Dataset Information

Poor performance of the rapid test for human brucellosis in health facilities in Kenya.

ABSTRACT: Human brucellosis is considered to be an important but typically under-diagnosed cause of febrile illness in many low and middle-income countries. In Kenya, and throughout East Africa, laboratory diagnosis for the disease is based primarily on the febrile antigen Brucella agglutination test (FBAT), yet few studies of the diagnostic accuracy of this test exist. Assessment of the performance of the FBAT is essential for its appropriate clinical use, as well as for evaluating surveillance data reported by public health systems. To assess FBAT performance, we collected sera from people with symptoms compatible with brucellosis attending two health facilities in Busia County, Kenya. Sera were tested using the FBAT and results compared with those from the Rose Bengal Test (RBT), an assay with well-known performance characteristics. Positives on either test were confirmed using the classical serum agglutination test (SAT)-Coombs test combination and a rapid IgM/IgG lateral flow immunochromatography assay (LFA). A questionnaire focussing on known risk factors for exposure to Brucella spp. was also conducted, and relationships with FBAT positivity examined using logistic regression. Out of 825 recruited individuals, 162 (19.6%) were classified as positive using the FBAT. In contrast, only eight (1.0%) were positive using the RBT. Of the 162 FBAT positives, one (0.62%) had an atypical agglutination in SAT and three (1.9%) showed low Coombs titres. Out of 148 FBAT positive individuals tested using the LFA, five (3.4%) were IgM positive and none were IgG positive. Poor or no correlation was observed between FBAT results and most established risk factors for Brucella infection. We observed substantial disagreement between the FBAT and a number of well-known serological tests, with the majority of reactive FBAT results appearing to be false positives. Poor FBAT specificity, combined with a lack of confirmatory testing, strongly suggests overdiagnosis of brucellosis is common in this low prevalence setting. This is expected to have important economic impacts on affected patients subjected to the long and likely unnecessary courses of multiple antibiotics required for treatment of the disease.

SUBMITTER: de Glanville WA

PROVIDER: S-EPMC5413359 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Poor performance of the rapid test for human brucellosis in health facilities in Kenya.

de Glanville William A WA Conde-Álvarez Raquel R Moriyón Ignacio I Njeru John J Díaz Ramón R Cook Elizabeth A J EAJ Morin Matilda M Bronsvoort Barend M de C BMC Thomas Lian F LF Kariuki Samuel S Fèvre Eric M EM

PLoS neglected tropical diseases 20170407 4

Human brucellosis is considered to be an important but typically under-diagnosed cause of febrile illness in many low and middle-income countries. In Kenya, and throughout East Africa, laboratory diagnosis for the disease is based primarily on the febrile antigen Brucella agglutination test (FBAT), yet few studies of the diagnostic accuracy of this test exist. Assessment of the performance of the FBAT is essential for its appropriate clinical use, as well as for evaluating surveillance data repo ...[more]

PMID: 28388625

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Project description:BackgroundBrucellosis is listed as one of six priority zoonoses in Tanzania's One Health strategic plan which highlights gaps in data needed for the surveillance and estimation of human brucellosis burdens. This study collected data on current testing practices and test results for human brucellosis in Arusha region, northern Tanzania.MethodsRetrospective data were extracted from records at 24 health facilities in Arusha region for the period January 2012 to May 2018. Data were captured on: the test reagents used for brucellosis, procurement and testing protocols, the monthly number of patients tested for brucellosis and the monthly number testing positive. Generalised linear mixed models were used to evaluate relationships between health facility characteristics and the probability that brucellosis testing was conducted in a given month, and the proportion of individuals testing positive.ResultsFour febrile Brucella agglutination tests were used widely. The probability of testing for brucellosis in a given month was significantly associated with an interaction between year of testing and facility ownership. Test probability increased over time with more pronounced increases in privately owned as compared to government facilities. The proportion of individuals testing positive for brucellosis was significantly associated with facility type and district, with individuals tested in hospitals in Meru, Monduli and Ngorongoro districts more likely to test positive.ConclusionsFebrile Brucella agglutination tests, known for their poor performance, were the mainstay of brucellosis testing at health facilities in northern Tanzania. The study indicates that historical data on human brucellosis in Arusha and other regions are likely to provide an inaccurate measure of true disease burden due to poor performance of the tests used and variation in testing practices. Measures to address these identified shortcomings could greatly improve quality of testing and surveillance data on brucellosis and ultimately inform prevention and control of this priority disease.

