DETERMINATE ACCURACY AND LINEARITY OF BSA TEST IN VACCINE BY ELISA

Abstract

Based on  Bovine serum albumin (BSA) is commonly used as a culture medium of vaccine production. According to the World Health Organization, residual BSA with high concentrations in vaccines has an adverse effect on human health. Therefore, the research team evaluated the technical parameters including accuracy, accuracy and linearity of the procedure for determining BSA content by ELISA method in vaccines. The residual BSA content in the experimental vaccine (Varivax) was carried out according to the procedure of the BSA diagnostic kit, China by the Elisa method. The sample vaccine is diluted in 3 dilutions: 1/20, 1/30, 1/40 so that the OD value of the sample vaccine is within the range of OD values ​​at BSA calibration curve concentrations from 2, 5ng/ml - 40 ng/ml. Results of study showed that the process specifications were determined including accuracy (t-table (- 2.29 - 2.39) < tα = 2.571), precision (%CV=0.79-1, 21%), linearity (R2 = 0.995, %CV = 0.28 - 4.47%, Δi=-2.47 - 10.95%). We conclussion that the process of determining BSA content by the Elisa method was evaluated as satisfactory with the specifications of accuracy, precision and linearity.