Diro 2007.

Study characteristics
Patient sampling	Consecutive and prospective enrolment of patients with suspected VL
Patient characteristics and setting	Sample size: 38 Age: median 25 years; range 16‐49. No children ≤ 12 years Sex: 95% men Presenting signs and symptoms: fever of 2 weeks or more, and splenomegaly or lymphadenopathy or both Pregnant women and people with a previous history of VL treatment were not included. Patients with a thick‐film‐positive malaria episode were excluded. Frequency of VL: 61% HIV: not tested Clinical setting: university hospital (Kahsay Abera Hospital in Humera and Gondar College of Medical Sciences) Country: Ethiopia Endemic Leishmania species:L. donovani
Index tests	Type: rK39 immunochromatographic test; Brand: Kalazar Detect, InBios International, Washington, USA; Sample: serum Type: Latex agglutination test in urine; Brand: KAtex, Kalon Biologicals Ltd, Guildford, UK; Sample: fresh urine
Target condition and reference standard(s)	Target condition: clinical VL Sample: spleen or lymph node aspirate Technique: parasitology: culture or direct smear (Giemsa stain) Reference standard category: parasitology including spleen aspirate ‐ no serology
Flow and timing
Comparative
Notes	Findings in context of active case detection were not included in this review. Same study as Boelaert 2008 ‐ Ethiopia but different analysis.
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Yes
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Yes
		Low	Low
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard?	Unclear
		Unclear	Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Unclear
		Unclear	Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Yes
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
Did all patients receive a reference standard?	Yes
		Low