Analytical performances of a point-of-care loop-mediated isothermal amplification assay to detect Group B Streptococcus in intrapartum pregnant women living in the Democratic Republic of the Congo.

OBJECTIVES: Group B Streptococcus (GBS) is the leading infectious cause of stillbirth and neonatal morbidity and mortality in sub-Saharan Africa. METHODS: Vaginal and rectovaginal swab samples were obtained from 274 intrapartum pregnant women in the Democratic Republic of the Congo to be analyzed for GBS DNA detection in parallel by the point-of-care BIOSYNEX AMPLIFLASH® GBS assay (Biosynex SA, Illkirch-Graffenstaden, France) and by reference quantitative polymerase chain reaction (qPCR). RESULTS: Rectovaginal swabbing, nearly two-fold more positive for GBS than vaginal swabbing alone, showed a high prevalence of GBS DNA positivity in 20.1% of eligible intrapartum pregnant women. In the event of significant bacterial carriage (i.e., cycle threshold ≤33 by reference qPCR), the AMPLIFLASH® GBS assay with rectovaginal swabbing showed high sensitivity (98.1%) and specificity (100.0%) for GBS DNA detection, with excellent concordance, reliability, and accuracy with the reference qPCR, and positive predictive values and negative predictive values above 99.0%. CONCLUSIONS: The study demonstrates a high rate of female rectogenital GBS colonization in pregnant Congolese women. The AMPLIFLASH® GBS assay harbored excellent analytical performances in the field, which makes it suitable to be used as point-of-care molecular assay in various hospital and non-hospital settings where rapid diagnosis of GBS is necessary.

Rotavirus and adenovirus infections in children with acute gastroenteritis after introducing the Rotasiil® vaccine in Kisangani, Democratic Republic of the Congo.

BACKGROUND: Although rotavirus vaccination has reduced the global burden of the virus, morbidity and mortality from rotavirus infection remain high in Sub-Saharan Africa. This study aimed to determine the prevalence of rotavirus and adenovirus infections in children under five years with acute gastroenteritis and to identify factors associated with rotavirus infection after the introduction of the Rotasiil® vaccine in 2019 in Kisangani, Democratic Republic of the Congo (DRC). METHODS: This study consisted of a cross-sectional hospital-based survey conducted from May 2022 to April 2023 in four health facilities in Kisangani, using a fecal-based test (rapid antigenic immuno-chromatographic diagnostic test, BYOSYNEX adenovirus/rotavirus BSS, Biosynex SA, Illkirch-Graffenstaden, France) of rotavirus and adenovirus infections among children under five years of age with acute gastroenteritis. RESULTS: A total of 320 children under five years of age with acute gastroenteritis were included. The prevalence of rotavirus infection was 34.4%, that of adenovirus was 6.3%, and that of both rotavirus and adenovirus coinfection was 1.3%. The prevalence of rotavirus was significantly higher in unvaccinated children than in vaccinated children (55.4% versus 23.1%; P < 0.001). This difference was observed only in children who received all three vaccine doses. Multivariate logistic regression analysis shows that the rate of rotavirus infection was significantly reduced in vaccinated children (adjusted OR: 0.31 [95% confidence intervals (CI): 0.19-0.56]; P < 0.001) and those whose mothers had an average (adjusted OR: 0.51 [95% CI: 0.25-0.91]; P = 0.018) or high level (adjusted OR: 0.34 [95% CI: 0.20-0.64]; P < 0.001) of knowledge about the rotavirus vaccine. CONCLUSIONS: The prevalence of rotavirus infection remains high in Kisangani despite vaccination. However, the prevalence of adenovirus infections was low in our series. Complete vaccination with three doses and mothers' average and high level of knowledge about the rotavirus vaccine significantly reduces the rate of rotavirus infection. It is, therefore, essential to strengthen the mothers' health education, continue with the Rotasiil® vaccine, and ensure epidemiological surveillance of rotavirus infection.

Clinical profile of children under 5 years of age with rotavirus diarrhoea in a hospital setting in Kisangani, DRC, after the introduction of the rotavirus vaccine, a cross-sectional study.

