Study on Clinical Application and Supervision of LC-MS in in Vitro Diagnosis Test.
10.3969/j.issn.1671-7104.2023.06.019
- Author:
Chaofu YE
1
;
Lan ZHANG
1
;
Yanqin KOU
1
;
Yuhang WANG
1
;
Xiaohe YANG
1
Author Information
1. Zhejiang Center for Medical Device Evaluation (Zhejiang Provincial Center of Medical Device Adverse Events Monitoring), Hangzhou, 310009.
- Publication Type:Journal Article
- Keywords:
clinical evaluation;
consistency;
laboratory developed tests (LDTs);
liquid chromatography-tandem mass spectrometry (LC-MS);
real-world data
- MeSH:
Chromatography, Liquid/methods*;
Tandem Mass Spectrometry/methods*;
Reference Standards;
Japan
- From:
Chinese Journal of Medical Instrumentation
2023;47(6):690-694
- CountryChina
- Language:Chinese
-
Abstract:
From the perspective of technical evaluation, this study reviewed the current situation of application and clinical application of medical device products were detected by liquid chromatography-tandem mass spectrometry in the market in recent years. The regulatory requirements of these products in China, USA, EU and Japan were compared and analyzed, and the monitoring situation of adverse events after listing, the standards for reference and the domestic and foreign regulatory documents were combined, the clinical application and regulatory risks of the product were analyzed. The problems such as pre-treatment, system matching, adequacy of performance index requirements, inter-room consistency, reference interval and registration unit were discussed and suggestions for supervision were given, with a view to the field of product R&D and production, review and approval of supervision to provide technical reference.
