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针对涂抹阴性肺结核的纳米孔测序 - - 在中国进行的一项多中心前性研究
Xiaojing Yan1, Guoli Yang2, Yunfei Wang3
1Medical Quality Control Center, Beijing Chest Hospital, Capital Medical University, Beijing, 101149, PR China.
Annals of clinical microbiology and antimicrobials
|June 14, 2024
概括
与传统方法相比,纳米孔测序显示在支气管支气管洗液 (BALF) 中检测Mycobacterium结核病 (MTB) 的灵敏度更高. 这种先进的技术是理想的诊断肺结核 (PTB) 在有限的唾液样本的患者.
科学领域:
- 医学诊断 医学诊断 医学诊断
- 微生物学 微生物学
- 基因组测序是指基因组的测序.
背景情况:
- 肺结核 (PTB) 的诊断依赖于对Mycobacterium结核病 (MTB) 的敏感检测.
- 像MGIT培养和Xpert MTB/RIF这样的传统方法在灵敏度和样本要求方面存在局限性.
- 支气管洗液 (BALF) 是用于诊断PTB的替代样本,特别是在唾液稀少的情况下.
研究的目的:
- 评估纳米孔测序的诊断准确性,用于在BALF中检测MTB.
- 将纳米孔测序的性能与MGIT培养和Xpert MTB/RIF试验进行比较.
- 确定纳米孔测序在疑似病例中诊断PTB的实用性.
主要方法:
- 展望性研究设计,涉及中国各地涉嫌PTB患者.
- 从2021年9月到2022年4月收集和分析BALF样本.
- 对诊断性能指标进行比较分析,包括灵敏度,AUC,尤登指数,准确度和NPV.
主要成果:
- 与MGIT培养 (36.11%) 和Xpert MTB/RIF (40.28%) 相比,纳米孔测序显示出明显更高的诊断率和灵敏度 (83.33%).
- 曲线下的面积 (AUC),尤登指数,准确度和负预测值 (NPV) 表示了纳米孔测序的优越MTB检测性能.
- 在纳米孔测序与其他测试之间观察到相当的一致性 (Fleiss' kappa值为0.219和0.303).
结论:
- BALF的纳米孔测序为MTB检测提供了更高的灵敏度,使其适合在唾液稀少个体中诊断PTB.
- 虽然非常敏感,但负的纳米孔测序结果需要通过额外的证据得到确认,才能排除PTB.
- 这种方法提高了肺结核的诊断能力,特别是在具有挑战性的病例中.
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