BACKGROUND: The Democratic Republic of the Congo (DRC) is one of the countries with the highest rotavirus mortality rate in the world. The aim of this study was to describe the clinical features of rotavirus infection after the introduction of rotavirus vaccination of children in the city of Kisangani, DRC. METHODS: We conducted a cross-sectional study of acute diarrhoea in children under 5 years of age admitted to 4 hospitals in Kisangani, DRC. Rotavirus was detected in children's stools by an immuno-chromatographic antigenic rapid diagnostic test. RESULTS: A total of 165 children under 5 years of age were included in the study. We obtained 59 cases of rotavirus infection, or 36% CI95 [27, 45]. The majority of children with rotavirus infection were unvaccinated (36 cases) and had watery diarrhoea (47 cases), of high frequency per day/per admission 9.6 ± 3.4 and accompanied by severe dehydration (30 cases). A statistically significant difference in mean Vesikari score was observed between unvaccinated and vaccinated children (12.7 vs 10.7 p-value 0.024). CONCLUSION: Rotavirus infection in hospitalized children under 5 years of age is characterized by a severe clinical manifestation. Epidemiological surveillance is needed to identify risk factors associated with the infection.

Diagnostic performances of Exacto® Triplex rapid test for diagnosis of HIV/HCV/HBsAg: a multicenter, cross-sectional, field study in the Central African Republic.

Introduction: the Exacto® Triplex HIV/HCV/HBsAg (Biosynex, Strasbourg, France) consists in lateral flow, immunochromatographic rapid diagnostic test simultaneously detecting human immunodeficiency virus (HIV)-1 and HIV-2 and hepatitis C virus (HCV)- specific antibodies (IgG and IgM) and hepatitis B virus (HBV) surface antigen (HBsAg) in serum, plasma and whole blood. We herein evaluated its diagnostic performances in the Central African Republic (CAR). Methods: cross-sectional study was conducted on prospectively collected panel of 550 sera from adult inpatients living in Bangui, including 200 HIV-positive, 100 HBsAg-positive, 50 HCV-positive, 200 negatives to three viruses according to reference immuno-enzymatic serological tests including Murex HCV (Diasorin, Saluggia, Italy) for HCV, Murex HBsAg (Diasorin) for HBV, Genscreen ULTRA HIV Ag-Ab HIV-1/2 Version 2 (Bio-Rad, Marnes-la-Coquette, France) and Murex HIV 1.2.0 Ag/Ab Combination (Diasorin), the 2 tests associated in the parallel algorithm for the reference strategy for the diagnosis of HIV in CAR. Serum samples were tested blindly in duplicate. The findings are reported following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Results: the Exacto® Triplex showed 99.5% (95% CI; 98.5-100.0), 96.0% [90.6-100.0] and 99.0% [97.1-100.0] sensitivities for HIV, HCV and HBsAg, respectively. The specificity, positive and negative predictive values (PPV and NPV) were 100.0% for all three viruses. The Youden's J index and Cohen's κ coefficient were 0.99 for HIV and HBsAg. For HCV, Youden's J and Cohen's κ coefficient were 0.96 and 0.98, respectively. In the epidemiological context of the CAR, the PPV and NPV for all three viral infections were high (≥99.0% to 100%). Conclusion: taken together, our STROBE-compliant study demonstrates that the Exacto® Triplex HIV/HCV/HBsAg showed high sensitivity and specificity for HIV and HBsAg (≥99.0%), and relatively high sensitivity (96.0%) and high specificity (100%) for HCV. These analytical performances are within the limits required by the WHO (i.e. sensitivity ≥99.0% and specificity ≥98.0%) for HIV and HBV. The Exacto® Triplex HIV/HCV/HBsAg is user-friendly at low cost, and appears highly desirable for routine use in the CAR, and likely other Central African countries.

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

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.

Analytical performances of Exacto® HIV self-test in the Central African Republic.

