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BACKGROUND: Environmental pollutants are known to be ubiquitous and may present toxic effects (endocrine-disruption properties, carcinogenicity …) and represent a real threat to human health. The aim of the present pilot study was to assess the content of environmental pollutants (inorganic, persistent, and non-persistent pollutants) in biological samples (urine, serum, and whole blood), collected from volunteers in Kinshasa, capital of Democratic Republic of Congo, in order to identify pollutants of interest and to design a protocol for a larger scale study. METHODS: From randomly selected 15 volunteers living in Kinshasa, aged from 25 to 66 years, (mean age = 43.4 years), including 10 men and 5 women, urine, whole blood, and serum samples were used in this study to estimate the contents in these environmental pollutants, using inductively coupled plasma mass spectrometry, gas chromatography coupled to mass spectrometry, and liquid chromatography coupled to mass spectrometry. RESULTS: When compared to data nationally and internationally available, the preliminary outcomes of this study indicated a very high level of exposure to environmental pollutants in the population of Kinshasa, especially for heavy metals, parabens and triclosan. To a lesser extent, contamination measured for glyphosate, phthalates, organochlorine pesticides, pyrethroids and dialkylphosphate pesticides was also significant. In contrast, the investigated population of Kinshasa was found to be weakly exposed to other persistent organic pollutants like polychlorinated biphenyls, brominated flame retardants, phenolic organohalogens, and perfluoroalkyl substances. CONCLUSION: Although the biologic fluids were collected from a limited number of volunteers (n = 15), the results of the present report clearly indicate that the population of Kinshasa is not spared by the investigated environmental pollutants. Moreover, this study gives us important information to design a larger scale study protocol. SUPPLEMENTARY INFORMATION: The online version ...

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. ; Peer reviewed

Background: Environmental pollutants are known to be ubiquitous and may present toxic effects (endocrine-disruption properties, carcinogenicity .) and represent a real threat to human health. The aim of the present pilot study was to assess the content of environmental pollutants (inorganic, persistent, and non-persistent pollutants) in biological samples (urine, serum, and whole blood), collected from volunteers in Kinshasa, capital of Democratic Republic of Congo, in order to identify pollutants of interest and to design a protocol for a larger scale study. Methods: From randomly selected 15 volunteers living in Kinshasa, aged from 25 to 66 years, (mean age = 43,4 years), including 10 men and 5 women, urine, whole blood, and serum samples were used in this study to estimate the contents in these environmental pollutants, using inductively coupled plasma mass spectrometry, gas chromatography coupled to mass spectrometry, and liquid chromatography coupled to mass spectrometry. Results: When compared to data nationally and internationally available, the preliminary outcomes of this study indicated a very high level of exposure to environmental pollutants in the population on Kinshasa, especially for heavy metals, parabens and triclosan. To a lesser extent, contamination measured for glyphosate, phtalates, organochlorine pesticides, pyrethroids and dialkylphosphate pesticides was also significant. In contrast, the investigated population of Kinshasa was found to be weakly exposed to other persistent organic pollutants like polychlorinated biphenyls, brominated flame retardants, phenolic organohalogens, and perfluoroalkyl substances. Conclusion: Although the biologic fluids were collected from a limited number of volunteers (n = 15), the results of the present report clearly indicate that the population of Kinshasa is not spared by the investigated environmental pollutants. Moreover, this study gives us important information to design a larger scale study protocol. ; Peer reviewed

In recent decades, more than 15% of antimalarials marketed in low- and middle-income countries were of poor quality, in which quinoline derivatives and quinine-based formulations represent 21%. These molecules are used for severe and/or cerebral malaria, as well as for falciparum-resistant malaria treatment [1,2]. This research work deals with the opportunity of using vibrational spectroscopy techniques combined with chemometrics for the quality control of local production of antimalarial drugs. Near Infrared (NIR) spectroscopy was chosen for its low-cost and rapid testing properties as well as the possibility to transfer calibrations to handheld devices to control medicines directly on field [3,4]. The main objective was to develop and validate PLS regression method using NIR spectroscopy to replace the high solvent consuming techniques such as HPLC. Indeed, HPLC analyses are difficult to perform in routine in low- and middle-income countries due to the supply and price of reagents and solvents. Furthermore, liquid chromatography devices often suffer from technical issues needing specialized technicians. The driven idea for the development of the quantitative method was the ease of implementation and use by low skilled staff together with the possibility to analyze different formulations. Multivariate analysis methods based on NIR spectroscopy have been developed and validated for the quality control of quinine sulfate tablets manufactured by a major local manufacturer in the Democratic Republic of Congo (DRC). The samples are prepared by dissolution of quinine salt in HCl 0.5 M that is a cheap and easily available medium in low- and middle-income countries. Calibration and validation samples were prepared by dissolving reference quinine sulfate in the presence of excipients using gravimetric data as reference. After being validated, the method was used to analyze commercial quinine sulfate tablets of 500 mg collected in the local market. The method is considered as valid within the acceptance limits as shown in Fig 1. This approach gives the guarantee that each further measurement of unknown samples is included within the tolerance limits at the +/- 10% acceptance limits with a 5.0 % risk level.

