Laboratory malaria diagnostic capacity in health facilities in five administrative zones of Oromia Regional State, Ethiopia

BackgroundIn Ethiopia, anti-malaria treatment is initiated after parasitological confirmation using blood film microscopy at health centers and hospitals, or serological rapid diagnostic tests at health posts. At health posts, the diagnosis is performed by health extension workers using rapid diagnostic tests after little training. However, there is paucity of data about the health extension workers’ performance on rapid diagnostic tests. Hence, periodic monitoring of the performances of health extension workers on malaria rapid diagnostic tests and predicted factors plays a pivotal role for the control of malaria.MethodsA cross sectional study was conducted in May 2020, among 75 health extension workers working at health posts in Bahir Dar Zuria district, Northwest Ethiopia. Their performance on malaria rapid diagnostic tests was assessed by distributing known positive and negative samples as confirmed by investigators using both rapid diagnostic test and blood film microscopy. Test results from health extension workers were then compared with that of investigators. Procedural errors committed while performing the tests were assessed using observational checklist. Data were analyzed using SPSS software version 20.ResultsThe overall sensitivity and specificity of health extension workers in detecting Plasmodium species were 96.8% and 98.7%, respectively with 97.3% result agreement between the health extension workers and investigators (kappa value = 0.949). The most common procedural errors committed by health extension workers was ‘not checking expiry date of the test kits’ followed by ‘not adhering to the appropriate time of reading results’ that 70.7% and 64% of the participants committed these errors, respectively. Total number of procedural errors committed by those who have got in-service training was decreased by 47.3% as compared to those without in-service training.ConclusionsHealth extension workers had high performance on malaria rapid diagnostic tests. However, in-service training and periodic supervision should be given in order to maximize performance on these tests.

To document factors that hinder or enable strategies to reduce the first and second delays of the Three Delays in rural and pastoralist areas in Ethiopia. A key informant study was conducted with 44 Health Extension Workers in Afar Region, Kafa Zone (Southern Nation, Nationalities and Peoples' Region), and Adwa Woreda (Tigray Region). Health Extension Workers were trained to interview women and ask for stories about their recent experiences of birth. We interviewed the Health Extension Workers about their experiences referring women for Skilled Birth Attendance and Emergency Obstetric and Newborn Care. Data were analysed using thematic analysis. Themes related to reducing the first delay, such as the tradition of home birth, decision-making, distance and unavailability of transport, did not differ between the three locations. Themes related to reducing the second delay differed substantially. Health Extension Workers in Adwa Woreda were more likely to call ambulances due to support from the Health Development Army and a functioning referral system. In Kafa Zone, some Health Extension Workers were discouraged from calling ambulances as they were used for other purposes. In Afar Region, few Health Extension Workers were called to assist women as most women give birth at home with Traditional Birth Attendants unless they need to travel to health facilities for Emergency Obstetric and Newborn Care. Initiatives to reduce delays can improve access to maternal health services, especially when Health Extension Workers are supported by the Health Development Army and a functioning referral system, but district (woreda) health offices should ensure that ambulances are used as intended.

BackgroundMalaria mortality is mainly a direct consequence of inadequate and/or delayed diagnosis and case management. Some important control interventions (e.g. long-lasting insecticidal nests) have contributed to reduce malaria morbidity and mortality in different parts of the world. Moreover, the development and effective use of rapid diagnostic tests (RDTs) hold promise to further enhance the control and elimination of malaria, particularly in areas where health services are deficient. The aim of this study was to determine knowledge, attitudes, practices and beliefs in relation to RDTs for malaria in rural Côte d’Ivoire.MethodsOne hundred individuals from Bozi and Yoho who sought care at the health centre in Bozi and were offered an RDT for malaria were interviewed in April 2010 using a pre-tested questionnaire on practice and perceptions in relation to RDTs for malaria. The relationships between acceptance of RDTs and factors related to opinions were identified, using generalized linear mixed models. Qualitative data from open-ended questions complemented the quantitative analysis.ResultsOnly 34 out of 100 patients who were offered an RDT for malaria were willing to undergo the test. People who perceived blood as a sacred body fluid were less likely to comply with an RDT. The concurrent availability and use of RDTs for HIV and malaria was associated with an unwilling attitude towards RDTs for malaria (Fisher’s exact test, p <0.001). The initial willingness of patients to accept malaria testing with RDTs was significantly related to general fear and wanting to know malaria infection status. For further and regular use of RDTs, a strong relationship was observed between acceptance and the idea that an RDT is a pretext used by health worker to know HIV status (odds ratio (OR) = 16.61, 95% confidence interval (CI) = 1.03-268.5). Those thinking that blood samples were useful for medical diagnoses were 8.31-times (95% CI = 2.22-31.1) more likely to undergo an RDT compared to those rejecting blood sampling as a diagnostic strategy.ConclusionSocio-cultural factors might be barriers for accepting RDTs in general health services. There are social representations of malaria and HIV/AIDS, symbolic for blood or experiences in relation to blood taking and blood-related diseases in relation to the introduction and routine use of RDTs. Special attention should be given to these barriers as otherwise the promotion of RDTs for prompt and effective diagnosis and subsequent management of malaria is hampered.

