Mbelele 2017

Study characteristics
Patient sampling	Cross‐sectional design, unknown manner of enrolment, prospective data collection
Patient characteristics and setting	Presenting signs and symptoms: presumed pulmonary TB Age: 18 years and older, mean 43 years (SD 15) Sex, female: 66% HIV infection: 15% History of TB: 14% Sample size: 262 Clinical setting: not reported Laboratory level: central Country: Tanzania World Bank Income Classification: low income High TB burden country: yes High MDR‐TB burden country: no High TB/HIV burden country: yes Prevalence of TB cases in the study: 32.4%
Index tests	Index: Xpert MTB/RIF
Target condition and reference standard(s)	Target condition: pulmonary TB Reference standard for pulmonary TB: LJ
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?	Unclear
		Unclear	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