Drain 2016.
| Study characteristics | |||
| Patient sampling | Cross‐sectional, prospective and consecutive enrolment | ||
| Patient characteristics and setting | Presenting signs and symptoms: HIV‐infected and HIV‐uninfected adults suspected of tuberculosis included if smear microscopy negative x 2; Presenting with at least two of four tuberculosis‐related symptoms: cough, fever, weight loss, night sweats for at least two weeks and a Karnofsky performance score >50
Age: mean 37 (SD 9)
Sex, female: 49%
HIV infection: 93%
Median CD4 cell count per µL: 168 (IQR 89 to 256) History of tuberculosis: not stated Sample size: 90 Clinical setting: outpatient Country: South Africa Tuberculosis incidence rate: 567 per 100,000 Number (proportion) of tuberculosis cases in the study: 57 (63%) |
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| Index tests | LF‐LAM | ||
| Target condition and reference standard(s) | Target: pulmonary tuberculosis Reference standard: any of sputum mycobacterial culture (solid and liquid) or nucleic acid amplification test; no extrapulmonary specimens tested |
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| Flow and timing | All patients were included in the analysis | ||
| Comparative | |||
| Notes | The study authors performed sputum induction for individuals who could not expectorate. They excluded individuals without some respiratory specimen available and 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 | High | ||
| 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? | Yes | ||
| 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 | |||