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

Does glucose-6-phosphate dehydrogenase deficiency worsen the clinical features of sickle cell disease? A multi-hospital-based cross-sectional study.

peer reviewed[en] BACKGROUND: The impact of glucose-6-phosphate dehydrogenase deficiency(G-6-PD) on the clinical course of sickle cell disease(SCD) is still controversial. The objectives of this study were to determine the prevalence of G-6-PD deficiency in patients with SCD and its effect on their clinical course. METHODS: A cross-sectional study of 122 SCD patients and 211 healthy blood donors was conducted in Kisangani city. Data were collected through clinical examination supplemented by patient medical records, and laboratory tests based on a survey form. G-6-PD activity was measured by spectrophotometry and the screening for SCD by the HemoTypeSC® rapid test. Statistical analysis was done using SPSS ver. 20.0. RESULTS: The prevalence of G-6-PD deficiency did not differ between SCD and non-SCD subjects, 35.2% vs. 33.6% respectively(p = .767). When comparing the hemoglobin level between SCD patients with and without G-6-PD deficiency, no significant difference was observed. However, in the 6 months prior to the study, SCD patients with G-6-PD deficiency had on average more transfusions than non-deficient SCD patients, 0.64 ± 0.897 vs. 0.24 ± 0.486(p = .004). Similarly, considering the clinical events of the last 12 months prior to the study, there were more hospitalizations, major vaso-occlusive crises and anemia requiring blood transfusion among G-6-PD deficient SCD patients compared to no-deficient, respectively 1.42 ± 1.451vs. 0.76 ± 1.112(p = .007); 1.37 ± 1.092 vs. 0.85 ± 1.014(p = .005); 0.74 ± 0.902 vs. 0.38 ± 0.739 (p = .007). CONCLUSION: The prevalence of G-6-PD deficiency in SCD patients was high but did not differ from that observed in controls. In addition, G-6-PD deficiency appeared to worsen the clinical features of SCD. Nevertheless, prospective studies further clarifying this observation are needed

Renal Abnormalities among Sickle Cell Disease Patients in a Poor Management Setting: A Survey in the Democratic Republic of the Congo.

peer reviewed[en] Background and objective: Sickle cell disease (SCD) is now a well-established cause of renal damage. In the northeast of the Democratic Republic of Congo (DRC), SCD is common. However, sickle cell nephropathy remains unstudied in this region. Thus, this study aimed to assess renal abnormalities in SCD patients in Kisangani (northeastern DRC). Methods: This cross-sectional study included 98 sickle cell patients selected from six health facilities in Kisangani and 89 healthy non-sickle cell subjects as the control group. Based on a survey form, a clinical examination and biological tests were performed to collect data related to the sex, age, weight, height, pressure, serum creatinine, serum uric acid, urinary albumin/creatinine ratio, and hemoglobin phenotype. We used a spectrophotometer to measure serum creatinine and uricemia, the sickle SCAN® device for hemoglobin phenotype, and an automatic multifunction analyzer for urine albumin/creatinine ratio. Data were entered into an Excel file and analyzed on SPSS 20.0. Results: The mean urine albumin-to-creatinine ratio was 11.79±9.03 mg/mmol in SCD patients, significantly higher than in AA (1.69±1.89 mg/mmol) and AS (2.97±4.46 mg/mmol) subjects. The decrease in glomerular filtration rate was more observed in SCD patients with hyperuricemia compared to those with normal uric acid levels. A significantly elevated prevalence of chronic kidney disease was observed among SCD patients (87.8%) compared to 23.8% in AS and 7.7% in AA subjects. Conclusions: This study highlighted that albuminuria and chronic kidney disease are common in SCD patients in Kisangani. More studies are needed to further document these complications

Implémentation de l’autotest de dépistage du Virus de l’Immunodéficience Humaine en République Démocratique du Congo

