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- Title
Impact of the Use of a Rapid Diagnostic Test for Visceral Leishmaniasis on Clinical Practice in Ethiopia: A Retrospective Study.
- Authors
Diro, Ermias; Lynen, Lutgarde; Assefa, Mahlet; Takele, Yegnasew; Mengesha, Bewketu; Adem, Emebet; Mohammed, Rezika; Kimutai, Robert; Hailu, Asrat; Boelaert, Marleen; van Griensven, Johan
- Abstract
Background: Diagnostic 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. Methods: Retrospective 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/Findings: From 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 / Discussion: A 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. Author Summary: The introduction of RDTs is one of the major advancements in leishmaniasis control programs. While the variability in performance from one endemic region to the other is well recognized, the utilization of these RDTs in the routine clinical setting has not been evaluated to date. In this study, we showed that the RDT use in routine practice setting has large deviations from the guidelines. Clinical suspicion of VL should be based on the full criteria of case definition as is recommended in the guidelines and the presence of the criteria should be checked by clinicians before requesting the RDT. Not respecting these clinical criteria can lead to low pretest probability of the disease and eventually low positive predictive value of the test used. Additionally, introducing regular monitoring activities with training and quality assurance system for leishmania RDTs is very important.
- Subjects
ETHIOPIA; RAPID diagnostic tests; VISCERAL leishmaniasis; AGGLUTINATION tests; DIAGNOSIS of HIV infections; BONE marrow
- Publication
PLoS Neglected Tropical Diseases, 2015, Vol 9, Issue 5, p1
- ISSN
1935-2727
- Publication type
Article
- DOI
10.1371/journal.pntd.0003738