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.

Antibodies, Viral ; Humans ; Immunoglobulin M ; Quality Control ; Reagent Kits, Diagnostic ; standards ; Rubella ; diagnosis ; Rubella virus

This review deals with the characteristics of various inflammatory mediators identified in the middle ear during otitis media and in cholesteatoma. The role of each inflammatory mediator in the pathogenesis of otitis media and cholesteatoma has been discussed. Further, the relation of each inflammatory mediator to the pathophysiology of the middle and inner ear along with its mechanisms of pathological change has been described. The mechanisms of hearing loss including sensorineural hearing loss (SNHL) as a sequela of otitis media are also discussed. The passage of inflammatory mediators through the round window membrane into the scala tympani is indicated. In an experimental animal model, an application of cytokines and lipopolysaccharide (LPS), a bacterial toxin, on the round window membrane induced sensorineural hearing loss as identified through auditory brainstem response threshold shifts. An increase in permeability of the blood-labyrinth barrier (BLB) was observed following application of these inflammatory mediators and LPS. The leakage of the blood components into the lateral wall of the cochlea through an increase in BLB permeability appears to be related to the sensorineural hearing loss by hindering K+ recycling through the lateral wall disrupting the ion homeostasis of the endolymph. Further studies on the roles of various inflammatory mediators and bacterial toxins in inducing the sensorineumral hearing loss in otitis media should be pursued.
Bacterial Toxins ; Chemokines ; Cholesteatoma ; Cochlea ; Cytokines ; Ear, Inner ; Ear, Middle ; Endolymph ; Evoked Potentials, Auditory, Brain Stem ; Hearing Loss ; Hearing Loss, Sensorineural ; Homeostasis ; Membranes ; Models, Animal ; Otitis ; Otitis Media ; Permeability ; Recycling ; Scala Tympani