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BACKGROUND: Natural infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or vaccination triggers antibody production against key viral antigens. However, there is limited evidence on the levels of antibodies produced in naturally infected individuals compared to those vaccinated in Ethiopia. Therefore, we aimed to detect and compare SARS-CoV-2 antibodies produced by naturally infected and vaccinated individuals. MATERIALS AND METHODS: We conducted a multicenter cross-sectional study among a total of 355 naturally infected and 355 vaccinated individuals from November 2022 to April 2023 at 10 selected health facilities in Addis Ababa, Ethiopia. We enrolled the participants consecutively upon their arrival at health facilities until the required sample size was achieved. We used a structured questionnaire to collect data on the demographic and clinical characteristics of the participants. We also collected 3-5 ml of blood samples from all participants and tested for anti-Spike (anti-S) and anti-nucleocapsid (anti-N) antibodies using Cobas 6000. We utilized frequency, mean, or median to describe the data, the Mann-Whitney U test to compare groups, and a generalized linear regression model to assess factors associated with anti-S antibody concentration. We analyzed the data with SPSS version 26, and the level of significance was set at P-value < 0.05. RESULTS: Of the naturally infected participants, 352 (99.5%) had anti-S antibodies and all (100%) had anti-N antibodies, whereas among vaccinated participants, all (100%) had anti-S antibodies, while 323 (91.6%) had anti-N antibodies. Anti-S antibodies produced by vaccinated individuals were significantly (P < 0.001) higher than those produced as a result of natural infection. Being young (P = 0.004), having hypertension (P < 0.001), and having diabetes (P < 0.001) were significantly associated with lower anti-S antibody levels, while being recently vaccinated and having a higher number of vaccine doses were significantly associated with higher anti-S antibody concentrations in vaccinated participants. Having diabetes (P < 0.001) were significantly associated with lower anti-S concentrations in participants who were naturally infected. CONCLUSION: There is a high seropositivity rate in both naturally infected and vaccinated individuals. However, vaccinated individuals had higher levels of SARS-CoV-2 antibodies than those who were naturally infected, which highlights the significant contribution of vaccination in increasing the protection of COVID-19 in Ethiopia.
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Anticorpos Antivirais , Vacinas contra COVID-19 , COVID-19 , SARS-CoV-2 , Humanos , Etiópia/epidemiologia , Estudos Transversais , COVID-19/imunologia , Anticorpos Antivirais/sangue , Masculino , Feminino , Adulto , SARS-CoV-2/imunologia , Pessoa de Meia-Idade , Adulto Jovem , Vacinas contra COVID-19/imunologia , Adolescente , Vacinação , Glicoproteína da Espícula de Coronavírus/imunologia , Idoso , CriançaRESUMO
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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Bilirrubina , Química Clínica , Etiópia , Humanos , Padrões de Referência , Reprodutibilidade dos TestesRESUMO
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: 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.
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Proteína C-Reativa , Esquizofrenia , Biomarcadores , Proteína C-Reativa/análise , Etiópia , Humanos , Inflamação , Interleucina-6RESUMO
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.
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Síndrome Metabólica , Esquizofrenia , Adulto , Estudos Transversais , Etiópia/epidemiologia , Feminino , Humanos , Masculino , Síndrome Metabólica/epidemiologia , Prevalência , Qualidade de Vida , Fatores de Risco , Esquizofrenia/epidemiologiaRESUMO
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.
