Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia.

PURPOSE: Rapid severe acute respiratory syndrome coronavirus 2 test kits are crucial for bridging diagnostic gaps in health facilities and community screening mainly in resource limited settings. However, there is no objective evidence on their diagnostic performance. Thus, the study aimed to evaluate comparative diagnostic performance of three selected SARS-CoV-2 IgG/IgM rapid test kits in Ethiopia. METHODS: A cross-sectional study was conducted among 200 clients between May and July 2020 in Addis Ababa, Ethiopia. The performance of three SARS-CoV-2 rapid test kits EGENE, CTK BIOTECKs Onsite, and ACON Biotech were evaluated using blood specimens against RT-PCR on respiratory swabs. Sensitivity, specificity, and agreement with each other and to RT-PCR were computed using Vassarstats, MedCalc and SPSS version 23 statistical software. RESULTS: Test kits showed a heterogeneous comparative diagnostic performance in their sensitivity and specificity. The sensitivity was 61.18% (95% CI: 49.96-71.37%), 74.12% (95% CI: 63.28-82.74%) and 83.53% (95% CI: 73.57-90.38%) for kit A, B and C, respectively. Similarly, the specificity was 96.52% (90.81-98.88%), 94.78% (88.52-97.86%) and 94.78% (88.52-97.86%) for test kit A, B and C, respectively. The test kits have an agreement with RT-PCR with kappa value of 0.60 (0.48-0.83), 0.71 (0.65-0.93), and 0.80 (0.76-1.04) for A, B, and C, respectively. There was a significant difference on diagnostic performance among the three test kits and PCR with a p-value < 0.001 Cochran's Q test. CONCLUSION: The diagnostic performance of the test kits was promising and recommended for COVID-19 diagnostics in combination with RT-PCR to detect more infected patients. It allows determining the seroprevalence of the virus and true extent of SARS-COV-2 community spread in resource limited settings. We underline countries to evaluate rapid diagnostic test kits before diagnostic use.

Performance evaluation of malaria microscopists working at rechecking laboratories in Ethiopia.

BACKGROUND: Microscopic diagnosis of Giemsa-stained thick and thin blood films has remained the standard laboratory method for diagnosing malaria. High quality performance of microscopists that examine blood slides in health facilities remains critically important. MATERIALS AND METHODS: A cross-sectional study was conducted to assess the performance of 107 malaria microscopists working at 23 malaria rechecking laboratories in Ethiopia. A set of 12 blood film slides was distributed to each microscopist. Data was collected and exported to SPSS version 20 for analysis. Chi-square, sensitivity, specificity, percent agreement, and kappa scores were calculated to assess performance in detecting and identification of Plasmodium species. RESULTS: The mean age of the participants was 30 ± 5 yrs and most of them (54; 50.5%) were working at regional reference laboratories. Overall, the sensitivity of participants in detecting and identifying malaria parasite species was 96.8% and 56.7%, respectively. The overall agreement on detection and identification of malaria species was 96.8% (Kappa = 0.9) and 64.8% (Kappa = 0.33), respectively. The least accurately identified malaria parasite species was P. malariae (3/107; 2.8%) followed by P. ovale (35/107; 32.7%). Participants working at hospital laboratories had the highest percentage (72.3 %, Kappa=0.51) of accurate species identification. Study participants that had participated in malaria microscopy and quality assurance trainings were significantly better at quantifying parasite densities (P<0.001). CONCLUSION: The accuracy of parasite identification and quantification differed strongly between participants and expert microscopists. Therefore, regular competency assessment and training for malaria microscopists should be mandatory to assure proper diagnosis and management of malaria in Ethiopia.

Assessing the outcome of Strengthening Laboratory Management Towards Accreditation (SLMTA) on laboratory quality management system in city government of Addis Ababa, Ethiopia.

