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Background As the Human Immunodeficiency Virus (HIV) rapid testing services expanded to reach the global target that 95% of people living with the virus will know their status by 2030, ensuring the quality of those services becomes critical. This study was conducted to assess the performance of HIV Rapid testing at sites in health facilities that were enrolled in the Rapid Test Quality Improvement Initiative (RTQII) in Ethiopia. Methods Characterized HIV proficiency testing (PT) panels of Dried Tube Specimen (DTS) were prepared, verified, and distributed to testing sites from August to December 2019. In addition on-site evaluation of HIV testing sites (HTSs) was conducted using a checklist to assess testing conditions. For proficiency testing, the study included 159 HIV testing sites (HTSs) in 41 Health facilities (HFs) in five administrative regions and two city administrations. The collected data was analyzed by SPSS version 20 and chi-square test was applied to identify the association between acceptable performance and contributing factors. Testing sites with 100% PT score as well as conducting the test with adherence to the National HIV Testing Algorithm were considered acceptable. Results The overall acceptable performance (100% PT score with the correct algorithm followed) was found to be 62% while 12% scored 80% and 11% scored between 20 and 60%. The rest 15% were not considered as acceptable due to failure to adhere to the National HIV Testing Algorithm. Testing sites that participated in External Quality Assessment/Proficiency Testing schemes have shown better performance than those that did not participate with 70% and 56% performance respectively (p = 0.057).

Background. Prolonged laboratory diagnostic process of tuberculosis can lead to failure to complete the diagnosis and increase dropout rate of smear positive pulmonary tuberculosis (PTB) cases. This implies such dropout patients without completing diagnosis are critical as infected individuals remain untreated in the community, providing more opportunities for transmission of the disease and adversely affecting the epidemic. The aim of this research is to determine the level of smear positive PTB diagnosis dropout rate of spot-morning-spot sputum microscopy diagnosis method in public health facilities, in Addis Ababa, Ethiopia. Methods. Retrospective review of patient documents in 13 public health facilities’ TB laboratory in Addis Ababa was conducted from October 2011 to March 2016. Data was computerized using Epi-info software and analysed using SPSS version 20.0 software. Descriptive numerical summaries were used to present the findings. Association between the dropout rate and demographic variables was assessed by Chi-square (X2). Bivariate model using Odds Ratio (OR) with a 95% Confidence Interval (CI) was calculated. P-Value less than 0.05 was taken as statistically significant. Results. Of 41,884 presumptive TB patients registered during the 53 months for laboratory investigation, 5.9% were positive for the first spot sputum smear microscopy. Among these positive cases, 142 (5.8%) and 298 (12.1%) did not come back to the laboratory to submitted early morning and second spot sputum specimens, respectively. The diagnostic dropout for morning sputum specimen in hospitals was 5.6% (58/1039) and in health centres was 5.9% (84/1424). However, higher proportion of dropout for second spot sputum specimen in hospitals was 16.4% (170/1039), compared to the health centres, 8.9% (128/1424). Diagnostic dropout of sputum smear microscopy had no significant association with sociodemographic variable (P value >0.05), while it had significant association with facility type (P value Conclusion. In this study smear positive pulmonary tuberculosis diagnostic dropout rate was high compared to WHO reported for the new strategy shift implying the importance of shifting to same-day approach. Hence, shifting from conventional to same day is crucial to minimize the TB diagnostic dropout rate in the study area and other similar settings. Further research is needed/recommended in the local setting to compare the yield and dropout rates between same-day and conventional sputum smear microscopy approach.

