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

Peter 2012a.

Study characteristics
Patient sampling Cross‐sectional, prospective and consecutive enrolment
Patient characteristics and setting Presenting signs and symptoms: HIV‐infected adults suspected of tuberculosis; Presenting with signs and symptoms suggestive of tuberculosis, but these not specified
Age: median 35 (IQR 29 to 40)
Sex, female: 60%
HIV infection: 100%
Median CD4 cell count per µL: 90 (IQR 47 to 197)
History of tuberculosis: 35%
Sample size: 241
Clinical setting: inpatient
Country: South Africa
Tuberculosis incidence rate: 567 per 100,000
Number (proportion) of tuberculosis cases in the study: 116 (48%)
Index tests LF‐LAM
Target condition and reference standard(s) Target condition: pulmonary tuberculosis and extrapulmonary tuberculosis
Reference standard: mycobacterial culture (liquid); there was no protocol to ensure a minimum standard of respiratory and extrapulmonary specimen testing
Flow and timing All patients were included in the analysis
Comparative  
Notes The study authors included all patients with symptoms of tuberculosis irrespective of their ability to produce sputum; clinicians chose the reference standard rather than it being directed by the study protocol. The reference standard included testing of pulmonary and extrapulmonary sites by mycobacterial culture.
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? Yes    
    High High
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? No    
Were all patients included in the analysis? Yes    
    High