Ali 2017
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, unclear manner of enrolment, retrospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: people with pulmonary TB, recently found to have smear‐positive sputum Age: ≤ 15 years 1 (0.8% ) 16 to 30 81 (64.3%) 31 to 45 23 (18.2%) 46 to 60 15 (11.9%) ≥ 60 6 (4.8%) Sex, female: 33% HIV infection: not reported History of TB: 57% Sample size: 126 Clinical setting: laboratory‐based Laboratory level: central Country: Sudan World Bank Income Classification: middle income High TB burden country: no High MDR‐TB burden country: no High TB/HIV burden country: no |
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| Index tests | Index: Xpert MTB/RIF | ||
| Target condition and reference standard(s) | Target condition: rifampicin resistance Reference standard for rifampicin resistance: LJ |
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| Flow and timing | |||
| Comparative | |||
| Notes | Participants were recruited from random geographical clusters during a one‐year period | ||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | Unclear | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | No | ||
| High | Unclear | ||
| DOMAIN 2: Index Test Xpert MTB/RIF | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| Low | Low | ||
| DOMAIN 3: Reference Standard | |||
| Is the reference standards likely to correctly classify the target condition? | Yes | ||
| Were the reference standard results for TB detection interpreted without knowledge of the results of the index test? | Unclear | ||
| Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test? | 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 | ||
| Low | |||