实验室核酸检测性能验证中ISO15189认可准则应用研究

Application of ISO15189 Criterion in Laboratory Nucleic Acid Testing Performance Verification

本文主要探讨实验室核酸检测性能验证中ISO15189认可准则应用。为了提高实验室核酸检测的时效性、有效性和准确性,需要建立核酸实验室质量认可管理体系,以保障血液核酸集中化检测的程序化和规范化。ISO15189标准为核酸检测实验室管理提供了科学的规范和思路,减少重复性实验室建设和仪器设备采购,最大限度为实验室服务对象和社会节约成本,保障了核酸检测有序、稳定地开展。

This paper mainly discusses the application of ISO15189 accreditation criteria in the performance verification of laboratory nucleic acid testing.In order to improve the timeliness,effectiveness and accuracy of laboratory nucleic acid testing,nucleic acid laboratory quality accreditation management system needs to be established to ensure the centralized detection of blood nucleic acid procedures and standardization.ISO15189 provides scientific standards and ideas for nucleic acid testing laboratory management.The construction of repeatable laboratories and the purchase of instruments and equipment are reduced,and the cost of laboratory services and the society are saved to the greatest extent so as to ensure the orderly and stable development of nucleic acid testing.