BLOOD DONORS AND BLOOD COLLECTION Transfusion safety on the African continent: an international quality control of virus testing in blood banks Syria Laperche, Geneviève Boukatou, Léonard Kouegnigan, Yacouba Nébié, Mohamed Ould Boulahi, Claude Tayou Tagny, Rakia Yahaya, Jean-Baptiste Tapko, Edward Murphy, and Jean Jacques Lefrère 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 anti- body (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 labora- tory 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 specific- ity 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 feasi- bility 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. T he reduction of transfusion-transmitted infec- tions (TTIs) is a priority of all national blood safety policies, and three such viruses, human immunodeficiency virus (HIV) and the viruses of hepatitis B (HBV) and C (HCV), have been targeted for highest vigilance. Paradoxically, western countries, where the prevalence of these pathogens is currently low in the blood donor population, have the most comprehensive screening systems, while African countries, where this prevalence is the highest in the world, 1-3 have the least. Many high-income countries, where the selection of low- risk volunteer donors is already rigorous, have imple- mented nucleic acid testing (NAT) to reduce the risk due to window period despite cost-effectiveness ratios that are well outside the typical range for most health care inter- ventions. 4 In African countries with crucial transfusion needs for anemic children and women, the risk of TTIs ABBREVIATIONS: S/CO = sample/cutoff; TTI(s) = transfusion- transmitted infection(s). From the National Reference Center for Hepatitis B and C and HIV in Transfusion, National Blood Transfusion Institute, Paris, France; the National Blood Transfusion Center, Brazzaville, Congo; the Regional Blood Transfusion Center, Libreville, Gabon; the National Blood Transfusion Center, Ouagadougou, Burkina-Faso; the Regional Blood Transfusion Center, Nouakchott, Mauritania; the University Teaching Hospital, Yaoundé, Cameroon; the Regional Blood Transfusion Center, Niamey, Niger; the World Health Organization (WHO), African Bureau, Brazzaville, Congo; and the University of California San Francisco and Blood Systems Research Institute, San Francisco, CA. Address reprint requests to: Syria Laperche, National Refer- ence Center for Hepatitis B and C and HIV in Transfusion, National Blood Transfusion Institute, 6 Rue Alexandre Cabanel, F-75015 Paris, France; e-mail: slaperche@ints.fr. Received for publication January 12, 2009; revision received March 27, 2009, and accepted April 5, 2009. doi: 10.1111/j.1537-2995.2009.02239.x TRANSFUSION 2009;49:1600-1608. 1600 TRANSFUSION Volume 49, August 2009