Study characteristics | |||
Patient sampling | Cross‐sectional design, unclear manner of enrolment, prospective data collection | ||
Patient characteristics and setting | Presenting signs and symptoms: people who were unable to produce sputum with a clinical suspicion of TB (presence of at least 1 of the following signs: cough of at least 2 weeks, chronic unexplained weight loss, fever, or recent chest x‐ray showing radiological features compatible with TB); specimens were frozen Age: adults, mean or median age not reported Sex, female: 46% HIV infection: 31% History of TB: not reported Sample size: 104 Clinical setting: laboratory‐based Laboratory level: central Country: Uganda World Bank Income Classification: low 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: 31.7% |
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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 |
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Flow and timing | |||
Comparative | |||
Notes | Frozen sediments of sputum specimens previously evaluated using MGIT and LJ were used in this study. | ||
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 | 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? | Unclear | ||
Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test? | |||
Unclear | 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 |