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Eletrólitos/sangue , Taxa de Filtração Glomerular , Pessoal de Saúde , Insuficiência Renal Crônica/diagnóstico , Adolescente , Adulto , Fatores Etários , Idoso , Biomarcadores/sangue , Creatinina/sangue , Estudos Transversais , Etiópia/epidemiologia , Feminino , Humanos , Modelos Logísticos , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Prevalência , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/epidemiologia , Fatores de Risco , Fatores Socioeconômicos , Adulto JovemRESUMO
INTRODUCTION: Ethiopia has made significant progress in reducing malnutrition in the past two decades. Despite such improvements, a substantial segment of the country's population remains chronically undernourished and suffers from micronutrient deficiencies and from increasing diet-related non-communicable diseases such as diabetes, hypertension and cancer. This survey aims to assess anthropometric status, dietary intake and micronutrient status of Ethiopian children, women and adolescent girls. The study will also assess coverage of direct and indirect nutrition-related interventions and map agricultural soil nutrients. The survey will serve as a baseline for the recently developed Ethiopian Food System Transformation Plan and will inform the implementation of the National Food and Nutrition Strategy. METHODS AND ANALYSIS: As a population-based, cross-sectional survey, the study will collect data from the 10 regions and 2 city administrations of Ethiopia. The study population will be women of reproductive age, children aged 0-59 months, school-aged children and adolescent girls. A total of 16 596 households will be surveyed, allowing the generation of national and regional estimates. A two-stage stratified cluster sampling procedure will be used to select households. In the first stage, 639 enumeration areas (EAs) will be selected using probability-proportional-to-size allocation. In the second stage, 26 eligible households will be selected within each EA using systematic random selection. Primary outcomes include coverage of direct and indirect nutrition interventions, infant and young child feeding (IYCF) practices, food insecurity, dietary intakes, mental health, anthropometric status, micronutrient status and soil nutrient status. ETHICS AND DISSEMINATION: The protocol was fully reviewed and approved by the Institutional Review Board of the Ethiopian Public Health Institute (protocol no: EPHI-IRB-317-2020). The study is based on voluntary participation and written informed consent is required from study participants. The findings will be disseminated via forums and conferences and will be submitted for publication in peer-reviewed journals.
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Desnutrição , Estado Nutricional , Criança , Lactente , Adolescente , Humanos , Feminino , Recém-Nascido , Pré-Escolar , Etiópia/epidemiologia , Estudos Transversais , Desnutrição/epidemiologia , Desnutrição/prevenção & controle , Inquéritos Nutricionais , SoloRESUMO
Purpose: To evaluate the role of C-reactive protein (CRP) in predicting severe COVID-19 patients. Methods: A prospective observational cohort study was conducted from July 15 to October 28, 2020, at Kuyha COVID-19 isolation and treatment center hospital, Mekelle City, Northern Ethiopia. A total of 670 blood samples were collected serially. SARS-CoV-2 infection was confirmed by RT-PCR from nasopharyngeal swabs and CRP concentration was determined using Cobas Integra 400 Plus (Roche). Data were analyzed using STATA version 14. P-value <0.05 was considered statistically significant. Results: Overall, COVID-19 patients had significantly elevated CRP at baseline when compared to PCR-negative controls [median 11.1 (IQR: 2.0-127.8) mg/L vs 0.9 (IQR: 0.5-1.9) mg/L; p=0.0004)]. Those with severe COVID-19 clinical presentation had significantly higher median CRP levels compared to those with non-severe cases [166.1 (IQR: 48.6-332.5) mg/L vs 2.4 (IQR: 1.2-7.6) mg/L; p<0.00001)]. Moreover, COVID-19 patients exhibited higher median CRP levels at baseline [58 (IQR: 2.0-127.8) mg/L] that decreased significantly to 2.4 (IQR: 1.4-3.9) mg/L after 40 days after symptom onset (p<0.0001). Performance of CRP levels determined using ROC analysis distinguished severe from non-severe COVID-19 patients, with an AUC value of 0.83 (95% CI: 0.73-0.91; p=0.001; 77.4% sensitivity and 89.4% specificity). In multivariable analysis, CRP levels above 30 mg/L were significantly associated with an increased risk of developing severe COVID-19 for those who have higher ages and comorbidities (ARR 3.99, 95% CI: 1.35-11.82; p=0.013). Conclusion: CRP was found to be an independent determinant factor for severe COVID-19 patients. Therefore, CRP levels in COVID-19 patients in African settings may provide a simple, prompt, and inexpensive assessment of the severity status at baseline and monitoring of treatment outcomes.
