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

Trajman 2014.

Study characteristics
Patient Sampling Cross‐sectional, consecutive, prospective
Patient characteristics and setting Presenting signs and symptoms: patients with a pleural effusion needing thoracentesis
Age: median 50 years (IQR 40 to 57)
Sex, female: 20%
Children: no
HIV infection: 5%
Clinical setting: secondary health facility (inpatient)
Past history of TB: not reported
Patients on anti‐TB treatment: not reported
Number of specimens evaluated: 85
Laboratory level: central
Country: Brazil
World Bank Income Classification: middle income
High TB burden: yes
High TB/HIV burden: yes
High MDR‐TB burden: no
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 TB detection: MGIT
Reference standard rifampicin resistance detection: MGIT‐DST
Speciation: not reported
Decontamination: no
Flow and timing  
Comparative  
Notes Patients were excluded if they had bleeding disorders contraindicating thoracentesis, if the fluid volume was insufficient for storage, or if a final diagnosis could not be ascertained. One of the main limitations of the study was the high number of presumptive (non‐confirmed) cases. The number of exclusions was also high: out of 203 eligible patients, 110 were excluded: 21 did not have a final diagnosis and 89 did not have sufficient fluid to store. "Cultures of pleural tissue, which could significantly improve accuracy of diagnosis, were not performed"
Study used frozen specimens
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?     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?     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? 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?   Low risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     Unclear
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? Unclear    
Were all patients included in the analysis? No    
Could the patient flow have introduced bias?   High risk