RESEARCH ON APPLICATION OF SERAZYM KIT FOR DETERMINATION OF RESIDUAL BOVINE SERUM ALBUMIN (BSA) IN VACCINE

Abstract

Bovine Serum Albumin (BSA) is a component that has been used widely in vaccine and biological procedure. However, it is also a component that can cause allegy for human use, therefore, it is necessary to ensure residual BSA in vaccine and biological products in the acceptable range for quality control and safety of a product before distribution. In National Institute for Control of Vaccines and Biologicals (NICVB), Serazym Bovine Serum Albumin (BSA) sensitive kit is used to determine residual BSA in different vaccines. To use this kit in routine test, procedure validation is needed to ensure the suitability of this kit in BSA determination with criteria of accuracy, repeatability, intermediate precision, and linearity indicators. In 6 performance for accuracy indicator, t value was between 0,24 and 1,04 which was smaller than t_α in student distribution at P=0,95 (t_α=2,447), coeficient of variations of repeatability and intermediate precision corresponding were 2,21% and 2,99%, which were not greater than 10%, and for linearity, recovery at each point was in the range ±7,80%, smaller than validation standard (±15%). The results showed that the kit met the set standards with high reliability and can be applied in quality control.