Suggestions for analytical performance verification and experimental designs for clinical laboratory tests / 中华检验医学杂志

ABSTRACT

The analytical performance verification of clinical laboratory tests plays the key role in the new edition of“Medical laboratory quality and Competence Accreditation Criteria” ( ISO151892012).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.