Short Communication: Evaluation of a New Rapid Diagnostic Test for Quality Assurance by Kala Azar Elimination Programme in Bangladesh

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.

Leishmaniasis: bone marrow aspirate smear and rapid antibody test

“…A new rapid test might be a solution and a less invasive technique. Nevertheless, the problem of the diagnostic properties of the available rapid test is frequently reported [ 3 ]. There are many possible explanations for false negative results.…”

Diagnostic accuracy of loop-mediated isothermal amplification (LAMP) for detection of Leishmania DNA in buffy coat from visceral leishmaniasis patients

“…Serological methods like direct agglutination test (DAT) and rK39 (recombinant k39 antigen-based immunochromatographic strip test) dipstick are now well standardized [3-5], but these tests are only for antibody detection and assessment of cure after treatment and discrimination between symptomatic and asymptomatic cases is not possible. Moreover, cross reactivity with other diseases and inconsistent performance in the case of HIV-VL co-infection are among other major obstacles of the serological tests [6].…”