Yang Yan-Wei, Zhang Xu, Lin Xiao, Sun Qi, Fu Hui, Lu Yi-Fu, Qiu Tian, Zhang Zhuo-Na, Xie Lin-Na, Zhang Hai-Jing, Zhang Miao, Hu Xiao-Jian, Qu Ying-Li, Zhao Feng, Lyu Yue-Bin, Zhu Ying, Shi Xiao-Ming
National Institute of Environmental Health,Chinese Center for Disease Control and Prevention,Beijing 100021,China.
China CDC Key Laboratory of Environment and Population Health,Beijing 100021,China.
Se Pu. 2025 Jun;43(6):559-570. doi: 10.3724/SP.J.1123.2024.11022.
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 analysis 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 to 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.
中国国家人体生物监测计划(CNHBP)于2016年启动。该计划旨在通过开展中国人群的现场流行病学调查以及对人体生物组织中的环境污染物进行监测,获取普通人群环境污染物的代表性暴露数据。这项工作将为政府制定环境污染防治政策提供科学依据。人体生物监测的目标之一是提供人体生物样本中化学污染物的准确且可比的数据。针对化学污染物的靶向定量分析,从分析方法、实验空白和分析过程等方面实施多维质量控制措施。质量控制程序分为两个阶段:(1)在检测前阶段,重点是生物监测分析方法的验证、空白筛选和控制;(2)在检测阶段,对大规模样本分析过程进行质量控制。CNHBP中使用的分析方法需要进行验证,以评估其性能和实用性,重点是方法检出限(MDL)和方法定量限(MQL)、基质效应、稳定性以及残留和稀释。所有监测指标都需要进行空白筛选程序,以识别、消除或减少空白干扰,每批次的空白值应小于MDL。实验室采用内部和外部质量控制措施相结合的方式,这些措施主要包括:(1)对10种监测指标的方法验证和检测过程均使用美国国家标准与技术研究院(NIST)、欧洲标准物质(ERM)和中国标准物质中心生产的生物基质标准物质,以确保方法的准确性和可溯源性;(2)对15种监测指标使用商业质量控制样品和内部质量控制样品来评估检测过程的稳定性;(3)九大类共60项监测指标参加了德国生物材料分析外部质量评估计划(G-EQUAS)并取得满意结果;(4)对15种监测指标进行盲样测试。总体而言,多维质量控制措施为生成高质量的生物监测数据提供了专业支持。