Project description:ObjectivesTo investigate the health managers perceived sustainability status of the health facilities institutional improvement projects and their experiences on factors that facilitated or constrained their maintenance, with intentions of informing relevant strategies or policies in Kenya's health sector.MethodsA qualitative study, nested within a quasi-experimental study. Thirty-three project-teams of health managers were purposively selected and interviewed based on their project implementation success rates post-training. The managers had previously undergone a 9-month leadership training, complimented with facility-based team coaching around the chosen projects. The training was funded by the US Agency for International Development; however, the implementation of the projects was based on how the participants could innovatively use the existing resource to create a positive change. The projects were housed within 20 public, 9 faith-based and 4 private health facilities in 19 counties in Kenya. The interviews explored the manager's experiences in sustaining the successfully implemented projects within the (24-60 months post-training period). We asked managers to describe factors they perceived enabled or hindered the sustainability of the successfully implemented institutional improvement project. The digitally audio-recorded interviews were transcribed verbatim. Data on barriers and enablers were thematically analysed.ResultsTwenty-nine out of the 33 successfully implemented projects reported sustainability within periods ranging from 24 to 60 months post-training. Seven themes related to drivers of sustainability emerged, namely; programme design, stakeholder's buy-in, board members, communication, coaching, presence of change champion, devolution and political good-will. Four sustainability inhibitors identified were: human resources constraints, policy implementation, misalignment of projects with daily operations, devolution and political interference.ConclusionsThe sustainability of institutional improvement strategies such as projects implemented post-leadership training in public and private health facilities depends on the quality of board members, communication management and institutionalisation of coaching culture. These findings are pertinent for planning and implementing similar health systems strengthening intervention in low-income countries.

Project description:Brucellosis is an important zoonotic disease globally, with particularly high burdens in pastoral settings. While the zoonotic transmission routes for Brucella spp. are well known, the relative importance of animal contact, food-handling and consumption practices can vary. Understanding the local epidemiology of human brucellosis is important for directing veterinary and public health interventions, as well as for informing clinical diagnostic decision making. We conducted a cross-sectional study in Ijara District Hospital, north-eastern Kenya. A total of 386 individuals seeking care and reporting symptoms of febrile illness were recruited in 2011. Samples were tested for the presence of Brucella spp. using a real-time PCR (RT-PCR) and results compared to those from the test for brucellosis used at Ijara District Hospital, the febrile Brucella plate agglutination test (FBAT). A questionnaire was administered to all participants and risk factors for brucellosis identified using logistic regression with an information theoretic (IT) approach and least absolute shrinkage and selection (LASSO). Sixty individuals were RT-PCR positive, resulting in a prevalence of probable brucellosis of 15.4% (95% CI 12.0-19.5). The IT and LASSO approaches both identified consuming purchased milk as strongly associated with elevated risk and boiling milk before consumption strongly associated with reduced risk. There was no evidence that livestock keepers were at different risk of brucellosis than non-livestock keepers. The FBAT had poor diagnostic performance when compared to RT-PCR, with an estimated sensitivity of 36.6% (95% CI 24.6-50.1) and specificity of 69.3% (95% CI 64.0-74.3). Brucellosis is an important cause of febrile illness in north-eastern Kenya. Promotion of pasteurisation of milk in the marketing chain and health messages encouraging the boiling of raw milk before consumption could be expected to lead to large reductions in the incidence of brucellosis in Ijara. This study supports the growing evidence that the FBAT performs very poorly in the diagnosis of brucellosis.

Project description:BackgroundBrucellosis occurs globally with highly variable incidence in humans from very low in North America and Western Europe to high in the Middle East and Asia. There are few data in Sub-Saharan Africa. This study estimated the incidence of human brucellosis in a pastoralist community in Kenya.MethodsBetween February 2015 and January 2016, we enrolled persons living in randomly selected households in Kajiado County. Free health care was offered at three facilities in the study area. Those who met the study clinical case definition completed a standardized questionnaire on demographics, clinical history and presentation. A blood sample was collected and tested by Rose Bengal test (RBT), then later tested at the Kenya Medical Research Institute laboratory for Brucella IgG and IgM by ELISA. Those who tested positive by both RBT and ELISA (IgG or IgM antibodies) were classified as confirmed while those that only tested positive for IgG or IgM antibodies were classified as probable. Further, sera were tested by polymerase chain reaction using a TaqMan Array Card (TAC) for a panel of pathogens causing AFI including Brucella spp. Annual incidence of brucellosis was calculated as the number of confirmed cases in one year/total number in the study population.ResultsWe enrolled a cohort of 4746 persons in 804 households. Over half (52.3%) were males and the median age was 18 years (Interquartile range (IQR) 9 months- 32 years). A total of 236 patients were enrolled at three health facilities; 64% were females and the median age was 40.5 years (IQR 28-53 years). Thirty-nine (16.5%) were positive for Brucella antibodies by IgG ELISA, 5/236 (2.1%) by IgM ELISA and 4/236 (1.7%) by RBT. Ten percent (22/217) were positive by TAC. We confirmed four (1.7%) brucellosis cases giving an annual incidence of 84/100,000 persons/year (95% CI 82, 87). The incidence did not significantly vary by gender, age and location of residence.ConclusionWe report a high incidence of brucellosis in humans among members of this pastoralist community. Brucellosis was the most common cause of febrile illness in this community.

