40 research outputs found

    Patient needs and point-of-care requirements for HIV load testing in resource-limited settings

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    Medecins Sans Frontieres (MSF) is an international, independent medical nongovernmental organization. One way in which MSF acts to improve patient care is to assist in the identification and development of adapted and appropriate tools for use in resource-limited settings. One strategy to achieve this goal is through active collaborations with scientists and developers, to make some of the field needs known and to help define the medical strategy behind the implementation of new diagnostic tests. Tests used in the field need to be effective in often extreme conditions and must also deliver high-quality, reliable results that can be used in the local context. In this article, we discuss some patient and health care provider needs for human immunodeficiency virus (HIV) load measurement in resource-limited settings. This is just one of the areas in which effective, quality tools are desperately needed, not only by MSF and other international nongovernmental organizations, but also by many other health service providers. We hope that, by clearly defining the needs of patients in MSF clinics-as well as we can assess this-and by explaining why these tools are needed, how they should perform, and how their results can be integrated into a program, we will encourage the development of such tools and hasten their implementation in areas where they are so urgently needed

    Patient needs and point-of-care requirements for HIV load testing in resource-limited settings

    Get PDF
    Medecins Sans Frontieres (MSF) is an international, independent medical nongovernmental organization. One way in which MSF acts to improve patient care is to assist in the identification and development of adapted and appropriate tools for use in resource-limited settings. One strategy to achieve this goal is through active collaborations with scientists and developers, to make some of the field needs known and to help define the medical strategy behind the implementation of new diagnostic tests. Tests used in the field need to be effective in often extreme conditions and must also deliver high-quality, reliable results that can be used in the local context. In this article, we discuss some patient and health care provider needs for human immunodeficiency virus (HIV) load measurement in resource-limited settings. This is just one of the areas in which effective, quality tools are desperately needed, not only by MSF and other international nongovernmental organizations, but also by many other health service providers. We hope that, by clearly defining the needs of patients in MSF clinics-as well as we can assess this-and by explaining why these tools are needed, how they should perform, and how their results can be integrated into a program, we will encourage the development of such tools and hasten their implementation in areas where they are so urgently neede

    Review of Two Decades of Cholera Diagnostics – How Far Have We Really Come?

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    BACKGROUND Cholera, an ancient scourge, continues to inflict high rates of mortality today. The rising incidence of epidemics in areas of poor sanitation and crowding highlight the need for better epidemic prevention and early response. Such interventions require the availability of rapid and accurate diagnostic techniques to trigger timely response and mitigate the scale of the outbreak. The current gold standard of bacterial culture is inadequate for rapid diagnosis, highlighting the overarching neglect of field diagnostic needs. This paper was written to support the World Health Organisation's Global Task Force on Cholera Control mandated Cholera and diarrhoeal disease laboratory Network (CholdiNet) in devising a protocol for the validation of Rapid Diagnostic Tests (RDTs) for Vibrio cholerae. The status of diagnostic tools for Vibrio cholerae is assessed, describing products that have been commercialised over the last two decades and discussing their peer-reviewed evaluation. METHOD Review of post-1990 peer-reviewed and grey literature on rapid diagnostic tests for Vibrio cholerae. RESULTS Since 1990, twenty four diagnostic tests have been developed for the detection of Vibrio cholerae in human faecal samples. Fourteen of these have also been described in the literature, with rapid chromatographic-immuno assays (CIA) featuring strongly. Polymerase chain reaction (PCR) assays maintain the ability to detect the lowest amount of bacteria; however CIAs achieve both low detection thresholds and high sensitivity and specificity, making them possible candidates for use in field conditions. Field and laboratory studies were performed in a wide range of settings demonstrating variability in performance, however only a few of these studies were sufficiently stringent, highlighting five RDTs that showed promise in field conditions; COAT, IP cholera dipstick, SMART, IP dipstick and Medicos. In light of non-independent reporting, the authors would like to see these five products undergoing additional studies, with further technical improvements if needed and commercial production. The authors hope that public health use of such a RDT in limited-resource field conditions on stool samples may contribute to effective reduction in cholera epidemic spread.This work was supported by an ANU Vice Chancellor’s travel grant. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscrip

    Evaluation of commercially available diagnostic tests for the detection of dengue virus NS1 antigen and anti-dengue virus IgM antibody.

