Floridia 2017.
Study characteristics | |||
Patient sampling | Cross‐sectional, prospective and consecutive enrolment | ||
Patient characteristics and setting | Presenting signs and symptoms: HIV‐infected adults included irrespective of symptoms. A positive WHO symptom screen was reported for 34% of participants.
Age: median 35 (IQR 30‐43)
Sex, female: 59%
HIV infection: 100%
Median CD4 cell count per µL: 278 (IQR 142 to 395) History of tuberculosis: not stated Sample size: 972 Clinical setting: outpatients Country: Mozambique Tuberculosis incidence rate: 551 per 100,000 Number (proportion) of tuberculosis cases in the study: 90 (9%) |
||
Index tests | LF‐LAM | ||
Target condition and reference standard(s) | Target: pulmonary tuberculosis Reference standard: nucleic acid amplification test; no extrapulmonary specimens tested |
||
Flow and timing | All patients were included in the analysis | ||
Comparative | |||
Notes | The study authors did not attempt sputum induction and excluded individuals without some respiratory specimen available. They did not attempt to identify extrapulmonary tuberculosis. | ||
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? | No | ||
High | 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 | 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 |