Vadwai 2011.

Study characteristics
Patient Sampling	Cross‐sectional, consecutive, prospective
Patient characteristics and setting	Presenting signs and symptoms: suspected extrapulmonary TB based on symptoms: brain: irritability, restlessness, neck stiffness, headache persistent for 2 to 3 weeks, vomiting, seizures, changes in mental condition or behaviour; intestinal tract, abdomen: abdominal pain, diarrhoea; lymph nodes: enlargement of lymph nodes, mass formation in the neck; cardiorespiratory: shortness of breath, hypertension, chest pain, dyspnoea; endometrium: pelvic pain, pelvic mass, irregular periods, infertility; skin (cutaneous): visible presence of ulcers or lesions, tender nodules Age: median 37 years Sex, female: 15% Children: 3% HIV infection: 3% Clinical setting: tertiary care centre Past history of TB: not reported Patients on anti‐TB treatment: no Number of specimens evaluated: 60 Laboratory level: central Country: India World Bank Income Classification: middle income High TB burden: yes High TB/HIV burden: yes High MDR‐TB burden: yes
Index tests	Xpert MTB/RIF WHO SOP or manufacturer's protocol followed: yes for pleural fluid, peritoneal fluid, pericardial fluid; no for CSF Manufacturer's involvement: yes, in design, analysis, or manuscript production (David Alland is among a group of co‐investigators who invented molecular beacons and receive income from licensees, including to Cepheid, for M tuberculosis detection)
Target condition and reference standard(s)	Target condition: pleural TB, TB meningitis, peritoneal TB, pericardial TB Reference standard TB detection: LJ and MGIT Reference standard rifampicin resistance detection: MGIT‐DST Speciation: yes Decontamination: yes, NALC‐NaOH
Flow and timing
Comparative
Notes	"Patients were enrolled only if they could provide detailed clinical history and radiological and histology/cytology reports, along with an adequate amount of specimen material"
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
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?			Unclear
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
For rifampicin resistance testing, were the reference standard results interpreted without knowledge of the results of the index test?	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