人用狂犬病疫苗ELISA快速鉴别试验的建立及验证

Establishment and validation of the rapid identification test on rabies vaccine by ELISA methods

目的:建立人用狂犬病疫苗快速鉴别试验并进行验证。方法:采用双抗体夹心ELISA,以4株抗狂犬病毒核蛋白单抗包被微孔板,通过捕捉检品中狂犬病病毒核蛋白进行快速鉴别试验,对该方法进行特异性、灵敏度、重复性和适用性验证。结果:采用双抗体夹心ELISA进行鉴别试验,验证结果显示该方法具有较高的特异性和灵敏性,RSD<15%,对于不同疫苗生产毒株均可有效鉴别。结论:双抗体夹心ELISA可以替代传统效力试验对人用狂犬病疫苗进行快速鉴别。

Objective：To establish and validate a method of rapid identification testing of rabies vaccine for human use which in order to replace the previously methods.Method：To set up the double-antibody sandwich ELISA methods that coated microplates by four strain monoclonal antibodies against rabies virus nucleoprotein.Then validate the method by specificity,sensitivity,repeatability and applicability.Results：The results of validiation show that the ELISA method had high specificity,and sensitivity.The RSD was less than 15%.The ELISA method had specific response with different rabies virus vaccine strains（such as CTN,PV,etc.）.Conclusion：The identification testing by ELISA is rapid,high specific and high sensitivity.It can replace the traditional potency test for the identification test of rabies vaccine.