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. 2020 Aug 27;2020(8):CD013359. doi: 10.1002/14651858.CD013359.pub2

Bholla 2016.

Study characteristics
Patient Sampling Cohort, consecutive, prospective
Patient characteristics and setting Presenting signs and symptoms: ≥ 1 palpable lymph nodes ≥ 1 cm persisting for longer than 4 weeks in spite of oral antibiotic therapy and a strong clinical suspicion or microbiological confirmation of mycobacterial infection
Age: 0 to 60 months (59%); 61 to 204 months (41%)
Sex, female: 39%
HIV infection: 20%
Sample size included for analysis: 75
Clinical setting: not reported
Laboratory level where index test was performed: not reported
Country: Tanzania
World Bank income classification: low income
High TB burden country: yes
High TB/HIV burden country: yes
High MDR‐TB burden country: no
Prevalence of tuberculosis cases in the study: 9%
Index tests Xpert MTB/RIF
Target condition and reference standard(s) Lymph node tuberculosis
MGIT; composite reference standard; clinical reference standard
Flow and timing Index and reference tests performed simultaneously
Comparative  
Notes There was a high percentage of culture contamination (48%), and only 1 culture was used to exclude TB, indicating an unclear ability of the reference standard to classify the target condition
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? 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? Unclear    
Were the reference standard results interpreted without knowledge of the results of the index tests? Yes    
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