Hanifa 2016.
| Study characteristics | |||
| Patient sampling | Cohort, prospective and consecutive enrolment with six months follow‐up | ||
| Patient characteristics and setting | Presenting signs and symptoms: HIV‐infected adults included irrespective of symptoms. A positive WHO symptom screen was reported for 53% of participants. Age: median 39 (IQR 32‐45) Sex, female: 61% HIV infection: 100% Median CD4 cell count per µL: 111 (IQR 56 to 161) History of tuberculosis: 30% Sample size: 424 Clinical setting: outpatients Country: South Africa Tuberculosis incidence rate: 567 per 100,000 Number (proportion) of tuberculosis cases in the study: 40(9%) |
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| Index tests | LF‐LAM | ||
| Target condition and reference standard(s) | Target condition: pulmonary tuberculosis, extrapulmonary tuberculosis, mycobacteraemia Reference standard: any of mycobacterial culture (liquid) or nucleic acid amplification test; extrapulmonary specimens tested for all |
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| Flow and timing | The study excluded 16 cases defined as ‘Clinical tuberculosis' from analysis. | ||
| Comparative | |||
| Notes | Sputum and non‐sputum samples were tested for mycobacteria for all participants; The study authors performed sputum induction for individuals who could not expectorate; The study had specimens collected for index test and reference standard tests greater than seven days apart. | ||
| 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? | Unclear | ||
| 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? | Yes | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
| Low | Low | ||
| 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? | No | ||
| High | |||