Clinical Transfusion Research Center, Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, Sichuan, China.
Key Laboratory of Transfusion Adverse Reactions, CAMS, Chengdu, Sichuan, China.
Transfusion. 2020 Aug;60(8):1773-1777. doi: 10.1111/trf.15921. Epub 2020 Jul 31.
A novel coronavirus has caused an international outbreak. Currently, there are no specific therapeutic agents for coronavirus infections. Convalescent plasma (CP) therapy is a potentially effective treatment option.
Patients who had recovered from COVID-19 and had been discharged from the hospital for more than 2 weeks were recruited. COVID-19 convalescent plasma (CCP)-specific donor screening and selection were performed based on the following criteria: 1) aged 18-55 years; 2) eligible for blood donation; 3) diagnosed with COVID-19; 4) had two consecutive negative COVID-19 nasopharyngeal swab tests based on PCR (at least 24 hr apart) prior to hospital discharge; 5) had been discharged from the hospital for more than 2 weeks; and 6) had no COVID-19 symptoms prior to convalescent plasma donation. In addition, preference was given to CCP donors who had a fever lasting more than 3 days or a body temperature exceeding 38.5°C (101.3°F), and who donated 4 weeks after the onset of symptoms. CCP collection was performed using routine plasma collection procedures via plasmapheresis. In addition to routine donor testing, the CCP donors' plasma was also tested for SARS-CoV-2 nucleic acid and S-RBD-specific IgG antibody.
Of the 81 potential CCP donors, 64 (79%) plasma products were collected. There were 18 female donors and 46 male donors. There were 34 first-time blood donors and 30 repeat donors. The average time between CCP collection and initial symptom onset was 49.1 days, and the average time between CCP collection and hospital discharge was 38.7 days. The average volume of CCP collected was 327.7 mL. All Alanine transaminase (ALT) testing results met blood donation requirements. HIV Ag/Ab, anti-HCV, anti-syphilis, and HBsAg were all negative; NAT for HIV, HBV, and HCV were also negative. In addition, all of the CCP donors' plasma units were negative for SARS-CoV-2 RNA. Of the total 64 CCP donors tested, only one had an S-RBD-specific IgG titer of 1:160, all others had a titer of ≥1:320.
Based on a feasibility study of a pilot CCP program in Wuhan, China, we demonstrated the success and feasibility of CCP collection. In addition, all of the CCP units collected had a titer of ≥1:160 for S-RBD-specific IgG antibody, which met the CCP quality control requirements based on the Chinese national guidelines for CCP.
一种新型冠状病毒引发了国际疫情。目前，针对冠状病毒感染尚无特效治疗药物。恢复期血浆（CP）治疗是一种潜在有效的治疗选择。
招募了从 COVID-19 中康复并已出院超过 2 周的患者。根据以下标准对 COVID-19 恢复期血浆（CCP）特异性供者进行筛查和选择：1）年龄 18-55 岁；2）有献血资格；3）诊断为 COVID-19；4）在出院前基于 PCR（至少相隔 24 小时）连续两次鼻咽拭子 COVID-19 检测呈阴性；5）已出院超过 2 周；6）在捐献血浆前无 COVID-19 症状。此外，我们优先选择发热持续超过 3 天或体温超过 38.5°C（101.3°F），且症状出现后 4 周捐献血浆的 CCP 供者。通过血浆置换术常规采集 CCP。除了常规供者检测外，还检测 CCP 供者的血浆中 SARS-CoV-2 核酸和 S-RBD 特异性 IgG 抗体。
在 81 名潜在的 CCP 供者中，采集了 64 份（79%）血浆制品。其中 18 名女性供者和 46 名男性供者。有 34 名首次献血者和 30 名重复献血者。CCP 采集与初始症状发作之间的平均时间为 49.1 天，与出院之间的平均时间为 38.7 天。采集的 CCP 平均体积为 327.7 毫升。所有丙氨酸转氨酶（ALT）检测结果均符合献血要求。HIV Ag/Ab、抗-HCV、抗梅毒和 HBsAg 均为阴性；HIV、HBV 和 HCV 的 NAT 检测也均为阴性。此外，所有 CCP 供者的血浆单位均检测不到 SARS-CoV-2 RNA。在接受检测的 64 名 CCP 供者中，仅有 1 人的 S-RBD 特异性 IgG 滴度为 1:160，其余供者的滴度均≥1:320。
基于中国武汉 CCP 方案的一项可行性研究，我们证明了 CCP 采集的成功和可行性。此外，所有采集的 CCP 单位的 S-RBD 特异性 IgG 抗体滴度均≥1:160，符合中国 CCP 国家指南的 CCP 质量控制要求。
