Walters 2017a.

Study characteristics
Patient Sampling	Cohort, consecutive, prospective
Patient characteristics and setting	Presenting signs and symptoms: 1 or more of cough ≥ 2 weeks, unexplained fever of ≥ 1 week, or poor growth or weight loss over preceding 3 months. Also included were children with any duration of cough, if 1 or more of the following were present: exposure to an identified TB source case in the past 12 months, positive tuberculin skin test if previously negative or unknown, or chest radiograph suggestive of TB as assessed by the study clinician. Infants younger than 3 months were also eligible if they had pneumonia unresponsive to appropriate antimicrobials, or unexplained and unresponsive sepsis syndrome Age, months: median (IQR) 16 (9 to 29) Sex, female: 48% HIV infection: 13% Sample size included for analysis: 379 Clinical setting: inpatient Laboratory level where index test was performed: intermediate Country: South Africa World Bank income classification: middle income High TB burden country: yes High TB/HIV burden country: yes High MDR‐TB burden country: yes Prevalence of tuberculosis cases in the study: 18%
Index tests	Xpert MTB/RIF
Target condition and reference standard(s)	Pulmonary tuberculosis MGIT; composite reference standard; clinical reference standard
Flow and timing	Index and reference tests were collected within pre‐specified time period
Comparative
Notes	No consensus has been reached for stool processing before Xpert; this study used centrifugation
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Yes
Did the study avoid inappropriate exclusions?	Yes
Could the selection of patients have introduced bias?		Low risk
Are there concerns that the included patients and setting do not match the review question?			High
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
Could the conduct or interpretation of the index test have introduced bias?		Low risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Unclear
DOMAIN 2: Index Test (Xpert Ultra)
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Yes
Could the reference standard, its conduct, or its interpretation have introduced bias?		Low risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			Low concern
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
Could the patient flow have introduced bias?		Low risk