Background. Human immunodeficiency virus (HIV) testing remains deficient in the Democratic Republic of Congo (DRC) because stigma, discrimination, and lack of confidentiality are major barriers to accessing traditional testing systems. HIV self-testing is an innovation that has the potential to circumvent these barriers, as it offers a discreet, convenient, and empowering way to test. This study aimed to analyze the implementation of HIV self-testing in terms of acceptability, practicality, and analytical performance among lay users in order to contribute to the reduction of HIV transmission in the DRC. Materials and Methods. This multicenter survey was conducted in four cities in the DRC (Kinshasa, Kisangani, Kindu, and Bunia) from 2016 to 2020. Acceptability was operationally defined as willingness to use the provided HIV self-test. Practicality was defined as successful manipulation of the self-test and correct interpretation of the test results. Analytical performance consisted of calculating the sensitivity (Se) and specificity (Sp) of the HIV self-test kits. The blood-based self-test Exacto HIV Test (Biosynex, France) and the oral-fluid-based self-test OraQuick HIV Self-test (OraSure, USA) were used in this study. Results. Overall, the HIV Self-test was associated with a very high level (greater than 90%) of acceptability. Levels of successful handling of HIV self-testing were high (97% to 99.8%) and similar for different types of self-testing (blood: 97.0% to 99.8%; gingival fluid: 99.8%) and different approaches to dispensing the self-testing (directly assisted: 93.2% to 99.8%; non-assisted: 93.2%). Levels of correct interpretation of results were generally high (80.2% to 95.1%). However, errors in interpretation of results were mostly observed with invalid results, when using the unassisted HIV self-test, and in users with a low educational level. Finally, the sensitivity and specificity of the blood self-test (Se: 99.6%; Sp: 100%) and the gingival fluid self-test (Se: 99.2% and Sp: 98.1%) were high and similar.Conclusion. Our study demonstrated that HIV self-testing is acceptable and practical with satisfactory high levels of sensitivity and specificity among lay users in DRC. Taken together, HIV self-testing is a usable option that could be implemented in DRC to increase access to HIV testing.Introduction. Le dépistage de l’infection par le virus de l’immunodéficience humaine (VIH) demeure lacunaire en République Démocratique du Congo (RDC) car la stigmatisation, la discrimination et l’absence de confidentialité constituent des obstacles majeurs à l’accès aux systèmes traditionnels de dépistage. L’autotest VIH est une innovation ayant le potentiel de contourner ces obstacles, car il offre un moyen discret, pratique et habilitant de faire le test. L’objectif de ce travail était d’analyser l’implémentation de l’autotest VIH en termes d’acceptabilité, de praticabilité et de performances analytiques chez des utilisateurs profanes en vue de contribuer à la réduction de la transmission du VIH en RDC. Matériel et méthodes. Cette enquête multicentrique a été menée dans quatre villes de la RDC (Kinshasa, Kisangani, Kindu et Bunia) de 2016 à 2020. L’acceptabilité a été opérationnellement définie comme le consentement à utiliser l’autotest VIH fourni. La praticabilité a été définie par la réussite de la manipulation de l’autotest et l’interprétation correcte des résultats du test. Les performances analytiques consistaient à calculer la sensibilité (Se) et la spécificité (Sp) des kits d’autotest VIH. L’autotest sanguin Exacto HIV Test (Biosynex, France) et l’autotest à fluide gingival OraQuick HIV Self-test (OraSure, Etats-Unis) ont été utilisés dans cette étude. Résultats. Dans l’ensemble, l’autotest VIH était associé à un niveau très élevée (supérieure à 90%) d’acceptabilité. Les niveaux de réussite de la manipulation de l’autotest VIH étaient élevés (97 % à 99,8 %) et similaires pour les différents types d’autotest (sanguin : 97,0 % à 99,8 % ; à fluide gingival : 99,8 %) et les différentes approches de dispensation de l’autotest (directement assistée : 93,2 % à 99,8 % ; non-assistée : 93,2 %). Les niveaux d’interprétation correcte des résultats ont été généralement élevés (80,2 % à 95,1%). Cependant, les erreurs d’interprétation des résultats ont été majoritairement observées devant les résultats invalides, lors de l’utilisation de l’autotest VIH non-assisté, et chez les utilisateurs ayant un faible niveau éducationnel. Enfin, la sensibilité et la spécificité de l’autotest sanguin (Se : 99,6 % ; Sp : 100%) et de l’autotest à fluide gingival (Se : 99,2 % et Sp : 98,1 %) étaient élevées et similaires.Conclusion. Notre étude a démontré que l’autotest VIH est acceptable et pratique avec des niveaux élevés et satisfaisants de sensibilité et de spécificité chez les utilisateurs profanes en RDC. Pris ensemble, l’autotest VIH est une option utilisable qui pourrait être implémentée en RDC pour accroitre l’accès au dépistage du VIH

