Diagnostic accuracy of nanopore sequencing for the rapid diagnosis of extrapulmonary tuberculosis: a protocol for a systematic review and meta-analysis.

BACKGROUND

Extrapulmonary tuberculosis (EPTB) is a serious type of tuberculosis (TB) which can cause systemic clinical manifestations. Rapid diagnosis of EPTB for intervention is of great importance. Nanopore sequencing as a third-generation gene sequencing method is a new kind of rapid TB detection. Previous studies have shown that nanopore sequencing has higher diagnostic sensitivity and specificity for TB diagnosis compared with other diagnostic methods. The aim of this research is to develop a systematic review and meta-analysis protocol for assessing the accuracy of nanopore sequencing in diagnosing EPTB.

METHODS AND ANALYSIS

This protocol was conducted in strict adherence to the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols guidelines. The study protocol has been prospectively registered with the International Prospective Register of Systematic Reviews under the unique identifier CRD42024608415. We will search Chinese databases and English databases in June 2026. Chinese databases will include Wanfang database, China National Knowledge Infrastructure. English databases will include PubMed, EMBASE and the Cochrane Library. Adhering strictly to the reference standard outlined in this protocol, we will screen the literature. The Quality Assessment of Diagnostic Accuracy Studies will be used by us to assess the methodological quality of the included studies. The statistical tools used are Stata with midas commands and RevMan, and we will perform meta-analysis, generate forest plots and Summary Receiver Operating Characteristic curves. A p value of less than 0.05 will be considered statistically significant. If significant heterogeneity exists and there is a sufficient number of studies, we will investigate its source through subgroup analysis and meta-regression.

ETHICS AND DISSEMINATION

This investigation uses publicly accessible data repositories, exempting it from ethical review board approval requirements. On finalisation of the analysis, findings will be prepared for dissemination through submission to a reputable medical journal employing rigorous peer review processes. The study methodology adheres to established protocols for systematic review and meta-analysis.

PROSPERO REGISTRATION NUMBER

CRD42024608415.