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

Chin 2019.

Study characteristics
Patient Sampling Cross‐sectional, consecutive, prospective
Patient characteristics and setting Presenting signs and symptoms: patients with suspected TB meningitis admitted to the neurology ward
Age: adults, range 20 to 41 years
Sex, female: not reported
Children: not reported
HIV infection: 18%
Clinical setting: tertiary care centre (inpatient)
Past history of TB: not reported
Participants on anti‐TB treatment: 1 participant had received treatment
Number of specimens evaluated: 11
Laboratory level: central
Country: Uganda
World Bank Income Classification: low
High TB burden: no
High TB/HIV burden: yes
High MDR‐TB burden: no
Index tests Xpert MTB/RIF and Xpert Ultra
WHO SOP or manufacturer's protocol followed: no
Target condition and reference standard(s) TB meningitis
MGIT
Speciation: not reported
Decontamination:no
Flow and timing  
Comparative  
Notes "CSF (2  ml) should be slowly pipetted directly into the Xpert Ultra cartridge. CSF should only be diluted with the manufacturer‐supplied sample reagent if less than 2  ml of CSF are available for Xpert Ultra testing." See the following article for full description of CSF processing details, Chin 2019a.
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?     High
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?     High
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?     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? Yes    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Low risk