Skip to main content
. 2021 Jan 15;2021(1):CD012768. doi: 10.1002/14651858.CD012768.pub3

Perez‐Risco 2018.

Study characteristics
Patient Sampling Study design unclear, manner of patient selection not reported, retrospective
Patient characteristics and setting Presenting signs and symptoms: Smear‐negative extrapulmonary patients
Age: adult
Sex, female: not reported
Children: 0%
HIV infection: not reported
Clinical setting: laboratory‐based evaluation
Past history of TB: not reported
Participants on anti‐TB treatment: not reported
Number of specimens evaluated: CSF 3; pleural fluid 24; urine 24; bone or joint fluid 24
Laboratory level: central
Country: Spain
World Bank Income Classification: high
High TB burden: no
High TB/HIV burden: no
High MDR‐TB burden: no
Index tests Xpert Ultra
WHO SOP or manufacturer's protocol followed: yes
Target condition and reference standard(s) Target condition: TB meningitis, pleural TB, genitourinary TB, bone or joint TB
Reference standard TB detection: MGIT and LJ culture
Speciation: yes
Decontamination: no
Flow and timing  
Comparative  
Notes The specimens were collected between May 1999 and May 2017; 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? Unclear    
Was a case‐control design avoided? Unclear    
Did the study avoid inappropriate exclusions? No    
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?     Unclear
DOMAIN 2: Index Test (Xpert MTB/RIF)
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? Unclear    
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?   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