VALIDATION OF POTENCY TEST OF THE HEPATITIS A VACCINE BY IN VIVO METHOD ON NMRI MOUSE LINE

Abstract

Validation of the analytical procedure is one of the important steps in assessing the suitability, stability and errors, if any, of each laboratory to ensure the reliability of the test results. Hepatitis A vaccine is one of the bio-products that have been evaluated for potency by both in vivo and in vitro methods. In this study, we focus on reporting the results of evaluating the in vitro potency of Hepatitis A vaccine (Havax) on NMRI mouse, using the HAV Ab ELISA diagnostic kit (Dia.Pro, Italy), code: 1120. The standard procedure for testing in vivo potency of Hepatitis A vaccine has been already available in the Vietnamese Pharmacopoeia, thus it was only partially validated in this study. We applied the intermediate accuracy as validation indicator: The experiment was conducted 6 times in 6 different days by the same team, under the same conditions of equipment, chemicals and materials. Acceptance criteria: Each test was valid and satisfactory; %CV of 6 trials was < 50% and the correlation potency (p=95%) of the test sample was not less than 1 compared to the standard vaccine. Test results: All criteria of intermediate accuracy were satisfied, given with %CV is 14.09%.