Abstract
BackgroundVisceral leishmaniasis (VL) is a systemic parasitic disease that is fatal unless treated. In Kenya, national VL guidelines rely on microscopic examination of spleen aspirate to confirm diagnosis. As this procedure is invasive, it cannot be safely implemented in peripheral health structures, where non-invasive, accurate, easy to use diagnostic tests are needed.MethodologyWe evaluated the sensitivity, specificity and predictive values of two rapid diagnostic tests (RDT), DiaMed IT LEISH and Signal-KA, among consecutive patients with clinical suspicion of VL in two treatment centres located in Baringo and North Pokot District, Rift Valley province, Kenya. Microscopic examination of spleen aspirate was the reference diagnostic standard. Patients were prospectively recruited between May 2010 and July 2011.Principal FindingsOf 251 eligible patients, 219 patients were analyzed, including 131 VL and 88 non-VL patients. The median age of VL patients was 16 years with predominance of males (66%). None of the tested VL patients were co-infected with HIV. Sensitivity and specificity of the DiaMed IT LEISH were 89.3% (95%CI: 82.7–94%) and 89.8% (95%CI: 81.5–95.2%), respectively. The Signal KA showed trends towards lower sensitivity (77.1%; 95%CI: 68.9–84%) and higher specificity (95.5%; 95%CI: 88.7–98.7%). Combining the tests did not improve the overall diagnostic performance, as all patients with a positive Signal KA were also positive with the DiaMed IT LEISH.Conclusion/SignificanceThe DiaMed IT LEISH can be used to diagnose VL in Kenyan peripheral health facilities where microscopic examination of spleen aspirate or sophisticated serological techniques are not feasible. There is a crucial need for an improved RDT for VL diagnosis in East Africa.
Highlights
Visceral Leishmaniasis (VL), known as kala-azar, is a systemic parasitic disease transmitted through the bite of an infected phlebotomine sandfly
A recent phase II multicentric evaluation of several rapid diagnostic tests (RDT) in East Africa led to similar findings; in this study sponsored by World Health Organisation (WHO)/Special Programme for Research and Training in Tropical Diseases (TDR), sensitivity of the DiaMed IT LEISH (87.2%; 95%CI: 82.5–90.8%) was significantly higher than the Signal KA (73.2%; 95%CI: 67.4–78.3%) [15,16]
The specificity estimates of the DiaMed IT LEISH (89.8%; 95%CI: 81.5–95.2%) and the Signal KA (95.5%; 95%CI: 88.7– 98.7%) were statistically comparable
Summary
Visceral Leishmaniasis (VL), known as kala-azar, is a systemic parasitic disease transmitted through the bite of an infected phlebotomine sandfly It is usually fatal if left untreated. According to Kenyan national guidelines for VL, demonstration of parasite amastigotes by microscopic examination of smears from splenic aspirates is needed to confirm diagnosis and initiate treatment. Splenic aspiration is an invasive procedure that is highly sensitive (93.1–98.7%) but carries a small but significant risk of major bleeding [3,4] It should be performed by experienced clinicians in reference hospitals or research centers, and is not suitable for use in first-line health services or district hospitals. In Kenya, national VL guidelines rely on microscopic examination of spleen aspirate to confirm diagnosis As this procedure is invasive, it cannot be safely implemented in peripheral health structures, where non-invasive, accurate, easy to use diagnostic tests are needed
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