Chappuis 2003.

Study characteristics
Patient sampling	Consecutive and prospective enrolment of patients with suspected VL
Patient characteristics and setting	Sample size: 195 Age (data available for 184 included participants): mean 23 years Sex (data available for 184 included participants): 59% men Presenting signs and symptoms: fever for 2 weeks or more and clinical splenomegaly Frequency of VL: 76% HIV: 0% Clinical setting: tertiary care centre (B.P. Koirala Institute of Health Sciences in Dharan) Country: Nepal Endemic Leishmania species:L. donovani
Index tests	Type: rK39 immunochromatographic test; Brand: InSure Rapid Test for Visceral Leishmaniasis, InBios Interational, Washington, USA; Sample: serum
Target condition and reference standard(s)	Target condition: clinical VL Sample: bone marrow; if bone marrow negative and spleen aspiration possible: spleen Technique: direct smear examination Reference standard category: parasitology including spleen aspirate ‐ no serology
Flow and timing	Eleven participants with an uncertain diagnosis were excluded.
Comparative
Notes
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?	Unclear
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