Hanif 2011.

Study characteristics
Patient Sampling	Cross‐sectional, consecutive, prospective
Patient characteristics and setting	Presenting signs and symptoms: patients with suspicion of TB due to symptoms such as fever, cough or weight loss or both, or because they were not responding to initial therapy for other diseases Age: range 20 to 57 years Sex, female: 39% Children: no HIV infection: no Clinical setting: national reference laboratory Past history of TB: not reported Patients on anti‐TB treatment: not reported Number of specimens evaluated: 29 Laboratory level: central Country: Kuwait World Bank Income Classification: middle income High TB burden: no High TB/HIV burden: no High MDR‐TB burden: no
Index tests	Xpert MTB/RIF WHO SOP or manufacturer's protocol: yes for lymph node aspirate, pleural fluid, and urine; no for CSF Manufacturer's involvement: no
Target condition and reference standard(s)	Target condition: TB meningitis, lymph node TB, pleural TB, genitourinary TB Reference standard for TB detection: LJ and MGIT Reference standard for rifampicin resistance: LJ‐DST and MGIT‐DST Speciation: yes Decontamination: no
Flow and timing
Comparative
Notes
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?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	No
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?		High 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