Boelaert 2008 ‐ Sudan.
| Study characteristics | |||
| Patient sampling | Consecutive and prospective enrolment of patients with suspected VL | ||
| Patient characteristics and setting |
Sample size: 294 Age: median 20 years; range 2‐72; 36% of the study population was ≤12 years old Sex: 64% men Presenting signs and symptoms: fever for 2 weeks or more, and splenomegaly or lymphadenopathy or both No children < 2 years old; no pregnant women; no patients with a thick‐film‐positive malaria episode Estimated frequency of VL: 37% HIV: not reported Clinical setting: two health centres (Umalkhair and Tabarakelleh) Country: Sudan Endemic Leishmania species:L. donovani |
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| Index tests |
Type: rK39 immunochromatographic test; Brand: Kalazar Detect, InBios International, Washington, USA; Sample: serum Type: latex agglutination test in urine; Brand: KAtex, Kalon Biological Ltd, Guildford, UK; Sample: fresh urine |
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| Target condition and reference standard(s) |
Target condition: clinical VL Approach: latent class analysis Tests included in latent class analysis: rK39 immunochromatographic test, latex agglutination, DAT, and parasitology (direct smear (Giemsa stain)) of lymph node, bone marrow or spleen sample |
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| Flow and timing | Three participants were excluded because of missing data. | ||
| 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? | 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? | 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 | |||