Evaluation of Sigma Metrics and Westgard Rule Selection and Implementation of Internal Quality Control in Clinical Chemistry Reference Laboratory, Ethiopian Public Health Institute.

Clinical laboratories are mandated to deliver accurate, reliable, timely and correctly reported result which, used in decision making for disease screening, diagnosis and monitoring. With aid of six sigma principles and metrics it is possible to assess the quality laboratory process and the quality control that is needed to ensure that the desired quality is achieved. Thus, this study was undertaken to evaluate the performance of biochemical parameters by calculating the sigma metrics of individual parameters using internal quality control (IQC) and Proficiency Testing (PT) results. The sigma metrics of 21 clinical chemistry parameters were calculated from COBAS 6000 analyzer with internal quality control (IQC) materials and external quality assurance scheme (EQAS) performance in national clinical chemistry laboratory for the period of six months. We obtained an excellent performance (≥ 6 sigma) for test parameters amylase pancreatic, amylase total, HDL, magnesium, AST, triglyceride, total bilirubin and ALT in both levels of quality control. Urea, creatinine and chloride were failed to meet the minimal sigma performance for both level 1 and 2. Sigma values of 3-6 were observed for ALP, Direct bilirubin, total protein, albumin, glucose, potassium, and phosphate with both levels of quality control. Though, stringent IQC strategy is not mandatory for analytes that scored sigma value ≥ 6. However, continuous monitoring quality control is required for renal function tests and process improvement will be designed for those with poor sigma values.

Serum level of high sensitive C-reactive protein and IL - 6 markers in patients with treatment-resistant schizophrenia in Ethiopia: a comparative study.

BACKGROUND: Accumulating evidence indicates that schizophrenia is accompanied by significant activation of the immune system; however, there is limited data from low and middle-income countries (LMIC). Inflammatory markers may be more relevant in LMIC settings where infectious conditions are more prevalent and may thus play some role in the causation and maintenance of schizophrenia. The aim of this study was to assess the level of inflammatory markers high sensitive C-reactive protein (hsCRP) and interleukin-6 (IL-6) in patients with schizophrenia. MATERIALS AND METHODS: The study population consisted of a total of 132 study participants; 82 participants with schizophrenia and 50 controls. hsCRP and IL-6 were measured using Cobas Integra 400 Plus and Cobas e 411 analysers respectively. RESULTS: The levels of hsCRP and IL-6 were significantly increased among participants with schizophrenia compared to controls: hsCRP mean value 2.87 ± 5.6 vs 0.67 ± 0.6 mg/L; IL-6 mean value 6.63 ± 5.6 vs 3.37 ± 4.0 pg/ml. Controlling for potential confounders (age, sex and body mass index), having a diagnosis of schizophrenia remained significantly associated with increased hsCRP and IL-6. CONCLUSION: The results confirm that inflammatory processes may have a role in the pathophysiology of schizophrenia regardless of setting. Despite failure of some interventions with anti-inflammatory properties, interventions to reduce inflammation are still worth pursuing.

Prevalence of metabolic syndrome among patients with schizophrenia in Ethiopia.

BACKGROUND: Globally, the prevalence of metabolic syndrome (MetS) is higher among patients with schizophrenia than the general population, and this leads to higher morbidity and mortality in this population. The aim of this study was to investigate the MetS prevalence among patients with schizophrenia in Ethiopia. METHODS: We conducted a cross-sectional analysis of baseline data of 200 patients with schizophrenia recruited from Amanuel Mental Specialized Hospital, Addis Ababa, Ethiopia. Lipid profile and blood glucose levels were measured using Roche Cobas 6000 clinical chemistry analyzer. The prevalence of MetS was assessed based on National Cholesterol Education Program Adult Treatment Panel III criteria. Patients' demographic information, clinical and laboratory data, lifestyle habits, particularly smoking and Khat chewing, were evaluated vis-à-vis MetS. RESULTS: The overall prevalence of MetS in patients with schizophrenia was 21.5% (17.1% male, 29.6% female) where Low HDL-cholesterol value was the most common metabolic disorders components in both males and females subgroups. In the multivariate analysis, the positive and negative symptoms score (PANSS, AOR = 1.03, 95% CI 1.001-1.054) was associated factors with MetS. CONCLUSION: In Ethiopia, patients with schizophrenia were found to have higher prevalence of MetS than the general population. Physicians/health care providers should routinely screen patients with schizophrenia for MetS and initiate timely management of those who develop the syndrome to reduce the health cost from caring for NCDs, improve the patients' quality of life, and prevent premature mortality.

Assessment of serum electrolytes and kidney function test for screening of chronic kidney disease among Ethiopian Public Health Institute staff members, Addis Ababa, Ethiopia.