We herein evaluated the analytical performances of the CE-IVD capillary blood Exacto® HIV self-test (Biosynex, Strasbourg, France) in the Central African Republic (CAR). A cross-sectional study was conducted on a representative national panel of 200 sera positive for HIV and 200 negative for HIV, randomly selected thorough the CAR for HIV seroprevalence surveillance survey, according to reference test. The Exacto® HIV self-test showed 99.5% (95% CI: 98.2-99.9) sensitivity and 100.0% (95% CI: 99.0-100.0) specificity. The Youden´s J index and Cohen´s Kappa coefficient were 0.995. At HIV-1 seroprevalence of 3.5% in the general adult population of the CAR, the positive and negative predictive values were 100% (95% CI: 99.0-100) and 99.9% (95% CI: 98.9-100), respectively. The results are within the limits required by the WHO (i.e. sensitivity ≥ 99.0% and specificity ≥ 98.0%), making Exacto® HIV self-test suitable for routine use in the CAR.

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

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.

Analytical performances of the AMPLIQUICK® Respiratory Triplex assay for simultaneous detection and differentiation of SARS-CoV-2, influenza A/B and respiratory syncytial viruses in respiratory specimens.

Although patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B and respiratory syncytial virus (RSV) show comparable or very similar manifestations, the therapeutic approaches of these respiratory viral infections are different, which requires an accurate diagnosis. Recently, the novel multiplex real-time reverse transcription-polymerase chain reaction assay AMPLIQUICK® Respiratory Triplex (BioSynex SA, Illkirch-Graffenstaden, France) allows simultaneous detection and differentiation of SARS-CoV-2, influenza A, influenza B, and RSV in respiratory tract samples. We herein evaluated the performance of the AMPLIQUICK® Respiratory Triplex for the detection of the four viruses in respiratory specimens, using Allplex™ Respiratory Panel 1 and 2019-nCoV assays (Seegene, Seoul, Korea) as reference comparator assays. A total of 359 archived predetermined respiratory samples, including 83, 145, 19 and 95 positive specimens for SARS-CoV-2, influenza A, influenza B and RSV respectively, were included. The AMPLIQUICK® Respiratory Triplex showed high concordance with the reference assays, with an overall agreement for SARS-CoV-2, influenza A, influenza B, and RSV at 97.6%, 98.8%, 98.3% and 100.0%, respectively, and high κ values ranging from 0.93 to 1.00, indicating an almost perfect agreement between assays. Furthermore, high correlations of cycle threshold (Ct) values were observed for positive samples of the four viruses between the AMPLIQUICK® Respiratory Triplex and comparator assays, with an overall high agreement between Ct values assessed by Bland-Altman analyses. In conclusion, these observations demonstrate that the multiplex AMPLIQUICK® Respiratory Triplex is a reliable assay for the qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and RSV in respiratory specimens, which may prove useful for streamlining diagnostics during the winter influenza-seasons.

Review of authorship for COVID-19 research conducted during the 2020 first-wave epidemic in Africa reveals emergence of promising African biomedical research and persisting asymmetry of international collaborations.

OBJECTIVES: The contribution of African authors to the biomedical literature is small. We evaluated the African and non-African scientific production published in the international literature on the COVID-19 in Africa during the first year of the epidemic (2020). METHODS: Papers on COVID-19 in Africa were extracted from the Medline (PubMed) database for bibliometric analysis including the proportions of three leading and last authors by study type, study country, authors' and laboratories/institutions' countries of affiliation and journal ranking. RESULTS: A total of 160 articles fulfilling the inclusion criteria were analysed. The majority (91.3%) was produced by half (53.7%) of African countries, with important regional disparities, and generally without sources of funding mentioned. The majority (>85.0) of authors in lead positions (first, second, third and last authors) were Africans. Only a small number (8.7%) of studies on COVID-19 in Africa were carried out by laboratories not on the African continent (mainly Europe, USA and China) and generally received funding. The last and first authors were more frequently of non-African origin in journals with an Impact Factor ranking ≥1, and more frequently of African origin in journals with a lower ranking (< 1). The first and last non-African authors tended to report their studies in high ranking ≥1 journals. CONCLUSIONS: Our study demonstrates that the emergence of promising African research capable of publishing in indexed but low-impact factor medical journals and reveals the persistence of a North-South asymmetry in international cooperation in biomedical research with Africa.

