色谱

色谱

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国家人体生物监测项目中化学污染物靶向定量分析的实验室质量控制策略

杨艳伟1, 张续1,2, 林潇1,2, 孙琦1,2, 付慧1, 陆一夫1,2, 邱天1,2, 张卓娜1,2, 谢琳娜1,2, 张海婧1,2, 张淼1, 胡小键1, 曲英莉1,2, 赵峰1,2, 吕跃斌1,2, 朱英1,2,*, 施小明2,3,*   

  1. 1.中国疾病预防控制中心环境与健康相关产品安全所,北京 100021;
    2.中国疾病预防控制中心环境与人群健康重点实验室,北京 100021;
    3.中国疾病预防控制中心,北京 102206
  • 收稿日期:2024-11-22
  • 通讯作者: *Tel：（010）50930161,E-mail：zhuying@nieh.chinacdc.cn（朱英）;Tel：（010）58900309,E-mail：shixm@chinacdc.cn（施小明）.
  • 基金资助:
    中央财政经费项目(131031108000150003).

Quality control strategy for targeted quantitative analysis of chemical pollutants in China National Human Biomonitoring Program

YANG Yanwei1, ZHANG Xu1,2, LIN Xiao1,2, SUN Qi1,2, FU Hui1, LU Yifu1,2, QIU Tian1,2, ZHANG Zhuona1,2, XIE Linna1,2, ZHANG Haijing1,2, ZHANG Miao1, HU Xiaojian1, QU Yingli1,2, ZHAO Feng1,2, LV Yuebin1,2, ZHU Ying1,2,*, SHI Xiaoming2,3,*   

  1. 1. National Institute of Environmental Health, Chinese Center for Disease Control and Prevention, Beijing 100021, China;
    2. China CDC Key Laboratory of Environment and Population Health, Beijing 100021, China;
    3. Chinese Center for Disease Control and Prevention, Beijing 102206
  • Received:2024-11-22
  • Supported by:
    Central Financial Funds（No. 131031108000150003）.

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摘要： 国家人体生物监测项目于2016年正式启动,该项目的目标是通过对我国人群进行现场流行病学调查,并监测人体生物样本中的环境污染物质,来获取具有代表性的环境污染物质在普通人群中的暴露负荷数据,为政府制定环境污染防控政策和采取相应干预措施提供重要的科学依据。为了获取人群生物样本中准确且可比的化学污染物数据,在国家人体生物监测项目的框架下,实验室从分析方法、实验空白到检测过程,对化学污染物的靶向定量分析实施了多维度的质量控制措施。项目的质控程序分为两个阶段进行：（1）检测前阶段生物监测分析方法的验证、空白的筛查与控制;（2）检测阶段大规模样本分析过程的质量控制。应用于国家人体生物监测项目的分析方法均需经过验证程序,以全面评估方法的性能及实用性,验证的重点包括方法检出限和方法定量限、基质效应、稳定性以及残留与稀释。所有监测指标均需通过空白筛查程序,以识别、消除或降低实验中的空白干扰,确保每批次的空白测定结果均低于方法检出限。实验室采用内部质量控制与外部质量控制相结合的方式,具体措施主要包括：（1）10类监测指标的方法验证及检测过程均使用包括美国国家标准与技术研究院（NIST）、欧洲标准局（ERM）及中国标准物质中心在内生产的生物基质标准物质,以确保方法的准确性及溯源性;（2）15类监测指标使用商品质控样和内部质控样,以评价测试过程的稳定性;（3）9类共60项监测指标参与德国外部质量评估计划（G-EQUAS）,并取得了满意的结果;（4）15类监测指标使用盲样。多维度的质控措施为生成高质量的生物监测数据提供了专业支撑。

关键词: 国家人体生物监测项目, 质量控制, 方法验证, 实验空白

Abstract: The China National Human Biomonitoring Program (CNHBP) was launched in 2016. The program aims to obtain representative exposure data of environmental pollutants in the general population by carrying out field epidemiological surveys of Chinese population and monitoring of environmental pollutants in human biological tissues. This work will provide a scientific basis for the government to formulate environmental pollution prevention and control policies. One of the objectives of human biomonitoring is to provide accurate and comparable data of chemical pollutants in human biological samples. Multi-dimensional quality control measures are implemented for the targeted quantitative analysis of chemical pollutants from the analysis method, experimental blank and detection processes. The quality control procedures are divided into two stages: (1) focusing on the verification of biomonitoring analysis method, blank screening and control in the pre-detection stage; (2) the quality control of the large-scale sample analysis process in the detection stage. Analysis methods used in CNHBP need be validated to evaluate the performance and practicability, with emphasis on method detection limit (MDL) and method quantification limit (MQL), matrix effects, stability, and residue and dilution. Blank screening procedures are required for all monitoring indicators to identify, eliminate or reduce blank interference, and the blank value of each batch should be less than the MDL. The laboratory adopts a combination of internal and external quality control measures, the measures mainly include: (1) method validation and detection process of the 10 types of monitoring indicators all used biological matrix reference materials produced by the National Institute of Standards and Technology (NIST), European Reference Materials (ERM) and China Center for Reference Materials, to ensure the accuracy and traceability of the methods; (2) commercial quality control samples and internal quality control samples were used to evaluate the stability of the testing process for the 15 types of monitoring indicators; (3) a total of 60 monitoring indicators of the nine categories participated in the German external quality assessment scheme for analyses in biological materials (G-EQUAS) and achieved satisfactory results; (4) 15 types of monitoring indicators were tested with blind samples. Overall, multi-dimensional quality control measures provide professional support for generating high-quality biomonitoring data.

Key words: China National Human Biomonitoring Program (CNHBP), quality control, method verification, experimental blank