Discussion and analysis of laboratory developed tests management model with the goal of product registration
10.3760/cma.j.cn114452-20231031-00248
- VernacularTitle:以产品注册为目标的实验室自建检测管理模式探讨与分析
- Author:
Hongwei ZHOU
1
;
Dingqiang CHEN
;
Yan HE
;
Lingxiao JIANG
;
Qian WANG
Author Information
1. 南方医科大学珠江医院检验医学部 广东省医学检验临床医学研究中心，广州510280
- Keywords:
Management model;
Laboratory developed tests;
Registration;
In vitro diagnostics
- From:
Chinese Journal of Laboratory Medicine
2024;47(1):20-23
- CountryChina
- Language:Chinese
-
Abstract:
Currently, the management of domestic laboratory developed test (LDT) is still in the exploration stage, and new plans and ideas need to be investigated that are suitable for our national development. By analyzing encountered issues, combining the actual needs of the government, healthcare reform, and patients, this article proposes that "promoting healthy development of LDT projects and focusing on the organic combination of patients′ interest protection and innovation support" is an important direction for LDT management, around which the new idea for LDT project management is proposed, that is, LDT management model targeting product registration. The core of this management model is to target product registration and to ensure low service fees for patients and continuous real-time data monitoring. Benefit and risk analysis demonstrate that this management model can to a larger extent balance the realistic demands of patients, medical institutions, in vitro diagnostics companies, and government management departments, which benefits promoting the perfection and development of LDT projects in our country.