Analytical performance of the point-of-care BIOSYNEX COVID-19 Ag BSS for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: a prospective field evaluation during the COVID-19 third wave in France.

BACKGROUND: The accuracy and reliability of rapid diagnostic tests are critical for monitoring and diagnosing SARS-CoV-2 infection in the general population. This study aimed to evaluate the analytical performance of the BIOSYNEX COVID-19 Ag BSS (Biosynex Swiss SA, Fribourg, Switzerland) antigen rapid diagnostic test (BIOSYNEX Ag-RDT), which targets the SARS-CoV-2 N-nucleocapsid protein for the diagnosis of COVID-19. The Ag-RDT was compared with a real-time RT-PCR (rtRT-PCR) as gold standard for performance measurement. METHODS: Two nasopharyngeal flocked swabs were prospectively collected simultaneously in March and April 2021 from 967 individuals aged ≥ 18 years tested for SARS-CoV-2 in two private laboratories, Paris, France. RESULTS: Overall, the Ag-RDT demonstrated high sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 81.8%, 99.6%, 96.6%, and 97.5%, respectively. The agreement (97.0%), reliability assessed using Cohen's κ-coefficient (0.87), and accuracy evaluated using Youden index (J) (81.6%) in detecting SARS-CoV-2 were high. The analytical performance of the Ag-RDT remained high when there was significant viral shedding (i.e., N gene Ct values ≤ 33 on reference RT-PCR). The sensitivity was only 55.2% in case of low or very low viral excretion (Ct > 33). CONCLUSIONS: The BIOSYNEX Ag-RDT is a promising, potentially simple diagnostic tool, especially in symptomatic COVID-19 patients with substantial viral excretion in the nasopharynx.

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.

High susceptibility to severe malaria among patients with A blood group versus those with O blood group: A cross-sectional study in the Democratic Republic of the Congo.

This study aimed to assess the association of severe malaria infection with the ABO blood groups among acute febrile patients at the General Hospital of Rungu, in the Democratic Republic of the Congo. This cross-sectional study was conducted between August and October 2018. Plasmodium falciparum-infected individuals were categorized as severe malaria and uncomplicated malaria. A total of 400 febrile patients were enrolled. The majority (n = 251; 62.8%) was positive P. falciparum in microscopy test, of whom 180 (71.7%) had uncomplicated malaria and 71 (28.3%) severe malaria; 32.3%, 18.3%, 2.8%, and 46.6% were found to be blood group of A, B, AB, and O, respectively. In the multivariate analysis using the logistic regression models, severe malaria was high among patients with A blood group compared to those with O blood group (45.8% vs. 13.7%; adjusted odds ratio: 5.3 [95% confidence interval: 2.7-10.5]; P < 0.001). This survey demonstrates that patients with A blood group had a high susceptibility to severe malaria compared to those with O blood group.

Uptake of HIV/AIDS Services Following a Positive Self-Test Is Lower in Men Than Women in the Democratic Republic of the Congo.

As far as HIV self-testing (HIVST) is concerned, proving the link to HIV care for users with a positive result contributes to understanding the implementation of HIVST. We sought to examine whether there were differences by sex in the uptake of HIV services following a positive self-test in the Democratic Republic of the Congo (DRC). This was a mixed-methods study exploring linkage to care for HIVST through a secondary analysis of collected data from three pilot surveys recently conducted in three cities (Kinshasa, Kisangani, and Kindu) during 2018 and 2020 in the DRC. Linkage to HIV care was defined as delayed when observed beyond 1 week. A total of 1,652 individuals were self-tested for HIV. Overall, the proportion of linkage to HIV care was high (n = 258; 82.2%) among individuals having a positive result with HIV self-test (n = 314), but it was significantly lower in men (65.2%) than women (89.2%). Furthermore, linkage to HIV care of men was significantly delayed as compared with that of women (40.0 vs. 20.7%). These findings show a lower uptake of care following a positive self-test in men than women. This trend already previously observed in sub-Saharan Africa shed light on the need to increase linkages to care among men newly diagnosed through HIV self-testing.

Comparative practicability and analytical performances of Credo VitaPCR™ Flu A&B and Cepheid Xpert® Xpress Flu/RSV platforms.

