The Quality Analysis of National Supervising Sampling for Rubella Virus IgM Diagnostic Kits in 2014.
- Author:
Tina YU
;
Shoufang QU
;
Xiaoyan ZHANG
;
Nan SUN
;
Shangxian GAO
;
Haining LI
;
Jie HUANG
- Publication Type:Journal Article
- MeSH: Antibodies, Viral; Humans; Immunoglobulin M; Quality Control; Reagent Kits, Diagnostic; standards; Rubella; diagnosis; Rubella virus
- From: Chinese Journal of Medical Instrumentation 2015;39(4):282-284
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo evaluate the quality status of rubella virus IgM diagnostic kits by national supervising sampling.
METHODSUsing legal inspection combining with exploratory study, the positive and negative coincidence rate, detection limit and repeatability of kits were verified.
RESULTSThe 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.
CONCLUSIONAt present, rubella 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 will prompt enterprises to improve quality.