Establishment of Reference Reagents for Single-Radial-Immunodiffusion Assay on the 2022/23 Seasonal Influenza Vaccine in Japan and Their Quality Validation

• Published in: Japanese Journal of Infectious Diseases Vol. 77; no. 2; pp. 105 - 111
• Main Authors: Shimasaki, Noriko, Kuwahara, Tomoko, Nishijima, Haruna, Nakamura, Kazuya, Sato, Kayoko, Murano, Keiko, Itamura, Shigeyuki, Akahori, Yukiko, Takashita, Emi, Kishida, Noriko, Arita, Tomoko, Nakauchi, Mina, Takeda, Makoto, Hasegawa, Hideki, Ryo, Akihide, Harada, Yuichi
• Format: Journal Article
• Language: English
• Published: Japan National Institute of Infectious Diseases 29.03.2024; Japan Science and Technology Agency
• Subjects: Antigens; Antisera; Assaying; Cross-reactivity; HA protein; Hemagglutinins; Immunodiffusion; Influenza; Influenza B; influenza B virus component; Quality control; quality validation; Reagents; reference reagent; seasonal influenza vaccine; single-radial-immunodiffusion assay; Vaccines; Japan; reference reagent; influenza B virus component; quality validation; seasonal influenza vaccine; single-radial-immunodiffusion assay

Potency tests for influenza vaccines are currently performed using a single-radial immunodiffusion (SRID) assay, which requires a reference antigen and anti-hemagglutinin (HA) serum as reference reagents. Reagents must be newly prepared each time a strain used for vaccine production is modified. The...