Performance and acceptability of pre-donation screening and post-donation testing for hepatitis B infection in a resource-limited blood service.

IF 1.6 4区医学 Q3 HEMATOLOGY

Vox Sanguinis Pub Date : 2025-08-01 Epub Date: 2025-06-03 DOI:10.1111/vox.70058

Claude Tayou Tagny, Biseuleu Loic, Mathias Ndemanou, Fopa Diderot, Claude Maugard, Daniel Candotti, Georges Nguefack-Tsague, Syria Laperche

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引用次数: 0

Abstract

Background and objectives: Hepatitis B virus (HBV) is the virus transmissible by transfusion in Cameroon with highest prevalence. The benefit of pre-donation screening (PDS) versus post-donation testing (PDT) remains to be confirmed because of controversial results produced by the use of different methodologies. This study aims to compare the performance and blood donor acceptability with PDT strategy in the reduction of HBV risk.

Materials and methods: A quasi-experimental study was conducted with two groups of participants. The consenting subjects chose prospectively and randomly either the PDS or the current PDT strategy. The donors included in the PDS group were screened for hepatitis B surface antigen (HBsAg) by using a World Health Organization (WHO)-prequalified HBsAg assay. The PDT strategy consisted of the routine double HBsAg testing with a combination of a rapid diagnostic test (RDT) and enzyme immuno assay (EIA). HBV confirmatory strategy combined testing for DNA detection and HBsAg neutralization assay. A questionnaire was designed to assess donor and staff satisfaction.

Results: A total of 2528 blood donors were included in the study, of whom 1146 and 1382 went through PDS and PDT screening, respectively. The sensitivity of PDS and PDT was 100% and 96.4% (95% confidence interval [CI]: 93.1-100), respectively, and the specificity was 99.9% (95% CI: 99.3-100) for the two screening strategies. The overall acceptability score of the donor in the PDS group was 8.16 ± 1.61 versus 8.00 ± 1.55 in the PDT group (odds ratio [OR] 95% CI: 0.16 (0.04-0.28); p = 0.012).

Conclusion: This study supports the benefits of safety and acceptability of the donor and also possible acceptable cost/benefit of the screening measure in the case of limited resources.

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在资源有限的血液服务中，捐献前筛查和捐献后检测乙型肝炎感染的表现和可接受性。

背景和目的：乙型肝炎病毒（HBV）是喀麦隆通过输血传播的病毒，发病率最高。捐献前筛查（PDS）与捐献后检测（PDT）的好处仍有待证实，因为使用不同方法产生的结果存在争议。本研究旨在比较PDT策略在降低HBV风险方面的表现和献血者接受度。材料与方法：拟实验研究分为两组。同意受试者前瞻性和随机选择PDS或当前PDT策略。纳入PDS组的献血者通过使用世界卫生组织（WHO）预认证的HBsAg检测筛查乙型肝炎表面抗原（HBsAg）。PDT策略包括常规双HBsAg检测，结合快速诊断试验（RDT）和酶免疫测定（EIA）。HBV确认策略结合DNA检测和HBsAg中和试验。设计了一份调查表来评估捐助者和工作人员的满意度。结果：共纳入2528例献血者，其中1146例进行了PDS筛查，1382例进行了PDT筛查。PDS和PDT的敏感性分别为100%和96.4%(95%可信区间[CI]: 93.1-100)，特异性为99.9% （95% CI: 99.3-100）。PDS组供者的总体可接受性评分为8.16±1.61，PDT组为8.00±1.55(优势比[OR] 95% CI: 0.16 (0.04-0.28)；p = 0.012)。结论：本研究支持供体的安全性和可接受性，以及在资源有限的情况下筛查措施的可能可接受的成本/效益。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Vox Sanguinis 医学-血液学

CiteScore

4.40

自引率

11.10%

发文量

156

审稿时长

6-12 weeks

期刊介绍： Vox Sanguinis reports on important, novel developments in transfusion medicine. Original papers, reviews and international fora are published on all aspects of blood transfusion and tissue transplantation, comprising five main sections: 1) Transfusion - Transmitted Disease and its Prevention: Identification and epidemiology of infectious agents transmissible by blood; Bacterial contamination of blood components; Donor recruitment and selection methods; Pathogen inactivation. 2) Blood Component Collection and Production: Blood collection methods and devices (including apheresis); Plasma fractionation techniques and plasma derivatives; Preparation of labile blood components; Inventory management; Hematopoietic progenitor cell collection and storage; Collection and storage of tissues; Quality management and good manufacturing practice; Automation and information technology. 3) Transfusion Medicine and New Therapies: Transfusion thresholds and audits; Haemovigilance; Clinical trials regarding appropriate haemotherapy; Non-infectious adverse affects of transfusion; Therapeutic apheresis; Support of transplant patients; Gene therapy and immunotherapy. 4) Immunohaematology and Immunogenetics: Autoimmunity in haematology; Alloimmunity of blood; Pre-transfusion testing; Immunodiagnostics; Immunobiology; Complement in immunohaematology; Blood typing reagents; Genetic markers of blood cells and serum proteins: polymorphisms and function; Genetic markers and disease; Parentage testing and forensic immunohaematology. 5) Cellular Therapy: Cell-based therapies; Stem cell sources; Stem cell processing and storage; Stem cell products; Stem cell plasticity; Regenerative medicine with cells; Cellular immunotherapy; Molecular therapy; Gene therapy.