摘要检验程序性能验证是新版《医学实验室质量和能力认可准则》（ ISO15189：2012）的核心技术要素。本文以新版认可准则及其在临床化学检验领域的应用说明为依据，主要参考美国临床和实验室标准协会的有关文件，结合我国临床实验室的具体实际，对定量检验程序分析性能验证实验方案的设计提出建议。（中华检验医学杂志，2015，38：428-430）

abstractsThe analytical performance verification of clinical laboratory tests plays the key role in the new edition of“Medical laboratory quality and Competence Accreditation Criteria” ( ISO15189:2012).This review, which is based on the new edition of accreditation criteria and “Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Chemistry”, and with the reference of documents issued from Clinical and Laboratory Standards Institute ( CLSI ) , will give some requirements of analytical performance verification and experimental designs for clinical laboratory tests.