BackgroundMedical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but access to these important tools is often limited in Africa. The regulation of health commodities by National Regulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new products. Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve access to new products. Whereas pharmaceutical products are widely regulated less attention has been placed on the regulation of other health products. A study was undertaken to assess regulation of medical diagnostics and medical devices across Partner States of the East African Community (EAC).MethodsData was collected during October 2012 through desk based review of documents and field research, including face to face interviews with the assistance of a structured questionnaire with closed and open ended questions. Key areas addressed were (i) existence and role of National Regulatory Authorities; (ii) policy and legal framework for regulation; (iii) premarket control; (iv) marketing controls; (v) post-marketing control and vigilance; (vi) country capacity for regulation; (vii) country capacity for evaluation studies for IVD and (viii) priorities and capacity building for harmonization in EAC Partner States.ResultsControl of medical devices and IVDs in EAC Partner States is largely confined to national disease programmes such as tuberculosis, HIV and malaria. National Regulatory Authorities for pharmaceutical products do not have the capacity to regulate medical devices and in some countries laboratory based organisations are mandated to ensure quality of products used. Some activities to evaluate IVDs are performed in research laboratories but post market surveillance is rare. Training in key areas is considered essential to strengthening regulatory capacity for IVDs and other medical devices.ConclusionsRegulation of medical devices and in vitro diagnostics has been neglected in EAC Partner States. Regulation is weak across the region, and although the majority of States have a legal mandate to regulate medical devices there is limited capacity to do so. Streamlining regulation in the EAC is seen as a positive aspiration with diagnostic tests considered a priority area for harmonisation.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-014-0524-2) contains supplementary material, which is available to authorized users.

Background Asymptomatic malaria infections are important parasite reservoirs and could sustain transmission in the population, but they are often unreported. A community-based survey was conducted to investigate the prevalence and factors associated with asymptomatic malaria infections in a historically high transmission setting in northern Uganda. Methods Using a cross-sectional design, 288 children aged 2–15 years were enrolled and tested for the presence of malaria parasites using rapid diagnostic tests (RDTs) and blood smear microscopy between January to May 2022. Statistical analysis was performed using the exact binomial and Fisher’s exact test with p ≤ 0.05 indicating significance. The logistic regression was used to explore factors associated with asymptomatic malaria infections. Results Overall, the prevalence of asymptomatic infection was 34.7% (95% CI 29.2–40.5) with the highest observed in children 5–10 years 45.9% (95% CI 35.0–57.0). Gweri village accounted for 39.1% (95% CI 27.6—51.6) of malaria infections. Median parasite density was 1500 parasites/µl of blood. Plasmodium falciparum was the dominant species (86%) followed by Plasmodium malariae (5%). Factors associated with asymptomatic malaria infection were sleeping under mosquito net (Adjusted Odds Ratio (aOR) 0.27; 95% CI 0.13–0.56), p = 0.001 and presence of village health teams (VHTs) (aOR 0.02; 95% CI 0.01–0.45), p = 0.001. Sensitivity and specificity were higher for the P. falciparum/pLDH RDTs compared to HRP2-only RDTs, 90% (95% CI 86.5–93.5) and 95.2% (95% CI 92.8–97.7), p = 0.001, respectively. Conclusion Asymptomatic malaria infections were present in the study population and this varied with place and person in the different age groups. Plasmodium falciparum was the dominant parasite species however the presence of P. malariae and Plasmodium ovale was observed, which may have implication for the choice and deployment of diagnostic tools. Individuals who slept under mosquito net or had presence of functional VHTs were less likely to have asymptomatic malaria infection. P.f/pLDH RDTs performed better than the routinely used HRP2 RDTs. In view of these findings, investigation and reporting of asymptomatic malaria reservoirs through community surveys is recommended for accurate disease burden estimate and better targeting of control.

Purpose: To determine the prevalence of Cryptosporidium by age, sex, and duration on antiretroviral therapy (ART) and establish hygienic malpractices that may predispose to infection. Methods: We enrolled 138 HIV/AIDS patients on ART from June to October 2018. Stool samples were collected from study participants, wet saline preparations made and examined, stool samples concentrated using formal ether concentration, and smears stained using the modified Ziehl–Neelsen technique. Structured questionnaires were used to collect demographic data and hygienic malpractices that predisposed study participants to cryptosporidiosis infection. Results: Of 138, 99 (71.7%) were females and 39 (28.7%) males. The age range was 9–69 years and mean age 37 years. The overall prevalence of cryptosporidiosis was three (2.17%). The most affected age-groups were 31–40 years (3.85%) and 21–30 years (3.22%), and only females (3.03%) were affected. The distribution of cryptosporidiosis according to the duration spent on ART showed that those who had spent <1 year on ART were the most affected (11.1%), followed by those who had spent 1–5 years 1 (2.2%), while those patients on ART for 6-10 years were 1 (1.7%) and those on ART for more than 10 years were not affected. There was no significant association between cryptosporidiosis and sex ( P =0.272), educational background ( P =0.670), handwashing ( P =0.853), drinking boiled water ( P =0.818), duration on ART ( P =0.263), occupation ( P =0.836), and age ( P =0.723). Conclusion: The prevalence reported in this study is low; however, it is still vital for clinicians to proceed to have cryptosporidiosis as the main differential in HIV/AIDS patients with gastrointestinal infections.

Background. Diabetic nephropathy (DN) is a common finding in diabetic patients. Microalbuminuria is the earliest clinical evidence of DN. Early detection of microalbuminuria is very important; it allows timely interventions to prevent progression to macroalbuminuria and later end-stage renal disease (ESRD). Objectives. To determine the prevalence of microalbuminuria in diabetic patients and establish its association with traditional serum renal markers in assessment of incipient nephropathy. Methods. This cross-sectional study involved 140 participants with diabetes mellitus (DM) attending the diabetic clinic of Mbarara Regional Referral Hospital. Questionnaires were used to obtain participant data after obtaining written informed consent. Data collected included: age, sex, level of education, history of smoking and alcohol consumption, hypertension, body mass index, family history, and duration of DM. Morning spot urine samples were collected from each participant and blood drawn for analysis of other renal markers. Urine microalbumin was determined quantitatively using immunoturbidity assay (Microalbumin kit, Mindray). Serum creatinine and uric acid and glucose levels were determined by spectrophotometric methods. Results. The overall prevalence of microalbuminuria was 22.9%. Using a simple and multiple linear regression model, serum creatinine (β=0.010, 95% CI (0.005, 0.014), P=0.0001) and glucose (β=0.030, 95% CI (0.011, 0.048), P=0.0017) levels were significantly associated with microalbuminuria. After adjusting for linearity, family history of DM was the only predictor of microalbuminuria (β=0.275, 95% CI (0.043, 0.508), P=0.002). Although microalbuminuria was weakly associated with eGFR (OR=1.2, 95% CI (0.24, 5.96)), the relationship was not statistically significant (P=0.824). Conclusion. The prevalence of microalbuminuria in patients with diabetes in this study was high. The study suggests the need to screen for microalbuminuria early to reduce the possible burden of ESRD. When serum creatinine is used as a renal function marker among diabetic patients, it should be combined with microalbuminuria for better assessment of incipient nephropathy.

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