NEW YORK – The World Health Organization has published updated guidelines for the rapid diagnosis of tuberculosis including new recommendations on the use of targeted next-generation sequencing (NGS) tests for drug-resistant TB.

纽约——世界卫生组织发布了最新的结核病快速诊断指南，包括关于使用靶向下一代测序（NGS）检测耐药结核病的新建议。

Specifically, the guidelines note that in people with bacteriologically confirmed pulmonary TB disease, targeted NGS may be used on respiratory samples to diagnose resistance to rifampicin, isoniazid, fluoroquinolones, pyrazinamide, and ethambutol rather than culture-based phenotypic drug susceptibility testing..

具体而言，指南指出，在细菌学确诊的肺结核患者中，靶向NGS可用于呼吸道样本，以诊断对利福平，异烟肼，氟喹诺酮类，吡嗪酰胺和乙胺丁醇的耐药性，而不是基于培养的表型药敏试验。。

The guidelines also state in people with bacteriologically confirmed rifampicin-resistant pulmonary TB disease, targeted NGS technologies may be used on respiratory samples to diagnose resistance to the other aforementioned drugs.

该指南还指出，在细菌学证实对利福平耐药的肺结核患者中，靶向NGS技术可用于呼吸道样本，以诊断对上述其他药物的耐药性。

The WHO specifically highlighted three NGS tests: Deeplex Myc-TB from Genoscreen in France; AmPORE-TB from Oxford Nanopore Diagnostics in the UK; and Tbseq from Hangzhou ShengTing Medical Technology in China. Each of these assays are able to diagnose resistance to different groups of drugs, the WHO noted, stating that where a product hasn't yet met the requirements for a specific drug, further improvements are needed, and a review of evidence is necessary, before clinical use..

世卫组织特别强调了三项NGS测试：来自法国Genoscreen的Deeplex Myc TB；英国牛津纳米孔诊断公司的AmPORE TB；和来自中国杭州盛庭医疗科技有限公司的Tbseq。世卫组织指出，这些检测方法中的每一种都能够诊断出对不同药物组的耐药性，并指出，如果一种产品尚未达到特定药物的要求，则需要进一步改进，并且在临床使用前需要对证据进行审查。。

The newly published guidelines also highlight various other molecular technologies for rapid TB diagnosis and resistance detection, including moderate-complexity automated nucleic acid amplification technologies (NAATs) for the detection of TB and resistance to rifampicin and isoniazid; lateral flow antigen detection tests; low-complexity automated NAATs for the detection of resistance to isoniazid and second-line anti-TB agents; and line-probe assays..

新发布的指南还强调了用于快速结核病诊断和耐药性检测的各种其他分子技术，包括用于检测结核病和利福平和异烟肼耐药性的中等复杂度自动核酸扩增技术（NAATs）；侧流抗原检测试验；低复杂性自动化NAAT，用于检测对异烟肼和二线抗结核药物的耐药性；和线探针测定。。

The guidelines are accompanied by a WHO operational handbook, which provides detailed guidance on implementing the targeted NGS tests for laboratory personnel, clinicians, as well as other stakeholders. It describes the recommended targeted NGS tests including their protocols, model algorithms, as well as the steps required to implement and scale up these tests..

该指南附有世卫组织操作手册，该手册为实验室人员，临床医生以及其他利益相关者实施有针对性的NGS检测提供了详细指导。它描述了推荐的目标NGS测试，包括它们的协议、模型算法，以及实现和扩展这些测试所需的步骤。。

The WHO also said it has also launched a new TB sequencing portal with more than 56,000 sequences. Developed in partnership with FIND and Unitaid, the portal contains the most advanced sequencing and phenotyping knowledgebase for Mycobacterium tuberculosis, according to the organization.

世卫组织还表示，它还推出了一个新的结核病测序门户，其中包含56000多个序列。据该组织称，该门户网站是与FIND和Unitaid合作开发的，其中包含最先进的结核分枝杆菌测序和表型知识库。

The portal also includes a dashboard to help users visualize the data used in the WHO mutation catalog published in November 2023, search for mutation frequencies and their association with drug resistance, as well as download summary data and upload new data.

该门户还包括一个仪表板，帮助用户可视化2023年11月发布的世卫组织突变目录中使用的数据，搜索突变频率及其与耐药性的关联，以及下载摘要数据和上传新数据。

'The diagnostic options for people with drug-resistant TB are increasing thanks to manufacturer engagement and research, generating new evidence,' Tereza Kasaeva, director of WHO's Global TB Programme, said in a statement. 'Ensuring that everyone in need can obtain a rapid and accurate diagnosis with the latest state-of-the-art technologies will advance efforts at preventing and finally ending TB.'.

世卫组织全球结核病项目主任特蕾莎·卡萨耶娃（TerezaKasaeva）在一份声明中说，由于制造商的参与和研究，耐药结核病患者的诊断选择正在增加，并产生了新的证据确保每个有需要的人都能通过最新的最先进技术获得快速准确的诊断，将推动预防和最终结束结核病的努力。”。