DETERMINATION OF OVALBUMIN CONTENTS BY ELISA METHODS

Abstract

Determination of Ovalbumin content in vaccines produced by egg embryo culture technology such as influenza vaccines is a mandatory criterion before marketing. The concentration of Ovalbumin in the vaccine allowed according to WHO recommendations and manufacturer registration standards is not more than 1µg/0.5 ml. According to the regulations of vaccines and biologicals, pre-tests as standard methods must be validated according to the ISO 17025:2015. The method is in-vitro experimental descriptive study. The procedure was validated using the ELISA method with the Serazym Ovalbumin kit (Seramun Diagnostica GmbH, Germany) for criteria including accuracy, precision, and linearity. In which, the results are respectively accuracy (t (-0,81-1,77) < tα = 2.571), precision (%CV=0,82-2,56%), linearity( R²(0,998)  > 0,95, % CV (0,05-5,12) ≤ 20% and Δi (-5,07– 3,84)  is within ± 15% of the theoretical value. The research results show that the criteria of accuracy, precision and linearity of the method are satisfactory and that the standard procedure is used as a routine method in testing.