title: [The Quality Analysis of National Supervising Sampling for Rubella Virus IgM Diagnostic Kits in 2014].
abstract: OBJECTIVE
  To evaluate the quality status of rubella 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.
  
  
  CONCLUSIONS
  At 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.
authors.forename: Tina
authors.initials: T
authors.lastname: Yu
authors.forename: Shoufang
authors.initials: S
authors.lastname: Qu
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Zhang
authors.forename: Nan
authors.initials: N
authors.lastname: Sun
authors.forename: Shangxian
authors.initials: S
authors.lastname: Gao
authors.forename: Haining
authors.initials: H
authors.lastname: Li
authors.forename: Jie
authors.initials: J
authors.lastname: Huang
mesh_terms: D000914:Antibodies, Viral; D006801:Humans; D007075:Immunoglobulin M; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012409:Rubella / Q000175:diagnosis*; D012412:Rubella virus
chemical_list: D000914:Antibodies, Viral; D007075:Immunoglobulin M; D011933:Reagent Kits, Diagnostic; C040901:rubella antibodies