Malbruny 2011.
| Study characteristics | |||
| Patient Sampling | Cross‐sectional, manner of selection not reported, prospective | ||
| Patient characteristics and setting | Presenting signs and symptoms: clinically suspected tuberculosis Age, months: mean 88 Sex, female: not reported HIV infection: not reported Sample size included for analysis: 12 Clinical setting: laboratory Laboratory level where index test was performed: research laboratory Country: France World Bank income classification: high income High TB burden country: no High TB/HIV burden country: no High MDR‐TB burden country: no Prevalence of tuberculosis cases in the study: 8% | ||
| Index tests | Xpert MTB/RIF | ||
| Target condition and reference standard(s) | Pulmonary TB, lymph node TB, tuberculous meningitis Solid culture; composite reference standard |
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| Flow and timing | Index and reference tests were collected within pre‐specified time period | ||
| 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? | Unclear | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| Could the selection of patients have introduced bias? | Unclear risk | ||
| Are there concerns that the included patients and setting do not match the review question? | 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 | ||
| Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
| DOMAIN 2: Index Test (Xpert Ultra) | |||
| DOMAIN 3: Reference Standard | |||
| Is the reference standards likely to correctly classify the target condition? | Unclear | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
| Could the reference standard, its conduct, or its interpretation have introduced bias? | Unclear risk | ||
| Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
| 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 | ||
| Could the patient flow have introduced bias? | Low risk | ||