The Quality Analysis of National Supervising Sampling for Rubella Virus IgM Diagnostic Kits in 2014
10.3969/j.issn.1671-7104.2015.04.013
- VernacularTitle:2014年度风疹病毒IgM抗体检测试剂盒国家监督抽验质量分析
- Author:
Ting YU
1
;
Shoufang QU
;
Xiaoyan ZHANG
;
Nan SUN
;
Shangxian GAO
;
Haining LI
;
Jie HUANG
Author Information
1. 中国食品药品检定研究院体外诊断试剂一室
- Keywords:
rubel a virus diagnostic kit;
national supervision;
quality analysis
- From:
Chinese Journal of Medical Instrumentation
2015;(4):282-284
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the quality status of rubel a virus IgM diagnostic kits by national supervising sampling. Methods Using legal inspection combining with exploratory study, the positive and negative coincidence rate, detection limit and repeatability of kits were verified. Results The results showed that 15 of 16 batches of kits were qualified using legal inspection, and the passing rate was 93.8%. The unqualified item was negative coincidence rate. In exploratory study, only 11 batches (68.8%) complied with industry standard. The unqualified items were negative coincidence rate, detection limit and repeatability. Conclusion At present, rubel a virus IgM diagnostic Kits have some quality problems in the market. It is recommended that we adopt industry standard and national reference panel in the registration inspection for the future, which wil prompt enterprises to improve quality.
