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. 2021 Jan;116(1):18-35.
doi: 10.1111/vox.12970. Epub 2020 Jul 20.

Guidance for the procurement of COVID-19 convalescent plasma: differences between high- and low-middle-income countries

Evan M Bloch  1 , Ruchika Goel  1   2 , Silvano Wendel  3 , Thierry Burnouf  4   5 , Arwa Z Al-Riyami  6 , Ai Leen Ang  7 , Vincenzo DeAngelis  8 , Larry J Dumont  9   10   11 , Kevin Land  12   13 , Cheuk-Kwong Lee  14   15 , Adaeze Oreh  16 , Gopal Patidar  17 , Steven L Spitalnik  18 , Marion Vermeulen  19 , Salwa Hindawi  20 , Karin Van den Berg  19 , Pierre Tiberghien  21 , Hans Vrielink  22 , Pampee Young  23 , Dana Devine  24   25 , Cynthia So-Osman  22   26
Affiliations

Guidance for the procurement of COVID-19 convalescent plasma: differences between high- and low-middle-income countries

Evan M Bloch et al. Vox Sang. 2021 Jan.

Abstract

Background and objectives: COVID-19 convalescent plasma (CCP) has been used, predominantly in high-income countries (HICs) to treat COVID-19; available data suggest the safety and efficacy of use. We sought to develop guidance for procurement and use of CCP, particularly in low- and middle-income countries (LMICs) for which data are lacking.

Materials and methods: A multidisciplinary, geographically representative group of individuals with expertise spanning transfusion medicine, infectious diseases and haematology was tasked with the development of a guidance document for CCP, drawing on expert opinion, survey of group members and review of available evidence. Three subgroups (i.e. donor, product and patient) were established based on self-identified expertise and interest. Here, the donor and product-related challenges are summarized and contrasted between HICs and LMICs with a view to guide related practices.

Results: The challenges to advance CCP therapy are different between HICs and LMICs. Early challenges in HICs related to recruitment and qualification of sufficient donors to meet the growing demand. Antibody testing also posed a specific obstacle given lack of standardization, variable performance of the assays in use and uncertain interpretation of results. In LMICs, an extant transfusion deficit, suboptimal models of donor recruitment (e.g. reliance on replacement and paid donors), limited laboratory capacity for pre-donation qualification and operational considerations could impede wide adoption.

Conclusion: There has been wide-scale adoption of CCP in many HICs, which could increase if clinical trials show efficacy of use. By contrast, LMICs, having received little attention, require locally applicable strategies for adoption of CCP.

Keywords: COVID-19; COVID-19 serotherapy; SARS-CoV-2; blood donors; blood transfusion.

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Conflict of interest statement

EMB reports personal fees and non‐financial support from Terumo BCT, personal fees and non‐financial support from Grifols Diagnostic Solutions, outside of the submitted work; EMB is a member of the United States Food and Drug Administration (FDA) Blood Products Advisory Committee. Any views or opinions that are expressed in this manuscript are that of the authors, based on his own scientific expertise and professional judgement; they do not necessarily represent the views of either the Blood Products Advisory Committee or the formal position of FDA, and also do not bind or otherwise obligate or commit either Advisory Committee or the Agency to the views expressed. PPY serves on the advisory board of Fresenius Kabi and Creative Testing Solutions.

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