Implémentation de l’autotest de dépistage du Virus de l’Immunodéficience Humaine en République Démocratique du Congo

Background. Human immunodeficiency virus (HIV) testing remains deficient in the Democratic Republic of Congo (DRC) because stigma, discrimination, and lack of confidentiality are major barriers to accessing traditional testing systems. HIV self-testing is an innovation that has the potential to circumvent these barriers, as it offers a discreet, convenient, and empowering way to test. This study aimed to analyze the implementation of HIV self-testing in terms of acceptability, practicality, and analytical performance among lay users in order to contribute to the reduction of HIV transmission in the DRC. Materials and Methods. This multicenter survey was conducted in four cities in the DRC (Kinshasa, Kisangani, Kindu, and Bunia) from 2016 to 2020. Acceptability was operationally defined as willingness to use the provided HIV self-test. Practicality was defined as successful manipulation of the self-test and correct interpretation of the test results. Analytical performance consisted of calculating the sensitivity (Se) and specificity (Sp) of the HIV self-test kits. The blood-based self-test Exacto HIV Test (Biosynex, France) and the oral-fluid-based self-test OraQuick HIV Self-test (OraSure, USA) were used in this study. Results. Overall, the HIV Self-test was associated with a very high level (greater than 90%) of acceptability. Levels of successful handling of HIV self-testing were high (97% to 99.8%) and similar for different types of self-testing (blood: 97.0% to 99.8%; gingival fluid: 99.8%) and different approaches to dispensing the self-testing (directly assisted: 93.2% to 99.8%; non-assisted: 93.2%). Levels of correct interpretation of results were generally high (80.2% to 95.1%). However, errors in interpretation of results were mostly observed with invalid results, when using the unassisted HIV self-test, and in users with a low educational level. Finally, the sensitivity and specificity of the blood self-test (Se: 99.6%; Sp: 100%) and the gingival fluid self-test (Se: 99.2% and Sp: 98.1%) were high and similar.Conclusion. Our study demonstrated that HIV self-testing is acceptable and practical with satisfactory high levels of sensitivity and specificity among lay users in DRC. Taken together, HIV self-testing is a usable option that could be implemented in DRC to increase access to HIV testing.Introduction. Le dépistage de l’infection par le virus de l’immunodéficience humaine (VIH) demeure lacunaire en République Démocratique du Congo (RDC) car la stigmatisation, la discrimination et l’absence de confidentialité constituent des obstacles majeurs à l’accès aux systèmes traditionnels de dépistage. L’autotest VIH est une innovation ayant le potentiel de contourner ces obstacles, car il offre un moyen discret, pratique et habilitant de faire le test. L’objectif de ce travail était d’analyser l’implémentation de l’autotest VIH en termes d’acceptabilité, de praticabilité et de performances analytiques chez des utilisateurs profanes en vue de contribuer à la réduction de la transmission du VIH en RDC. Matériel et méthodes. Cette enquête multicentrique a été menée dans quatre villes de la RDC (Kinshasa, Kisangani, Kindu et Bunia) de 2016 à 2020. L’acceptabilité a été opérationnellement définie comme le consentement à utiliser l’autotest VIH fourni. La praticabilité a été définie par la réussite de la manipulation de l’autotest et l’interprétation correcte des résultats du test. Les performances analytiques consistaient à calculer la sensibilité (Se) et la spécificité (Sp) des kits d’autotest VIH. L’autotest sanguin Exacto HIV Test (Biosynex, France) et l’autotest à fluide gingival OraQuick HIV Self-test (OraSure, Etats-Unis) ont été utilisés dans cette étude. Résultats. Dans l’ensemble, l’autotest VIH était associé à un niveau très élevée (supérieure à 90%) d’acceptabilité. Les niveaux de réussite de la manipulation de l’autotest VIH étaient élevés (97 % à 99,8 %) et similaires pour les différents types d’autotest (sanguin : 97,0 % à 99,8 % ; à fluide gingival : 99,8 %) et les différentes approches de dispensation de l’autotest (directement assistée : 93,2 % à 99,8 % ; non-assistée : 93,2 %). Les niveaux d’interprétation correcte des résultats ont été généralement élevés (80,2 % à 95,1%). Cependant, les erreurs d’interprétation des résultats ont été majoritairement observées devant les résultats invalides, lors de l’utilisation de l’autotest VIH non-assisté, et chez les utilisateurs ayant un faible niveau éducationnel. Enfin, la sensibilité et la spécificité de l’autotest sanguin (Se : 99,6 % ; Sp : 100%) et de l’autotest à fluide gingival (Se : 99,2 % et Sp : 98,1 %) étaient élevées et similaires.Conclusion. Notre étude a démontré que l’autotest VIH est acceptable et pratique avec des niveaux élevés et satisfaisants de sensibilité et de spécificité chez les utilisateurs profanes en RDC. Pris ensemble, l’autotest VIH est une option utilisable qui pourrait être implémentée en RDC pour accroitre l’accès au dépistage du VIH