How Do We Best Diagnose Malaria in Africa?

Context and objectiveEthiopia’s primary care has a weak referral system for sick children. We aimed to identify health post and child factors associated with referrals of sick children 0–59 months...

BackgroundAccurate early diagnosis and prompt treatment is one of the key strategies to control and prevent malaria in Ethiopia where both Plasmodium falciparum and Plasmodium vivax are sympatric and require different treatment regimens. Microscopy is the standard for malaria diagnosis at the health centres and hospitals whereas rapid diagnostic tests are used at community-level health posts. The current study was designed to assess malaria microscopy capacity of health facilities in Oromia Regional State and Dire Dawa Administrative City, Ethiopia.MethodsA descriptive cross-sectional study was conducted from February to April 2011 in 122 health facilities, where health professionals were interviewed using a pre-tested, standardized assessment tool and facilities’ laboratory practices were assessed by direct observation.ResultsOf the 122 assessed facilities, 104 (85%) were health centres and 18 (15%) were hospitals. Out of 94 health facilities reportedly performing blood films, only 34 (36%) used both thin and thick smears for malaria diagnosis. The quality of stained slides was graded in 66 health facilities as excellent, good and poor quality in 11(17%), 31 (47%) and 24 (36%) respectively. Quality assurance guidelines and malaria microscopy standard operating procedures were found in only 13 (11%) facilities and 12 (10%) had involved in external quality assessment activities, and 32 (26%) had supportive supervision within six months of the survey. Only seven (6%) facilities reported at least one staff’s participation in malaria microscopy refresher training during the previous 12 months. Although most facilities, 96 (79%), had binocular microscopes, only eight (7%) had the necessary reagents and supplies to perform malaria microscopy. Treatment guidelines for malaria were available in only 38 (31%) of the surveyed facilities. Febrile patients with negative malaria laboratory test results were managed with artemether-lumefantrine or chloroquine in 51% (53/104) of assessed health facilities.ConclusionsThe current study indicated that most of the health facilities had basic infrastructure and equipment to perform malaria laboratory diagnosis but with significant gaps in continuous laboratory supplies and reagents, and lack of training and supportive supervision. Overcoming these gaps will be critical to ensure that malaria laboratory diagnosis is of high-quality for better patient management.

BackgroundMalaria transmission in Ethiopia is unstable and variable, caused by both Plasmodium falciparum and Plasmodium vivax. The Federal Ministry of Health (FMoH) is scaling up parasitological diagnosis of malaria at all levels of the health system; at peripheral health facilities this will be through use of rapid diagnostic tests (RDTs). The present study compared three RDT products to provide the FMoH with evidence to guide appropriate product selection.MethodsPerformance of three multi-species (pf-HRP2/pan-pLDH and pf-HRP2/aldolase) RDTs (CareStart®, ParaScreen® and ICT Combo®) was compared with 'gold standard' microscopy at three health centres in Jimma zone, Oromia Regional State. Ease of RDT use by health extension workers was assessed at community health posts. RDT heat stability was tested in a controlled laboratory setting according to WHO procedures.ResultsA total of 2,383 patients with suspected malaria were enrolled between May and July 2009, 23.2% of whom were found to be infected with Plasmodium parasites by microscopy. All three RDTs were equally sensitive in detecting P. falciparum or mixed infection: 85.6% (95% confidence interval 81.2-89.4). RDT specificity was similar for detection of P. falciparum or mixed infection at around 92%. For detecting P. vivax infection, all three RDTs had similar sensitivity in the range of 82.5 to 85.0%. CareStart had higher specificity in detecting P. vivax (97.2%) than both ParaScreen and ICT Combo (p < 0.001 and p = 0.05, respectively). Health extension workers preferred CareStart and ParaScreen to ICT Combo due to the clear labelling of bands on the cassette, while the 'lab in a pack' style of CareStart was the preferred design. ParaScreen and CareStart passed all heat stability testing, while ICT Combo did not perform as well.ConclusionsCareStart appeared to be the most appropriate option for use at health posts in Ethiopia, considering the combination of quantitative performance, ease of use and heat stability. When new products become available, the choice of multi-species RDT for Ethiopia should be regularly re-evaluated, as it would be desirable to identify a test with higher sensitivity than the ones evaluated here.

