BMJ Open. 2026 Sep 2;16(9):e124499. doi: 10.1136/bmjopen-2026-124499.
ABSTRACT
INTRODUCTION: Tuberculous pericarditis is a severe, high-mortality manifestation of extrapulmonary tuberculosis. Its diagnosis is hindered by the invasive nature of specimen collection and the limited sensitivity of conventional microbiological tests. Third-generation sequencing (TGS) offers a promising, rapid and comprehensive molecular approach for detecting Mycobacterium tuberculosis, but its specific diagnostic accuracy for tuberculous pericarditis has not been systematically evaluated. This planned systematic review and meta-analysis aims to precisely determine the diagnostic performance of TGS for this condition.
METHODS AND ANALYSIS: A protocol has been prospectively registered with PROSPERO. We will comprehensively search multiple databases (PubMed, Embase, Web of Science, SCOPUS, Cochrane Library) from inception to July 2027. We will include diagnostic accuracy studies that evaluate TGS against a composite reference standard for tuberculous pericarditis. Where available, we will also separately analyse studies that use a definitive reference standard. Two independent reviewers will screen records, extract data and assess methodological quality using the QUADAS-2 tool. A bivariate random-effects model will be used to pool sensitivity and specificity, with results summarised using hierarchical summary receiver operating characteristic curves. Heterogeneity will be explored via subgroup analysis and meta-regression. The certainty of evidence will be graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.
ETHICS AND DISSEMINATION: Given that this investigation exclusively draws on open-source, non-identifiable data, formal institutional ethics clearance is not required. On finalisation, the findings of this systematic review will be disseminated via a suitable peer-reviewed journal. In parallel, every research phase-spanning protocol design to the final report-will rigorously comply with the established methodological standards for systematic reviews and meta-analyses of diagnostic test accuracy.
TRIAL REGISTRATION NUMBER: CRD420261429012.
PMID:42692502 | DOI:10.1136/bmjopen-2026-124499