title: Impact of the use of a rapid diagnostic test for visceral leishmaniasis on clinical practice in Ethiopia: a retrospective study.
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
  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
  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.
authors.affiliation: University of Gondar, Gondar, Ethiopia; Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Ermias
authors.initials: E
authors.lastname: Diro
authors.affiliation: Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Lutgarde
authors.initials: L
authors.lastname: Lynen
authors.affiliation: Yale University, Hartford, Connecticut, United States of America.
authors.forename: Mahlet
authors.initials: M
authors.lastname: Assefa
authors.affiliation: University of Gondar, Gondar, Ethiopia.
authors.forename: Yegnasew
authors.initials: Y
authors.lastname: Takele
authors.affiliation: University of Gondar, Gondar, Ethiopia.
authors.forename: Bewketu
authors.initials: B
authors.lastname: Mengesha
authors.affiliation: University of Gondar, Gondar, Ethiopia.
authors.forename: Emebet
authors.initials: E
authors.lastname: Adem
authors.affiliation: University of Gondar, Gondar, Ethiopia.
authors.forename: Rezika
authors.initials: R
authors.lastname: Mohammed
authors.affiliation: Drugs for Neglected Diseases initiative (DNDi) Africa, Nairobi, Kenya.
authors.forename: Robert
authors.initials: R
authors.lastname: Kimutai
authors.affiliation: Addis Ababa University, Addis Ababa, Ethiopia.
authors.forename: Asrat
authors.initials: A
authors.lastname: Hailu
authors.affiliation: Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Marleen
authors.initials: M
authors.lastname: Boelaert
authors.affiliation: Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: van Griensven
mesh_terms: D000328:Adult; D000372:Agglutination Tests / Q000379:methods; D000953:Antigens, Protozoan / Q000276:immunology*; D001853:Bone Marrow / Q000276:immunology; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005002:Ethiopia; D005260:Female; D019983:Guideline Adherence; D015658:HIV Infections / Q000175:diagnosis / Q000276:immunology; D006761:Hospitals; D006801:Humans; D007898:Leishmaniasis, Visceral / Q000175:diagnosis*; D008297:Male; D017410:Practice Guidelines as Topic; D015800:Protozoan Proteins / Q000276:immunology*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013154:Spleen / Q000276:immunology; D055815:Young Adult
chemical_list: D000953:Antigens, Protozoan; D015800:Protozoan Proteins; C079253:K39 antigen, Leishmania