ter Horst 2009 ‐ HIV neg.
| Study characteristics | |||
| Patient sampling | Consecutive and prospective enrolment of patients with suspected VL | ||
| Patient characteristics and setting |
Sample size: 179 Age: reported for larger population (n = 699): mean age is 25,4 (standard deviation 10,1) Sex: reported for larger population (n = 699): ratio men:women is 15:1 Presenting signs and symptoms: clinical VL case definition (not specified) No patients with previous history of VL treatment. Frequency of VL: 94% HIV: all HIV negative Clinical setting: kala‐azar treatment centre supported by Médecins sans frontières (Kahsay Abera Hospital in Humera) Country: Ethiopia Endemic Leishmania species:L. donovani |
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| Index tests | Type: rK39 immunochromatographic test; Brand: DiaMed AG, Switzerland; Sample: blood | ||
| Target condition and reference standard(s) |
Target condition: clinical VL Combination of parasitology (direct smear, Giemsa stain) of spleen aspirate sample and serology (DAT) Definition of VL: (1) spleen parasitology positive; or (2) DAT positive ≥ 1:3200 Definition of non‐VL: (1) DAT ≤ 1:400; or (2) DAT≤ 1:3200 and spleen parasitology negative Reference standard category: combination of parasitology and serology |
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| Flow and timing | Many patients with unknown HIV status were not included. | ||
| 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? | Unclear | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
| 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? | Unclear | ||
| Were all patients included in the analysis? | No | ||
| Did all patients receive a reference standard? | Yes | ||
| High | |||