Thit 2017.
Study characteristics | |||
Patient sampling | Cohort, prospective and consecutive enrolment with six months follow‐up | ||
Patient characteristics and setting | Presenting signs and symptoms: irrespective of symptoms. WHO tuberculosis symptom screen positive in 33%. in overall population who could produce sputum signs and symptoms suggestive of tuberculosis, but not specified
Age: median 34 (IQR 30‐41)
Sex, female: 50%
HIV infection: 100%
Median CD4 cell count per µL: 270 (IQR 128 to 443) History of tuberculosis: not stated Sample size: 517 Clinical setting: outpatient and inpatients Country: Myanmar Tuberculosis incidence rate: 358 per 100.000 Number (proportion) of tuberculosis cases in the study: 54 (12%) |
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Index tests | LF‐LAM | ||
Target condition and reference standard(s) | Target condition: pulmonary tuberculosis Reference standard: any of sputum mycobacterial culture (solid and liquid) or nucleic acid amplification test; no extrapulmonary specimens tested. The study did not report if they speciated mycobacteria isolates |
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Flow and timing | The study had specimens collected for index and reference standard tests greater than seven days apart. | ||
Comparative | |||
Notes | The study authors attempted sputum induction and excluded individuals without some respiratory specimen available. They did not attempt to identify extrapulmonary tuberculosis. The study did not report if they speciated mycobacteria isolates. | ||
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 All tests | |||
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? | No | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
High | Unclear | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | No | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
High |
Abbreviations: LF‐LAM: lateral flow urine lipoarabinomannan assay (Alere Determine™ TB lipoarabinomannan); IQR: interquartile range; SD: standard deviation; WHO: World Health Organization