Determination of in vitro potency in inactivated Janpanese encephalitis vaccine by ELISA method

Abstract

Background/Purpose:ELISA is one of the antigen quantification methods with many
advantages: fast, simple, accurate, suitable for vaccine samples with high protein content and
purity. In order to evaluate the suitability of the ELISA method in testing the in vitro potency of
the inactivated Japanese encephalitis vaccine, from February to August 2020, at the Department
of Viral Vaccine control - National Institute for control of Vaccine and biologicals, we
conducted experimental studies in the laboratory to evaluate the accuracy, precision, robustness,
specificity, and linearity of this procedure. The process follows the Korean commercial ELISA
kit.
Methods: Empirical description research in the laboratory
Results: The results of the criteria all met the requirements of ISO/IEC 17025:2017 and
WHO/VSQ/97.02 in terms of accuracy, accuracy, robustness, specificity, linearity of the
procedure with linear interval (detection)) from 42-663 ng/ml.
Conclusion: This study has demonstrated that the in vitro efficacy test procedure of
inactivated VNNB vaccine on Vero cells, strain Beijing-1 by ELISA method at NICVB's
laboratory is appropriate and reliable.