Bates 2013.

Study characteristics
Patient Sampling	Cross‐sectional design, manner of selection not reported, prospective
Patient characteristics and setting	Presenting signs and symptoms: suspected tuberculosis defined as having tuberculosis on the basis of a symptom‐and‐risk factor screen (≥ 1 of 5 factors: cough for longer than 2 weeks, weight loss, malnutrition, HIV, or tuberculosis contact) according to the Zambia National TB Programme and WHO guidelines Age: median (IQR) 24 (12 to 74) months Sex, female: not reported HIV infection: 32% Sample size included for analysis: 142 for expectorated sputum; 788 for gastric aspirate lavage Clinical setting: inpatient Laboratory level where index test was performed: university hospital laboratory (tertiary referral centre) Country: Zambia World Bank income classification: middle income High TB burden country: yes High TB/HIV burden country: yes High MDR‐TB burden country: no Prevalence of TB cases in the study: 5%
Index tests	Xpert MTB/RIF
Target condition and reference standard(s)	Target condition: pulmonary tuberculosis Reference standard: MGIT
Flow and timing	Index and reference tests were collected simultaneously
Comparative
Notes	Only 1 culture was used to exclude TB, indicating an unclear ability of the reference standard to classify the target condition
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?			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?			Low concern
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