Suggestions for analytical performance verification and experimental designs for clinical laboratory tests
10.3760/cma.j.issn.1009-9158.2015.06.017
- VernacularTitle:浅析定量检验程序分析性能验证实验方案设计
- Author:
Xiuming ZHANG
- Publication Type:Journal Article
- Keywords:
Clinical laboratory techniques;
Laboratory proficiency testing;
Research design
- From:
Chinese Journal of Laboratory Medicine
2015;(6):428-430
- CountryChina
- Language:Chinese
-
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” ( 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.
