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. 2019 Oct 21;2019(10):CD011420. doi: 10.1002/14651858.CD011420.pub3

Thit 2017.

Study characteristics
Patient sampling Cohort, prospective and consecutive enrolment with six months follow‐up
Patient characteristics and setting Presenting signs and symptoms: irrespective of symptoms. WHO tuberculosis symptom screen positive in 33%. in overall population who could produce sputum signs and symptoms suggestive of tuberculosis, but not specified
 Age: median 34 (IQR 30‐41)
 Sex, female: 50%
 HIV infection: 100%
 Median CD4 cell count per µL: 270 (IQR 128 to 443)
History of tuberculosis: not stated
 Sample size: 517
 Clinical setting: outpatient and inpatients
 Country: Myanmar
 Tuberculosis incidence rate: 358 per 100.000
 Number (proportion) of tuberculosis cases in the study: 54 (12%)
Index tests LF‐LAM
Target condition and reference standard(s) Target condition: pulmonary tuberculosis
Reference standard: any of sputum mycobacterial culture (solid and liquid) or nucleic acid amplification test; no extrapulmonary specimens tested. The study did not report if they speciated mycobacteria isolates
Flow and timing The study had specimens collected for index and reference standard tests greater than seven days apart.
Comparative  
Notes The study authors attempted sputum induction and excluded individuals without some respiratory specimen available. They did not attempt to identify extrapulmonary tuberculosis. The study did not report if they speciated mycobacteria isolates.
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    
    Low Low
DOMAIN 2: Index Test All tests
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    
    Low Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? No    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
    High Unclear
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? No    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
    High  

Abbreviations: LF‐LAM: lateral flow urine lipoarabinomannan assay (Alere Determine™ TB lipoarabinomannan); IQR: interquartile range; SD: standard deviation; WHO: World Health Organization