BACKGROUND: Chronic kidney disease (CKD), which is characterized by its asymptomatic nature until an end stage, is one of the most common public health problems in the world. Thus, a regular checkup, especially for those individuals with high risk groups is inevitably important, and the screening has been done with laboratory findings. However, in developing countries, including Ethiopia screening for CKD are rarely done, and it is becoming common to hear sudden death from the kidney failure. Therefore, we aimed to screen serum electrolyte levels and estimated glomerular filtration rate (eGFR) among Ethiopian Public Health Institute (EPHI) staff members for an early detection of CKD and to identify the factors associated with it. METHODS: A cross-sectional study was conducted from July 1 to October 28, 2018 among EPHI staff members. The level of serum creatinine and electrolytes were measured using COBAS 6000 analyzer. Then, eGFR was calculated using MDRD and CKD-EPI equations. Data analysis were done using SPSS version 20, and the factors associated with the outcome variable were assessed using logistic regression. P values < 0.05 were considered as statistically significant. RESULTS: This study found that 3.6 and 1.9% of the study participants were at CKD stage II by MDRD and CKD-EPI equations, respectively. Out of the total study participants, 9.5% had hyperkalemia (serum potassium level > 5.0 mmol/L) and 8.5% had hypocalcemia (serum calcium level < 2.15 mmol/L). An older age (P = 0.006), high BMI (P = 0.045) and previous history of CVDs (P = 0.033) were found to be significantly associated factors with reduced glomerular filtration rate. Nine percent of the study participants were obese, 6.1% had family history of kidney failure, 18% self-reported history of hypertension, 3.4% diabetic and 5.3% had CVDs. About 51.2% of the study participants were males, and the majorities, (66%) of the study participants were found to be alcohol consumers. CONCLUSIONS: The prevalence of a stage II kidney disease was relatively low and none of the participants was under serious kidney disease (GFR < 60 mmol/min/1.73m2). An older age, high BMI and previous history of CVDs were significantly associated with reduced GFR. Hyperkalemia and hypokalemia were the major electrolyte disorders in the study participants.

Cardiometabolic syndrome and associated factors among Ethiopian public servants, Addis Ababa, Ethiopia.

Non-communicable diseases (NCDs) are increasingly becoming the global cause of premature death encompassing cardiovascular diseases (CVDs), cancer, respiratory diseases and diabetes mellitus. However, cardiometabolic risk factors in the general population, especially among the high-risk groups have rarely been assessed in Ethiopia. The study aimed to assess the prevalence of metabolic syndrome, its components and associated factors among staff in the Ethiopian Public Health Institute (EPHI). An institutional-based cross-section study was conducted from March to June 2018 among EPHI staff members. A total of 450 study participants were involved in the study, and the World Health Organization NCD STEPS survey instrument version 3.1 was used for the assessment. The biochemical parameters were analyzed by using COBAS 6000 analyzer. Statistical package for the social science (SPSS) version 20 was used for data analysis. Both bivariate and multivariate logistic regression analyses were used to identify associated risk factors. p value < 0.05 was considered for statistical significance. The overall prevalence of metabolic syndrome was 27.6% and 16.7% according to IDF and NCEP criteria respectively, with males having greater prevalence than females (35.8% vs 19.4%). Central obesity, low high-density lipoprotein (HDL) and hypertension had a prevalence of 80.2%, 41.3%, and 23.6%, respectively. In multivariate analysis increasing age and having a higher body mass index (25-29.9) were significantly associated with metabolic syndromes. The magnitude of metabolic syndrome was relatively high among public employees. Preventive intervention measures should be designed on the modification of lifestyle, nutrition and physical activities, and early screening for early identification of cardiometabolic risks factors should be practised to reduce the risk of developing cardiovascular diseases.

Distribution and determinants of serum high-sensitivity C-reactive protein in Ethiopian population.

BACKGROUND: C-reactive protein (CRP) is an important inflammatory marker associated with different disease conditions, and its concentration differs among ethnicity. This study aimed to determine the distribution and determinants of serum high-sensitive method CRP (hsCRP) that can measure the typically low concentrations, among the Ethiopian population, for which there is no data. METHODS: A cross-sectional community-based study was conducted in April-June 2015. A total of 5162 individuals aged 15-69 were included. Behavioral, physical, and biochemical measurements were taken using the WHO STEPS non-communicable diseases (NCDs) risk factors assessment tool. Serum hsCRP was determined using Cobas Integra 400 Plus (Roche). Factors associated with hsCRP levels were also considered. RESULTS: median hsCRP was 0.80 mg/L (Interquartile range, 0.19-2.12) (males: 0.91 mg/L, females: 0.74 mg/L). More than 18% of the study participants had hsCRP greater than 3 mg/L according to the American Heart Association and Centers for Diseases Control and Preventions cut off value. Higher BMI, living in Somali and in Dire Dawa region, and not consuming of fruit or vegetables were independent risk factors for high hsCRP levels. CONCLUSION: Serum hsCRP levels distribution is comparable to other studies. Until now, no data have been reported in the literature about the Ethiopian population.

Evaluation of Antihyperglycemic Effect of Extract of Moringa stenopetala (Baker f.) Aqueous Leaves on Alloxan-Induced Diabetic Rats.

