Chipinduro 2017.

Study characteristics
Patient Sampling	Cross‐sectional, manner of selection not reported, unknown
Patient characteristics and setting	Presenting signs and symptoms: participants were children 5 to 16 years of age presenting with a chronic cough of 2 weeks and any of the classic signs and symptoms of TB, including weight loss, loss of appetite, persistent fever without an apparent cause, night sweats, or history of close contact with a TB index patient, defined as living in close proximity (sharing a room within a household) with an adult diagnosed with TB within the preceding 12 months Age, months: median 127 Sex, female: 56% HIV infection: 50% Sample size included for analysis: 218 Clinical setting: outpatient Laboratory level where index test was performed: not reported Country: Zimbabwe 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: 9%
Index tests	Xpert MTB/RIF
Target condition and reference standard(s)	Pulmonary tuberculosis Solid culture (LJ); composite reference standard; clinical reference standard
Flow and timing	Index test and reference standard were collected within pre‐specified interval
Comparative
Notes	Study evaluated Xpert MTB/RIF in stool and induced sputum; no consensus has been reached on the proper stool processing method for 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?	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?	Unclear
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?		Unclear 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