Study characteristics | |||
Patient sampling | Cross‐sectional design, unknown manner of enrolment, prospective data collection | ||
Patient characteristics and setting | Presenting signs and symptoms: clinical signs of pulmonary TB Age: 18 to 60 years Sex, female: not reported HIV infection: 0% History of TB: not reported Sample size: 218 Clinical setting: laboratory‐based Laboratory level: central Country: Egypt World Bank Income Classification: middle income High TB burden country: no High MDR‐TB burden country: no High TB/HIV burden country: no Prevalence of TB cases in the study: 32.1% |
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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 Target condition: rifampicin resistance Reference standard for rifampicin resistance: Middlebrook 7H11 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 | 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? | Yes | ||
Low |