中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2013年
2期
105-108
,共4页
分子诊断技术%诊断技术和方法%敏感性和特异性
分子診斷技術%診斷技術和方法%敏感性和特異性
분자진단기술%진단기술화방법%민감성화특이성
Molecular diagnostic techniques%Diagnostic techniques and procedures%Sensitivity and specificity
根据CAP和ISO15189认可的要求,从不同认可体系对方法学验证要求的异同、确证和验证试验的差异、方法学验证的基本要素和方法学验证的步骤等方面探讨临床分子诊断的方法学验证及其要素.
根據CAP和ISO15189認可的要求,從不同認可體繫對方法學驗證要求的異同、確證和驗證試驗的差異、方法學驗證的基本要素和方法學驗證的步驟等方麵探討臨床分子診斷的方法學驗證及其要素.
근거CAP화ISO15189인가적요구,종불동인가체계대방법학험증요구적이동、학증화험증시험적차이、방법학험증적기본요소화방법학험증적보취등방면탐토림상분자진단적방법학험증급기요소.
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.