Background Knowing customers’ level of satisfaction is relevant to improve and provide quality health care services. In the clinical laboratory, monitoring customers’ satisfaction is an important indicator of the quality management system and required by international laboratory standards. However, in Ethiopia, there has not been baseline data about the satisfaction level of patients’ with laboratory services at the national level. The aim of this national level survey was to assess patients’ satisfaction level with laboratory services at public hospitals in Ethiopia. Methods A national survey was conducted using an institutional based cross-sectional study design was employed from 01 to 30 November 2017. A total of 2399 patients were selected randomly from 60 public hospitals. Data was collected using structured questionnaire, entered in Epi Info and analyzed with SPSS software. Multiple logistic regression model was fitted to identify predictors of patients’ satisfaction with laboratory services. A p-value of less than 0.05 was taken as statistically significant. Result Overall, 78.6% of the patients were satisfied with the clinical laboratory services. Patients were dissatisfied with cleanness of latrine (47%), long waiting time (30%), clear and understandable advisory service during specimen collection (26%), adequacy of waiting area (25%), easy accessibility of laboratory (19%) and latrine location (20%), availability of requested service (18%), unfair payment of service (17%) and missing of result (12%). The educational status (P = 0.032), and distance (P = 0.000) were significantly associated with client overall satisfaction level. Conclusion Most laboratory patients’ were satisfied with the service provided by public hospital laboratories in public hospitals in Ethiopia. However, patients’ were dissatisfied with the accessibility of sites, adequacy of waiting area, cleanness of latrine, long TAT, communication, missing of results, availability of requested service and cost of service. Therefore, responsible bodies in each level should act on the identified gaps and improve the need of patients in each hospital laboratory. In addition, all hospital laboratories should conduct a satisfaction survey and meet the needs of laboratory patients.

Background: Worldwide Tuberculosis (TB) is the ninth leading cause of death from a single infectious agent, positioning on top of Human Immuno Deficiency Virus (HIV) and it is still an eminently serious public health problem. In developing countries, Ziehl-Neelsen (ZN)-stained sputum smear microscopy is the most widely used diagnostic method in diagnosing Pulmonary Tuberculosis (PTB). This study was aimed to compare the diagnostic performances of ZN-method with Xpert MTB/RIF assay for the diagnosis of PTB in Addis Ababa, Ethiopia. Methods: Facility-based cross-sectional study design was conducted from September 2016 to June 2017 on a total of 244 sputum samples collected from presumptive TB patients. The L-J sputum culture was used as a gold standard to compare the diagnostic performances of Xpert MTB/RIF assay and ZN-methods. Kappa values were analyzed by using statistical package for Social Science (SPSS) version 20 software at 95% Confidence Interval (CI). The Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of ZN-stained sputum smear microscopy and Xpert MTB/RIF assay were calculated against the gold standard. Results: The Sensitivity, Specificity, PPV and NPV of ZN-stained sputum smear microscopy were 68.38%, 95.28%, 93.02% and 76.58% respectively, while for Xpert MTB/ RIF assay were 88.89%, 81.89%, 81.89% and 88.89% respectively. The results of the two diagnostic approaches were concordant with the gold standard with a kappa value of ZN 0.650 and 0.743 for Xpert MTB/RIF assay. Conclusion: This study concludes that the sensitivity of Xpert MTB/RIF assay was better than ZN-stained direct sputum smear microscopy for the diagnosis of pulmonary tuberculosis.

Introduction Physician is a central figure in the client list of clinical laboratory. Monitoring physicians’ satisfaction with laboratory service is an important indicator of the quality management system and required by international laboratory standards. However, there is no national data on physician satisfaction with laboratory services in Ethiopia. Therefore, the aim of this national survey was to assess satisfaction level of physicians with laboratory services at public hospitals in Ethiopia. Methods Institutional based cross-sectional study design was employed from November 1-30/2017. A total of 327 physicians were randomly selected from 60 public hospitals from all regions of Ethiopia. Data was collected using pre-tested self-administered questionnaire and analyzed with SPSS version 23 software. Logistic regression model was fitted to identify predictors of physician satisfaction with laboratory services. A p-value of less than 0.05 was taken as statistically significant. Results Overall, 55% of physicians were satisfied with the clinical laboratory services. More than half of the physicians were satisfied with the existing laboratory request form (69%), legibility and completeness of laboratory report (61%), notification of new test (78%) and test interruption (70%). On the other hand, many physicians were dissatisfied with the absence of laboratory hand book (87.5%), the existing test menu (68%), lab-physician interface (62%), availability of referral and/or back up service (62%), notification of Turn Around Time (TAT) (54%), timely notification of panic result (55%), long TAT (33.1%), provision of urgent service (67%), and timely advisory service (57%). Most of the physicians perceived that consistent quality of service was not delivered at all working shifts (71%). At 5% level of significance, we did not find enough evidence to conclude that sex, age, marital status, education level, and experience were statistically associated with physician satisfaction (p-values > 0.05). Conclusion This national survey revealed nearly half of the physicians were unsatisfied with laboratory service at public hospitals in Ethiopia, which mainly related to lack of adequate test menu, laboratory hand book, on time notification of panic result, provision of urgent service, timely advisory service, delivery of quality services in all working shifts and weak lab-physician interface. Therefore, hospital management should address the gaps and improve the needs of physicians for better patient health care. In addition, laboratories should evaluate and monitor physician satisfaction level at regular interval.