To compare the practicability (usability and satisfaction) and analytical performances of VitaPCR™ Flu A&B Assay (Credo Diagnostics Biomedical Pte. Ltd., Singapore, Republic of Singapore) and Xpert® Xpress Flu/RSV kit (Cepheid, Sunnyvale, USA), two rapid point-of-care (POC) nucleic acid amplification tests (NAATs) by reference to multiplex RT-PCR for respiratory viruses. Nasopharyngeal swabs (n=117) were collected from patients with influenza-like illness in Paris, France. Thawed specimens were further analyzed with both NAATs. The usability was comparable for both NAATs. Satisfaction questionnaire was better for the VitaPCR™ platform for the short time of test result in 20 minutes. Both NAATs showed comparable sensitivities (VitaPCRTM: 95.0%; Xpert® Xpress: 97.5%) and specificities (100%) for influenza A/B RNA detection, with excellent reliability and accuracy between both NAATs. Both VitaPCR™ and Xpert® Xpress NAATs can be implemented in hospital setting as POC NAATs to rapidly detect influenza A/B RNA in symptomatic patients.

Self-testing for HIV, HBV, and HCV using finger-stick whole-blood multiplex immunochromatographic rapid test: A pilot feasibility study in sub-Saharan Africa.

BACKGROUND: 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.

Performances of the VitaPCR™ SARS-CoV-2 Assay during the second wave of the COVID-19 epidemic in France.

To assess the practicability (usability and satisfaction) and analytical performances of the VitaPCR™ SARS-CoV-2 Assay (Credo Diagnostics Biomedical Pte. Ltd.), a rapid point-of-care nucleic acid amplification test (NAAT), by reference to real-time reverse-transcription polymerase chain reaction (rRT-PCR) for respiratory viruses. The practicability of the VitaPCR™ Assay and Instrument was assessed from usability evaluation and a satisfaction questionnaire. Nasopharyngeal swabs were collected from 239 patients with coronavirus disease 2019 (COVID-19)-like illness during the second epidemic wave, in Paris, France. Overall, the usability of the VitaPCR™ Instrument was high. The satisfaction questionnaire indicated a high appreciation of the VitaPCR™ NAAT mainly for the short duration of analysis in only 20 min. A total of 140 and 99 samples were positive and negative for SARS-CoV-2 RNA by rRT-PCR, respectively. In the event of significant viral load (i.e., N gene Ct values 33), the platform's analytical performances dropped significantly, with lower sensitivity, concordance, and accuracy, while its specificity remained high. The VitaPCR™ SARS-CoV-2 Assay is an accurate rapid point-of-care NAAT, suitable for clinical practice for the rapid diagnosis of COVID-19, especially in patients with COVID-19-suspected symptoms.

Management of sickle cell disease: current practices and challenges in a northeastern region of the Democratic Republic of the Congo.

BACKGROUND: The Democratic Republic of the Congo (DRC) is the third most affected country worldwide by sickle cell disease (SCD). However, this disease is still orphaned in the country; large-scale control actions are rare, and little is known about its management. OBJECTIVE: To assess current practices in the management of SCD in Kisangani, DRC. METHODS: This cross-sectional study was conducted in six health facilities in Kisangani. It involved 198 presumed sickle cell patients attending the above health facilities. The study focused on the sociodemographic and clinical data of the participants, obtained through a clinical examination and their medical records. Diagnostic confirmation of SCD was made by high-performance liquid chromatography coupled to mass spectrometry. Data were analyzed using SPSS 20.0. RESULTS: The diagnosis of SCD was confirmed in 194 (98.0%; 95% CI: 94.9-99.2) participants, while it was not confirmed in 4 (2.0%; 95% CI: 0.8-5.1) participants. The diagnosis was mainly made by the Emmel test (42.9%). 45.8% of participants had previously been transfused with the blood of their parents. Folic acid was taken by 48.5% of participants and the previous intake of hydroxyurea was reported in 5.1% of participants. The participants vaccinated against Pneumococcus were 13.6% and against Haemophilus influenzae type b 28.3%. Penicillin prophylaxis was received by only 1.5% and malaria prophylaxis by 11.6% of participants. CONCLUSION: Standard-care practices for SCD patients in Kisangani are insufficient. The Congolese government should regard this disease as a health priority and consider actions to improve its management.

