临床检验程序不精密度、正确度及诊断准确度验证的实用性方法

摘要

目的 国际标准 ISO 15189被认为是确保高质量临床实验室服务和促进检验医学认可项目一致化有价值的指南.对检验程序必须进行验证以确保其性能特征与试验的预期范围是一致的.研究目的是建立一种实用性方法,用于实施验证已经在实验室使用至少2年的已确认的检验程序,该方法符合 ISO 15189第5.5.1.2章节的要求.方法 首先,识别已批准的文件并确定评价不同方法的性能特征;其次,对实验室使用的检验程序进行分析,并对制造商报告的性能规范进行检查;最后,确定操作流程图,将实验室的性能特征与厂商的声明进行比较.结果 根据指南的要求以及所执行试验的性质和预期目的,选择适当的性能特征用于验证过程,验证的内容主要包括:定量方法的不精密度与正确度,定性方法的诊断准确度,半定量方法的不精密度与诊断准确度.结论 文章提出的验证方法,综合考虑了技术可能性、风险与成本等各方面因素,符合确保结果准确度的基本要求,可以作为一种应用简单且灵活的程序来帮助实验室满足 ISO 15189的质量要求.%Objective To propose a practice model for implementing procedures employed for the verification of validated ex-amination procedures already used for at least 2 years in their laboratory,in agreement with the ISO 15189 requirement at the Section 5.5.1.2.Methods In order to identify the operative procedure to be used,approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods;the examination proce-dures used in laboratory were analyzed and checked for performance specifications reported by manufacturers.Then,opera-tive flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers. Results The choice of performance characteristics for verification was based on approved documents used as guidance,and the specific purpose tests undertaken,a consideration being made of:imprecision and trueness for quantitative methods;diag-nostic accuracy for qualitative methods;imprecision together with diagnostic accuracy for semi-quantitative methods.Conclu-sion The described approach,balancing technological possibilities,risks and costs and assuring the compliance of the funda-mental component of result accuracy,appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.