Regulation of medical diagnostics and medical devices in the East African community partner states.

BACKGROUND: Medical 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). METHODS: Data 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. RESULTS: Control 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. CONCLUSIONS: Regulation 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.

Insulin therapy among diabetic patients in rural communities of Sub-Saharan Africa: a perspective review.

In this perspective review, we describe a brief background on the status quo of diabetes mellitus-related therapies and glycemic control among patients in rural communities in sub-Saharan Africa. The article discusses insulin therapy as well as the difficulties in obtaining insulin and oral hypoglycemic medications for diabetic patients living in sub-Saharan Africa. We wrap up our discussion with suggestions on solutions and opportunities for future research to tackle this health challenge in these impoverished communities. We conducted a literature search from PubMed and Google Scholar up until August 2023. Key words were used to generate search terms used to retrieve the required information. All types of literature with pertinent information on the current topic were included in the study. Diabetes mellitus is on the rise in sub-Saharan Africa. Several studies have reported poor glycemic control, low screening rates for diabetes mellitus, cigarette smoking, high alcohol consumption, prescription of antidiabetic therapy, and associated costs as contributors to the uptake of antidiabetic treatment. Although there is paucity of data on the extent of insulin therapy uptake and its possible modifiable contributors among the diabetic patients in the region, the anticipated increase in the number of people with diabetes on the continent makes it critical for global leaders to address the research gaps in insulin therapy among rural communities of sub-Saharan Africa, thus reducing the burden of diabetes in these populations.

FKBP11 upregulation promotes proliferation and migration in hepatocellular carcinoma.

BACKGROUND: Hepatocellular carcinoma (HCC) is one of the leading causes of cancer related deaths world over. Early diagnosis and effective treatment monitoring significantly improves patients' outcomes. FKBP11 gene is highly expressed in HCC and could play a role in its development, early diagnosis and treatment. OBJECTIVE: This study aimed to evaluate the expression of FKBP11 in HCC, its correlation with patients' clinical characteristics and potential role in HCC development. METHODS: Expression was determined by bioinformatics analysis, quantitative real-time PCR, western blot, and immunohistochemistry. CCK-8, Transwell and wound healing assays were used to investigate involvement in HCC development. RESULTS: FKBP11 was significantly upregulated in HCC cells, tissues and blood (all p< 0.001). Its receiver operator characteristic (ROC) curve had an AUC of 0.864 (95% CI: 0.823-0.904), at a sensitivity of 0.86 and specificity of 0.78 indicating a good diagnostic potential in HCC. Its expression was markedly reduced after surgery (p< 0.0001), indicating a potential application in HCC treatment follow-up. Knockdown of FKBP11 in HCC cells attenuated proliferation and migration, suggesting a possible role in HCC pathogenesis. CONCLUSION: This study thus found that FKBP11 is upregulated in HCC, and the upregulation promotes HCC development. FKBP11 levels are significantly reduced post-surgery and could be a potential diagnostic and prognostic marker for HCC.

Upregulation of the long non-coding RNA, LIPCAR promotes proliferation, migration, and metastasis of hepatocellular carcinoma.

BACKGROUND: Hepatocellular carcinoma (HCC) early diagnosis remains a challenge to date. Alpha-feto protein, though less sensitive remains widely used for both diagnosis and prognosis. Recently however, a number of molecular biomarkers have been suggested as alternatives to Alpha feto protein, especially for early diagnosis. OBJECTIVE: To determine the role of the long non-coding RNA, LIPCAR in the pathogenesis and early diagnosis of hepatocellular carcinoma. METHODS: Quantitative real-time PCR, and Fluorescence in situ hybridization assays were conducted to determine LIPCAR expression in HCC vs normal blood samples, and HCC cell lines vs normal liver cell lines. Transfection was done to upregulate LIPCAR in one HCC cell line, and used to study cell proliferation, migration, apoptosis and epithelial-mesenchymal transformation. Animal experiment was finally done to determine its effect on metastasis. RESULTS: LIPCAR was significantly upregulated in HCC blood samples and HCC cell lines compared to their respective normal ones. Its overexpression promoted hepatocellular carcinoma cell proliferation, and migration, while inhibiting apoptosis. Its overexpression also promoted epithelial-mesenchymal transformation in hepatocellular carcinoma cells, and metastasis in vivo. CONCLUSION: The study demonstrated that the lncRNA, LIPCAR is significantly upregulated in hepatocellular carcinoma patients and that its upregulation promotes HCC proliferation, migration, and metastases.

Microalbuminuria and Traditional Serum Biomarkers of Nephropathy among Diabetic Patients at Mbarara Regional Referral Hospital in South Western Uganda.

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 (ß = 0.010, 95% CI (0.005, 0.014), P = 0.0001) and glucose (ß = 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 (ß = 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.

Prevalence of cryptosporidiosis and hygiene practices among HIV/AIDS patients in southwest Uganda.

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.