ArticleBMJ open2026
Diagnostic accuracy of the Xpert MTB Host-Response assay for tuberculosis disease in adolescents and adults: a systematic review and individual patient data meta-analysis protocol.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
6 authors.
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Abstract
introductionTuberculosis (TB) remains a major global health challenge, with an estimated 10.8 million new cases and 1.25 million deaths in 2023. Despite advances in molecular detection of Mycobacterium TB (MTB), significant diagnostic gaps remain: in 2023, only 48% of newly diagnosed TB cases received rapid diagnostic testing, far below the 100% target. These challenges are intensified in high-burden settings, where sputum collection and distinguishing TB from other illnesses are difficult. The Xpert MTB Host Response (Xpert-HR) assay measures host immune gene expression from blood, shows promise but variable accuracy across studies. Hence, this study will perform an Individual Patient Data Meta-Analysis (IPDMA) to evaluate the diagnostic accuracy, subgroup performance, predictive values and clinical benefit of Xpert-HR compared with conventional sputum-based testing. METHODS AND ANALYSIS: This systematic review and IPDMA will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Diagnostic Test Accuracy guidelines. Prospective studies including adolescents (>12 years) or adults with presumed TB tested using the Xpert MTB Host-Response assay will be identified through PubMed, Embase and Web of Science. Study quality will be assessed using an adapted diagnostic accuracy tool. Diagnostic accuracy will be pooled using random-effects models, with subgroup analyses where applicable. Decision curve analysis will evaluate clinical utility. Predictive values will be estimated across TB prevalences of 1-10%. Both one-stage and two-stage IPDMA approaches will be explored, and the proportion of unevaluable samples will be reported. ETHICS AND DISSEMINATION: The review will be based on deidentified individual patient data to be obtained upon request from the corresponding authors of studies fulfilling all the data sharing agreement. Ethical approval has been obtained from the Ethical Committee of the Medical Faculty of Heidelberg University (Approval No. S-043/2026). The results will be disseminated through publication in a peer-reviewed journal, and through presentations at academic conferences. PROSPERO REGISTRATION NUMBER: CRD420251071857.
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