Abstract
BackgroundDiagnostic guidelines for Visceral Leishmaniasis (VL) in the East African region are complex. Patients meeting the VL clinical case definition should be tested by rK39 rapid diagnostic test (RDT) followed by the Direct Agglutination Test (DAT) or tissue aspiration if RDT-negative. Otherwise, RDT-positive patients should be started on VL treatment. We evaluated how this guideline is adhered to by assessing the routine clinical practice in a university hospital in North-West Ethiopia.MethodsRetrospective record analysis was done for all patients who had an rK39-RDT done at University of Gondar (UoG) Hospital between June 2012 and June 2013. We described the diagnostic work-up performed and the proportion initiated on VL treatment by test result.Results/FindingsFrom a total of 928 patients tested, 308 (33.2%) were rK39 RDT-positive. Spleen or bone marrow aspiration was done for 237 (77.2%) RDT-positive patients. Of these, 165 were confirmed parasitologically, yielding a positive predictive value of 69.6%. Only 126 (20.3%) of the 620 patients with a negative rK39 test underwent further testing by tissue aspiration, of which 22 (17.5%) were also parasitology positive. HIV test results were available for 570 (61.4%) patients and 36 (6.3%) were HIV-infected. Of the 187 parasitologically confirmed patients, 182 (97.3%) were started on VL treatment.Conclusions / DiscussionA negative rK39 test was often not followed by further testing and a positive rK39 test result was followed by tissue aspiration in three out of four cases. Further research is required to understand why the diagnostic work-up did not comply with the guidelines, including evaluating adherence to the VL clinical case definition and quality of rK39-RDT testing.
Highlights
Visceral leishmaniasis (VL) is a vector borne, fatal disease caused by the protozoan parasite Leishmania
While the variability in performance from one endemic region to the other is well recognized, the utilization of these Rapid diagnostic tests (RDT) in the routine clinical setting has not been evaluated to date
We showed that the RDT use in routine practice setting has large deviations from the guidelines
Summary
Visceral leishmaniasis (VL) is a vector borne, fatal disease caused by the protozoan parasite Leishmania. While the diagnostic performance of this test was found to be consistently high in the Indian sub-continent, its sensitivity was suboptimal in the East-African region [5,6,7,8,9,10,11,12,13,14,15,16,17,18,19]. Because antileishmanial antibodies wane only slowly after treatment, the rK39 RDT remains positive for several months to years after treatment, making the test useless to diagnose VL relapse in a patient who presents again with fever after an initial cure. Diagnostic guidelines for Visceral Leishmaniasis (VL) in the East African region are complex.
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