BACKGROUND: Diabetes is a serious metabolic disorder with complications that result in significant morbidity and mortality. Current drugs used for diabetes therapy are not free from side effects and do not restore normal glucose homeostasis. Therefore, the purpose of this study is to evaluate the antidiabetic effect of Moringa stenopetala (Baker f.) aqueous leaves extract. METHODS: Thirty rats of weight 90-150 gram were distributed to five groups (n= 6). Then labelled as diabetic control (DC), normal control (NC), extract treated (MS 250 and 500mg/kg), and glibenclamide treated (GL 5mg/kg). The experimental rats were induced by intra-peritoneal injection of Alloxan monohydrate at a dose of 180 mg/kg after dissolving in normal saline. Clinical biochemistry such as AST, ALT, ALP, urea, creatinine, and cholesterol, blood glucose level, histopathological and preliminary phytochemical screening were evaluated. RESULTS: Phytochemical tests revealed the presence of different secondary metabolites. Alkaloid, flavonoid, tannin, saponin, phytosteroids, phenols and terpenoids. Moringa stenopetala (Baker f.) leaves aqueous extract (250 and 500mg/kg) improved the body weight of rats, showed remarkable reduction in blood glucose concentration (P<0.05), and significantly decreased serum urea, creatinine, ALT, AST and ALP (P < 0.05). Levels of serum cholesterol remained unaltered in the experimental groups when compared with diabetic control. Histopathology of non-treated rats showed deterioration of insulin producing pancreas cells; nevertheless, ß-cells restoration was observed due to administration of Moringa stenopetala (Baker f.) aqueous leaves extract. CONCLUSION: It is possible to conclude that oral administration of Moringa stenopetala (Baker f.) aqueous leaf extracts (250mg/kg and 500mg/kg) for 28 days showed beneficial effects on antihyperglycemia, improved body weight and Alloxan damaged pancreatic ß-cells, and restored biochemical changes.

Prevalence of Hyperhomocysteinaemia and Associated Factors among Ethiopian Adult Population in a 2015 National Survey.

Hyperhomocysteinaemia (HHcy) is an independent risk factor for major cardiovascular diseases, but data on the prevalence and predictors of HHcy in low- and middle-income countries like Ethiopia are scant. The aim of this study was to estimate the prevalence of HHcy and associated risk factors in the Ethiopian adult population. A cross-sectional survey on risks of noncommunicable diseases (NCDs) using the STEPwise approach to surveillance (STEPS) survey was conducted between April and June 2015. A total of 4,175 study participants were surveyed. Serum homocysteine (Hcy) and metabolic profile were determined using Cobas Integra 400 Plus and CardioChek PA analyzer, respectively. Factors associated with HHcy were determined using logistic regression. The mean serum tHcy concentration was 14.6 µmol/L, with 16.4 µmol/L in males and 13.4 µmol/L in females. Overall, 38% had HHcy, with figures in males (49%) higher than females (30%). Increased age, being male, and high blood pressure and/or taking blood pressure medication, as well as low consumption of fruit and/or vegetables, were independent risk factors for HHcy. In conclusion, the prevalence of HHcy among the adult Ethiopian population is alarmingly high. Improving diets through the promotion of fruit and vegetable consumption is needed to reduce the risk of NCDs.

The serum concentration of vitamin B12 as a biomarker of therapeutic response in tuberculosis patients with and without human immunodeficiency virus (HIV) infection.

BACKGROUND: Prior to clinical trials of new tuberculosis (TB) drugs or therapeutic vaccines, it is necessary to develop monitoring tools to predict treatment outcomes in TB patients. METHODS: Micronutrients concentration level was determined from a total of 262 study participants with five clinical groups: 57 TB patients coinfected with HIV (HIV+TB+), 87 active TB Patients (TB cases), 71 HIV infected without active and latent TB infection (HIV+TST-), 22 latent TB infection (TST+) and 25 healthy controls (TST-). Vitamin A concentration was measured using high-performance liquid chromatography (HPLC), whereas iron and vitamin B12 concentrations were measured using Cobas® 6000 analyzer. RESULT: The serum concentration levels of iron, vitamin A and vitamin B12 had a significant difference between active TB and latent (LTBI) or healthy controls. Six months after treatment, the serum concentration levels of vitamin A, vitamin B12 and iron in tuberculosis became indistinguishable from the levels of LTBIs and healthy control individuals. The concentration levels of iron and vitamin B12 in HIV+TB+patients at the end of TB treatment were normalized to the levels observed in healthy controls (TST-) regardless of HAART treatment. However, the concentration level of vitamin A in HIV+TB+patients HAART untreated at the end of TB treatment was not normalized to the levels observed in healthy controls (TST-) or HAART untreated HIV+TST-. CONCLUSION: Detecting serum concentration levels of vitamin B12 and vitamin A might be used as a biomarker of the diagnostic method of active TB regardless of HIV-infected individuals. Moreover, detecting serum concentration of vitamin B12 might also be used for TB treatment responses monitoring biomarker in TB-HIV-co-infected individuals regardless of HAART (in)eligibility and therapy.