Analytical performances of five SARS-CoV-2 whole-blood finger-stick IgG-IgM combined antibody rapid tests.

Facing the ongoing pandemic caused by SARS-CoV-2, there is an urgent need for serological assays identifying individuals previously infected by coronavirus disease 2019 (COVID-19), including rapid diagnostic tests (RDTs). We herein compared five new CE-IVD-labeled commercially available SARS-CoV-2 whole-blood finger-stick IgG/IgM combined RDTs, in parallel according to the manufacturers' instructions, with two serum panels obtained from 48 patients with confirmed COVID-19 (panel I) and from a group of 52 patients randomly selected, for whom serum samples collected before the COVID-19 epidemic (from October 1 to November 30, 2019) were negative for SARS-CoV-2 IgG (panel II). We found a sensitivity of 95.8 %, 91.6 %, 92.3 %, 97.9 % and 91.4 %, and a specificity of 98.1 %, 86.5 %, 100 %, 98.1 % and 84.6 %, for BIOSYNEX COVID-19 BSS (IgG/IgM) (Biosynex Swiss SA, Freiburg, Switzerland), Humasis COVID-19 IgG/IgM Test (Humasis Co., Ltd., Gyneonggi, Republic of Korea), LYHER COVID-19 IgM/IgG Rapid Test (Medakit Ltd, Hong Kong, China), SIENNA™ COVID-19 (IgG/IgM) Rapid Test Cassette (Salofa Oy, Salo, Finland) and NG-BIOTECH COVID-19 (IgG/IgM) (NG-Biotech, Guipry, France), respectively. Commercially available SARS-CoV-2 IgG/IgM combined RDTs have a sufficient sensitivity for identifying individuals with past SARS-CoV-2 infection, but some RDTs may lack of specificity, with risk of false positivity mainly for the IgM band.

Unexpected high frequency of unspecific reactivities by testing pre-epidemic blood specimens from Europe and Africa with SARS-CoV-2 IgG-IgM antibody rapid tests points to IgM as the Achilles heel.

We aimed to evaluate the rates of false-positive test results of three rapid diagnostic tests (RDTs) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific immunoglobulin G (IgG) and IgM detection. Two serum panels from patients hospitalized in Paris, France, and from patients living in Bangui, Central African Republic, acquired before the 2019 COVID-19 outbreak, were tested by 3 CE IVD-labeled RDTs for SARS-CoV-2 serology (BIOSYNEX® COVID-19 BSS [IgG/IgM]; SIENNA™ COVID-19 IgG/IgM Rapid Test Cassette; NG-Test® IgG-IgM COVID-19). Detectable IgG or IgM reactivities could be observed in 31 (3.43%) of the 902 IgG and IgM bands of the 3 RDTs used with all pre-epidemic sera. The frequencies of IgG/IgM reactivities were similar for European (3.20%) and African (3.55%) sera. IgM reactivities were observed in 9 European and 14 African sera, while IgG reactivity was observed in only 1 African serum (15.1% vs. 0.66%). The test NG-Test® IgG-IgM COVID-19 showed the highest rates of IgG or IgM reactivities (6.12% [18/294]), while the test BIOSYNEX® COVID-19 BSS (IgG/IgM) showed the lowest rate (1.36% [4/294]). Some combinations of 2 RDTs in series allowed decreasing significantly the risk of false-positive test results. Our observations point to the risk of false-positive reactivities when using currently available RDT for SARS-CoV-2 serological screening, especially for the IgM band, even if the test is CE IVD-labeled and approved by national health authorities, and provide the rational basis for confirmatory testing by another RDT in case of positive initial screening.

Comparison of practicability and effectiveness between unassisted HIV self-testing and directly assisted HIV self-testing in the Democratic Republic of the Congo: a randomized feasibility trial.

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 and effectiveness 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. TRIAL REGISTRATION: PACTR201904546865585. Registered 03 April 2019 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=6032.