Hanrahan 2013
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, consecutive enrolment, prospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: prolonged (> 2 weeks) cough and/or other TB symptoms Age: 18 years and older, median 35 years (IQR 29 to 44) Sex, female: 65% HIV infection: 69% History of TB: 10% Sample size: 553 Clinical setting: outpatient Laboratory level: peripheral Country: South Africa, Johannesburg World Bank Income Classification: middle income High TB burden country: yes High MDR‐TB burden country: yes High TB/HIV burden country: yes TB incidence rate: 993 per 100,000 MDR‐TB prevalence: % MDR‐TB among new TB cases = 1.4% (Source: survey in Gauteng province, 2002) and among retreatment cases = 5.5% (Source: survey in Gauteng province, 2002) Prevalence of TB cases in the study: 11.6% |
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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: MGIT 960 |
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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 | 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 | 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? | Yes | ||
| Low | |||