Saini 2018.
Study characteristics | |||
Patient Sampling | Cross‐sectional, manner of selection not reported, prospective | ||
Patient characteristics and setting | Presenting signs and symptoms: cough for longer than 2 weeks, fever, lethargy, contact with an adult patient with TB, positive tuberculin skin test, or chest radiograph consistent with TB. In addition, the patient needed to have negative testing by AFB smear and Xpert before moving to bronchoscopy for BAL Age, months: median (IQR) 120 (66 to 156) Sex, female: 53% HIV infection: 0% Sample size included for analysis: 41 Clinical setting: inpatient Laboratory level where index test was performed: central Country: India World Bank income classification: middle income High TB burden country: yes High TB/HIV burden country: yes High MDR‐TB burden country: yes Prevalence of tuberculosis cases in the study: 27% | ||
Index tests | Xpert MTB/RIF | ||
Target condition and reference standard(s) | Pulmonary tuberculosis MGIT; composite reference standard; clinical reference standard |
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Flow and timing | Participants were enrolled for BAL sample collection if they had probable TB and negative testing by AFB smear and Xpert by standard less invasive methods | ||
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 | ||
Did the study avoid inappropriate exclusions? | No | ||
Could the selection of patients have introduced bias? | High risk | ||
Are there concerns that the included patients and setting do not match the review question? | High | ||
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 | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (Xpert Ultra) | |||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Low risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
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 | ||
Could the patient flow have introduced bias? | Low risk |