Drug counterfeiting is a sad and worrisome reality, especially in developing countries where quality control is not effective and sometimes not existing at all despite political will of governments. The consequences are harmful in particular for substandard medicines that pose more threats to populations in those countries due to their direct negative impact on patients such as failure of medical treatment including development of drug resistance and even death. Socio-economic consequences and negative reputation concerning the pharmaceutical industry are also observed. Unfortunately accurate detailed data on such medicines are not easy to obtain. Most of the time available data are often estimated from case reports or studies carried out in a specific area and during a defined period.Health authorities' in the Democratic Republic of Congo are trying to identify this scourge by set up several strategies to fight against. One of them is built on the best knowledge of drugs from several horizons through the assessment of their quality to allow appropriate measurement. In this context, we have focused our study towards amoxicillin alone and/or combined with potassium clavulanate since it is one the very used medicines in pediatric medications. The formulations are powder for suspension. Two analytical methods were developed based on the USP monography, applying isocratic liquid chromatography. Prior to their application in routine, we evaluated the suitability of these methods through validation applying the accuracy profile of total error. Since it was planned to transfer the methods to DRC, several operating factors were taken into account namely operator, day and equipment. Interesting results were obtained in terms of trueness (relative biases below than 2.3%), precision (RSD of Intermediate precision below 2.8%), accuracy (beta-expectation tolerance intervals between -6.0% and 3.8%) for the concentration levels of interest. The latter were able to allow monitoring the quality of the two active ingredients here above in the 65 samples from Congolese market. They were collected in Kinshasa, Lubumbashi, Matadi and Kolwezi at official and non-official medicines distributors, in peripheral area. The dramatic results obtained confirm that substandard and counterfeit medicines remain a crucial problem on public health in low-income countries. Appropriate measures are really needed to set up the drug quality improvement. ; Peer reviewed

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. ; Peer reviewed

INTRODUCTION: Sickle Cell Disease (SCD) and albinism are both recessive hereditary diseases in human kind with a high prevalence in sub-Saharan Africa. This study aimed to determinate the prevalence of sickle cell trait in people living with albinism (PLA). METHODS: a cross-sectional descriptive survey was conducted in PLA attending the "Hôpital du Cinquantenaire de Kisangani". In total, by non-probabilistic convenience sampling, 82 albinos and 139 non-albinos and without any antecedents of albinism in their family were included, selected from students in the Faculty of Medicine and Pharmacy at the University of Kisangani. Blood samples were collected on "dried blood spot" and analyzed by mass spectrometry at CHU of Liège. Data were entered into an Excel file and analysed on SPSS 20.0 (Chicago, IL). RESULTS: forty-six of the 82 albinos (56.1%) were female and 43.9% male with a sex ratio of 1.28. Among albinos, 18.3% had hemoglobin AS (HbAS) and 81.7% hemoglobin AA (HbAA) compared to 18% of subjects with hemoglobin AS and 82% hemoglobin AA in the control group. The difference was not statistically significant (Chi-square=0.003, ddl=1, p=0.9544). CONCLUSION: this study highlighted that the prevalence of the sickle cell trait is high among people living with albinism, but does not differ from that observed in non-albinos in the Democratic Republic of the Congo. It is therefore important to raise awareness among this category of people about sickle cell disease and the importance of its premarital screening. ; Peer reviewed

Background: In the context of old pharmaceutical legislation and regulations not adapted to current realities, the aim of the present studywas to evaluate the existing pharmaceutical system in peri-urban areas of Kinshasa. Methods: A prospective study was carried out during the period 2016–2018. The most used antimalarial medicines were identified through household and pharmaceutical establishment surveys. The samples of the obtained medicines were assayed with generic separation methods using the high-performance liquid chromatography technique coupled to a diode array detector. The registration status was checked for 126 antimalarial brand names. A characterization was carried out in 196 pharmaceutical establishments on the basis of standards set out by the Ministry of Health. Results: Of the 75 samples assayed, 19% (14/75)were non-compliant. Of the 124 brand names, 46.0% (57/124) were unlicensed and 14.5% (18/124) had an expired licence. Of the 196 pharmaceutical establishments, only 2 (1.0%) had an authorization to practice, none met all the Ministry of Health minimum standards and 24.5% (48/196) met the World Health Organization Guidelines for the Storage of Essential Medicines and Other Health Commodities. Conclusions: More resources should be mobilized to apply regulator sanctions. ; Peer reviewed

BACKGROUND: In the context of old pharmaceutical legislation and regulations not adapted to current realities, the aim of the present study was to evaluate the existing pharmaceutical system in peri-urban areas of Kinshasa. METHODS: A prospective study was carried out during the period 2016–2018. The most used antimalarial medicines were identified through household and pharmaceutical establishment surveys. The samples of the obtained medicines were assayed with generic separation methods using the high-performance liquid chromatography technique coupled to a diode array detector. The registration status was checked for 126 antimalarial brand names. A characterization was carried out in 196 pharmaceutical establishments on the basis of standards set out by the Ministry of Health. RESULTS: Of the 75 samples assayed, 19% (14/75) were non-compliant. Of the 124 brand names, 46.0% (57/124) were unlicensed and 14.5% (18/124) had an expired licence. Of the 196 pharmaceutical establishments, only 2 (1.0%) had an authorization to practice, none met all the Ministry of Health minimum standards and 24.5% (48/196) met the World Health Organization Guidelines for the Storage of Essential Medicines and Other Health Commodities. CONCLUSIONS: More resources should be mobilized to apply regulator sanctions.