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评估病原体减少技术对 COVID-19 恢复期血浆中和活性的影响。

Assessment of the impact of pathogen reduction technologies on the neutralizing activity of COVID-19 convalescent plasma.

机构信息

Department of Hematology, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.

Blood Transfusion Services, King Abdulaziz University Hospital, Jeddah, Saudi Arabia.

出版信息

Transfus Apher Sci. 2023 Jun;62(3):103688. doi: 10.1016/j.transci.2023.103688. Epub 2023 Mar 4.

Abstract

COVID-19 convalescent plasma (CCP) could improve the clinical outcome of COVID-19 patients when high-titer CCP is administered in early stages of disease. However, CCP donors have a risk profile like first-time donors, pathogen reduction treatment (PRT) may mitigate such risk but should not impact CCP quality. The current study aims to assess the impact of PRT-technologies available in Saudi Arabia on the neutralizing activity of CCP. STUDY DESIGN: and Methods: CCP was collected from eligible donors by plasmapheresis. The neutralization titer was determined with an in-house microneutralization assay (MNA) using a local SARS-CoV-2 clinical isolate. Selected units were split and subject to PRT with amotosalen/UVA (AS) or Riboflavin/UVB (RB) (pairwise side-by-side comparison) followed by a second MNA analysis. 51 CCP units were collected, 27 were included in the analysis reaching the minimum MNA titer of 1:40 (4 reached high titer (≥1:250)). 27 CCP units were treated with AS and 14 with RB, the median MNA pre-treatment titer was 1:80 (1:40-640). The impact of AS and RB PRT on CCP neutralizing activity was not significantly different, nor in the total analysis neither in the pairwise comparison (94.6 vs 96.4 % retention, p > 0.05). No correlation of titer and blood group was observed, but a trend for increasing MNA titer with donor age, choosing donors with an age > 45 years would increase the number of high-titer CCP donors. The difference in impact of AS and RB on CCP MNA titer was below the limit of detection of the assay (0.5-fold).

摘要

COVID-19 恢复期血浆(CCP)可改善 COVID-19 患者的临床结局,尤其是在疾病早期给予高滴度 CCP 时。然而,CCP 供体具有与初次供体相似的风险特征,病原体减少处理(PRT)可能会降低这种风险,但不应影响 CCP 的质量。本研究旨在评估沙特阿拉伯现有的 PRT 技术对 CCP 中和活性的影响。

研究设计和方法

通过血浆分离术从合格的供体中采集 CCP。使用本地 SARS-CoV-2 临床分离株的内部微量中和测定(MNA)测定中和效价。选择单位进行 AMotosalen/UVA(AS)或 Riboflavin/UVB(RB)的 PRT(成对并排比较),然后进行第二次 MNA 分析。收集了 51 个 CCP 单位,其中 27 个单位进行了分析,达到了最低 MNA 效价 1:40(4 个达到高滴度(≥1:250))。27 个 CCP 单位用 AS 处理,14 个用 RB 处理,中位 MNA 预处理效价为 1:80(1:40-640)。AS 和 RB PRT 对 CCP 中和活性的影响无显著差异,无论是总分析还是两两比较均无差异(94.6%与 96.4%的保留率,p>0.05)。未观察到效价与血型之间的相关性,但随着供体年龄的增加,MNA 效价呈上升趋势,选择年龄>45 岁的供体将增加高滴度 CCP 供体的数量。AS 和 RB 对 CCP MNA 效价的影响差异低于测定的检测限(0.5 倍)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fb1/9984302/caa3ccf4456e/gr1_lrg.jpg

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