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

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.

Promoting access to COVID-19 convalescent plasma in low- and middle-income countries

“…This is most notable in the United States (US) where a national, expanded access program was devised to scale up collections and transfusions of CCP for hospitalized patients with severe or life threatening COVID-19 [1]. More modest collection of CCP outside of the US has been undertaken -primarily-to support clinical trials [2]. CCP has been found to be safe conferring comparable risk to non-immune plasma transfusion [3].…”

“…The challenges pertaining to provision of a safe and adequate blood supply in LMICs pre-date COVID-19, and span donor mobilization, collections, processing, infectious testing and transfusion itself [17][18][19]. These general obstacles apply, similarly to the procurement of CCP [2]. Limited capacity for testing impedes the ability to identify suitable donors for CCP.…”

“…mobilization of internal resources to bolster local supplies of CCP. There are already published guidelines on procurement of CCP in LMICs that draw on ways to navigate obstacles such as use of whole blood collection for preparation of CCP in the absence of apheresis equipment [2,28]. There are examples where local capacity has been developed, rapidly, even in austere environments.…”

Plasma-based COVID-19 treatments in low-and middle-income countries and the risk of transfusion-transmitted infections

“…Donation testing to prevent transmission of blood-borne infections including HIV is among the most basic standards in modern blood banking. Furthermore, ethical principles imply that safety and efficacy should be maximized for collection and use of CCP as an experimental product 4 . For these reasons, the WP GBS has argued that preparation and use of CCP should take place in nationally coordinated initiatives under which recognized quality standards are met by blood establishments 5 .…”

“…3 Blood Bank, Hospital Sírio-Libanês, São Paulo, Brasil. 4 Anglogold Ashanti Health Foundation Hospital, Obuasi, Ghana. 5…”