Background: More than 80% of maternal deaths can prevented if pregnant women access to essential maternity care like antenatal care, institutional delivery and postnatal care. To reduce maternal mortality, Ethiopian government trained Health Extension Workers who working at grass root level. Even though, Health Extension Workers trained and assigned to health posts, the challenges they faced on provision of maternal health services was not investigated. Therefore, this study was to explore challenges of maternal health services utilization and provision from health posts in Bale Zone, Oromiya Region, Southeast Ethiopia. Methods: Explorative qualitative design was conducted. Women less than one-year child and married men were participated in focus group discussions. While health extensions workers and supervisors, women’s affairs, religious leaders, district and zonal health extension programs coordinators were participated in in-depth interviews. Five focus group discussions and thirty-one in-depth interviews conducted. Data collected by tape recording and note taking using semi- structured guiding questionnaires from April 15-May 15 in 2014. Randomly five districts selected from zone and one Sub - district selected purposively from each district. The results analyzed by thematic coding analysis and presented in a narrative form. Results: Participants claimed that community was not comfortable with Health Extension Workers. Most of Health Extension Workers complained for shortage of equipments, electric powers and water supplies. Some Health Extension Workers left jobs totally due to un-equivalent salary with their workload and some left their jobs for several months by closing health posts. There was also communication gap between district health office and health center on supervisions. Conclusions: Even though, Antenatal care services utilization from Health Extension Workers was good, the delivery and postnatal care services utilization were not as such. In general, the attitudes of the communities toward health extension workers, shortage of equipments, shortage of water supply, lack of electric power, Health Extension Workers left the jobs totally, Health Extension Workers left the jobs for several months and movement of communities from one place to another place were the major challenges of maternal health services utilizations from health posts. The Oromiya Health Bureau, Bale Zone Health Department and District Health Office should have to work cooperatively to avail necessary equipments and infrastructures for health posts, to reconsider salary of health extension workers, to train additional health extension workers for better maternal health services utilizations and provisions.

BackgroundGraphical symbols on in vitro diagnostics (IVD symbols) replace the need for text in different languages and are used on malaria rapid diagnostic tests (RDTs) marketed worldwide. The present study assessed the comprehension of IVD symbols labelled on malaria RDT kits among laboratory staff in four different countries.MethodsParticipants (n = 293) in Belgium (n = 96), the Democratic Republic of the Congo (DRC, n = 87), Cambodia (n = 59) and Cuba (n = 51) were presented with an anonymous questionnaire with IVD symbols extracted from ISO 15223 and EN 980 presented as stand-alone symbols (n = 18) and in context (affixed on RDT packages, n = 16). Responses were open-ended and scored for correctness by local professionals.ResultsPresented as stand-alone, three and five IVD symbols were correctly scored for comprehension by 67% and 50% of participants; when contextually presented, five and seven symbols reached the 67% and 50% correct score respectively. 'Batch code' scored best (correctly scored by 71.3% of participants when presented as stand-alone), 'Authorized representative in the European Community' scored worst (1.4% correct). Another six IVD symbols were scored correctly by less than 10% of participants: 'Do not reuse', 'In vitro diagnostic medical device', 'Sufficient for', 'Date of manufacture', 'Authorised representative in EC', and 'Do not use if package is damaged'. Participants in Belgium and Cuba both scored six symbols above the 67% criterion, participants from DRC and Cambodia scored only two and one symbols above this criterion. Low correct scores were observed for safety-related IVD symbols, such as for 'Biological Risk' (42.7%) and 'Do not reuse' (10.9%).ConclusionComprehension of IVD symbols on RDTs among laboratory staff in four international settings was unsatisfactory. Administrative and outreach procedures should be undertaken to assure their acquaintance by end-users.

