Dorman 2018

Study characteristics
Patient sampling	Cross‐sectional design, consecutive enrolment, prospective data collection, multicentre study
Patient characteristics and setting	Presenting signs and symptoms: presumed pulmonary TB Age: adults, median 28 years (IQR 28 to 50) Sex, female: 40% HIV infection: 44% History of TB: 21% Sample size: 1439 for detection of MTB, 551 for rifampicin resistance Clinical setting: both outpatient and inpatient Laboratory level: central (reference) Country: Belarus, Brazil, China, Georgia, India, Kenya, South Africa, Uganda World Bank Income Classification: low and middle income High TB burden country: yes (Brazil, China, India, Kenya, South Africa) High MDR‐TB burden country: yes (Belarus, China, India, Kenya, South Africa) High TB/HIV burden country: yes (Brazil, China, India, Kenya, South Africa, Uganda) Prevalence of TB cases in the study: 32.1%
Index tests	Index: Xpert MTB/RIF and Xpert Ultra
Target condition and reference standard(s)	Target condition: pulmonary TB Reference standard for pulmonary TB: LJ and MGIT 960 Target condition: rifampicin resistance Reference standard for rifampicin resistance: MGIT 960
Flow and timing
Comparative
Notes	25 participants (3%) who were smear‐positive but in whom all cultures were negative were excluded from the analysis
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
		Unclear