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. 2021 Jan 15;2021(1):CD012768. doi: 10.1002/14651858.CD012768.pub3

Meldau 2019.

Study characteristics
Patient Sampling Cohort, consecutive, prospective
Patient characteristics and setting Presenting signs and symptoms: patients with any TB symptoms including any cough, fever, night sweats, loss of weight, haemoptysis or chest pain or both, and features consistent with a pleural effusion on chest x‐ray
Age: Adult; median 39 years (IQR 28 to 57)
Sex, female: 11%
Children: not reported
HIV infection: definite TB: 7%
Clinical setting: tertiary care hospital
Past history of TB: 6%
Participants on anti‐TB treatment: not reported
Number of specimens evaluated: 149
Laboratory level: central
Country: South Africa
World Bank Income Classification: middle
High TB burden: yes
High TB/HIV burden: yes
High MDR‐TB burden: yes
Index tests Xpert MTB/RIF and Xpert Ultra
WHO SOP or manufacturer's protocol followed: yes
Target condition and reference standard(s) Pleural tuberculosis
Composite reference standard: MGIT culture and/or histology
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)
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 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? Yes    
For rifampicin resistance testing, were the reference standard results interpreted without knowledge of the results of the index test?      
Could the reference standard, its conduct, or its interpretation have introduced bias?   Low 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