Blood Donation Screening Laboratory, French Military Blood Institute, Clamart, France.
Cerus Corporation, Concord, California, USA.
Transfusion. 2023 Sep;63(9):1633-1638. doi: 10.1111/trf.17506. Epub 2023 Aug 24.
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-infected patients exhibit disease ranging from asymptomatic to severe pneumonia, multi-organ failure, and death. convalescent COVID plasma (CCP) from recovered patients with high levels of neutralizing antibodies has demonstrated therapeutic efficacy to reduce the morbidity of coronavirus disease 2019 (COVID-19) in some studies. The development of assays to characterize the activity of CCP to neutralize SARS-CoV-2 infectivity offers the possibility to improve potential therapeutic efficacy. Lyophilization of CCP may increase the availability of this therapy. We hypothesized that SARS-CoV-2 antibody profiles of pooled lyophilized pathogen-reduced CCP from COVID-19-recovered blood donors retains virus-neutralizing efficacy as reported for frozen pathogen-reduced CCP.
Pooled lyophilized pathogen-reduced plasma was prepared from recovered COVID plasma donors. Antibodies to SARS-CoV-2 were characterized in each donor plasma prior to pathogen reduction and lyophilization and after lyophilization of individual CCP, and in the lyophilized CCP pool. Several complimentary assays were used to characterize antibody levels, neutralizing capacity, and the spectrum of antigen reactivity. The mean values for individual plasma samples and the value in the pool were compared.
The mean ratio for antibody binding to SARS-CoV-2 antigens before and after treatment was 0.95 ± 0.22 mean fluorescent intensity (MFI) units. Antibody activity to an array of influenza virus antigens demonstrated a mean activity ratio of 0.92 ± 0.12 MFI before and after treatment.
The antibody activity in pooled pathogen-reduced lyophilized CCPs demonstrated minimal impact due to pathogen reduction treatment and lyophilization.
感染严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的患者表现出从无症状到严重肺炎、多器官衰竭和死亡等不同程度的疾病。来自康复患者的高滴度中和抗体的恢复期 COVID 血浆（CCP）在一些研究中已证明具有降低 2019 年冠状病毒病（COVID-19）发病率的治疗效果。开发用于表征 CCP 中和 SARS-CoV-2 感染能力的检测方法为提高潜在治疗效果提供了可能。CCP 的冻干可增加这种治疗方法的可用性。我们假设，来自 COVID-19 康复献血者的汇集冻干减毒病原体 CCP 的 SARS-CoV-2 抗体谱保留了报告的冷冻减毒 CCP 的病毒中和功效。
从康复的 COVID 血浆供体中制备汇集冻干减毒病原体 CCP。在进行病原体减少和冻干之前以及在单独的 CCP 冻干后以及在冻干 CCP 池后，对每个供体血浆中的 SARS-CoV-2 抗体进行了特征描述。使用几种互补的检测方法来描述抗体水平、中和能力和抗原反应谱。比较了单个血浆样本的平均值和池中的平均值。
治疗前后 SARS-CoV-2 抗原结合抗体的平均值比为 0.95±0.22 平均荧光强度（MFI）单位。针对一系列流感病毒抗原的抗体活性在治疗前后的平均活性比为 0.92±0.12 MFI。
汇集减毒冻干 CCP 中的抗体活性由于病原体减少处理和冻干的影响最小。