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    Commercially available diagnostic test kits for detection of dengue virus (DENV) non-structural protein 1 (NS1) and anti-DENV IgM were evaluated for their sensitivity and specificity and other performance characteristics by a diagnostic laboratory network developed by World Health Organization (WHO), the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Pediatric Dengue Vaccine Initiative (PDVI). Each network laboratory contributed characterized serum specimens for the panels used in the evaluation. Microplate enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT formats) were represented by the kits. Each ELISA was evaluated by 2 laboratories and RDTs were evaluated by at least 3 laboratories. The reference tests for IgM anti-DENV were laboratory developed assays produced by the Armed Forces Research Institute for Medical Science (AFRIMS) and the Centers for Disease Control and Prevention (CDC), and the NS1 reference test was reverse transcriptase polymerase chain reaction (RT-PCR). Results were analyzed to determine sensitivity, specificity, inter-laboratory and inter-reader agreement, lot-to-lot variation and ease-of-use. NS1 ELISA sensitivity was 60-75% and specificity 71-80%; NS1 RDT sensitivity was 38-71% and specificity 76-80%; the IgM anti-DENV RDTs sensitivity was 30-96%, with a specificity of 86-92%, and IgM anti-DENV ELISA sensitivity was 96-98% and specificity 78-91%. NS1 tests were generally more sensitive in specimens from the acute phase of dengue and in primary DENV infection, whereas IgM anti-DENV tests were less sensitive in secondary DENV infections. The reproducibility of the NS1 RDTs ranged from 92-99% and the IgM anti-DENV RDTs from 88-94%

    The outcome of a test-treat package versus routine outpatient care for Ghanaian children with fever: a pragmatic randomized control trial

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    Background Over-diagnosis of malaria among African children results in mismanagement of non-malaria infections. Limited laboratory capacity makes it difficult to implement policies that recommend pre-treatment confirmation of infections so a new approach with a package for on-the-spot management of fevers was evaluated. Methods Febrile children presenting to outpatient clinic were randomized to receive either a ‘test-treat’ package (history with clinical examination; point-of-care tests; choice of artesunate-amodiaquine, co-amoxiclav and/or paracetamol) or routine outpatient care in a secondary health care facility in Kumasi, Ghana. A diagnosis of malaria, bacterial, viral or mixed malarial and bacterial infections was made using pre-defined criteria. Outcome was resolution of all symptoms including fever on day 7. Results The median age of the patients was 37.5 months (IQR: 19 to 66 months), with 56.7% being males. Compared to routine care the test-treat package resulted in less diagnoses of malaria, (37.2% vs 46.2%, p = 0.190) and mixed malaria and bacterial infections (14.0% vs 53.8%, p < 0.001) but more diagnoses of viral (33.1% vs 0.0%, p < 0.001) and bacterial infections only (15.7% vs 0.0%, p < 0.001). Less anti-malarials (51.2% vs 100.0%, p < 0.001) and antibiotics (29.7% vs 48.7%, p < 0.001), were prescribed in the test-treat group on completion of study, more test-treat package patients were clinically well (99.2% vs 80.7%, p < 0.001) and febrile (0.8% vs 10.1%, p = 0.001) and less were admitted for inpatient care (0.0% vs 8.4% p = 0.001) compared to the routine care group. Conclusion Test-treat package improves the effectiveness of outpatient diagnosis and treatment of children with fever and reduces inappropriate prescribing of anti-malarials and antibiotics. The package provides clinicians with the option for immediate diagnosis and treatment of non-malaria fevers. The test-treat package now needs to be evaluated in other settings including primary health care facilities

    Review of Two Decades of Cholera Diagnostics – How Far Have We Really Come?

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    <div><h3>Background</h3><p>Cholera, an ancient scourge, continues to inflict high rates of mortality today. The rising incidence of epidemics in areas of poor sanitation and crowding highlight the need for better epidemic prevention and early response. Such interventions require the availability of rapid and accurate diagnostic techniques to trigger timely response and mitigate the scale of the outbreak. The current gold standard of bacterial culture is inadequate for rapid diagnosis, highlighting the overarching neglect of field diagnostic needs. This paper was written to support the World Health Organisation's Global Task Force on Cholera Control mandated Cholera and diarrhoeal disease laboratory Network (CholdiNet) in devising a protocol for the validation of Rapid Diagnostic Tests (RDTs) for <em>Vibrio cholerae</em>. The status of diagnostic tools for <em>Vibrio cholerae</em> is assessed, describing products that have been commercialised over the last two decades and discussing their peer-reviewed evaluation.</p> <h3>Method</h3><p>Review of post-1990 peer-reviewed and grey literature on rapid diagnostic tests for <em>Vibrio cholerae</em>.</p> <h3>Results</h3><p>Since 1990, twenty four diagnostic tests have been developed for the detection of <em>Vibrio cholerae</em> in human faecal samples. Fourteen of these have also been described in the literature, with rapid chromatographic-immuno assays (CIA) featuring strongly. Polymerase chain reaction (PCR) assays maintain the ability to detect the lowest amount of bacteria; however CIAs achieve both low detection thresholds and high sensitivity and specificity, making them possible candidates for use in field conditions. Field and laboratory studies were performed in a wide range of settings demonstrating variability in performance, however only a few of these studies were sufficiently stringent, highlighting five RDTs that showed promise in field conditions; COAT, IP cholera dipstick, SMART, IP dipstick and Medicos. In light of non-independent reporting, the authors would like to see these five products undergoing additional studies, with further technical improvements if needed and commercial production. The authors hope that public health use of such a RDT in limited-resource field conditions on stool samples may contribute to effective reduction in cholera epidemic spread.</p> </div
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