Abstract
Objective To establish a rapid detection method for the glycoprotein antigens of rabies vaccine. Methods Use two strains gene engineering antibody of anti-rabies virus glycoprotein, sandwich ELISA assay was been set up. Phalanx titration had been used to determine the best working concentration of the coated antibody and HRP labeled antibody. Then the specificity, sensitivity, repeatability and applicability were been validated. Results The coated antibody concentration was 200 ng/well, and the best dilution ratio of HRP-antibody was 1∶2 000. The method has fine specificity and sensitivity. The coefficient of variation of is below 15%. Different vaccines producing by CTN, aG, PM1503 and PV strain can be effective detected. Conclusions Glycoprotein detection method by ELISA was successfully established, and is suitable for rabies vaccine production. It is of great significance for quality control of rabies vaccine production, and laying the groundwork for the alternative potency test. Key words: Rabies vaccine; Human use; Glycoprotein detection; Validation
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