Boehme 2011

Study characteristics
Patient sampling	Cross‐sectional design, consecutive enrolment, prospective data collection, site in a multicentre study
Patient characteristics and setting	Presenting signs and symptoms: cough lasting at least 2 weeks Age: median 38 years (IQR 29 to 50) Sex, female: 39% HIV infection: 19% History of TB: not reported Sample size: 6648 Clinical setting: special facility for prisoners (Azerbaijan); 2 health centres and 1 district hospital (Peru); 1 health centre and 1 provincial hospital (South Africa, Cape Town); emergency unit of referral hospital (Uganda); health centre (India); MDR‐TB evaluation facility (Philippines) Laboratory level: central (Azerbaijan, Peru, Philippines, South Africa, Uganda); intermediate (India) Country: Azerbaijan, India, Peru, Philippines, South Africa, Uganda World Bank Income Classification: middle income (Azerbaijan, India, South Africa, Philippines); low income (Uganda) High TB burden country: yes (India, Philippines, South Africa) High MDR‐TB burden country: yes (Azerbaijan, India, Peru, Philippines, South Africa) High TB/HIV burden country: yes (India, South Africa, Uganda) Prevalence of TB cases in the study: 26.4%
Index tests	Index: Xpert MTB/RIF
Target condition and reference standard(s)	Target condition: pulmonary TB Reference standard for pulmonary TB: LJ, Ogawa, MGIT 960 Target condition: rifampicin resistance Reference standard for rifampicin resistance: LJ proportion method; MGIT 960; MTBDRplus
Flow and timing	Participants who were smear‐negative and culture‐negative but treated for TB on the basis of clinical and radiological findings (clinical tuberculosis) were not included in determination of specificity
Comparative
Notes	Follow‐up reported for all sites combined: 24/153 participants with culture‐negative, clinically‐diagnosed TB had positive results on MTB/RIF testing. 20/24 participants had follow‐up, and all 20 improved on TB treatment
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?	No
		High