Establishment of Reference Intervals for Serum Protein Electrophoresis of Apparently Healthy Adults in Addis Ababa, Ethiopia.

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.

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.

Comparison of Selected Clinical Chemistry Assay Results by two Analyzers: Cobas 6000 (c501) and Cobas Integra 400 Plus.

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.

Phenotypic characterization of carbapenem non-susceptible gram-negative bacilli isolated from clinical specimens.

BACKGROUND: Multidrug resistant, extremely drug-resistant, pan-drug resistant, carbapenem-resistant, and carbapenemase-producing gram-negative bacteria are becoming more common in health care settings and are posing a growing threat to public health. OBJECTIVE: The study was aimed to detect and phenotypically characterize carbapenem no- susceptible gram-negative bacilli at the Ethiopian Public Health Institute. MATERIALS AND METHODS: A prospective cross-sectional study was conducted from June 30, 2019, to May 30, 2020, at the national reference laboratory of the Ethiopian Public Health Institute. Clinical samples were collected, inoculated, and incubated for each sample in accordance with standard protocol. Antimicrobial susceptibility testing was conducted using Kirby-Bauer disk diffusion method. Identification was done using the traditional biochemical method. Multidrug-resistant and extensively drug-resistant isolates were classified using a standardized definition established by the European Centre for Disease Prevention and Control and the United States Centers for Disease Prevention and Control. Gram-negative organisms with reduced susceptibility to carbapenem antibiotics were considered candidate carbapenemase producers and subjected to modified carbapenem inactivation and simplified carbapenem inactivation methods. Meropenem with EDTA was used to differentiate metallo-ß-lactamase (MBL) from serine carbapenemase. Meropenem (MRP)/meropenem + phenylboronic acid (MBO) were used to differentiate Klebsiella pneumoniae carbapenemase (KPC) from other serine carbapenemase producing gram-negative organisms. RESULTS: A total of 1,337 clinical specimens were analyzed, of which 429 gram-negative bacterial isolates were recovered. Out of 429 isolates, 319, 74, and 36 were Enterobacterales, Acinetobacter species, and Pseudomonas aeruginosa respectively. In our study, the prevalence of multidrug-resistant, extensively drug-resistant, carbapenemase-producing, and carbapenem nonsusceptible gram-negative bacilli were 45.2%, 7.7%, 5.4%, and 15.4% respectively. Out of 429 isolates, 66 demonstrated reduced susceptibility to the antibiotics meropenem and imipenem. These isolates were tested for carbapenemase production of which 34.8% (23/66) were carbapenemase producers. Out of 23 carbapenemase positive gram-negative bacteria, ten (10) and thirteen (13) were metallo-beta-lactamase and serine carbapenemase respectively. Three of 13 serine carbapenemase positive organisms were Klebsiella pneumoniae carbapenemase. CONCLUSION: This study revealed an alarming level of antimicrobial resistance (AMR), with a high prevalence of multidrug-resistant (MDR) and extremely drug-resistant, carbapenemase-producing gram-negative bacteria, particularly among intensive care unit patients at the health facility level. These findings point to a scenario in which clinical management of infected patients becomes increasingly difficult and necessitates the use of "last-resort" antimicrobials likely exacerbating the magnitude of the global AMR crisis. This mandates robust AMR monitoring and an infection prevention and control program.

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.

Iron deficiency anemia among children aged 2-5 years in southern Ethiopia: a community-based cross-sectional study.

BACKGROUND: Iron-deficiency anemia (IDA) is a common type of nutritional anemia in low-income countries, including Ethiopia. However, there is limited data on iron deficiency anemia prevalence and associated factors in Ethiopia, particularly for children aged 2 to 5 years. OBJECTIVES: To establish the prevalence of iron deficiency anemia and associated risk factors, focusing on iron-rich food consumption among children aged 2 to 5 years in southern Ethiopia. METHODS: A community-based cross-sectional study was conducted in southern Ethiopia in 2017, involving 331 randomly selected children aged 2 to 5 years old. A structured questionnaire was used to collect information about the children and the households. Venous blood was collected from each child in a test tube to measure hemoglobin, ferritin, and C-reactive protein (CRP). Hemoglobin levels were determined using Hemocue®301 and adjusted for altitude. Anemia was defined as hemoglobin levels <11 g/dl. Ferritin was adjusted for inflammation based on CRP concentration and low ferritin concentration defined as adjusted ferritin concentration <12 µg/L. IDA was considered when a child had both hemoglobin level <11g/dl and low ferritin concentration. Bi-variable and multivariable logistic regression models were performed to identify factors associated with IDA and iron-rich food consumption. RESULTS: The prevalence of iron deficiency anemia was 25%, and the total anemia prevalence was 32%. Only 15% of children consumed iron-rich foods in the preceding 24 h, and 30% of children consumed iron-rich foods at least once in the preceding week. IDA decreased as the height for age z-score increased (Adjusted Odds Ratio 0.7; 95% CI [0.5-0.9]). Mothers with increased educational level (AOR 1.1; 1.0-1.2) and households with increased dietary diversity (AOR 1.4; 1.2-1.6) consumed more iron-rich foods. CONCLUSIONS: Iron deficiency anaemia was a moderate public health problem in southern Ethiopia, and the iron-rich food consumption was low. Interventions should focus on food supplementation and fortification, food diversification and nutritional education, and promoting women's education.

Early Detection of Renal Impairment Among Patients with Type 2 Diabetes Mellitus Through Evaluation of Serum Cystatin C in Comparison with Serum Creatinine Levels: A Cross-Sectional Study.

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.

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.

Is hypothyroidism rare in multidrug resistance tuberculosis patients on treatment? A systematic review and meta-analysis.

BACKGROUND: Hypothyroidism is one of the adverse drug reactions that associated with Multidrug Resistant Tuberculosis (MDR-TB) medications. Extremely variable magnitude of hypothyroidism in MDR-TB patients has been reported from different parts of the world. However, there is no evidence that tried to estimate the pooled prevalence of hypothyroidism to confirm the rareness of hypothyroidism in MDR-TB patients on treatment. Therefore, we did a systematic review and meta-analysis to estimate the prevalence of hypothyroidism in MDR-TB patients on treatment, and to summarize the demographic and clinical characteristics of the patients. METHODS: We conducted a systematic review and meta-analysis on studies reported around the world on the prevalence of hypothyroidism in MDR-TB patients on treatment. We searched electronic databases: PubMed/Medline, EMBASE, CINAHL, Science Direct, Academic Search Complete and Google scholar for English language articles without limiting publication year. We also reviewed the bibliographies of relevant studies and conducted an electronic search for relevant conference abstracts. Eligible studies were cross-sectional and cohort studies that included at least five participants. We used a random-effects model to estimate the pooled prevalence of hypothyroidism. The registration number of this review study protocol is CRD42018109237. RESULTS: We included 30 studies and pooled data on a total of 6,241 MDR-TB patients. The crude prevalence of hypothyroidism was extremely heterogeneous. The pooled prevalence of hypothyroidism in MDR-TB patients on treatment was 17.0% (95% CI: 13.0-20.0). Ethionamide and para-aminosalicylic acid (PAS) were the most frequently reported drugs that associated with the occurrence of hypothyroidism. CONCLUSION: This review revealed that hypothyroidism is not a rare adverse drug reaction in MDR-TB patients on treatment. Ethionamide and PAS were the most frequently reported drugs that associated with the occurrence of hypothyroidism. Screening of hypothyroidism in MDR-TB patients on treatment is important while targeting patients on Ethionamide and PAS based treatment regimen.