Current situation in laboratory developed tests supervision
10.3760/cma.j.issn.1009-9158.2016.01.014
- VernacularTitle:国外医学检验实验室自建检测方法监管现状
- Author:
Beili WANG
;
Wei GUO
;
Baishen PAN
- Publication Type:Journal Article
- Keywords:
Clinical laboratory techniques;
Quality control
- From:
Chinese Journal of Laboratory Medicine
2016;(1):55-59
- CountryChina
- Language:Chinese
-
Abstract:
Laboratory developed tests ( LDT) are usually referred to the diagnostic methods for the medical laboratory , which can only be used in the medical laboratory and can not be sold to other medical laboratories , hospitals and individuals .The paper shows the draft guideline of LDT issued by Food and Drug Administration ( FDA) and the suggestions of clinical laboratory experts and relevant academic groups for different FDA monitoring models.
