人用狂犬病疫苗ELISA快速鉴别试验的建立及验证

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.