Background Improving the quality of medical laboratory services is a high priority in many countries. However, quality management systems for laboratories in resource-limited settings are often inadequate. Objectives This article shares the experiences, benefits and challenges of the laboratory journey towards accreditation in a primary healthcare laboratory in Addis Ababa, Ethiopia. Methods A retrospective review of laboratory records in Addis Ketema Health Center was conducted from 2012 to 2015. The study was supplemented by observations from some of the authors of this article who worked in the laboratory. Results The laboratory journey towards accreditation began with a baseline assessment in 2012 using the World Health Organization African Region Stepwise Laboratory Quality Improvement Process Towards Accreditation; the baseline score was 78 points (0 stars). After mentorship support, the laboratory improved to 198 points (3 stars) in 2013 and 249 points (5 stars) in 2014. The laboratory scaled up to International Organization for Standardization 15189 requirements and received limited-scope accreditation for tuberculosis sputum microscopy and hematology tests in 2015. After adopting and implementing the standards, steady improvement was observed in the reliability of the laboratory services. Lack of resources was the major challenge the laboratory encountered. Conclusion Even though a remarkable quality performance improvement was observed over the entire process, inadequate skilled personnel was the major challenge identified in the road towards accreditation. Therefore, an appropriate, workload-based staffing structure should be developed to improve and sustain medical laboratory quality standards in resource-limited settings.

Background Coronavirus disease (COVID-19) is a highly transmittable virus that continues to disrupt livelihoods, particularly those of low-income segments of society, around the world. In Ethiopia, more specifically in the capital city of Addis Ababa, a sudden increase in the number of confirmed positive cases in high-risk groups of the community has been observed over the last few weeks of the first case. Therefore, this study aims to assess knowledge, practice and associated factors that can contribute to the prevention of COVID-19 among high-risk groups in Addis Ababa. Methods A cross-sectional in person survey (n = 6007) was conducted from 14–30 April, 2020 following a prioritization within high-risk groups in Addis Ababa. The study area targeted bus stations, public transport drivers, air transport infrastructure, health facilities, public and private pharmacies, hotels, government-owned and private banks, telecom centers, trade centers, orphanages, elderly centers, prison, prisons and selected slum areas where the people live in a crowded areas. A questionnaire comprised of four sections (demographics, knowledge, practice and reported symptoms) was used for data collection. The outcomes (knowledge on the transmission and prevention of COVID-19 and practice) were measured using four items. A multi variable logistic regression was applied with adjustment for potential confounding. Results About half (48%, 95% CI: 46–49) of the study participants had poor knowledge on the transmission mode of COVID-19 whereas six out of ten (60%, 95% CI: 58–61) had good knowledge on prevention methods for COVID-19. The practice of preventive measures towards COVID-19 was found to be low (49%, 95% CI: 48–50). Factors that influence knowledge on COVID-19 transmission mechanisms were female gender, older age, occupation (health care and grocery worker), lower income and the use of the 8335 free call centre. Older age, occupation (being a health worker), middle income, experience of respiratory illness and religion were significantly associated with being knowledgeable about the prevention methods for COVID-19. The study found that occupation, religion, income, knowledge on the transmission and prevention of COVID-19 were associated with the practice of precautionary measures towards COVID-19. Conclusion The study highlighted that there was moderate knowledge about transmission modes and prevention mechanisms. Similarly, there was moderate practice of measures that contribute towards the prevention of COVID-19 among these priority and high-risk communities of Addis Ababa. There is an urgent need to fill the knowledge gap in terms of transmission mode and prevention methods of COVID-19 to improve prevention practices and control the spread of COVID-19. Use of female public figures and religious leaders could support the effort towards the increase in awareness.

