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. 2020 Aug 27;2020(8):CD013359. doi: 10.1002/14651858.CD013359.pub2

Hasan 2017.

Study characteristics
Patient Sampling Cross‐sectional, convenience, prospective
Patient characteristics and setting Presenting signs and symptoms: children younger than 15 years based on clinical symptoms, chest radiography, and Kenneth Jones score ≥ 5
Age, months: median (IQR) 82 (24 to 108)
Sex, female: 22%
HIV infection: 0%
Sample size included for analysis: 50
Clinical setting: inpatient and outpatient
Laboratory level where index test was performed: intermediate
Country: Pakistan
World Bank income classification: middle income
High TB burden country: yes
High TB/HIV burden country: no
High MDR‐TB burden country: yes
Prevalence of tuberculosis cases in the study: 18%
Index tests Xpert MTB/RIF
Target condition and reference standard(s) Pulmonary tuberculosis
MGIT; composite reference standard; clinical reference standard
Flow and timing Index and reference tests were collected within pre‐specified time period
Comparative  
Notes The index test was performed on stool; no stool processing method for Xpert has been established; centrifugation was used in this study
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? No    
Did the study avoid inappropriate exclusions? Yes    
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?     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