| 张孝明,杨振,许四宏,石大伟,孙彬裕,李丽莉,李颖.血源筛查核酸检测体系的发展、应用及监管[J].中国药事,2019,33(9):1063-1070 |
| 血源筛查核酸检测体系的发展、应用及监管 |
| The Nucleic Acid Testing System for Blood Source Screening: Development, Application and Regulation |
| 投稿时间：2019-06-29 |
| DOI：10.16153/j.1002-7777.2019.09.017 |
| 中文关键词: 肝炎 艾滋病 核酸检测 血源筛查 传染病 输血安全 |
| 英文关键词: Hepatitis AIDS nucleic acid testing blood source screening infectious diseases transfusion safety |
| 基金项目: |
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| 摘要点击次数: 1517 |
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| 中文摘要: |
| 目的：对我国血源筛查核酸检测体系的研发、应用和监管提供建议。方法：概述血源筛查核酸检测的技术方法，梳理核酸血筛体系的研究进展、应用及监管现状，并结合我国国情提出针对性建议。结果与结论：应用核酸检测试剂检测病原体核酸，可显著缩短病原体检测"窗口期"。近年来，国产核酸检测试剂的灵敏度及检测仪器的自动化水平都有了显著提升，但是国产核酸检测体系质量和性能还有很大进步空间。建议加大对符合我国国情的核酸检测试剂的研究投入；加强核酸检测体系使用的管理；统筹规范检测模式、检验标准和检验参考品。 |
| 英文摘要: |
| Objective:To provide suggestions for the development and research, application and regulation of the nucleic acid testing (NAT) system used for blood source screening in China. Methods:The technical approaches of NAT for blood source screening were summarized and the NAT's research progress, application and regulation status were overviewed. Suggestions were provided based on national situation of China. Results and Conclusion:Application of NAT in blood source screening to detect pathogen nucleic acid can significantly shorten the "window period" of pathogen detection. In recent years, the sensitivity of domestic NAT reagents and the automation level of detection instruments have been significantly improved. However, there is still much room for improvement in the quality and performance of the domestic NAT system. It is suggested that the research input for NAT reagents suitable for our national conditions should be increased, the management of the use of NAT systems should be strengthened, and the detection mode, detection standards and reference materials should be coordinated and standardized. |
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