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

Introduction Tuberculosis (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.