Objective Sputum smear microscopy reading errors are likely to result in failure to detect persons with infectious TB. This study was intended to review misdiagnosis of pulmonary TB and associated factors in peripheral laboratories. Results During the study period 1033 (10.5%) sputum smear positive and 8783 (89.5%) smear negative slides were reported by peripheral laboratories. The slides were re-read by the central referral laboratories (CRLs) as the reference standard reading. Of 1033 positive slides reported by peripheral laboratories, 25 (2.4%) were false positive. Out of 8783 smear negative slides reported by peripheral laboratories, 35 (0.4%) were false negative. The sensitivity, specificity, positive predictive value and negative predictive value of peripheral laboratories were 96.64, 99.72, 97.58, and 99.61% respectively. The peripheral laboratories and CRLs have an observed agreement (Po) of 0.9939. Of 135 peripheral laboratories, 93 (68.9%) read negative and positive slides correctly, 49 (36.3%) did not have lens cleaning tissue papers, 11 (8.1%) lacked frosted slides, and 14 (10.4%) had shortage of reagents. As conclusions, the peripheral laboratories and CRLs had high agreement for sputum smear microscopy reading. However, a few TB cases were misdiagnosed despite having the disease; these individuals might continue to spread the infection in the community.

Background: Tuberculosis remains a global health problem despite availability of effective tools. Globally, there were 40% of the 10+ million patients with TB did not get diagnosed or notified. The study was aimed to compare the diagnostic performances of iLED-FM and GeneXpert test for the diagnosis of PTB in Addis Ababa, Ethiopia. Methods: Facility-based cross-sectional study was conducted on a total of 286 sputum samples collected from health centers and hospitals clients with presumptive TB from December 2016 to March 2017. Kappa value, Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of iLED-FM and GeneXpert were calculated against the gold standard. Results: The sensitivity, specificity, PPV and NPV of iLED-FM was 80.15%, 95.48%, 93.75% and 85.06%, for GeneXpert 88.55%, 92.90%, 91.34% and 90.57%, respectively. Kappa value of iLED-FM was 0.765 and 0.817 for GeneXpert. Out of 55 HIV positive presumptive TB patients enrolled in the study, 19 (34.55%) were sputum smear positive by iLED-FM. However, 24 (43.64%) TB cases were detected by GeneXpert. Conclusion: The sensitivity of Xpert MTB/RIF assay was better than iLED-FM in the diagnosis of PTB. It should be implemented as primary diagnostic test in areas where overlapping synergy of TB and HIV/AIDS is high.

Background. Early detection and treatment of Helicobacter pylori (H. pylori) infection in women of child bearing ages may reduce the risk of maternal health disorder. This study was conducted to determine the burden of H. pylori infections and associated risk factors among women of child bearing ages in Kolfe Keranio Subcity Woreda 9 Health Centers, Addis Ababa, Ethiopia. Methods. Facility based cross sectional study design was conducted from April to October 2015. The study recruited 195 pregnant and 137 nonpregnant women with age range of 16-40 years. Sociodemographic data of study participants were collected by structured questionnaire. Venous blood was analyzed to determine hemoglobin, H. pylori stool antigen test kit was used to assess H. pylori infection, and fresh fecal (stool) was used to examine intestinal parasites among study subjects. Data was entered and analyzed using SPSS version 19. Bivariate and multivariate logistic regression model using odds ratio (OR) at 95% confidence interval (CI) were calculated. P-value less than 0.05 was taken as statistically significant. Results. The overall burden of H. pylori infection among study participants was 29% (96/332). H. pylori infection was statistically significantly associated with pregnancy status (AOR: 1.825, CI (1.42-2.15), P=0.020), history of hyperemesis gravidarum (AOR=7.028, C.I (2.47-19.99), P=0.018), and low hemoglobin value (AOR=0.177, CI (0.083–0.379), p=0.003). There was no statistically significant association between H. pylori infection and sociodemographic characteristics and some expected risk factors like smoking, Khat chewing, alcohol drinking habit, and presence of intestinal parasites. Conclusion. In this study, H. pylori infection was still a public health problem in the study area. H. pylori infected women also had high rate of anemia compared to women who had not H. pylori infected. Hence clinician and other responsible bodies should give a special attention for women who had been infected with H. pylori. Further large case control studies are warranted to understand more the role of H. pylori, HG, and other associated risk factors.

