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[用于传染病实验室检测的参考材料的生产和管理]

Eun-Bi Oh¹, Sung-Hee Hong¹, Eun-Ju Lee¹

¹질병관리청 진단분석국 신종병원체분석과.

Jugan geon-gang gwa jilbyeong

|December 3, 2025

概括

高质量的参考材料 (RMs) 确保了准确的传染病检测. 韩国疾病控制和预防局系统地根据可靠诊断结果的国际标准生产RM.

科学领域:

临床诊断和传染病监测临床诊断和传染病监测
生物技术和参考材料生产

背景情况:

准确的传染病检测严重依赖于参考材料 (RMs) 的质量.
来自ISO,KS和WHO的既定指南为RM生产和评估提供了一个框架.

研究的目的:

概述韩国疾病控制和预防局 (KDCA) 自2016年以来生产高质量的RM的系统方法.
详细说明开发和验证RM的过程,用于传染病测试和新出现的病原体.

主要方法:

年度项目计划,包括要求审查和遵守KS A ISO 35和KS A ISO 17034指南.
系统的生产过程:材料规划,原材料采购,配送和包装.
同质性和稳定性评估,以确认候选RMS的符合性特征.

主要成果:

生产符合传染病诊断的严格质量标准的RM.
验证的RM用于积极控制,内部质量保证和方法开发.
在国家文化收藏中建立病原体存储库,以使其易于访问.

结论:

在KDCA的系统的RM生产确保了传染病检测结果的可靠性和准确性.
这些RM对于当前的诊断,质量保证和对新出现的疾病的准备至关重要.
简化RM的可访问性支持更广泛的公共和私营部门的研究和测试能力.

关键词:

传染性疾病是传染性疾病.质量控制质量控制参考材料参考材料是指参考材料.

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