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Objective Lipid abnormalities during childhood might be associated with a higher risk of atherosclerosis development in adulthood. In Ethiopia, there were no data on this area. The present work was aimed at assessing the lipid profile abnormalities among children and adolescents aged between 5 and 17 years, in Addis Ababa, Ethiopia. Materials and Methods The present school-based cross-sectional study was done from March 2019 to October 2019 in the capital city, Addis Ababa. A total of 504 students were randomly recruited for this study. The total cholesterol, triglyceride, low-density lipoprotein, and high-density lipoprotein-cholesterol levels were determined using the Cobas c501 automated chemistry analyzer. The prevalence of lipid abnormalities was described in percentages. Bivariate and multivariate analyses were performed, and data with p -value less than 0.05 was considered statistically significant. Results Dyslipidemia in at least one of the lipid profiles was observed in 322 (63.9%) school children, whereas only one of the participants had an abnormality in all four lipid profile tests. The prevalence of total cholesterol 200 mg/dL or higher, low-density lipoprotein 130 mg/dL or higher, high-density lipoprotein less than 40 mg/dL, and triglycerides 130 mg/dL or higher was in 14 (2.8%), 16 (3.2%), 294 (58.4%), and 46 (19.1%) participants, respectively. Conclusion In the current work, the majority of the study participants had a normal lipid profile except increased prevalence of a reduced concentration of high-density lipoprotein-cholesterol. The overall prevalence of serum lipid abnormalities was 63.9%. Serum lipid levels did not show significant differences with sex, age, fasting habits, or obesity.
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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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Background: Moringa stenopetala is used for medicinal and nutritional purposes. This study was, therefore, conducted to assess the contribution of Moringa stenopetala based diet in reducing under nutrition in under-five children in four districts of Southern Ethiopia. Method: A community-based comparative cross-sectional study design was employed from August to September 2016 in randomly selected comparative sites among 732 under five children. Anthropometric measurements of weight and height of children were measured based on the standard measurement protocol. Regarding moringa stenopetala diet, the consumption habit was collected by using a seven days food frequency questionnaire. Amount of moringa stenopetala leaf biomass portion size consumption was measured with local measurement and converted to kilograms. Anthropometric data were analyzed using WHO Anthro software to determine the nutritional status of the child. An independent t-test was conducted to compare the mean difference of WHO-Z score of child nutritional index. Statistical mean significance difference was measured based on p-value less than 0.05 with 95% confidence level. In addition chi-square test with a p-value, less than 0.05 with a 95% confidence level was used to compare the prevalence of stunting, wasting, and underweight in moringa stenopetala based diet and non-moringa stenopetala based diet consuming area. Result: The prevalence of stunting was 19% vs. 28.8%, wasting 4.7% vs. 9.6%, and underweight 12.19% vs 13.71% in moringa stenopetala based diet consuming and non-consuming participants respectively. There was a significant difference in stunting and wasting (p < 0.05) among moringa stenopetala based diet-consuming and non-consuming participants. Conclusion: The present study showed that moringa stenopetala based diet consumption had a significant contribution in reducing under-nutrition in under-five children.
