VALIDATION OF IDENTITY TEST OF THE VARICELLA COMPONENT IN THE PRIORIX-TETRA VACCINE BY SERONEUTRALIZATION METHOD

Abstract

Priorix-tetra is a freeze-dried vaccine that combines measles, mumps, rubella, and varicella vaccine, live, attenuated. Each strain of the virus produced base on different types of cells. Evaluation quality of vaccine is one of the essential criteria when registering and lot release in Vietnam. Identification is one of the critical tests to confirm the presence of viral antigens in the vaccine, so the identification assay of the Varicella component in the Priorix-Tetra vaccine was developed and designed according to the manufacturer's instructions, and partially validated with specificity criteria. The procedure was to confirm the presence of the Varicella component in the Priorix-Tetra, the standard vaccine, and there was no marker in the negative control. The procedure for identifying the varicella component in the Priorix-Tetra vaccine has high reliability according to the specificity evaluation criteria by the laboratory conditions of the NICVB.