Peter 2012a.
| Study characteristics | |||
| Patient sampling | Cross‐sectional, prospective and consecutive enrolment | ||
| Patient characteristics and setting | Presenting signs and symptoms: HIV‐infected adults suspected of tuberculosis; Presenting with signs and symptoms suggestive of tuberculosis, but these not specified Age: median 35 (IQR 29 to 40) Sex, female: 60% HIV infection: 100% Median CD4 cell count per µL: 90 (IQR 47 to 197) History of tuberculosis: 35% Sample size: 241 Clinical setting: inpatient Country: South Africa Tuberculosis incidence rate: 567 per 100,000 Number (proportion) of tuberculosis cases in the study: 116 (48%) |
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| Index tests | LF‐LAM | ||
| Target condition and reference standard(s) | Target condition: pulmonary tuberculosis and extrapulmonary tuberculosis Reference standard: mycobacterial culture (liquid); there was no protocol to ensure a minimum standard of respiratory and extrapulmonary specimen testing |
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| Flow and timing | All patients were included in the analysis | ||
| Comparative | |||
| Notes | The study authors included all patients with symptoms of tuberculosis irrespective of their ability to produce sputum; clinicians chose the reference standard rather than it being directed by the study protocol. The reference standard included testing of pulmonary and extrapulmonary sites by mycobacterial culture. | ||
| 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? | Yes | ||
| High | High | ||
| 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? | No | ||
| Were all patients included in the analysis? | Yes | ||
| High | |||