Yu Guocan, Xu Xudong, Shen Yanqin, Ling Yuyang
Tuberculosis Diagnosis and Treatment Center of Zhejiang Province, Hangzhou Red Cross Hospital, Hangzhou, Zhejiang, China
Hangzhou Red Cross Hospital, Hangzhou, Zhejiang, China.
BMJ Open. 2025 Sep 2;15(9):e103676. doi: 10.1136/bmjopen-2025-103676.
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.
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.
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.
CRD42024608415.
肺外结核病（EPTB）是一种严重的结核病类型，可引起全身临床表现。快速诊断EPTB以进行干预至关重要。纳米孔测序作为第三代基因测序方法，是一种新型的结核病快速检测方法。先前的研究表明，与其他诊断方法相比，纳米孔测序在结核病诊断中具有更高的诊断敏感性和特异性。本研究的目的是制定一项系统评价和荟萃分析方案，以评估纳米孔测序在诊断EPTB中的准确性。
本方案严格遵循系统评价和荟萃分析方案的首选报告项目指南。该研究方案已在国际前瞻性系统评价注册库中进行前瞻性注册，唯一标识符为CRD42024608415。我们将于2026年6月检索中文数据库和英文数据库。中文数据库将包括万方数据库、中国知网。英文数据库将包括PubMed、EMBASE和Cochrane图书馆。我们将严格按照本方案中概述的参考标准筛选文献。我们将使用诊断准确性研究的质量评估来评估纳入研究的方法学质量。使用的统计工具是带有midas命令的Stata和RevMan，我们将进行荟萃分析，生成森林图和汇总接受者操作特征曲线。p值小于0.05将被视为具有统计学意义。如果存在显著异质性且研究数量充足，我们将通过亚组分析和荟萃回归来探究其来源。
本调查使用可公开获取的数据存储库，无需伦理审查委员会批准。分析完成后，将通过提交给采用严格同行评审流程的知名医学期刊来准备研究结果以进行传播。该研究方法遵循既定的系统评价和荟萃分析方案。
PROSPERO注册号：CRD42024608415。
