Luetkemeyer 2016
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, unknown manner of enrolment, prospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: cough, fever, night sweats, or weight loss Age: 18 years and older, median 46 years (IQR 35 to 54) Sex, female: 38% HIV infection: 45% History of TB: 13% Sample size: 992 Clinical setting: inpatient and outpatient Laboratory level: central Country: Brazil, South Africa and USA World Bank Income Classification: high and middle income High TB burden country: yes (South Africa), no (USA) High MDR‐TB burden country: yes (South Africa), no (USA) High TB/HIV burden country: yes (South Africa), no (USA) Prevalence of TB cases in the study: 22.4 |
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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: solid media and MGIT 960 Target condition: rifampicin resistance Reference standard for rifampicin resistance: Middlebrook agar |
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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? | Unclear | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| Unclear | 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 | |||