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

doi:10.19982/j.issn.1000-6621.20260285

Abstract

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

CLC Number:

Huang Huan, Wang Xiaomin, Song Zhe, Li Xuelin, Ding Feng, Wang Jin, Zeng Jianfeng, Wu Haiwu, Zhong Xinguang, Lu Shuihua. Interpretation of the World Health Organization’s Target Product Profiles for Tuberculosis Screening Test Products[J]. Chinese Journal of Antituberculosis, 2026, 48(9): 1250-1258. doi: 10.19982/j.issn.1000-6621.20260285

Figures/Tables 4

项目	新版TPPs		旧版TPPs
项目	最佳要求	最低要求	最佳要求	最低要求
样本类型	不需要实物样本,或需要易于获得的自我收集的样本	需要易于获取的样本,包括非物理样本,例如图像和声音	非痰液样本(如尿液、口腔黏膜渗出液、唾液、呼出气或指尖血)	痰液;最好是非痰液样本(如尿液、口腔黏膜渗出液、唾液、呼出气或指尖血);影像技术
人工样本制备	无需手动准备、严格计时或测量	在采集现场进行最少的人工制备,没有严格的时间或测量	样品制备应集成,或无需人工制备(废物处理除外);无需精确计时和测量	2个步骤(不含废物处理);无需精确计时和测量
仪器要求	无需仪器	便携式或移动设备,可选择使用电池或太阳能进行POC设置,或可对样品进行高效批量测试的集中式仪器	无需仪器	小型、便携式或手持设备(<1kg);应可选择电池或太阳能供电
电力要求	可以使用电池或太阳能供电,或者不需要电源(如果不涉及仪器)	内置UPS的标准工作电流,适用于功率可变的场所	无需仪器	电池或太阳能供电
维护与校准	无需维护,自行或远程校准	1年后或超过20000次测试(以先到者为准)后进行预防性维护和校准;包括维护警报	一次性使用,无需维护	直到1年后或1000个样本后才需要进行预防性维护;仅需要简单的工具和最少的专业知识;应包括指示何时需要维护的警报;该设备应该能够远程校准,应该自我校准,或者不需要校准
温度和湿度	5~50℃之间,湿度90%	5~40℃之间,湿度70%	5~50℃之间,湿度90%	5~40℃之间,湿度70%
结果数据的文档记录与展示	在测试设备上使用视觉读数(例如条形码)进行无仪器测试,以数字方式记录和报告数据;应将结果数据传输给进行筛查的工作人员数字化,以提高效率和与护理的联系	数字读数显示测试详细信息,包括结果。应包含保存结果的功能,并且结果应能够以标准格式(例如XML或CSV)导出到第三方仪器(例如通过USB)或连接软件	具有视觉读数功能的无仪器测试,并且能够使用单独的可连接读取器保存结果	测试菜单必须易于导航;仪器应具有集成的LCD屏幕、简单的键盘或触摸屏,并且能够使用仪器或单独的读取器保存结果
内部质控要求	-	-	应包括用于处理样本和检测结核病的内部控制	仅包含用于处理样品的内部控制
培训与教育	最少的培训或教育	具有执行其他健康相关程序技能的工作人员的最低培训与教育时间为1d	-	-
数据存储	管理测试部署地点的管理机构(MoH或NTP)应能够指定或同意测试数据的存储位置,而不影响测试的支持和最佳使用		-	-
数据所有权	测试数据、其管理和所有权必须符合当地法规的要求		-	-
安全与隐私	为了促进卫生项目根据其环境中的法律、法规和政策及最佳实践进行使用,测试应提供可配置的功能,以便可以:为用户和接受测试的人员透明地收集个人数据,包括同意;仅出于与健康计划目的相符的目的收集和处理;仅限于相关和必要的内容;准确收集;以可识别的形式存储,但存储时间不超过必要的时间;通过静态和传输加密确保完整性和机密性		-	-
监管要求	检测和系统的设计、开发和制造应符合ISO 13485和ISO 14971或更高标准或法规,并符合ISO IEC 62304。制造设施应进行高风险分类评估,并由国际医疗器械监管机构论坛(前身为全球协调工作组)创始成员之一的监管机构进行认证以供使用;如果适用,该测试必须注册用于体外诊断用途;对于非体外诊断测试,应遵循适当的监管要求		-	-
语言支持	与最少的语言相同,再加上允许部署位置的其他居民使用的其他语言	对于部署测试的每个国家,应以一种流行语言提供说明;例如,官方语言或事实上的国家语言,以及当地监管或贸易合规要求规定的任何语言	-	-
环境影响	测试和任何相关仪器应尽量减少对环境的不利影响。例如,通过:具有本地生产的潜力;最大限度地减少浪费;最大限度地提高副产品的可重复使用性和回收利用;创建多用途平台;规定仪器报废后的回收利用;功耗和辐射排放低	-	-

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适用范围	新版TPPs		旧版TPPs
适用范围	最佳要求	最低要求	最佳要求	最低要求
预期使用目的	为了提供能够鉴定以下人群的筛查测试产品的特征:(1)需要进一步接受结核病诊断评估的疑似结核病患者;(2)不太可能有结核病的个体及筛查测试产品能有效排除结核病的个体		开发一种可在患者首次接触医疗系统时使用的检测,以识别任何活动性结核病症状或危险因素的患者,包括合并HIV感染、无结核病,以及需要转诊进行确认评估的患者	开发一种可在患者首次接触医疗系统时使用的检测,以识别任何活动性肺结核症状或危险因素的患者,包括合并HIV感染、无结核病,以及需要转诊进行确认评估的患者
目标人群	结核病患病率低至0.25%的一般人群和结核病高危人群	结核病患病率低至1%的一般人群和结核病高危人群	在中等至高流行国家任何地点出现活动性结核病症状和体征的成人和儿童	在中等至高流行国家中出现活动性肺结核症状和体征的成人和儿童
预期使用者	未接受(或接受最少)培训或指导的外行或者照护人员,支持自检	接受过一些结核病筛查测试产品培训的医护人员或技术员	接受过最低培训的社区卫生工作者和非正式提供者	经过辅助护士级别培训的医护人员
应用场所	这些检测可以在社区环境、拥有基本基础设施(包括电力和水)的医疗机构及家庭环境中进行		社区级、乡村级或更高级别的医疗系统	卫生站和初级保健诊所或医疗系统更高级别

文件版本	最佳要求	最低要求
新版TPPs
高敏感度、高特异度筛查测试产品	≤1美元	≤3美元
高敏感度筛查测试产品	≤1美元	≤2美元
高特异度筛查测试产品	≤1美元	≤2美元
旧版TPPs	<1美元	<2美元