Survey and analysis of use and quality control of nitrocellulose membranes in in vitro diagnostic reagent manufacturing enterprises
10.19745/j.1003-8868.2025128
- VernacularTitle:体外诊断试剂生产企业硝酸纤维素膜使用及质控情况调查分析
- Author:
Zheng-shan WU
1
;
Bo-yang ZHUANG
1
;
Qian-qian LI
1
;
Yu-ting ZHU
1
Author Information
1. 福建省药品审评与监测评价中心,福州 350001
- Publication Type:Journal Article
- Keywords:
in vitro diagnostic reagent;
manufacturing enterprise;
nitrocellulose membrane;
usage;
quality control
- From:
Chinese Medical Equipment Journal
2025;46(7):75-80
- CountryChina
- Language:Chinese
-
Abstract:
Totally 45 in vitro diagnostic(IVD)reagent manufacturing enterprises were investigated in terms of the use and quality control of nitrocellulose(NC)membranes.The influences of the NC membrane performance indexes on IVD reagent quality were analyzed,including the within-run stability,crawling speed,protein absorption and pore size.The defficiencies of the enterprises were pointed out in the acceptance standard of NC membrane,and some suggestions were put forward including enhancing the performance of domestic NC membrane,improving the acceptance standard,optimizing NC membrane supply chain management by the enterprises and strengthening the internal management of the enterprises.References were provided for the development of IVD industries.[Chinese Medical Equipment Journal,2025,46(7):75-80]
