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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.

Demiraw Bikila,1 Tadesse Lejisa,1 Yosef Tolcha,1 Chala Bashea,1 Mehari Meles,1 Tigist Getahun,1 Genet Ashebir,1 Wossene Habtu,1 Feyissa Challa,1 Ousman Mohammed,2 Melkitu Kassaw,3 Adisu Kebede,4 Letebrhan G/Egzeabher,5 Endalkachew Befekadu,6 Mistire Wolde,7 Aster Tsegaye7 1Department of National Clinical Chemistry Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia; 2Department of Medical Laboratory Sciences, Wollo University, Dessie, Ethiopia; 3Food Science and Nutrition Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia; 4National Capacity Building Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia; 5Department of Medical Laboratory, Yekatit 12 General Hospital, Addis Ababa, Ethiopia; 6Department of Medical Laboratory, Saint Amanuel Mental Specialized Hospital, Addis Ababa, Ethiopia; 7Department of Medical Laboratory Sciences, College of Health Science, Addis Ababa University, Addis Ababa, EthiopiaCorrespondence: Demiraw Bikila, Department of National Clinical Chemistry Reference Laboratory, Ethiopian Public Health Institute, Addis Ababa, Ethiopia, Email demiraw1234@gmail.comBackground: Even though several factors affect reference intervals (RIs), company-derived values are currently in use in many laboratories worldwide. However, few or no data are available regarding serum proteins RIs, especially in resource-limited countries such as Ethiopia.Objective: To establish RIs for serum protein electrophoresis of apparently healthy adults in Addis Ababa, Ethiopia.Methods: A cross-sectional study was conducted on a total of 297 apparently healthy adults from April to October 2019 in four selected sub-cities (Akaki, Kirkos, Arada, and Yeka) of Addis Ababa, Ethiopia. Laboratory analysis of collected samples was performed using the Capillarys 2 Flex Piercing analyzer, while statistical analysis was conducted using SPSS version 23 and Med-Calc software. The Mann–Whitney test was used to check partitions. A non-parametric method of reference range establishment was performed as per CLSI guideline EP28A3C.Results: The established RIs were: albumin 53.83– 64.59%, 52.24– 63.55%; alpha-1 globulin 3.04– 5.40%, 3.44– 5.60%; alpha-2 globulin 8.0– 12.67%, 8.44– 12.87%; and beta-1 globulin 5.01– 7.38%, 5.14– 7.86%. Moreover, the albumin to globulin ratios were 1.16– 1.8 and 1.09– 1.74 for males and females, respectively. The combined RIs for beta-2 globulin and gamma globulin were 2.54– 4.90% and 12.40– 21.66%, respectively.Conclusion: The established reference interval for serum protein fractions revealed gender-specific differences, except for beta-2 globulin and gamma globulin.Keywords: serum protein electrophoresis, reference interval, Addis Ababa, Ethiopia

Objective:The present study aimed to estimate the consumption of Na and K and to assess salt-related knowledge, attitude and behaviour among adults in Addis Ababa, Ethiopia.Design:A community-based cross-sectional study was conducted. Estimates of Na and K intake were made using repeated multiple-pass 24-h dietary recall as well as using random urine. The usual intake of Na and K from the 24-h dietary recall was determined using the National Cancer Institute methodology. Estimated 24-h Na and K excretion was calculated using International Cooperative Study on Salt, Other Factors, and Blood Pressure and Tanaka formula.Settings:Addis Ababa, the capital city of Ethiopia.Participants:Individuals aged 20 years and above residing in the city.Result:The mean Na and K intake estimated using the diet recall data was 3·0 (0·9) g/d and 1·9 (0·6) g/d, respectively. Based on the urine analysis, the estimated mean Na and K intakes were 3·3 (0·7) g/d and 1·9 (0·4) g/d, respectively. Moreover, the analysis showed that the mean Na:K ratio was 2·5 (1·4). The daily intake of K was below the recommended amount for all study participants. More than 98 % and 90 % of participants had an excess intake of Na and Na:K ratio, respectively.Conclusion:We found a high prevalence of inadequate K intake as well as excess intake of Na resulting in an increased prevalence of excess Na:K ratio. Thus, interventions targeting to decrease Na intake and to increase K intake are needed.

Comparison of assay results is very important for having a comparable backup analyzer to provide a quality laboratory service without interruption. Even though, several factors affect assay results by different instruments, little or no data is available regarding assay results comparison between Cobas 6000 (c501) and Cobas integra 400 plus in the study area. Thus, the present study was aimed to compare assay results of two fully auto-mated clinical chemistry analyzers: Cobas 6000 (c501) and Cobas Integra 400 Plus at the National Clinical Chemistry Reference Laboratory of Ethiopian Public Health Institute, Addis Ababa, Ethiopia.The assay results for the 20 selected clinical chemistry parameters were obtained from 52 randomly selected samples on Cobas 6000 (c501) and Cobas integra 400 plus. Statistical analysis was done using Med-Calc software. The 2019 CLIA proposed acceptance limits for proficiency testing were used to check bias or difference obtained from correlation and regression analysis.Assay results comparison revealed almost perfect data correlations among all selected clinical chemistry parameters: Albumin, ALP, ALT, Alpha-amylase (AMYL), AST, Direct bilirubin, Total bilirubin, Total cholesterol, Creatine kinase, Creatine kinase MB-subunit, Creatinine, GGT, Glucose, HDLC4, LDH, Phosphate, Total Protein, Triglycerides, Uric acid, and Urea, on both analyzers with coefficient of determination (R2) ranging from 98.9% to 99.99% and coefficient of correlation (r) ranging from 99.4% to 100%, depicting the precision and reliability of assay results, standardization, and system equivalency. Moreover, the calculated bias/difference is lower than both CLIA total allowable error and CLIA allowable error.In summary, regression/correlation analysis and calculated bias or difference revealed almost equivalent data representation of both analyzers as per the CLIA standard, thus showing that both fully automated analyzers are standardized and properly calibrated to be used simultaneously and inter-changeably as the main and back up analyzers for selected clinical chemistry parameters analyzed at the clinical chemistry reference laboratory.

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 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 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 2). 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.