Exploration of verification and validation of clinical molecular diagnostics method inspection procedure
10.3760/cma.j.issn.1009-9158.2019.07.004
- VernacularTitle:临床分子检验项目的检验程序验证与确认
- Author:
Linlin XIAO
1
;
Quhao WEI
;
Weiwei LIU
Author Information
1. 上海交通大学附属第六人民医院南院检验科
- Keywords:
Verification;
Validation;
Clinical molecular diagnostics
- From:
Chinese Journal of Laboratory Medicine
2019;42(7):503-506
- CountryChina
- Language:Chinese
-
Abstract:
Molecular testing are more and more widely used in clinical practice. The premise of clinical application is the verification or validation of the molecular testing procedure. Establishing a verification and validation model suitable for the testing procedures of clinical molecular testing is helpful for the practitioners of clinical molecular testing to carry out the verification and validation work more conveniently and efficiently. It is also helpful for the standardization of testing and quality control significantly. This article will elaborate on the status of verification and validation of molecular testing projects, the requirements of the ISO15189 accreditation system, the establishment of verification validation models and the prospects in the field.
