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. 2019 Jun 7;2019(6):CD009593. doi: 10.1002/14651858.CD009593.pub4

Reddy 2017

Study characteristics
Patient sampling Cross‐sectional design, random enrolment, prospective data collection
Patient characteristics and setting Presenting signs and symptoms: TB symptoms
Age: 18 to 60 years
Sex, female: 47%
HIV infection: not reported
History of TB: 33%
Sample size: 705
Clinical setting: outpatient
Laboratory level: central
Country: South Africa
World Bank Income Classification: middle income
High TB burden country: yes
High MDR‐TB burden country: yes
High TB/HIV burden country: yes
Prevalence of TB cases in the study: 23.8%
Index tests Index: Xpert MTB/RIF
Target condition and reference standard(s) Target condition: pulmonary TB
Reference standard for pulmonary TB: MGIT 960
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
Low Low
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
Low Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes
Were the reference standard results for TB detection interpreted without knowledge of the results of the index test? Yes
Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?
Low Low
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
Low