Helb 2010
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, consecutive enrolment, retrospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: cough lasting at least 2 weeks Age: median 34 years, range 18 to 76 years Sex, female: 30.8% HIV infection: 0.9% History of TB: 1.9% Sample size: 107 Clinical setting: TB hospital, unclear whether inpatient or outpatient or both Laboratory level: central Country: Vietnam World Bank Income Classification: middle income High TB burden country: yes High MDR‐TB burden country: yes High TB/HIV burden country: no TB incidence rate: 199 per 100,000 MDR‐TB prevalence: Percent MDR‐TB among new TB cases = 2.7% (Source: nationwide survey, 2006) and among retreatment cases = 19% (Source: nationwide survey, 2006) Proportion of TB cases in the study: 76.6% |
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| Index tests | Index: Xpert MTB/RIF assay | ||
| Target condition and reference standard(s) | Target condition: pulmonary TB Reference standard: LJ culture and MGIT 960 |
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| Flow and timing | |||
| Comparative | |||
| Notes | Rifampicin resistance data were not reported | ||
| 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? | 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? | Unclear | ||
| Unclear | |||