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

Singh 2016

Study characteristics
Patient sampling Cross‐sectional design, unknown manner of enrolment, prospective data collection
Patient characteristics and setting Presenting signs and symptoms: presumptive pulmonary TB
Age: range 15 to 60 years
Sex, female: not reported
HIV infection: 0%
History of TB: not reported
Sample size: 72
Clinical setting: not reported
Laboratory level: central
Country: India
World Bank Income Classification: middle income
High TB burden country: yes
High MDR‐TB burden country: yes
High TB/HIV burden country: yes
Index tests Index: Xpert MTB/RIF
Target condition and reference standard(s) Target condition: rifampicin resistance
Reference standard for rifampicin resistance: 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? Unclear
Was a case‐control design avoided? Yes
Did the study avoid inappropriate exclusions? Yes
Unclear 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
Low Unclear
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? Yes
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