BackgroundThe present External Quality Assessment (EQA) assessed reading and interpretation of malaria rapid diagnostic tests (RDTs) in the Democratic Republic of the Congo (DRC).MethodsThe EQA consisted of (i) 10 high-resolution printed photographs displaying cassettes with real-life results and multiple choice questions (MCQ) addressing individual health workers (HW), and (ii) a questionnaire on RDT use addressing the laboratory of health facilities (HF). Answers were transmitted through short message services (SMS).ResultsThe EQA comprised 2344 HW and 1028 HF covering 10/11 provinces in DRC. Overall, median HW score (sum of correct answers on 10 MCQ photographs for each HW) was 9.0 (interquartile range 7.5 – 10); MCQ scores (the % of correct answers for a particular photograph) ranged from 54.8% to 91.6%. Most common errors were (i) reading or interpreting faint or weak line intensities as negative (3.3%, 7.2%, 24.3% and 29.1% for 4 MCQ photographs), (ii) failure to distinguish the correct Plasmodium species (3.4% to 7.0%), (iii) missing invalid test results (8.4% and 23.6%) and (iv) missing negative test results (10.0% and 12.4%). HW who were trained less than 12 months ago had best MCQ scores for 7/10 photographs as well as a significantly higher proportion of 10/10 scores, but absolute differences in MCQ scores were small. HW who had participated in a previous EQA performed significantly better for 4/10 photographs compared to those who had not. Except for two photographs, MCQ scores were comparable for all levels of the HF hierarchy and non-laboratory staff (HW from health posts) had similar performance as to laboratory staff. Main findings of the questionnaire were (i) use of other RDT products than recommended by the national malaria control programme (nearly 20% of participating HF), (ii) lack of training for a third (33.6%) of HF, (iii) high proportions (two-thirds, 66.5%) of HF reporting stock-outs.ConclusionsThe present EQA revealed common errors in RDT reading and interpretation by HW in DRC. Performances of non-laboratory and laboratory staff were similar and dedicated training was shown to improve HW competence although to a moderate extent. Problems in supply, distribution and training of RDTs were detected.

Rapid diagnostic tests (RDTs) are the current complement to microscopy for ensuring prompt malaria treatment. However, non-estimation of the parasite density is one of the limits of these RDTs. This study aimed to estimate the parasite density based on the time of positivity of two RDTs, SD Bioline Malaria Ag-Pf/Pan and Paracheck™-Pf. A highly parasitized blood sample underwent successive dilutions. On each resulting dilution, a thick blood film and two RDTs were performed. The time of onset of the positivity of the diluted blood samples was recorded from each RDT. A linear regression model was determined to estimate a range of parasite density from the time of positivity. The model was then assessed using known parasites density of additional blood samples from symptomatic malaria patients. For each RDT, the curve representing the time of positivity showed three stages. The latency stage, before the test line of the RDT appears, lasted 2 min 40 s for SD Bioline and 3 min 14 s for Paracheck. The optimal stage during which the line of positivity appears lasted from 2 min 40 s to 6 min (SD Bioline), and from 3 min14 s to 7 min 2 s (Paracheck). A phase of pre-negativity spanned from 6 min to 14 min 20 s (SD Bioline) and 7 min 2 s to 14 min 40 s (Paracheck). Two linear regressions equations were drawn to link the mean time of positivity appearance to the mean parasite density (Dm), that is, Dm = - 119.5tm + 81943.3 (SD Bioline) and Dm = - 142.0tm + 99779.1 (Paracheck). Based on the statistical models, RDTs time of positivity ranged from 2 min 40 s to 11 min 25 s, and from 3 min 14 s to 11 min 33 s for SD Bioline and Paracheck respectively. The linear regression models obtained from the time of positivity of RDTs allows the prediction of malaria parasite density. There was no significant difference between the theoretical malaria parasite density and the one observed with microscopy. Key words: Malaria parasite density, linear regression model, rapid diagnostic tests (RDTs), Cote d'Ivoire.

Background: The Malaria and HIV rapid diagnostic tests (RDTs) are some of the commonest tests that are used in Ghana to support malaria and HIV management/care respectively. When these devices are used, they are categorized as potentially infectious. This paper aims to highlight the availability and management of used malaria and HIV RDTs in various healthcare facilities and by health service providers in the greater Accra region of Ghana.Methods: Data was obtained from 400 health facilities including hospitals, clinics, health centres, and pharmacies and over the counter medicine seller’s shops using purposive sampling technique with the aid of structured questionnaires and observation of practices.Results: Seventy percent of the facilities (n=280) used only malaria RDTs, 29% (n=116) used both malaria and HIV RDTs and 1% (n=4) reported using HIV RDTs only. 81.7% (n=326) which formed the majority used less than 10 RDTs daily. There was poor waste segregation, storage, transportation, treatment and disposal of waste. Facilities that had some sort of on-site treatment of waste used single chambered incinerators.Conclusions: Each of the categories of health facilities had a common practice of poor hazardous waste management. We therefore recommend that there should be enhancement of education and training of practitioners in the health facilities and the general public on the optimal use of the RDTs and disposal or the management of healthcare waste in general. The environmental protection agency and ministry of health should collaborate and enforce all the regulations on healthcare waste management in the various facilities.

