Moure 2011
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, enrolment by convenience, retrospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: not reported; participants found to be smear‐negative on microscopy Age: older than 15 years; mean: 42 years Sex, female: not reported HIV infection: not reported History of TB: not reported Sample size: 107 Clinical setting: laboratory‐based Laboratory level: central Country: Spain World Bank Income Classification: high income High TB burden country: no High MDR‐TB burden country: no High TB/HIV burden country: no TB incidence rate: 15 per 100,000 MDR‐TB prevalence: percentage MDR‐TB among new TB cases = 0.2% (Source: Survey in Galicia region, 2005) and among retreatment cases = 1.5% (Source: Survey in Galicia region, 2005) Prevalence of TB cases in the study: 72.9% |
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| Index tests | Index: Xpert MTB/RIF | ||
| Target condition and reference standard(s) | Target condition: pulmonary TB Reference standard for pulmonary TB: LJ culture and MGIT 960 |
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| Flow and timing | |||
| Comparative | |||
| Notes | Sample set included 1 pulmonary biopsy specimen Of 85 pulmonary and extrapulmonary specimens tested, 6 were positive by Xpert MTB/RIF for rifampicin resistance, and 7 specimens were positive by the reference standard |
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| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | No | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| High | Low | ||
| 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 | Unclear | ||
| 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? | Yes | ||
| 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 | |||