Article2009

Transfusion safety on the African continent: an international quality control of virus testing in blood banks

Syria Laperche · Geneviève B Boukatou · Leonard Kouegnigan · Yacouba Nébié · Mohamed Ould Boulahi · Claude Tayou Tagny +4 more

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Blood donation and transfusion practices Clinical Laboratory Practices and Quality Control Blood transfusion and management

Abstract

BACKGROUND: Following World Health Organization recommendations that a quality control (QC) system be implemented in African blood centers, a pilot study of the performance of human immunodeficiency virus antibody (anti-HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody (anti-HCV) testing by several Sub-Saharan African blood centers was initiated. STUDY DESIGN AND METHODS: A reference laboratory sent a panel of 25 samples to six African blood center laboratories. The panel included eight negative samples; four anti-HIV-1–, one anti-HIV-2–, four anti-HCV–, and five HBsAg-positive samples; and three samples consisting of mixtures of two sera to mimic coinfections. Sensitivity, specificity, and overall quality (correct positive or negative status) scores were calculated. RESULTS: From the 21 sets of results obtained (seven for each virus), eight were from rapid tests (two for HIV, three for HBV, and three for HCV) and 13 were from enzyme immunoassays (EIAs; all HIV EIAs were antigen/antibody combination assays). Overall assay sensitivity was 98% for HIV, 75% for HBV, and 88% for HCV; agreement between blood centers using the same assay was good. Sensitivity of rapid tests was notably poorer than EIAs, with overall sensitivity quality scores of 64.5% for rapid tests (20% for HBsAg rapid tests) compared to 100% for EIAs. The overall specificity quality scores were 98.3 and 94.5% for EIAs and rapid tests, respectively. CONCLUSIONS: This pilot QC study organized for blood centers of Sub-Saharan Africa showed the feasibility of the approach despite some logistic constraints. Although interlaboratory variability was small, the poor performance of rapid tests, especially for HBsAg, raises policy questions about their use as the only screening assay.

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References

2008Blood safety in Sub‐Saharan Africa: a multi‐factorial problem 2005Predonation screening of blood donors with rapid tests: implementation and efficacy of a novel approach to blood safety in resource‐poor settings 2004Cost‐effectiveness of nucleic acid test screening of volunteer blood donations for hepatitis B, hepatitis C and human immunodeficiency virus in the United States 2001Estimated risk of HIV transmission by blood transfusion in Kenya 2007Hepatitis B surface antigen, hepatitis C and HIV antibodies in a low-risk blood donor group, Nigeria.

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2010Reduction of the risk of transfusion‐transmitted human immunodeficiency virus (HIV) infection by using an HIV antigen/antibody combination assay in blood donation screening in Cameroon 2009Health economics of blood transfusion safety – focus on sub-Saharan Africa 2019Seroprevalence of transfusion transmitted infections among blood donors in Gash Barka Zonal Blood Transfusion Center, Barentu, Eritrea, 2014 through 2017 2016The contribution of unsafe blood transfusion to human immunodeficiency virus incidence in sub‐Saharan Africa: reexamination of the 5% to 10% convention 2013Le groupe de recherches transfusionnelles d’Afrique francophone : bilan des cinq premières années 2018Updated characteristics of blood services, donors and blood products in 11 French‐speaking African countries

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