Capillary whole-blood IgG-IgM COVID-19 selftest as a serological screening tool for SARSCoV-2 infection adapted to the general public

The practicability of a prototype capillary whole-blood IgG-IgM COVID-19 self-test (Exacto® COVID-19 self-test, Biosynex Swiss SA, Freiburg, Switzerland) as a serological screening tool for SARS-CoV-2 infection adapted to the general public was evaluated in across-sectional, general adult population study performed between April and May 2020 in Strasbourg, France, consisting of face-to-face, paper-based, semi-structured, and selfadministrated questionnaires. Practicability was defined as the correct use of the self-test and the correct interpretation of the result. The correct use of self-test was conditioned by the presence of the control band after 15-min of migration. The correct interpretation of the tests was defined by the percent agreement between the tests results read and interpret by the participants compared to the expected results coded by the numbers and verified by trained observers. A total of 167 participants (52.7% female; median age, 35.8 years; 82% with post-graduate level) were enrolled, including 83 and 84 for usability and test results interpretation substudies, respectively. All participants (100%; 95% CI: 95.6– 100) correctly used the self-test. However, 12 (14.5%; 95% CI: 8.5–23.6) asked for verbal help. The percent agreement between the tests results read and interpret by the participants compared to the expected results was 98.5% (95% CI: 96.5–99.4). However, misinterpretation occurred in only 2.3% of positive and 1.2% of invalid test results. Finally, all (100%) participants found that performing the COVID-19 self-test was easy; and 98.8% found the interpretation of the self-test results easy. Taken together, these pilot observations demonstrated for the first-time, high practicability and satisfaction of COVID-19 selftesting for serological IgG and IgM immune status, indicating its potential for use by the general public to complete the arsenal of available SARS-CoV-2 serological assays in the urgent context of the COVID-19 epidemic

Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Due to their ease-of-use, lateral flow assay SARS-CoV-2 antigen-detecting rapid diagnostic tests could be suitable candidates for antigen-detecting rapid diagnostic self-test (Ag-RDST). We evaluated the practicability of the Ag-RDST BIOSYNEX Antigen Self-Test COVID-19 Ag+ (Biosynex Swiss SA, Freiburg, Switzerland), using self-collected nasal secretions from the turbinate medium (NMT), in 106 prospectively included adult volunteers living in Paris, France. The majority of the participants correctly understood the instructions for use (94.4%; 95% confidence interval (CI): 88.3–97.4), showing a great ability to perform the entire self-test procedure to obtain a valid and interpretable result (100%; 95% CI: 96.5–100), and demonstrated the ability to correctly interpret test results (96.2%; 95% CI: 94.2–97.5) with a high level of general satisfaction. About one in eight participants (# 15%) needed verbal help to perform or interpret the test, and only 3.8% of test results were misinterpreted. By reference to multiplex real-time RT-PCR, the Ag-RDST showed 90.9% and 100% sensitivity and specificity, respectively, and high agreement (98.1%), reliability (0.94), and accuracy (90.9%) to detect SARS-CoV-2 antigen. Taken together, our study demonstrates the high usability and accuracy of BIOSYNEX Antigen Self-Test COVID-19 Ag+ for supervised self-collected NMT sampling in an unselected adult population living in France

Comparaison de la faisabilité et de l'efficacité entre l'autotest du VIH non assisté et l'autotest du VIH assisté en RDC: un essai de faisabilité randomisé

