Du 2015.

Study characteristics
Patient Sampling	Cross‐sectional, consecutive, prospective
Patient characteristics and setting	Presenting signs and symptoms: patients found to be smear‐negative on prior testing with radiographic evidence of pleural effusion and those subsequently undergoing thoracocentesis and pleural biopsy Age: mean 39 years, SD 13 Sex, female: 44% Children: 0% HIV infection: 4% Clinical setting: 4 tertiary care centres (inpatient) Past history of TB: not reported Patients on anti‐TB treatment: not reported Number of specimens evaluated: 126 Laboratory level: central Country: China 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 Manufacturer's involvement: no
Target condition and reference standard(s)	Target condition: pleural TB Reference standard for TB detection: LJ and MGIT Reference standard for rifampicin resistance: MGIT‐DST Speciation: yes Decontamination: yes, NALC‐NaOH
Flow and timing
Comparative
Notes	Study included specimens found to be smear‐negative on prior testing. In the present study, 4 specimens were smear‐positive specimens for pleural fluid and 15 were smear‐positive for pleural tissue The reference standard for both pleural fluid and pleural tissue was pleural biopsy culture
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?	No
Could the selection of patients have introduced bias?		High 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
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