Malaria is a serious mosquito-borne parasitic disease and is one of the most significant causes of death worldwide. In this report we discuss a case of a 26-year-old female healthcare worker who presented to the emergency department with signs and symptoms of persistent fevers, chills, headaches, nausea, and malaise. The patient9s history was obtained and several laboratory tests were performed leading to the diagnosis of malaria caused by <i>Plasmodium ovale</i>. The rapid diagnostic test for malaria was negative, and the Giemsa – stained peripheral blood smears were positive for the presence of malarial parasites. Images of the peripheral blood smears were sent to the Centers for Disease Control and Prevention, which confirmed the presence of <i>Plasmodium ovale</i>. We also report 5 other false negative RDTs for <i>P. ovale</i> in our institution in 2016, and the performance of RDTs for all malaria cases during that year. This case demonstrates the importance of obtaining multiple pieces of laboratory data in order to accurately diagnose a patient with malaria, illustrates that evaluation of Giemsa – stained peripheral blood smears is still the gold standard in the laboratory diagnosis of malaria, and emphasizes the importance for clinical laboratory scientists to maintain maximum competency in peripheral blood smear evaluation for bloodborne parasites. <b>ABBREVIATIONS:</b>CBC - Complete blood count, RDT - Rapid Diagnostic Test, RBCs - Red blood cells, CDC - Centers for Disease Control and Prevention, AST - Aspartate Aminotransferase, ALT - Alanine Aminotransferase

BackgroundRapid diagnostic tests (RDTs) for malaria are increasingly being considered for routine use in Africa. However, many RDTs are available and selecting the ideal test for a particular setting is challenging. The appropriateness of RDT choice depends in part on patient population and epidemiological setting, and on decision makers' priorities. The model presented (available online) can be used by decision makers to evaluate alternative RDTs and assess the circumstances under which their use is justified on economic grounds.MethodsAn interactive model based on a decision-tree structure and a cost-benefit framework was designed to compare different diagnostic strategies. Variables included in the model can be modified by users, including RDT and treatment costs, test accuracies (sensitivity and specificity), probabilities for developing severe illness, case-fatality rates, and clinician response to negative test results. To illustrate how the model can be used, a comparison is made of presumptive treatment with two available RDTs, one detecting histidine-rich protein-2 (HRP2) and one detecting Plasmodium lactate dehydrogenase (pLDH). Data inputs were obtained from a study comparing the RDTs at seven sites in Uganda.ResultsApplying the model in the illustrative Ugandan context demonstrates that if only direct expenditures are considered, the pLDH test is the preferred option for adult patients except in high transmission settings, while young children are best treated presumptively in all settings. When health outcomes are considered, the HRP2 test gains an advantage in almost all settings and for all age groups. Introducing possible adverse consequences of using an antimalarial into the analysis, such as adverse drug reactions, or the development of resistance, considerably strengthens the case for using RDTs. When the model is adjusted to account for less than complete adherence to test results, the efficiency of using RDTs drops sharply.ConclusionModel output demonstrates that which test is preferable varies by location, depending on factors such as malaria transmission intensity and the costs and accuracies of the RDTs under consideration. Despite the uncertainties and complexities involved, adaptable models such as the one presented here can serve as a practical tool to assist policy makers in efficient deployment of new technologies.

The conventional microscopy is the gold standard in laboratory diagnosis of malaria but time-consuming and requires a lot of training and expertise. However, Rapid Diagnostic Tests (RDTs) could be considered in endemic regions especially in poor settings, where there is shortage of power supply and less qualified personnel. This is a comparative study between Microscopy and RDTs. The study was carried out in two health facilities in Kano metropolis; Sir, Muhammad Sunusi Specialist hospital (SMSSH) and Bayero University Health Clinic (BUHC). A retrospective analysis was carried out in which the capacities of facilities for malaria parasites (MP) microscopy and RDT were assessed for the previous year. Later a prospective analysis was carried out by implementing a modified Lot Quality Assurance Sampling (LQAS) model over a period of 3 months. Giemsa stained Slides for Malaria Parasite Microscopy were sampled giving a total Slides of 432 and their corresponding blood specimens also sampled for the respective RDTs using SD Bioline Kits. The specificity of MP slide microscopy and RDTs in SMSSH and BUHC were 84% and 94% respectively while that of RDTs were 95% and 94% respectively. However, the sensitivity of MP microscopy in SMSSH and BUHC was found to be 95% and 94% and that of RDT was 72% and 78% respectively. Result showed that microscopic examination of malaria parasite is still the method of choice and also gold standard especially for confirmation of clinical diagnosis.Keywords: Malaria; microscopy; RDTs; sensitivity and specificity