Machado de Assis 2012.
| Study characteristics | |||
| Patient sampling | Consecutive and prospective enrolment of patients with suspected VL | ||
| Patient characteristics and setting |
Sample size: 404 Age: median 13 years; range 1 month ‐ 77 years; standard deviation 17 years Sex: 58% men Presenting signs and symptoms: fever + coming from endemic area + one of the following: splenomegaly, hepatomegaly, anaemia, leucopenia, and thrombocytopaenia Frequency of VL: 67% HIV: people with known immunodeficiency were excluded Clinical setting: two university hospitals and two research centres in four different states Country: Brazil Endemic Leishmania species:L. infantum |
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| Index tests | Type: rK39 immunochromatographic test; Brand: IT‐LEISH, DiaMed Latino‐America S.A, Cressier sur Morat, Switzerland; Sample: finger prick sample of blood | ||
| Target condition and reference standard(s) |
Target condition: clinical VL Sample: bone marrow Approach: latent class analysis Tests included in latent class analysis: rK39 immunochromatographic test, rK39‐ELISA, IFAT, DAT, microscopy of bone marrow sample |
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| Flow and timing | People with missing data or inconclusive test results were not mentioned | ||
| Comparative | |||
| Notes | Same study as Machado de Assis 2011 but different analysis. Same study as Peruhype‐Magalhaes 2012 but different brand of index test. | ||
| 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? | Unclear | ||
| Did the study avoid inappropriate exclusions? | Unclear | ||
| Unclear | 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? | Unclear | ||
| Did all patients receive a reference standard? | Yes | ||
| Unclear | |||