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BACKGROUND: Serological testing for SARS-CoV-2 plays an important role for epidemiological studies, in aiding the diagnosis of COVID-19, and assess vaccine responses. Little is known on dynamics of SARS-CoV-2 serology in African settings. Here, we aimed to characterize the longitudinal antibody response profile to SARS-CoV-2 in Ethiopia. METHODS: In this prospective study, a total of 102 PCR-confirmed COVID-19 patients were enrolled. We obtained 802 plasma samples collected serially. SARS-CoV-2 antibodies were determined using four lateral flow immune-assays (LFIAs), and an electrochemiluminescent immunoassay. We determined longitudinal antibody response to SARS-CoV-2 as well as seroconversion dynamics. RESULTS: Serological positivity rate ranged between 12%-91%, depending on timing after symptom onset. There was no difference in positivity rate between severe and non-severe COVID-19 cases. The specificity ranged between 90%-97%. Agreement between different assays ranged between 84%-92%. The estimated positive predictive value (PPV) for IgM or IgG in a scenario with seroprevalence at 5% varies from 33% to 58%. Nonetheless, when the population seroprevalence increases to 25% and 50%, there is a corresponding increases in the estimated PPVs. The estimated negative-predictive value (NPV) in a low seroprevalence scenario (5%) is high (>99%). However, the estimated NPV in a high seroprevalence scenario (50%) for IgM or IgG is reduced significantly to 80% to 85%. Overall, 28/102 (27.5%) seroconverted by one or more assays tested, within a median time of 11 (IQR: 9-15) days post symptom onset. The median seroconversion time among symptomatic cases tended to be shorter when compared to asymptomatic patients [9 (IQR: 6-11) vs. 15 (IQR: 13-21) days; p = 0.002]. Overall, seroconversion reached 100% 5.5 weeks after the onset of symptoms. Notably, of the remaining 74 COVID-19 patients included in the cohort, 64 (62.8%) were positive for antibody at the time of enrollment, and 10 (9.8%) patients failed to mount a detectable antibody response by any of the assays tested during follow-up. CONCLUSIONS: Longitudinal assessment of antibody response in African COVID-19 patients revealed heterogeneous responses. This underscores the need for a comprehensive evaluation of seroassays before implementation. Factors associated with failure to seroconvert needs further research.
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Formação de Anticorpos , COVID-19/imunologia , SARS-CoV-2/imunologia , Adulto , Anticorpos Antivirais/imunologia , COVID-19/epidemiologia , Teste Sorológico para COVID-19/métodos , Etiópia/epidemiologia , Feminino , Humanos , Imunoensaio , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Estudos Prospectivos , Estudos SoroepidemiológicosRESUMO
BACKGROUND: Hyperuricemia is related not only to an increased risk of gouty arthritis but also to an increased risk of cardiovascular diseases, resistant hypertension, insulin resistance and progression of type 2 diabetes mellitus. However, to the best of our knowledge, the prevalence of hyperuricemia and its associated factors have rarely been assessed in Ethiopian populations. Therefore, this study aimed to determine the prevalence of hyperuricemia and its associated factors among adult staff members of the Ethiopian Public Health Institute. METHODS: An institution-based cross-sectional study was conducted from July 1 to October 28, 2018. A total of 402 study participants were selected using a simple random sampling technique. An interviewer-administered questionnaire was used to collect the data. A blood sample of approximately 5 mL was collected from each study participant after overnight fasting through standardized methods for biochemical tests, and analyses were carried out with an automated COBAS 6000 analyzer. Data analysis was performed by SPSS version 20 software. The factors associated with the outcome variable were identified by bivariable and multivariable logistic regression analyses, and a p value <0.05 was used to declare statistical significance. RESULTS: The mean age of the study participants was 37.13±10.5 (mean ± SD), and 51.5% of the participants were male. The overall prevalence of hyperuricemia (>5.7 mg/dL for females and >7 mg/dL for males) was found to be 31.0%. The multivariable logistic analysis revealed that age (AOR=1.59, 95% CI 1.01-2.78), sex (AOR=1.66, 95% CI 1.02-2.70), cigarette smoking (AOR=2.05, 95% CI 1.01-4.19) and serum low-density lipoprotein (LDL) (AOR=1.70, 95% CI 1.01-2.87) were significantly associated with hyperuricemia. CONCLUSION: The prevalence of hyperuricemia was relatively high compared to similar studies. Early screening for hyperuricemia in the general population, especially in those who are smokers, of older age and with high serum LDL levels, is vital to control its adverse effects at an early stage.
