Marcy 2016.

Study characteristics
Patient Sampling	Cohort, manner of selection not reported, prospective
Patient characteristics and setting	Presenting signs and symptoms: children aged ≤ 13 years with suspicion of intrathoracic tuberculosis based on ≥ 1 of the following: persistent cough; persistent fever; failure to thrive, defined as recent deviation in the growth curve or weight‐for‐age z‐score < −2 standard deviations; failure of broad‐spectrum antibiotics for pulmonary infection; suggestive chest radiograph anomaly Age, months: median (IQR) 86 (49 to 85) Sex, female: 49% HIV infection: 100% Sample size included for analysis: 272 Clinical setting: not reported Laboratory level where index test was performed: not reported Country: Burkina Faso; Cambodia; Cameroon; Vietnam World Bank income classification: low and 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: 11%
Index tests	Xpert MTB/RIF
Target condition and reference standard(s)	Pulmonary tuberculosis MGIT and LJ; composite reference standard
Flow and timing	Index and reference tests were collected within pre‐specified time period
Comparative
Notes	No method for stool processing with Xpert has been established; 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?	Unclear
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?			Low concern
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