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中国防痨杂志 ›› 2026, Vol. 48 ›› Issue (9): 1250-1258.doi: 10.19982/j.issn.1000-6621.20260285

• 标准解读 • 上一篇    下一篇

世界卫生组织《结核病筛查测试产品的目标产品特征》解读

黄欢1, 王小敏1, 宋喆1, 李雪林1, 丁峰1, 王瑾1, 曾剑锋1, 吴海武2, 钟新光3, 卢水华1()   

  1. 1 深圳市第三人民医院/国家感染性疾病临床医学研究中心肺病医学部, 深圳 518112
    2 江西省赣州市第五人民医院肝病科, 赣州 341000
    3 广东省东莞市第六人民医院传染病科, 东莞 523000
  • 收稿日期:2026-05-21 出版日期:2026-09-10 发布日期:2026-09-08
  • 通信作者: 卢水华 E-mail:lushuihua66@126.com
  • 基金资助:
    新发突发与重大传染病防控国家科技重大专项(2025ZD01907900);深圳市医学研究专项资金项目(D250403009);深圳市医学研究专项资金项目(C2405002);深圳市基础研究专项自然科学基金(JCYJ20250604144008011);深圳市高水平医院建设专项经费资助(XKJS-2025020);深圳市科技创新委员会基金(JSGGZD20220822095200001)

Interpretation of the World Health Organization’s Target Product Profiles for Tuberculosis Screening Test Products

Huang Huan1, Wang Xiaomin1, Song Zhe1, Li Xuelin1, Ding Feng1, Wang Jin1, Zeng Jianfeng1, Wu Haiwu2, Zhong Xinguang3, Lu Shuihua1()   

  1. 1 Department of Pulmonary Medicine, Shenzhen Third People’s Hospital/National Clinical Research Center for Infectious Diseases, Shenzhen 518112, China
    2 Department of Hepatology, The Fifth People’s Hospital of Ganzhou, Jiangxi Province, Ganzhou 341000, China
    3 Department of Infectious Diseases, Dongguan Sixth People’s Hospital, Guangdong Province, Dongguan 523000, China
  • Received:2026-05-21 Online:2026-09-10 Published:2026-09-08
  • Contact: Lu Shuihua E-mail:lushuihua66@126.com
  • Supported by:
    National Science and Technology Major Project for the Prevention and Control of Emerging, Acute and Major Infectious Diseases(2025ZD01907900);Shenzhen Special Fund Project for Medical Research(D250403009);Shenzhen Special Fund Project for Medical Research(C2405002);Basic Research Special Program of Shenzhen Natural Science Foundation(JCYJ20250604144008011);Shenzhen Special Fund for High-level Hospital Construction(XKJS-2025020);Research Fund of Shenzhen Municipal Science and Technology Innovation Commission(JSGGZD20220822095200001)

摘要:

全球结核病防控长期依赖患者因症就诊的“被动发现”模式,导致每年约20%~40%的患者未被及时发现,巨大的诊断缺口已成为实现“终结结核病流行策略”目标的主要障碍。为扩大筛查规模、提升主动发现能力,亟需开发适用于大规模社区及高危人群的筛查测试产品。2025年,世界卫生组织首次发布专门针对筛查场景的《结核病筛查测试产品的目标产品特征》,系统规定了筛查测试产品在适用范围、检测性能、定价策略及操作特性等方面的最低与最佳要求。该文件的核心更新在于基于数学建模提出三类适配不同场景的筛查测试产品:高敏感度和高特异度一步筛查测试产品、高敏感度两步筛查测试产品和高特异度一步筛查测试产品,为新型筛查技术的研发提供了明确的性能基准与应用方向。作为首份专项针对结核病筛查测试产品研发的战略指导文件,它不仅为产品开发提供了规范性框架,也为各国结核病防控部门、资助机构及筛查产品制造商等利益相关方提供了决策依据,有望加速创新测试的转化落地,推动结核病主动筛查策略的优化与普及。

关键词: 结核, 诊断技术和方法, 总结性报告(主题)

Abstract:

Global tuberculosis (TB) prevention and control has long relied on the passive case finding model, where patients seek medical attention only after symptom onset. This pattern leaves approximately 20%-40% of TB cases undetected each year, and the persistent diagnostic gap has emerged as a major obstacle to achieving the strategic targets of the WHO End TB Strategy. To scale up screening coverage and strengthen active case finding capacity, there is an urgent need to develop screening test products applicable to large-scale community settings and high-risk populations. In 2025, the World Health Organization (WHO) issued its first Target Product Profiles for Tuberculosis Screening Test Products dedicated to screening scenarios. The document systematically defines the minimum and optimal requirements for screening test products across multiple dimensions, including intended use, diagnostic performance, pricing strategy, and operational attributes. The core update of this guidance is the proposal of three categories of screening test products adapted to distinct scenarios, informed by mathematical modelling: single-step screening assays with both high sensitivity and high specificity, high-sensitivity two-step screening assays, and high-specificity single-step screening assays. These profiles establish clear performance benchmarks and application roadmaps for the research and development of innovative screening technologies. As the first strategic guidance document exclusively focused on TB screening test products, it provides not only a normative framework for product development, but also decision-making reference for stakeholders including national TB control programs, funding agencies, and screening test manufacturers. It is expected to accelerate the translation and deployment of innovative diagnostic tests, and advance the optimization and widespread adoption of active TB screening strategies.

Key words: Tuberculosis, Diagnostic techniques and procedures, Consensus development conferences as topic

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