Etude observationnelle sur l’hémovigilance transfusionnelle à Kinshasa, République Démocratique du Congo: Haemovigilance in blood transfusion: an observational study from Kinshasa, the Democratic Republic of the Congo

Context and objective. Although most countries in sub-Saharan Africa have transfusion centers, haemovigilance data are paradoxically scarce. The objective of the present study was to identify the recipient adverse effect (RAT) of blood transfusion. Methods. We conducted a cross-sectional observational study in two blood transfusion centers in Kinshasa, between July and November 2015. The general principles of haemovigilance during the transfusion episode were observed to identify the EIR. On each blood product, bacteriological, immunological, serological and parasitic analyzes were systematically performed. Results. 346 subjects were enrolled (female, 53.2%).The overall frequency of RAT during transfusion was 2.9%. It was most commonly urticaria (5 cases), pruritus (4 cases), fever (3 cases) and vomiting (3 cases). Control tests on patients with RAT yielded the following results: 2 seropositive for Human Immunodeficiency Virus (HIV), 2 seropositive for Hepatitis C virus (HVC), and 1 seropositive for Rapid Plasma Reagent (RPR) test. Conclusion. RAT is relatively common in Kinshasa due partially to compatibility error. The observance of the protocols of haemovigilance system is not optimal in both hospitals studied. A large multicenter study should be performed to better identify the concerns and thus secure blood products. Contexte et objectif. Bien que la plupart de pays d’Afrique subsaharienne aient de centres transfusionnels, mais les données sur l’hémovigilance sont paradoxalement fragmentaires. L’objectif de la présente étude était d’identifier l’effet indésirable du receveur (EIR) transfusionnel. Méthodes. Nous avons réalisé une étude observationnelle transversale dans deux centres de transfusion sanguine à Kinshasa, entre juillet et novembre 2015.Les principes généraux de l’hémovigilance au cours de l’épisode transfusionnel ont été observés en vue d’identifier l’EIR. Pour tout cas d’EIR, le contrôle du groupe sanguin, des analyses bactériologique, immunologique (test de compatibilité), sérologique et parasitaire ont été systématiquement effectués dans la poche du produit sanguin labile (PSL) et du receveur. Résultats.346 sujets ont été enrôlés (sexe féminin, 53,2%).La fréquence globale d’EIR durant la transfusion a été de 2,9%.Il s’agissait de l’urticaire (5 cas), d’un prurit (4 cas), de la fièvre (3 cas) et de vomissements (3 cas). Alors qu’en milieu alcalin, tous les tests étaient compatibles, deux cas d’incompatibilités ont été observés à la fois en milieu albumineux et de Coombs. Après contrôle de qualité des cas ayant présenté l’EIR, 5 PSL de donneurs se sont révélés positifs (HIV, 2 cas ; HVC, 2 cas et rapid plasma reagen test, RPR, 1 cas). Conclusion. L’EIR est relativement fréquente à Kinshasa due en partie par une erreur de compatibilité. L’observance des protocoles du système de l’hémovigilance n’est pas optimale dans les deux formations étudiées. Une étude multicentrique à grande échelle est à envisager pour mieux identifier les écueils de l’hémovigilance et ainsi sécuriser les PSL

Auto-test sur sang prélevé au bout du doigt pour la détection d'HIV, HBV et HCV utilisant un test immunochromatographique multiplex: étude pilote en Afrique subsaharienne

