VALIDATION OF POTENCY TEST OF THE INFLUENZA VACCINE BY SRD METHOD

There are currently 3 types of influenza vaccines: single-strain influenza vaccines (H1N1, or H5N1, or H7N9...), trivalent vaccines (containing 3 strains at the same time: H1N1, H3N2 and B/Victoria or B/Yamagata) and quadrivalent vaccines (containing 4 strains at the same time: H1N1, H3N2, B/Victoria and B/Yamagata). The potency of inactivated influenza vaccines is determined through the HA antigen component by the single immunodiffusion method (SRD). This is a standard procedure already in the pharmacopoeia, so we only evaluated a partical validaiton which included accuracy, precision, linearity and specificity. The results showed that the procedure met the requirements for specificity, linearity and accuracy (the recovery rate of the standard was 102.01%, in the range of 80-125%); Repeatability (intra-assay) CV = 3.73%; intermediate precision given with CV % was 6.46%.