97.5%（范围为3.4%-98.6%），在CCP装置中为97.7%（范围为95.4%-98.6%）。对于常规血浆，95.0% （95% CI = 91.2%-97.5%）符合高滴度CCP的中和抗体阈值。对于CCP， 100% （95% CI = 95.1%-100.0%）符合高滴度CCP的中和阈值。结论：传统血浆单位显示出与CCP单位相似的中位抗体浓度。在没有CCP许可且滴度未知的国家或地区，多次常规血浆单位输血可能具有临床效用。

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来源期刊

Transfusion 医学-血液学

CiteScore

4.70

自引率

20.70%

发文量

426

审稿时长

1 months

期刊介绍： TRANSFUSION is the foremost publication in the world for new information regarding transfusion medicine. Written by and for members of AABB and other health-care workers, TRANSFUSION reports on the latest technical advances, discusses opposing viewpoints regarding controversial issues, and presents key conference proceedings. In addition to blood banking and transfusion medicine topics, TRANSFUSION presents submissions concerning patient blood management, tissue transplantation and hematopoietic, cellular, and gene therapies.