peer reviewedBACKGROUND: The burden of HIV, HBV, and HCV infections remains disproportionately high in sub-Saharan Africa, with high rates of co-infections. Multiplex rapid diagnostic tests for HIV, HBV and HCV serological testing with high analytical performances may improve the "cascade of screening" and quite possibly the linkage-to-care with reduced cost. Based on our previous field experience of HIV self-testing, we herein aimed at evaluating the practicability and acceptability of a prototype finger-stick whole-blood Triplex HIV/HCV/HBsAg self-test as a simultaneous serological screening tool for HIV, HBV, and HCV in the Democratic Republic of the Congo (DRC). METHODS: A cross-sectional multicentric study consisting of face-to-face, paper-based, and semi-structured questionnaires with a home-based and facility-based recruitment of untrained adult volunteers at risk of HIV, HBV, and HCV infections recruited from the general public was conducted in 2020 in urban and rural areas in the DRC. The practicability of the Triplex self-test was assessed by 3 substudies on the observation of self-test manipulation including the understanding of the instructions for use (IFU), on the interpretation of Triplex self-test results and on its acceptability. RESULTS: A total of 251 volunteers (mean age, 28 years; range, 18-49; 154 males) were included, from urban [160 (63.7%)] and rural [91 (36.3%)] areas. Overall, 242 (96.4%) participants performed the Triplex self-test and succeeded in obtaining a valid test result with an overall usability index of 89.2%. The correct use of the Triplex self-test was higher in urban areas than rural areas (51.2% versus 16.5%; aOR: 6.9). The use of video IFU in addition to paper-based IFU increased the correct manipulation and interpretation of the Triplex self-test. A total of 197 (78.5%) participants correctly interpreted the Triplex self-test results, whereas 54 (21.5%) misinterpreted their results, mainly the positive test results harboring low-intensity band (30/251; 12.0%), and preferentially the HBsAg band (12/44; 27.3%). The rates of acceptability of reuse, distribution of the Triplex self-test to third parties (partner, friend, or family member), linkage to the health care facility for confirmation of results and treatment, and confidence in the self-test results were very high, especially among participants from urban areas. CONCLUSIONS: This pilot study shows evidence for the first time in sub-Saharan Africa on good practicability and high acceptability of a prototype Triplex HIV/HCV/HBsAg self-test for simultaneous diagnosis of three highly prevalent chronic viral infections, providing the rational basis of using self-test harboring four bands of interest, i.e. the control, HIV, HCV, and HBsAg bands. The relatively frequent misinterpretation of the Triplex self-test points however the necessity to improve the delivery of this prototype Triplex self-test probably in a supervised setting. Finally, these observations lay the foundations for the potential large-scale use of the Triplex self-test in populations living in sub-Saharan Africa at high risk for HIV, HBV, and HCV infections

Field evaluation of capillary blood and oral-fluid HIV self-tests in the Democratic Republic of the Congo.

BackgroundHIV self-testing (HIVST) is an additional approach to increasing uptake of HIV testing services. The practicability and accuracy of and the preference for the capillary blood self-test (Exacto Test HIV) versus the oral fluid self-test (OraQuick HIV self-test) were compared among untrained individuals in the Democratic Republic of the Congo (DRC).MethodsThis multicenter cross-sectional study (2019) used face-to-face, tablet-based, structured questionnaires in a facility-based HIVST approach. Volunteers from the general public who were at high risk of HIV infection, who were between 18 and 49 years of age, and who had signed an informed consent form were eligible for the study. The successful performance and correct interpretation of the self-test results were the main outcomes of the practicability evaluation. The successful performance of the HIV self-test was conditioned by the presence of the control band. The sensitivity and specificity of the participant-interpreted results compared to the laboratory results were estimated for accuracy. Preference for either type of self-test was assessed. Logistic regression models were used to examine factors associated with participants' preference.ResultsA total of 528 participants were included in this survey. The rate of successful performance of the HIV self-tests was high, with the blood test (99.6%) and the oral-fluid test (99.4%) yielding an absolute difference of 0.2% (95% CI: -1.8 to 1.1; P = 0.568). The rate of correct interpretation of the HIV self-test results was 84.4% with the blood test versus 83.8% with the oral-fluid test (difference = 0.6; 95% CI: -0.2 to 1.7; P = 0.425). Misinterpretation (25.4% for the blood test and 25.6% for the oral-fluid test) and inability to interpret (20.4% for the blood test and 21.1% for the oral-fluid test) test results were significantly more prevalent with invalid tests. The Exacto Test HIV self-test and the OraQuick HIV self-test showed 100% and 99.2% sensitivity, and 98.9% and 98.1% specificity, respectively. Preference for oral-fluid-based HIVST was greater than that for blood-based HIVST (85.6% versus 78.6%; P = 0.008). Preference for the blood test was greater among participants with a university education (86.1%; aOR = 2.4 [95% CI: 1.1 to 4.9]; P = 0.016), a higher risk of HIV infection (88.1%; aOR = 2.3 [95% CI: 1.0 to 5.3]; P = 0.047), and knowledge about the existence of HIVST (89.3%; aOR = 2.2 [95% CI: 1.0 to 5.0]; P = 0.05).ConclusionOur field observations demonstrate that blood-based and oral-fluid-based HIVST are both practicable approaches with a high and comparable rate of accuracy in the study setting. Although preference for the oral-fluid test was generally greater, preference for the blood test was greater among participants with a university education, a high risk of HIV infection, and knowledge about the existence of HIVST. Both approaches seem complementary in the sense that users can choose the type of self-test that best suits them for a similar result. Taken together, our observations support the use of the two HIV self-test kits in the DRC