Abstract
In Bangladesh, serological tests have been widely used for the primary screening of visceral leishmaniasis (VL). Several serologic tests are available for the diagnosis of VL. Selection of the best test is important to permit diagnostic differentiation between symptomatic and asymptomatic patients and to reduce cross-reactivity. We evaluated the effectiveness of a new serological test “Onsite Leishmania Ab Rapid Test” as a part of “quality assurance” activities for the kala azar elimination programme of the Government of Bangladesh. Plasma samples of 100 parasitologically confirmed cases of VL along with 101 healthy controls were tested, and “Onsite Leishmania Ab Rapid Test” strip tests were positive in 94 out of 100 confirmed VL cases, whereas four out of 51 healthy subjects from the VL endemic areas also tested positive. All the 50 healthy volunteers tested negative. Thus, the sensitivity and specificity of “Onsite Leishmania Ab Rapid Test” strip test were found to be 94% (95% CI: 87–98) and 96% (95% CI: 90–99), respectively. This study showed that the performance of the “Onsite Leishmania Ab Rapid Test” strip tests was up to the recommended level.
Highlights
Kala azar or visceral leishmaniasis (VL) is a vector-borne parasitic disease endemic in 45 of districts of Bangladesh where million people have been estimated to be at risk of contracting the disease [1]
Elimination of kala azar from Bangladesh and its neighboring countries largely depends on strict adherence to the regional strategic plan that strongly recommends the use of rapid diagnostic tests for diagnosis of VL
The commitment of the Government of Bangladesh (GoB) to follow the national strategy for elimination of VL is reflected by the present study which was commissioned to ICDDR,B for quality assurance of the diagnostic kits procured by the programme
Summary
Kala azar or visceral leishmaniasis (VL) is a vector-borne parasitic disease endemic in 45 of districts of Bangladesh where million people have been estimated to be at risk of contracting the disease [1]. Bangladesh, and Nepal together account for about 60% of all the new cases of kala azar which is an estimated 500,000 every year [2]. The governments of India, Bangladesh, and Nepal signed an agreement in 2005 to make joint efforts to eliminate kala azar from this region. The Government of Bangladesh (GoB) procured a new RDT kit with the brand name of “Onsite Leishmania Ab Combo” (CTK Biotech Inc., San Diego, Calif, USA) for the kala azar elimination programme through open bidding as per existing policy. The aim of the study was to evaluate the sensitivity and specificity of “Onsite Leishmania Ab Rapid Test” strips to determine whether these kits conformed to the standard set by the kala azar elimination programme
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