Huerga 2017.
| 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 cough for more than 2 weeks or any cough and at least any of loss of weight, night sweats, or fever
Age: median 35 (IQR:29‐44)
Sex, female: 52%
HIV infection: 100%
Median CD4 cell count per µL: 109 (IQR 43 to 214) History of tuberculosis: 25% Sample size: 474 (275 included in analysis) Clinical setting: outpatient and inpatients Country: Kenya Tuberculosis incidence rate: 319 per 100,000 Number (proportion) of tuberculosis cases in the study: 156 (57%) |
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| Index tests | LF‐LAM | ||
| Target condition and reference standard(s) | Target: pulmonary and extrapulmonary tuberculosis. Reference standard: any of mycobacterial culture (solid and liquid) or nucleic acid amplification test. Extrapulmonary specimens collected for participants without respiratory samples available |
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| Flow and timing | The study excluded participants with at least one sample with no result or contaminated result (culture) from analysis in the absence of a positive result. | ||
| Comparative | |||
| Notes | The study authors performed sputum induction for individuals who could not expectorate. They included individuals without respiratory specimen available and attempted to identify extrapulmonary tuberculosis; Not all participants received the same reference standard and not all participants were included in the analysis. | ||
| 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? | No | ||
| Were all patients included in the analysis? | No | ||
| High | |||