Project description:BackgroundHealth workers' compliance with outpatient malaria case-management guidelines has been improving in Africa. This study examined the factors associated with the improvements.MethodsData from 11 national, cross-sectional health facility surveys undertaken from 2010-2016 were analysed. Association between 31 determinants and improvement trends in five outpatient compliance outcomes were examined using interactions between each determinant and time in multilevel logistic regression models and reported as an adjusted odds ratio of annual trends (T-aOR).ResultsAmong 9,173 febrile patients seen at 1,208 health facilities and by 1,538 health workers, a higher annual improvement trend in composite "test and treat" performance was associated with malaria endemicity-lake endemic (T-aOR = 1.67 annually; p<0.001) and highland epidemic (T-aOR = 1.35; p<0.001) zones compared to low-risk zone; with facilities stocking rapid diagnostic tests only (T-aOR = 1.49; p<0.001) compared to microscopy only services; with faith-based/non-governmental facilities compared to government-owned (T-aOR = 1.15; p = 0.036); with a daily caseload of >25 febrile patients (T-aOR = 1.46; p = 0.003); and with under-five children compared to older patients (T-aOR = 1.07; p = 0.013). Other factors associated with the improvement trends in the "test and treat" policy components and artemether-lumefantrine administration at the facility included the absence of previous RDT stock-outs, community health workers dispensing drugs, access to malaria case-management and Integrated Management of Childhood Illness (IMCI) guidelines, health workers' gender, correct health workers' knowledge about the targeted malaria treatment policy, and patients' main complaint of fever. The odds of compliance at the baseline were variable for some of the factors.ConclusionsTargeting of low malaria risk areas, low caseload facilities, male and government health workers, continuous availability of RDTs, improving health workers' knowledge about the policy considering age and fever, and dissemination of guidelines might improve compliance with malaria guidelines. For prompt treatment and administration of the first artemether-lumefantrine dose at the facility, task-shifting duties to community health workers can be considered.

Project description:BACKGROUND:Malaria rapid diagnostic tests (RDTs) are a simple, point-of-care technology that can improve the diagnosis and subsequent treatment of malaria. They are an increasingly common diagnostic tool, but concerns remain about their use by community health workers (CHWs). These concerns regard the long-term trends relating to infection prevention measures, the interpretation of test results and adherence to treatment protocols. This study assessed whether CHWs maintained their competency at conducting RDTs over a 12-month timeframe, and if this competency varied with specific CHW characteristics. METHODS:From June to September, 2015, CHWs (n?=?271) were trained to conduct RDTs using a 3-day validated curriculum and a baseline assessment was completed. Between June and August, 2016, CHWs (n?=?105) were randomly selected and recruited for follow-up assessments using a 20-step checklist that classified steps as relating to safety, accuracy, and treatment; 103 CHWs participated in follow-up assessments. Poisson regressions were used to test for associations between error count data at follow-up and Poisson regression models fit using generalized estimating equations were used to compare data across time-points. RESULTS:At both baseline and follow-up observations, at least 80% of CHWs correctly completed 17 of the 20 steps. CHWs being 50 years of age or older was associated with increased total errors and safety errors at baseline and follow-up. At follow-up, prior experience conducting RDTs was associated with fewer errors. Performance, as it related to the correct completion of all checklist steps and safety steps, did not decline over the 12 months and performance of accuracy steps improved (mean error ratio: 0.51; 95% CI 0.40-0.63). Visual interpretation of RDT results yielded a CHW sensitivity of 92.0% and a specificity of 97.3% when compared to interpretation by the research team. None of the characteristics investigated was found to be significantly associated with RDT interpretation. CONCLUSIONS:With training, most CHWs performing RDTs maintain diagnostic testing competency over at least 12 months. CHWs generally perform RDTs safely and accurately interpret results. Younger age and prior experiences with RDTs were associated with better testing performance. Future research should investigate the mode by which CHW characteristics impact RDT procedures.

Dataset Information

Poor performance of the rapid test for human brucellosis in health facilities in Kenya.

Publications

Poor performance of the rapid test for human brucellosis in health facilities in Kenya.

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