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Background and Objective Medical machine learning (ML) models tend to perform better on data from the same cohort than on new data, often due to overfitting, or co-variate shifts. For these reasons, external validation (EV) is a necessary practice in the evaluation of medical ML. However, there is still a gap in the literature on how to interpret EV results and hence assess the robustness of ML models. METHODS: We fill this gap by proposing a meta-validation method, to assess the soundness of EV procedures. In doing so, we complement the usual way to assess EV by considering both dataset cardinality, and the similarity of the EV dataset with respect to the training set. We then investigate how the notions of cardinality and similarity can be used to inform on the reliability of a validation procedure, by integrating them into two summative data visualizations. RESULTS: We illustrate our methodology by applying it to the validation of a state-of-the-art COVID-19 diagnostic model on 8 EV sets, collected across 3 different continents. The model performance was moderately impacted by data similarity (Pearson ρ = 0.38, p< 0.001). In the EV, the validated model reported good AUC (average: 0.84), acceptable calibration (average: 0.17) and utility (average: 0.50). The validation datasets were adequate in terms of dataset cardinality and similarity, thus suggesting the soundness of the results. We also provide a qualitative guideline to evaluate the reliability of validation procedures, and we discuss the importance of proper external validation in light of the obtained results. CONCLUSIONS: In this paper, we propose a novel, lean methodology to: 1) study how the similarity between training and validation sets impacts the generalizability of a ML model; 2) assess the soundness of EV evaluations along three complementary performance dimensions: discrimination, utility and calibration; 3) draw conclusions on the robustness of the model under validation. We applied this methodology to a state-of-the-art model for the diagnosis of COVID-19 from routine blood tests, and showed how to interpret the results in light of the presented framework.
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COVID-19 , Estudos de Coortes , Humanos , Aprendizado de Máquina , Reprodutibilidade dos Testes , SARS-CoV-2RESUMO
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.
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Síndrome Metabólica/epidemiologia , Síndrome Metabólica/etiologia , Adulto , Glicemia , Índice de Massa Corporal , Doenças Cardiovasculares/complicações , Diabetes Mellitus/fisiopatologia , Etiópia/epidemiologia , Exercício Físico/tendências , Feminino , Humanos , Hipertensão/fisiopatologia , Estilo de Vida/etnologia , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Obesidade Abdominal/complicações , Estresse Ocupacional/fisiopatologia , Prevalência , Saúde Pública , Administração em Saúde Pública , Fatores de Risco , Seguridade SocialRESUMO
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.
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População Negra , Proteína C-Reativa , Biomarcadores , Proteína C-Reativa/análise , Estudos Transversais , Feminino , Humanos , Masculino , Fatores de RiscoRESUMO
Mitochondria are organelles with highly dynamic ultrastructure maintained by flexible fusion and fission rates governed by Guanosine Triphosphatases (GTPases) dependent proteins. Balanced control of mitochondrial quality control is crucial for maintaining cellular energy and metabolic homeostasis; however, dysfunction of the dynamics of fusion and fission causes loss of integrity and functions with the accumulation of damaged mitochondria and mitochondrial deoxyribose nucleic acid (mtDNA) that can halt energy production and induce oxidative stress. Mitochondrial derived reactive oxygen species (ROS) can mediate redox signaling or, in excess, causing activation of inflammatory proteins and further exacerbate mitochondrial deterioration and oxidative stress. ROS have a deleterious effect on many cellular components, including lipids, proteins, both nuclear and mtDNA and cell membrane lipids producing the net result of the accumulation of damage associated molecular pattern (DAMPs) capable of activating pathogen recognition receptors (PRRs) on the surface and in the cytoplasm of immune cells. Chronic inflammation due to oxidative damage is thought to trigger numerous chronic diseases including cardiac, liver and kidney disorders, neurodegenerative diseases (Parkinson's disease and Alzheimer's disease), cardiovascular diseases/atherosclerosis, obesity, insulin resistance, and type 2 diabetes mellitus.
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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.
