Accuracy of nanopore sequencing technology for rapid diagnosis of tuberculous mediastinal and hilar lymphadenopathy using endobronchial ultrasound-guided transbronchial needle aspiration specimens: protocol for a systematic review and meta-analysis.

INTRODUCTION: Accessing samples from mediastinal and hilar lymph nodes is considerably more difficult, rendering the diagnosis of tuberculous mediastinal and hilar lymphadenopathy particularly challenging. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive interventional technique used for sampling mediastinal and hilar lymph nodes. Nanopore sequencing technology (NST) permits the rapid identification ofgenes directly from clinical samples. NST has significantly improved the diagnostic accuracy for both pulmonary and extrapulmonary tuberculosis; its accuracy in diagnosing tuberculous mediastinal and hilar lymphadenopathy using EBUS-TBNA specimens has not yet been systematically evaluated.

METHODS AND ANALYSIS: Adhering to Preferred Reporting Items for a Systematic Review and Meta-Analysis Protocols (PRISMA-P) and PRISMA-Diagnostic Test Accuracy Studies (DTA) guidelines, this protocol (PROSPERO: CRD420251274529) will synthesise evidence from five international databases (PubMed, Embase, SCOPUS, Web of Science and Cochrane Library) and two Chinese databases (China National Knowledge Infrastructure and Wanfang Database). The literature search is planned to be conducted between 1 December 2026 and 31 December 2026 (start and end dates of the search). The publication dates of the included literature ranged from the inception of the relevant databases to 31 December 2026. Data extraction from the included studies is anticipated to be completed by 31 May 2027, and the final reporting of findings is expected by 31 December 2027. Study selection followed the PICT framework: participants (P): patients with suspected tuberculous mediastinal and hilar lymphadenopathy; index test (I): the index test was defined as NST; comparator (C): the reference standard for tuberculous lymphadenopathy; target condition (T): the target condition was confirmed tuberculous mediastinal and hilar lymphadenopathy. Two independent investigators will perform a three-step screening process, extract data and assess methodological quality using Quality Assessment of Diagnostic Accuracy Studies. Bivariate random-effects models implemented in STATA V.15.0 will be used to pool sensitivity, specificity and hierarchical summary receiver operating characteristic curves when four or more studies are available; for fewer studies, Meta-DiSc V.1.4 will be employed. If substantial heterogeneity is detected (I² statistic >50%), meta-regression and subgroup analysis will be performed across prespecified covariates.

ETHICS AND DISSEMINATION: This study is based on publicly available data and therefore does not require ethics committee approval. Upon completion, the findings will be submitted for publication in a peer-reviewed medical journal. The review is conducted in accordance with established guidelines for systematic review and meta-analysis.

PROSPERO REGISTRATION NUMBER: CRD420251274529.