基于纳米孔的向测序测试用于直接识别结核病,基因型和检测耐药性突变:对下一代向测序技术的并排比较
Andrea Maurizio Cabibbe1, Kiarash Moghaddasi1, Virginia Batignani1
1Emerging Bacterial Pathogens Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Journal of clinical microbiology
|September 6, 2024
概括
牛津纳米孔诊断公司的AMPORE结核病试验可从呼吸道样本中快速准确地检测耐药结核病 (TB). 这种针对性下一代测序 (tNGS) 测试显示出高有效性,并且与现有方法相比,显著减少了报告时间.
科学领域:
- 分子诊断学 分子诊断学
- 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:
- 针对*Mycobacterium tuberculosis*的下一代定向测序 (tNGS) 提供了全面的耐药性预测.
- 世界卫生组织 (WHO) 批准了tNGS在2024年在呼吸道样本中临床使用.
- 现有的针对耐药结核病分析的解决方案可能需要更长的周转时间.
研究的目的:
- 为了评估牛津纳米孔诊断的AMPORE TB测试的性能,这是世卫组织批准的tNGS诊断测试.
- 评估AMPORE结核病试验在检测呼吸道样本中耐药性突变方面的准确性.
- 为了比较AmPORE结核病试验的周转时间和性能与GenoScreen Deeplex Myc-TB试验.
主要方法:
- 从Xpert MTB/RIF阳性结核病唾液样本的104个DNA样本使用AMPORE结核病套件进行了测试.
- 样品使用牛津纳米孔MinION设备进行了测序,数据由专有软件分析.
- 世卫组织的突变目录被用于药物耐药性解释,Deeplex Myc-TB作为比较试验.
主要成果:
- 安波尔结核病试验的有效率高达98% (102/104个样本).
- 与Deeplex Myc-TB相比,它在检测与关键结核病药物耐药性相关的突变方面取得了100%的积极和消极一致.
- 该试验显著减少了从提取的DNA到报告22个样本的批次的周转时间,约为5-6小时.
结论:
- AmPORE结核病试验显示出良好的性能和高有效性,用于对耐药结核病进行分析.
- 它将tNGS报告的时间从几天大幅缩短到几个小时,提供更快的诊断解决方案.
- 该测试提供了一种灵活和高效的选择,用于在*Mycobacterium tuberculosis*中检测耐药性的临床使用.
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