中国血吸虫病防治杂志(中英文) ›› 2026, Vol. 38 ›› Issue (2): 123-126, 159.

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卫生行业标准《疟原虫检测 免疫层析法》(WS/T 10029—2025)解读

徐岁1, 朱国鼎1, 2, 曹俊1, 2*   

  1. 1 国家卫生健康委员会寄生虫病预防与控制技术重点实验室、江苏省寄生虫与媒介控制技术重点实验室、江苏省寄生虫病防治研究所(江苏 无锡 214064);2 南京医科大学公共卫生学院全球健康中心(江苏 南京 211166)
  • 出版日期:2026-06-02 发布日期:2026-06-02
  • 通讯作者: 曹俊 caojuncn@hotmail.com
  • 作者简介:徐岁,女,硕士,助理研究员。研究方向:病原生物学
  • 基金资助:
    国家疾病预防控制局公共卫生人才培养支持项目

Interpretation of a health industry standard Detection of Plasmodium spp. Immune⁃chromatographic test (WS/T 10029—2025)

XU Sui1, ZHU Guoding1, 2, CAO Jun1, 2*   

  1. 1 National Health Commission Key Laboratory of Parasitic Disease Control and Prevention, Jiangsu Provincial Key Laboratory of Parasite and Vector Control Technology, Jiangsu Institute of Parasitic Diseases, Wuxi, Jiangsu 214064, China; 2 Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu 211166, China 
  • Online:2026-06-02 Published:2026-06-02

摘要: 疟疾是全球最严重的公共卫生问题之一。我国在实现消除疟疾目标后,每年仍报告数千例输入性疟疾病例,及时、准确的诊断是病例救治和防止输入再传播的关键。疟原虫抗原检测阳性是疟疾的确诊依据之一。基于免疫层析法的疟疾快速诊断试纸条(rapid diagnostic test,RDT)因操作简便、检测快速,已成为疟疾临床诊断的重要工具。然而,各级医疗机构和疾病预防控制人员在使用疟疾RDT的过程中仍存在诸多误区。为规范检测技术标准与操作流程,国家疾病预防控制局组织制定了推荐性卫生行业标准《疟原虫检测 免疫层析法》(WS/T 10029—2025),并于2026年3月1日正式实施。该标准对免疫层析法检测疟原虫抗原的原理、样本采集与检测操作步骤及结果判定等进行了系统规范,为各级医疗和疾病控制机构开展相关检测提供了技术依据和操作规范。本文结合我国输入性疟疾流行特征,对该标准的核心内容进行了解读,以促进其推广应用。

关键词: 疟疾, 疟原虫检测, 免疫层析, 卫生行业标准

Abstract: Malaria remains one of the most serious public health problems worldwide. After China achieved the target for malaria elimination, thousands of imported malaria cases are still reported annually. Timely and accurate diagnosis is critical to clinical treatment of cases and prevention of re⁃establishment of imported malaria. Detection of Plasmodium antigens is one of the criteria for definitive diagnosis of malaria. Malaria rapid diagnostic tests (RDTs) based on the immunochromatographic assay have become an important tool for clinical diagnosis of malaria due to convenient procedures and rapid detection. Nevertheless, there are still multiple misunderstandings pertaining to use of malaria RDTs among workers in medical and disease control and prevention institutions at all levels across China. To standardize technical guidelines and operational procedures for detection of Plasmodium spp., the National Disease Control and Prevention Administration has arranged the formulation of a recommended health industry standard Detection of Plasmodium spp. Immune⁃chromatographic test (WS/T 10029—2025), which has been officially implemented since March 1, 2026. This standard systematically defines the core contents for detection of Plasmodium antigens using immunochromatographic assays, including the testing principles, sample collection and detection procedures, and result interpretation, which provides the technical basis and operational specifications for detection of Plasmodium antigens in medical and disease control and prevention institutions at all levels. Based on analysis of the epidemiological characteristics of imported malaria in China, this article interprets the core content of this standard, aiming to promote its dissemination, implementation, and practical applications.

Key words: Malaria, Plasmodium detection, Immunochromatography, Health industry standard

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