Sundar 2007.

Study characteristics
Patient sampling	Consecutive and prospective enrolment of patients with suspected VL
Patient characteristics and setting	Sample size: 352 Age: median 15 years; interquartile range 2‐65 Sex: 55% men Presenting signs and symptoms: fever for 2 weeks or more and splenomegaly No children < 1 year old; no pregnant women; no people with past kala‐azar history Frequency of VL: 80% HIV: known HIV infection exclusion criterion Clinical setting: two research centres, in Muzaffarpur and Patna Country: India Endemic Leishmania species:L. donovani
Index tests	Type: rK39 immunochromatographic test; Brand: InBios International, Washington, USA; Sample: serum or blood Type: rK26 immunochromatographic test; Brand: InBios International, Washington, USA; Sample: serum or blood Type: latex agglutination test in urine; Brand: KAtex, Kalon Biologicals, Aldershot, UK; Sample: fresh urine
Target condition and reference standard(s)	Target condition: clinical VL Combination of parasitology (direct smear, Giemsa stain) of spleen aspirate sample and serology (DAT) and clinical diagnosis / follow‐up / response to therapy Definition of VL: (1) spleen parasitology positive; or (2) clinical diagnosis and DAT positive ≥ 1:3200 and response to anti‐leishmanial therapy Definition of non‐VL: spleen parasitology negative and alternative diagnosis and no VL during follow‐up of six months Reference standard category: combination of parasitology and serology
Flow and timing	No withdrawals explained.
Comparative
Notes	Same study as Boelaert 2008 ‐ India but different analysis and additional test (rK26 immunochromatographic test). Group of 100 healthy endemic controls not included in this review.
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?	Yes
		Low	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?	Yes
		Low	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