Assuntos
Hiper-Homocisteinemia/epidemiologia , Hipertensão/epidemiologia , Adolescente , Adulto , Fatores Etários , Idoso , População Negra , Estudos Transversais , Etiópia/epidemiologia , Feminino , Preferências Alimentares , Homocisteína/sangue , Humanos , Hiper-Homocisteinemia/sangue , Hipertensão/sangue , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Fatores SexuaisRESUMO
BACKGROUND: Drugs of abuse could interfere with the hypothalamic-pituitary-gonadal axis, causing impaired functions of the gland and associated functions of target organs. Drugs of abuse tend to cause changes in the endocrine system, and these changes could be physiological, molecular, biochemical, genetic, and cellular. METHOD: A case-control study design was conducted from a total of 171 male consented study participants (148 drug abusers and 23 controls). The serum gonadal and cortisol hormone levels were assayed using the electrochemiluminescence immunoassay method. Socio-demographic variables were collected using a semi-structured questionnaire by the interview method. Nonparametric statistical tools (Mann-Whitney test and median) were used to compare the groups. In all cases, P < 0.05 was considered statistically significant. RESULT: The median age for drug abusers and control groups was 27, and the age difference between drug abusers and control group was not statistically important. The median estradiol levels among chronic khat chewers (39.4 pg/ml), marijuana (44 pg/mL), and users of heroin (40.2 pg/mL) were significantly higher than control groups (23 pg/mL), P < 0.003. However, the median luteinizing hormone levels among chronic khat chewers (5 IU/L), marijuana users (5 IU/L), and heroin users (5.6 IU/L) were significantly lower than those of control groups (6.2 IU/L), P < 0.02. The median testosterone levels among chronic khat chewers (6.1 ng/mL), marijuana users (6.3 ng/mL), and heroin users (6.6 ng/mL) were significantly lower than control groups (8.0 ng/mL), P < 0.003. However, cortisol and follicle stimulating hormone did not show statistically significant difference between users of khat, marijuana, and heroin compared with the control group. CONCLUSION: The drug abuser group had significantly lower testosterone and luteinizing hormone levels compared with control groups. Drug abuse has been shown to affect gonadal hormones in an unusual physiological phenomenon. These findings reveal the need for intervention programs to solve these problems.
RESUMO
BACKGROUND: Serum indices (SI) including hemolyzed, lipemic, and icteric samples, affects the accuracy of test result. The aim of this study was to evaluate SI values done by visual inspections and potential false result risks by comparing with actual measurements done by Cobas 6000 Chemistry analyzer at Ethiopian Public Health Institute (EPHI), Addis Ababa, Ethiopia. METHODS: An observational, cross-sectional study was conducted from April to May 2017 on samples referred to Clinical Chemistry laboratory of EPHI, Ethiopia. These samples SI values, after visual inspection by three trained observers, was analyzed again on Roche Cobas 6000 analyzer (RCA). The generated data was analyzed by using weighted kappa methods on STAT statistical software version 20. RESULTS: From a total of 1509 samples, SI values identified by the RCA as hemolysis, icteric, and lipemic were 933 (62%), 74(5%) and 59(4%) respectively. The SI average weighted kappa between RCA and visual inspection were: 0.1870, 0.3421, and 0.1259 for hemolysis, icteric, and lipemic samples, respectively. Combined inter-observers variability among observers for hemolysis, Icterus, and lipemic samples were 0.4758, 0.3258, and 0.3628 respectively. The best agreement among observers was in the case of hemolysis (0 grades), while the lowest agreement was observed in the case of icterus (+3 grades). In addition, test parameters, such as CK-MB (22%), and LDH (20%) were falsely accepted, whereas Cl- and Na+ (up to 25%) were falsely rejected tests by observers. On the other hand, results rejected by Cobas SI assessments included CK-MB (22%), LDH (20%), and BIL-D (4%). CONCLUSION: Visual inspection of SI showed poorly agreement with automated system. Thus, there is genuine need for more training of Laboratory professionals on identification of SI, and as much as possible SI should be done by automated system to improve quality of test results.