CAP and ISO15189 accreditation requirements of verification and validation tests for clinical molecular diagnostic assays
10.3760/cma.j.issn.1009-9158.2013.02.003
- VernacularTitle:CAP和ISO15189认可对临床分子诊断方法学验证的要求
- Author:
Ming GUAN
;
Weiwei LIU
- Publication Type:Journal Article
- Keywords:
Molecular diagnostic techniques;
Diagnostic techniques and procedures;
Sensitivity and specificity
- From:
Chinese Journal of Laboratory Medicine
2013;(2):105-108
- CountryChina
- Language:Chinese
-
Abstract:
College of American Pathologists (CAP) and International Standard Organization (ISO)15189 accreditation provides requirements to the verification and validation tests for clinical molecular diagnostic assays.The article will introduce the requirements in these aspects including the differences between the two accreditation systems,the differences between the verification and validation tests,the essential factors and standardized framework of the verification and validation tests for clinical molecular diagnostic assays.