INTRODUCTION: Strengthening Laboratory Management Toward Accreditation (SLMTA) is a competency-based management training programme designed to bring about immediate and measurable laboratory improvement. The aim of this study is to assess the outcome of SLMTA on laboratory quality management system in Addis Ababa, Ethiopia. METHODS: The study used an Institutional based cross sectional study design that employed a secondary and primary data collection approach on the participated institution of medical laboratory in SLMTA. The study was conducted in Addis Ababa city government and the data was collected from February 'April 2014 and data was entered in to EPI-data version 3.1 and was analyzed by SPSS version 20. RESULTS: The assessment finding indicate that there was a significant improvement in average scores (141.4; range of 65-196, 95%CI=86.275-115.5, p=0.000) at final with 3 laboratories become 3 star, 6 laboratories were at 2 star, 11 were 1 star. Laboratory facilities respondents which thought getting adequate and timely manner mentorship were found 2.5 times more likely to get good success in the final score(AOR=2.501, 95% CI=1.109-4.602) than which did not get it. CONCLUSION: At the end of SLMTA implementation,3 laboratories score 3 star, 6 laboratories were at 2 star, 11 were at 1 star. The most important contributing factor for not scoring star in the final outcome of SLMTA were not conducting their customer satisfaction survey, poor staff motivation, and lack of regular equipment service maintenance. Mentorship, onsite and offsite coaching and training activities had shown a great improvement on laboratory quality management system in most laboratories.

Laboratory system strengthening and quality improvement in Ethiopia.

BACKGROUND: In 2010, a National Laboratory Strategic Plan was set forth in Ethiopia to strengthen laboratory quality systems and set the stage for laboratory accreditation. As a result, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme was initiated in 45 Ethiopian laboratories. OBJECTIVES: This article discusses the implementation of the programme, the findings from the evaluation process and key challenges. METHODS: The 45 laboratories were divided into two consecutive cohorts and staff from each laboratory participated in SLMTA training and improvement projects. The average amount of supportive supervision conducted in the laboratories was 68 hours for cohort I and two hours for cohort II. Baseline and exit audits were conducted in 44 of the laboratories and percent compliance was determined using a checklist with scores divided into zero- to five-star rating levels. RESULTS: Improvements, ranging from < 1 to 51 percentage points, were noted in 42 laboratories, whilst decreases were recorded in two. The average scores at the baseline and exit audits were 40% and 58% for cohort I (p < 0.01); and 42% and 53% for cohort II (p < 0.01), respectively. The p-value for difference between cohorts was 0.07. At the exit audit, 61% of the first and 48% of the second cohort laboratories achieved an increase in star rating. Poor awareness, lack of harmonisation with other facility activities and the absence of a quality manual were challenges identified. CONCLUSION: Improvements resulting from SLMTA implementation are encouraging. Continuous advocacy at all levels of the health system is needed to ensure involvement of stakeholders and integration with other improvement initiatives and routine activities.

Assessment of laboratory logistics management information system practice for HIV/AIDS and tuberculosis laboratory commodities in selected public health facilities in Addis Ababa, Ethiopia.

INTRODUCTION: Logistics management information system for health commodities remained poorly implemented in most of developing countries. To assess the status of laboratory logistics management information system for HIV/AIDS and tuberculosis laboratory commodities in public health facilities in Addis Ababa. METHODS: A cross-sectional descriptive study was conducted from September 2010-January 2011 at selected public health facilities. A stratified random sampling method was used to include a total of 43 facilities which, were investigated through quantitative methods using structured questionnaires interviews. Focus group discussion with the designated supply chain managers and key informant interviews were conducted for the qualitative method. RESULTS: There exists a well-designed logistics system for laboratory commodities with trained pharmacy personnel, distributed standard LMIS formats and established inventory control procedures. However, majority of laboratory professionals were not trained in LMIS. Majority of the facilities (60.5%) were stocked out for at least one ART monitoring and TB laboratory reagents and the highest stock out rate was for chemistry reagents. Expired ART monitoring laboratory commodities were found in 25 (73.5%) of facilities. Fifty percent (50%) of the assessed hospitals and 54% of health centers were currently using stock/bin cards for all HIV/AIDS and TB laboratory commodities in main pharmacy store, among these only 25% and 20.8% of them were updated with accurate information matching with the physical count done at the time of visit for hospitals and health centers respectively. CONCLUSION: Even though there exists a well designed laboratory LMIS, keeping quality stock/bin cards and LMIS reports were very low. Key ART monitoring laboratory commodities were stock out at many facilities at the day of visit and during the past six months. Based on findings, training of laboratory personnel's managing laboratory commodities and keeping accurate inventory control procedures were recommended.