Validation of Potency Test of the Influenza Vaccine by Srd Method
Year: 2025
Type: article
Abstract: 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%.
Authors: Nguyen Thi Ly, Luu Thi Dung, Nguyen Kim Bach, Pham Minh Tung
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4414797359
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