Boelaert 2004 ‐ classic.
| Study characteristics | |||
| Patient sampling | Consecutive and prospective enrolment of patients with suspected VL | ||
| Patient characteristics and setting |
Sample size: 310 Age (reported for 181 new VL cases): median 25, interquartile range 13‐36 Sex (reported for 181 new VL cases): male:female ratio 1.7:1 Presenting signs and symptoms: fever of 14 days or more and splenomegaly Frequency of VL: 59% HIV: not reported Clinical setting: tertiary care centre (B.P. Koirala Institute of Health Sciences in Dharan) Country: Nepal Endemic Leishmania species:L. donovani |
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| Index tests |
Type: rK39 immunochromatographic test Brand: InSure Rapid test for Visceral Leishmaniasis, InBios International, Washington, USA Sample: serum |
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| Target condition and reference standard(s) |
Target condition: clinical VL (3/310 participants were relapse cases) Sample: bone marrow; if negative, possible and no malaria: spleen Technique: direct smear (Giemsa stain) Definition of VL: bone marrow or spleen parasitology positive Definition of non‐VL: bone marrow negative, and spleen negative or spleen aspirate not done Reference standard category: parasitology including spleen aspirate ‐ no serology |
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| Flow and timing | one participant was excluded because of a missing serum sample | ||
| Comparative | |||
| Notes | Same study as Boelaert 2004 ‐ LCA 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 | |||