National Blood Services, Magen David Adom, Ramat Gan, Israel.
Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.
Vox Sang. 2022 Feb;117(2):185-192. doi: 10.1111/vox.13162. Epub 2021 Jun 14.
Passive immunization using investigational COVID-19 convalescent plasma (CCP) is a promising therapeutic strategy and could improve outcome if transfused early and contain high levels of anti-SARS-CoV-2 antibodies. We report the management of a national CCP collection and distribution program in Israel.
From 1 April 2020 to 15 January 2021, 4020 volunteer donors donated 5221 CCP units and 837 (20.8%) donors donated more than once. Anti-nucleocapsid IgG antibodies were determined using chemiluminescent immunoassay method (Abbott). A statistical model based on repeated IgG tests in sequential donations was created to predict the time of antibody decline below sample/cut-off (S/CO) level of 4.0.
Ninety-six percent of CCP donors suffered a mild disease or were asymptomatic. Older donors had higher antibody levels. Higher antibody levels (S/CO ≥4) were detected in 35.2% of the donors. Low positive (S/CO ≥1.4-3.99) were found in 37%, and 27.8% had undetectable antibodies (S/CO ≤1.4). The model predicted decrease antibody thresholds of 0.55%/day since the first CCP donation, providing guidance for the effective timing of future collections from donors with high antibody levels.
An efficient CCP collection and distribution program was achieved, based on performing initial and repeated plasma collections, preferably from donors with higher antibody levels, and only antibody-rich units were supplied for therapeutic use. The inventory met the quantity and quality standards of the authorities, enabled to respond to the growing demand of the medical system and provide a product that may contribute to improve prognosis in patients with COVID-19.
使用研究性 COVID-19 恢复期血浆(CCP)进行被动免疫是一种很有前途的治疗策略,如果早期输注且含有高水平的抗 SARS-CoV-2 抗体,则可以改善预后。我们报告了以色列一项全国性 CCP 采集和分发计划的管理情况。
从 2020 年 4 月 1 日至 2021 年 1 月 15 日,4020 名志愿者献血者捐献了 5221 单位 CCP,其中 837 名(20.8%)献血者不止一次捐献。使用化学发光免疫分析方法(雅培)测定抗核衣壳 IgG 抗体。建立了一个基于连续捐献中重复 IgG 检测的统计模型,以预测抗体下降至样本/临界值(S/CO)水平 4.0 以下的时间。
96%的 CCP 献血者患有轻症或无症状疾病。年龄较大的献血者抗体水平较高。35.2%的献血者检测到较高的抗体水平(S/CO≥4)。37%的人检测到低阳性(S/CO≥1.4-3.99),27.8%的人检测不到抗体(S/CO≤1.4)。该模型预测,自首次 CCP 献血以来,抗体下降阈值为 0.55%/天,为具有高抗体水平的献血者提供了未来采集的有效时间指导。
通过进行初始和重复的血浆采集,建立了一个高效的 CCP 采集和分发计划,最好从抗体水平较高的献血者中采集,并且仅供应含有丰富抗体的单位用于治疗。该库存符合当局的数量和质量标准,能够满足医疗系统不断增长的需求,并提供一种可能有助于改善 COVID-19 患者预后的产品。