Safianowska 2012
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, consecutive enrolment, prospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: presumptive TB Age: mean 61 years, range 20 to 97 years Sex, female: 36.6% HIV infection: 0% History of TB: not reported Sample size: 145 Clinical setting: laboratory‐based Laboratory level: intermediate Country: Poland World Bank Income Classification: high income TB incidence rate: 23 per 100,000 MDR‐TB prevalence: percentage MDR‐TB among new TB cases = 0.5% (Source: nationwide surveillance, 2011) and among retreatment cases = 3.5% (Source: nationwide surveillance, 2011) High TB burden country: no High MDR‐TB burden country: no High TB/HIV burden country: no Prevalence of TB cases in the study: 11.8% |
||
| Index tests | Index: Xpert MTB/RIF | ||
| Target condition and reference standard(s) | Target condition: pulmonary TB Reference standard for pulmonary TB: LJ culture Target condition: rifampicin resistance Reference standard for rifampicin resistance: LJ media, method not specified |
||
| Flow and timing | |||
| Comparative | |||
| Notes | |||
| 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 | Unclear | ||
| DOMAIN 2: Index Test Xpert MTB/RIF | |||
| 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 for TB detection interpreted without knowledge of the results of the index test? | No | ||
| Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test? | No | ||
| 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 | |||