Study characteristics | |||
Patient sampling | Cross‐sectional design, consecutive enrolment, prospective data collection | ||
Patient characteristics and setting | Presenting signs and symptoms: HIV‐infected adults screened for pulmonary TB irrespective of symptoms Age: 18 years and older, median 38 years (IQR 31 to 45) Sex, female: 64% HIV infection: 100% History of TB: 6% Sample size: 195 Clinical setting: both outpatient and inpatient Laboratory level: central Country: Ghana World Bank Income Classification: middle income High TB burden country: no High MDR‐TB burden country: no High TB/HIV burden country: yes Prevalence of TB cases in the study: 17.9% |
||
Index tests | Index: Xpert MTB/RIF | ||
Target condition and reference standard(s) | Target condition: pulmonary TB Reference standard for pulmonary TB: LJ and MGIT 960 |
||
Flow and timing | |||
Comparative | |||
Notes | Screening study | ||
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 |