Zetola 2014
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, consecutive enrolment, retrospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: (i) people with presumed pulmonary TB at high risk for MDR‐TB, (ii) people who had been treated with anti‐TB drugs and in whom TB had again been diagnosed, i.e. all retreatment categories (failure, default, and relapse), (iii) HIV‐positive people with signs or symptoms of TB, (iv) people who were seriously ill and suspected of having TB regardless of HIV status, and (v) people with unknown HIV status presenting with clinical evidence of HIV infection and signs or symptoms of PTB Age: 18 years or older, median 37 years (IQR 31 to 44) Sex, female: 40% HIV infection: 75% History of TB: 62% Sample size: 370 Clinical setting: not reported Laboratory level: central Country: Botswana World Bank Income Classification: middle income High TB burden country: no High MDR‐TB burden country: no High TB/HIV burden country: yes |
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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 | |||
| 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 | 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? | |||
| Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test? | Yes | ||
| Low | 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 | |||