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

Sarfaraz 2018.

Study characteristics
Patient Sampling Cohort, manner of selection not reported, prospective
Patient characteristics and setting Presenting signs and symptoms: patients presenting with 1 or more superficial lymph nodes (i.e. cervical, axillary, and inguinal nodes) measuring > 2 cm in largest diameter and persisting for more than 1 month, with or without constitutional symptoms of fever, anorexia, and weight loss
Age: > 14 years of age; median 23 years (IQR 18 to 32)
Sex, female: 79%
Children: no
HIV infection: 1%
Clinical setting: outpatient
Past history of TB: not reported
Participants on anti‐TB treatment: not reported
Number of specimens evaluated: 261
Laboratory level: central
Country: Pakistan
World Bank Income Classification: middle income
High TB burden: yes
High TB/HIV burden: no
High MDR‐TB burden: yes
Index tests Xpert MTB/RIF
WHO SOP or manufacturer's protocol followed: yes
Target condition and reference standard(s) Lymph node TB, tissue
MGIT; LJ
Composite reference standard includes histopathology
Rifampicin resistance
MGIT‐DST
Speciation: not reported
Decontamination: yes (NALC–NaOH)
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? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Could the selection of patients have introduced bias?   Unclear 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?     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? Unclear    
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?   Unclear 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