2017年，WHO推荐升级版Xpert MTB/RIF Ultra，检测灵敏度进一步提升，尤其适用于痰涂片阴性和儿童结核病。 2024年12月5日，WHO正式预认证Xpert MTB/RIF Ultra，这是首个符合WHO全部质量、性能和安全标准的结核 病诊断和抗生素敏感性检测工具。 时至今日，核酸扩增技术正沿着 提升速度 、 简化操作 、 降低污染 及 拓展应用场景 的方向持续发展，并与多种前 沿技术深度融合，在医疗诊断、生物信息等领域展现出巨大潜力。尽管部分前沿探索仍处于研究阶段，但其发展方向已 清晰可见： 点击免费限量礼盒 特别提示 微信机制调整，点击顶部"仪器信息网" → 右上方"…" → 设为 ★ 星标，否则很可能无法看到我们的推送。 2010年12月8日。 世界卫生组织 (WHO) 正式批准并推荐使用Xpert MTB/RIF，这是一种 全自动核酸扩增检测技术 (NAAT)， 将结 核 病诊断时间从3个月缩短至100分钟，这种 全自动核酸扩增检测仪器系统 融合DNA技术与全自动操作流程，被纳入全 球结核病防控项目，推动传染病快速检测技术规模化应用。 Xpert MTB/RIF是由美国Cepheid ...

Group 1: Tuberculosis Overview - Tuberculosis (TB) is a serious infectious disease caused by Mycobacterium tuberculosis, posing a significant global public health threat [3] - In 2021, China accounted for 7.4% of the global TB incidence, ranking third worldwide, with a treatment success rate for drug-resistant TB at only 53% compared to 95% for regular TB [3][6] - In 2021, there were 1.6 million deaths from TB globally, making it the 13th leading cause of death, just after COVID-19 [6] Group 2: Drug-Resistant Tuberculosis - The emergence of drug-resistant TB (MDR-TB and XDR-TB) complicates TB control efforts, leading to increased treatment difficulty, lower cure rates, and higher mortality [5] - In 2021, there were 450,000 new cases of MDR/RR-TB, with a treatment success rate of only 60% [6] Group 3: Limitations of Traditional Testing Methods - Traditional drug resistance testing methods are time-consuming, often taking weeks to months, and have low sensitivity and specificity [7] - Rapid molecular testing can provide quicker results but is limited in identifying a comprehensive range of drug resistance mutations [7] Group 4: Reversible Terminator Sequencing (RTS) - RTS is a high-precision DNA sequencing technology that allows for single-base resolution sequencing, significantly improving accuracy and sensitivity [8] - The technology is suitable for rapid diagnosis and clinical applications, completing the sequencing process in a short time [8] Group 5: Targeted Next-Generation Sequencing (tNGS) - tNGS integrates multiplex PCR/hybrid capture with next-generation sequencing, providing precise analysis of specific gene regions and comprehensive drug resistance information [9] - The tNGS method can analyze multiple antibiotic resistance genes simultaneously, aiding in early diagnosis and personalized treatment strategies [16] Group 6: Gold Standard Testing Kit - The Mycobacterium tuberculosis complex drug resistance gene mutation detection kit (RTS) combines tNGS with multiplex PCR, covering 13 resistance genes and over 200 mutation sites [13] - The kit can provide results in under 12 hours, with a sequencing run time of less than 5 hours, allowing for rapid detection of drug resistance [13] Group 7: Clinical Data and Performance - Clinical studies show that tNGS has an average consistency of 95.10% with phenotypic antimicrobial susceptibility testing (AST) and 97.05% with whole genome sequencing (WGS) [18] - In 158 bronchoalveolar lavage fluid samples, tNGS had a positivity rate of 87.95%, outperforming Xpert MTB/RIF [18] Group 8: Competitor Products - Cepheid's Xpert MTB/RIF offers rapid detection of Mycobacterium tuberculosis and rifampicin resistance with a sensitivity of 133 bacteria/mL, providing results in 2 hours [19] - Hain Lifescience's GenoType MTBDRplus uses linear probe hybridization for detecting TB and drug resistance, with a 48-hour turnaround time [20] - Becton Dickinson's BD MAX MDR-TB detects multiple drug resistance genes with high sensitivity and specificity, providing results in 2 hours [21] Group 9: Company Profile - Guangzhou Jinquirui Biotechnology Co., Ltd. focuses on the development, production, and sales of precision medical in vitro diagnostic products, established in 2016 [22] - The company has developed various technologies, including multiplex PCR and tNGS, and has received multiple core technology patents [24] - Jinquirui is one of the few companies in China providing a comprehensive solution for tumor and infection diagnostics, including gene sequencing instruments and clinical applications [24]