Introduction: Number of samples and time of sputum collection has a great impact on the positivity yield of sputum smear microscopy examination. However, the impact is not yet extensively studied in Ethiopia. Therefore, the aim of this study was to assess the serials sputum sample collection impacts on the diagnostic yield of smear microscopy examination in Ethiopia at variation at different institutional settings. Methods: Institution based retrospective cohort study was conducted from October 2011 to March 2016. Two thousand four hundred sixty-three sputum smear microscopy positive result were reviewed from TB patient records. The collected data were computerized using Epi-info software and analyzed using SPSS version 20 software. Numerical summaries were used to describe the positivity yield of spot, morning and spot (SMS) sputum smear microscopy examination. Results: Of 2463 sputum smear-positive TB cases, 2384 (96.8%), 2458 (99.8%) and 2394 (97.2%) were detected by the first spot, morning and second spot sputum smear microscopy diagnosis, respectively. On the other hand, morning sputum smear results had the incremental yield of 74 (3.0%) and 64 (2.6%) from first spot sample and second spot sample, respectively. The results of 1892 (76.8%) TB cases were in agreement (detected) by three consecutive sputum specimen (SMS). Conclusion: The three consecutive sputum smear microscopy examination had 3% incremental yield compare to spot-spot (SS). The hospitals were participating in International External Quality Assurance Schemes (IEQAS) had better incremental (increased) yield in both SMS and SS approach compared to the health centers. Hence, strong TB quality assurances systems should be implemented in respective health facilities before practicing two spots (SS) sputum smear microscopy diagnostic approach as routine to TB laboratory diagnostic method.

Background: Despite availability of antiretroviral therapy, HIV is responsible for 2.7 million new infections and 2.0 million deaths from worldwide. Anti-Retroviral treatment failure is not a commonly diagnosis in healthcare facilities in Ethiopia and there is dearth of information on the extent and predictors of treatment failure among adults receiving HIV care in the study setting. The aim of the current study is to assess the incidence and predictors of Anti-Retroviral Treatment (ART) failure among adults receiving HIV care at Zewditu Memorial Hospital, Addis Ababa, Ethiopia. Methods: Facility based retrospective cohort study design was employed on archived data from 2011 to 2016. Data compilation checklist was developed from intake card and ART follow-up card. The collected data were coded and entered using Epi Info 7 and analysed using Statistical Packages for Social Science (SPSS) version 20 software. Results: The overall incidence rate of ART treatment failure were 4.91 cases per person months follow up with 2.1, 0.24 and 0.13 immunological, clinical and virological treatment failure cases per 100 person years of follow-up respectively. Conclusion: The incidence of Anti-Retroviral Treatment failure was considerable among the study participants. The predictors for ART failure were WHO stage 3 at start, CD4 count at base line, disclosure and opportunistic infections. Comprehensive interventions have to be in place to tackle treatment failure among adults on ART through rendering optimum care focusing on adults with advanced WHO stage, lower CD4 count at baseline, opportunistic infections and people who did not disclose their HIV status.

Background Provision of quality laboratory services is an essential aspect of a promoting safe motherhood and better outcomes for newborn. Therefore; this study was intended to assess status of focused antenatal care (FANC) laboratory services at public health facilities in Addis Ababa, Ethiopia. Methods Institution based, descriptive cross-sectional study was conducted from April to May 2015. The study included 13 randomly selected health facilities and 13 purposively selected laboratory service providers. The status of FANC laboratory service was assessed by using pre-tested structured questionnaire and observation checklist. The study supplemented with qualitative data through in-depth interview of laboratory service providers. The quantitative data were coded and analysed by using SPSS Version 20 software and qualitative data was transcribed, coded, categorized and thematically analysed by the principal investigator. Results Only 5 (38.5 %) out of 13 visited health facilities reported the availability of all types of basic FANC laboratory investigations. Comparing the availability of individual tests in the study facilities, urine dipstick, urine microscopy and stool examination were available in all institutions. However, only 7 (53.8 %) of the health facilities reported the availability of hepatitis B virus screening test. Rapid syphilis (RPR) test was found in 10 (76.9 %) facilities. All laboratory facilities had at least one or more basic FANC laboratory tests interruption for more than a day within the last 1 year due to shortage of reagent and electric power disruption. Conclusions Majority of the health facilities reported incomplete provision of FANC laboratory investigations. Laboratory supply shortage and electric power disruption were the facilities’ major challenge to screen pregnant women for pregnancy related health conditions. Since such conditions may affect the outcome of pregnancy, therefore extensive efforts should be targeted to avoid services interruption by taking improvement measures including the fulfilment of all FANC laboratory resources.