MSTP, Renaissance School of Medicine at Stony Brook University, Stony Brook, New York, USA.
Renaissance School of Medicine at Stony Brook University, Stony Brook, New York, USA.
Transfusion. 2021 May;61(5):1461-1470. doi: 10.1111/trf.16293. Epub 2021 Feb 8.
Convalescent plasma is undergoing randomized trials as a potential therapeutic option for COVID-19 infection. Little empirical evidence exists regarding the determination of donor eligibility and experiences with donor selection.
This prospective study was conducted at a tertiary care hospital in New York to select plasma donors for a randomized, double-blind, controlled convalescent plasma trial. Clearance for donation required successful completion of an online questionnaire and an in-person screening visit, which included (a) completion of a Donor Health Questionnaire (DHQ), (b) Immunoglobulin G (IgG) antibody testing using an immunochromatographic anti- severe acute respiratory coronavirus 2 (SARS-CoV-2) test, (c) Polymerase chain reaction (PCR) testing if <28 days from symptom resolution, and (d) routine blood bank testing.
After receiving 3093 online questionnaires, 521 individuals presented for in-person screening visits, with 40.1% (n = 209) fully qualifying. Subjects (n = 312) failed to progress due to the following reasons: disqualifying answer from DHQ (n = 30, 9.6%), insufficient antibodies (n = 198, 63.5%), persistent positive PCR tests (n = 14, 4.5%), and blood donation testing labs (n = 70, 22.4%). Importantly, 24.6% and 11.1% of potential donors who reported having PCR-diagnosed infection had low or undetectable SARS-CoV-2 antibody levels, respectively. Surprisingly, 62.9% (56/89) of subjects had positive PCR tests 14-27 days after symptom resolution, with 13 individuals continuing to be PCR positive after 27 days.
It is feasible for a single site to fully qualify a large number of convalescent plasma donors in a short period of time. Among otherwise qualified convalescent plasma donors, we found high rates of low or undetectable antibody levels and many individuals with persistently positive PCR tests.
恢复期血浆作为 COVID-19 感染的潜在治疗选择正在进行随机试验。关于供者资格的确定和供者选择经验，几乎没有经验证据。
本前瞻性研究在纽约的一家三级保健医院进行，旨在为一项随机、双盲、对照恢复期血浆试验选择血浆供者。供者捐献的许可需要成功完成在线问卷和亲自筛查访问，包括（a）完成供者健康问卷（DHQ），（b）使用免疫层析抗严重急性呼吸冠状病毒 2（SARS-CoV-2）检测 IgG 抗体检测，（c）如果距症状缓解<28 天，则进行聚合酶链反应（PCR）检测，以及（d）常规血库检测。
在收到 3093 份在线问卷后，有 521 人进行了亲自筛查访问，其中 40.1%（n=209）完全符合条件。由于以下原因，受试者（n=312）未能继续进行：DHQ 中的不合格答案（n=30，9.6%）、抗体不足（n=198，63.5%）、持续阳性的 PCR 检测（n=14，4.5%）和血液检测实验室（n=70，22.4%）。重要的是，分别有 24.6%和 11.1%报告经 PCR 诊断感染的潜在供者具有低或无法检测到的 SARS-CoV-2 抗体水平。令人惊讶的是，62.9%（56/89）的受试者在症状缓解后 14-27 天内出现阳性 PCR 检测，其中 13 人在 27 天后仍呈 PCR 阳性。
单个地点在短时间内完全有资格筛选大量恢复期血浆供者是可行的。在其他符合条件的恢复期血浆供者中，我们发现抗体水平低或无法检测的比例很高，且许多人 PCR 检测持续呈阳性。
