Abstract

The analytical performance verification of clinical laboratory tests plays the key role in the new edition of laboratory quality and Competence Accreditation (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.(Chin J Lab Med, 2015, 38: 428-430) Key words: Clinical laboratory techniques; Laboratory proficiency testing; Research design

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