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

Sun 2019.

Study characteristics
Patient Sampling Cohort, consecutive, prospective
Patient characteristics and setting Presenting signs and symptoms: patients with symptoms such as pain, swelling in the joints, tenderness, effusion, restriction of movements, and systematic symptoms such as fever, loss of weight/appetite, elevated erythrocyte sedimentation rate, and cough, breathlessness, and history of TB
Age: osteoarticular TB: median 51 years (range 16 to 86)
Sex, female: osteoarticular TB: 55%
Children: no
HIV infection: 0%
Clinical setting: national level TB referral centre
Past history of TB: not reported
Participants on anti‐TB treatment: not reported
Number of specimens evaluated: 166
Laboratory level: central
Country: China
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 and Xpert Ultra
WHO SOP or manufacturer's protocol followed: yes
Target condition and reference standard(s) Bone or joint TB, fluid
MGIT
Composite reference standard: clinical, laboratory, histopathological, radiological and ≥ 6 months’ follow‐up
Rifampicin resistance
LJ‐DST
Speciation: yes
Decontamination: Yes
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? Unclear    
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? Unclear    
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