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

Van Rie 2013.

Study characteristics
Patient Sampling Cross‐sectional, consecutive, prospective
Patient characteristics and setting Presenting signs and symptoms: HIV‐infected patients with suspicion of LNTB
Age: mean 36 years, range 18 to 73 years
Sex, female: 49%
Children: no
HIV infection: 100%
Clinical setting: tertiary care centre (inpatient and outpatient)
Past history of TB: not reported
Patients on anti‐TB treatment: no
Number of specimens evaluated: 344
Laboratory level: central
Country: South Africa
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: lymph node TB
Reference standard TB detection: MGIT
Reference standard rifampicin resistance detection: 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? 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?     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