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BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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Bilirubin , Chemistry, Clinical , Ethiopia , Humans , Reference Standards , Reproducibility of ResultsABSTRACT
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.
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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.
Subject(s)
Electrolytes/blood , Glomerular Filtration Rate , Health Personnel , Renal Insufficiency, Chronic/diagnosis , Adolescent , Adult , Age Factors , Aged , Biomarkers/blood , Creatinine/blood , Cross-Sectional Studies , Ethiopia/epidemiology , Female , Humans , Logistic Models , Male , Mass Screening , Middle Aged , Prevalence , Renal Insufficiency, Chronic/blood , Renal Insufficiency, Chronic/epidemiology , Risk Factors , Socioeconomic Factors , Young AdultABSTRACT
Introduction: Cardiovascular disease (CVD) is the foremost killer disease worldwide. ASCVD is one of the most common types of CVD. It is mainly associated with a condition called atherosclerosis. Its occurrence is linked to several risk factors. Hypertension, diabetes, dyslipidemia, smoking, genetic factors, and so on are examples. The presence of ASCVD, as well as its risk factors, causes a variety of disruptions in the body's physiological and biological functions. The presence of abnormal physiological and biological functions, for example, tends to disrupt hematological parameters. Purpose: The study's aim was to assess and compare the pattern of hematological parameters in people with established atherosclerotic cardiovascular disease (ASVD) versus people with ASCVD risks alone who attended TASH Addis Ababa, Ethiopia, as well as to correlate hematological parameters with the novel inflammatory marker hs-CRP. Methods: A prospective cross-sectional comparative study with 100 study participants was conducted during where October 2019-March 2020 proposal development, sample collection, and lab analysis period, and from March 2020-June to 2021 data entry, analysis, and writing period. A serum sample was collected from each study participant for the lipid and hsCRP analyses and whole blood for hematological parameter determination. The socio-demographic characteristics of the study participants were obtained through a well-structured questionnaire. Results: The ASCVD-risk group had significantly higher mean platelet volume (MPV), which was associated with the presence of the risk. Furthermore, hs-CRPs show a significant correlation with MPV in a correlation analysis of highly sensitive C-reactive protein (hs-CRP) with hematological parameters. Thus, using these affordable, routinely tested, and easily available tests may help to infer future ASCVD risk as well as the presence of ASCVD morbidity while hsCRP level in comparison group vs cases requires further study.
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Background: 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.
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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.
Subject(s)
Metabolic Syndrome/epidemiology , Metabolic Syndrome/etiology , Adult , Blood Glucose , Body Mass Index , Cardiovascular Diseases/complications , Diabetes Mellitus/physiopathology , Ethiopia/epidemiology , Exercise/trends , Female , Humans , Hypertension/physiopathology , Life Style/ethnology , Male , Middle Aged , Obesity/complications , Obesity, Abdominal/complications , Occupational Stress/physiopathology , Prevalence , Public Health , Public Health Administration , Risk Factors , Social WelfareABSTRACT
BACKGROUND: Although investigations on different pharmacological activities of the experimental plant, Ficus sur have been conducted, its folklore use for diuresis has not yet been validated. The current study, therefore, focused on the diuretic activity of aqueous and 80% methanol extracts of F. sur Forssk. leaves in rats. METHODS: Rats were randomly assigned into eight groups each consisting of six rats. Test groups received either 100 mg/kg, 200 mg/kg, or 400 mg/kg of aqueous or 80% methanol leaves extract. The negative control group and positive control were treated with 2 mL/100 g of distilled water and furosemide (10 mg/kg), respectively. Thereafter urine volume was recorded every hour until the end of the fifth hour, and cumulative urine volume of each rat was measured. Then, diuretic activity, diuretic index, saliuretic index, natriuretic index and carbonic anhydrase inhibition index in each group were calculated, and results were compared among the groups. RESULTS: The middle (200 mg/kg) and the highest (400 mg/kg) doses of both extracts significantly increased diuresis at the fifth hour (p<0.001) compared to the negative control, although the diuretic activity was less than that of the positive control. Regarding electrolyte excretion, all dose levels of both extracts showed significant natriuresis (p<0.001) and chloriuresis (p<0.01) compared to the negative control. Aqueous extract displayed more significant diuretic effect than 80% methanol extract. The aqueous and 80% methanol extracts produced alkaline urine. CONCLUSION: The crude leaves extracts of F. sur increased urinary excretion and concentration of urinary electrolytes in a dose-dependent manner. These findings are in agreement with the traditional claim for use of F. sur as diuretic agent.
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BACKGROUND: The proportion of patients with end-stage renal disease caused by diabetes has progressively increased during the last few decades. Serum creatinine level is the most commonly used biochemical parameter to estimate GFR in routine practice. However, 50% of GFR can be lost before significant elevation of serum creatinine. Cystatin C is found to be a new promising marker for early detection of renal diseases. OBJECTIVE OF THE STUDY: The aim of this study was to determine the value of serum cystatin C and serum creatinine levels for early detection of renal disease in patients with type 2 diabetes mellitus. METHODOLOGY: A hospital-based comparative cross-sectional study was conducted with a sample size of 120. For early detection of renal disease in patients with type 2 diabetes mellitus, serum creatinine and cystatin C levels were measured and compared. RESULT AND DISCUSSION: Serum creatinine and cystatin C levels were significantly increased in patients with type 2 diabetes mellitus compared to healthy controls. The mean±SD value of serum creatinine was found to be 0.87±0.44 mg/dL in patients and 0.63±0.27 mg/dL in control. Serum cystatin C level was also found to be significantly (P=0.0001) higher in patients (0.92±0.38 mg/L) compared to controls (0.52±0.20 mg/L). The mean±SD of eGFR in three equations (Creatinine Equation, Cystatin C Equation, and Creatinine-Cystatin C Equation) were 105.7±27.5 mL/min/m2, 90.4±28.2 mL/min/m2, and 100±29.5 mL/min/m2, respectively. CONCLUSION: Cystatin C-based GFR estimation equations detect renal impairment in patients with type 2 diabetes mellitus earlier than creatinine-based GFR estimation equations.