Background: HIV self-testing (HIVST) can be performed using directly assisted and unassisted approaches in facilities or communities to reach different populations. The aim of this study was to compare the practicability andeffectiveness of the two delivery approaches for HIVST, unassisted HIVST (UH) and directly assisted HIVST (DAH), in the field setting of Kisangani, the Democratic Republic of the Congo (DRC). Methods: A randomized (1:1), non-blinded, non-inferiority trial using a blood-based and facility-based HIVST method was carried out in four facilities in Kisangani, the DRC, targeting populations at high risk for HIV infection. The primary outcome was the difference in the practicability of the HIV self-test between the two arms. Practicability was defined as successfully performing the test and correctly interpreting the result. Requests for assistance, positivity rate, linkage to care, and willingness to buy an HIV self-test kit constituted the secondary outcomes for HIVST effectiveness. The adjusted risk ratios (aRRs) were calculated using Poisson regression. Results: The rate of successfully performing the test was same (93.2%) in the UH and DAH arms. The rate of correctly interpreting the results was 86.9% in the UH arm versus 93.2% in the DAH arm, for a difference of − 6.3%. After the follow-up 72 h later, participants in the UH arm had a significantly lower chance of correctly interpreting the test results than those in the DAH arm (aRR: 0.60; P = 0.019). Although the positivity rate was 3.4% among the participants in the DAH arm and 1.7% among those in the UH arm, no significant differences were found between the two arms in the positivity rate, requests for assistance, and linkage to care. Willingness to buy an HIV self-test was higher in the UH arm than in the DAH arm (92.3% versus 74.1%; aRR: 4.20; P < 0.001).Conclusion: The results of this study indicate that UH is as practicable and effective as DAH among individuals at high risk for HIV infection in Kisangani, the DRC. However, additional support tools need to be assessed to improve the interpretation of the self-test results when using the UH approach.STI and AIDS National Control Programme, Kinshas

Vulnerability of sickle cell disease persons to the COVID-19 in sub-Saharan Africa

DREPAKI

Acceptability, feasibility, and individual preferences of blood-based HIV self-testing in a population-based sample of adolescents in Kisangani, Democratic Republic of the Congo.

BACKGROUND:Adolescents living in sub-Saharan Africa constitute a vulnerable population at significant risk of HIV infection. This study aims to evaluate the acceptability, feasibility, and accuracy of home-based, supervised HIV self-testing (HIVST) as well as their predictors among adolescents living in Kisangani, Democratic Republic of the Congo (DRC). METHODS:A cross-sectional, door-to-door survey using a blood-based HIV self-test and a peer-based supervised HIVST approach was conducted from July to August 2018 in Kisangani, DRC. The acceptability and feasibility of HIVST were assessed among adolescents' consenting to use and interpret HIV self-test. The accuracy of HIVST was estimated by the sensibility and specificity of adolescent-interpreted HIV self-test. Factors associated with acceptability and feasibility of HIVST were analyzed with logistic regression. RESULTS:A total of 628 adolescents (including 369 [58.8%] females) aged between 15 and 19 years were enrolled. Acceptability of HIVST was high (95.1%); 96.1% of participants correctly used the self-test, and 65.2% asked for verbal instructions. The majority of adolescents (93.5%) correctly interpreted their self-test results. The Cohen's κ coefficient between the results read by adolescents and by supervisors was 0.62. The correct interpretation decreased significantly when adolescents had no formal education or attended primary school as compared to those currently attending university (37.0% versus 100%; adjusted OR: 0.01 [95% CI: 0.004-0.03]). In the hands of adolescents at home, the sensitivity of the Exacto Test HIV Self-test was estimated at 100%, while its specificity was 96.0%. The majority of participants (68.0%) affirmed that post-test counseling was essential, and that face-to-face counseling (78.9%) was greatly preferred. CONCLUSIONS:Home-based, supervised HIVST using a blood-based self-test and peer-based approach can be used with a high degree of acceptability and feasibility by adolescents living in Kisangani, DRC. Misinterpretation of test results is challenging to obtaining good feasibility of HIVST among adolescents with poor educational level. Face-to-face post-test counseling seems to be preferred among Kisangani's adolescents