Each new vaccine is required to meet the strict standards issued by the European Medicines Agency (EMA) in order to be licensed. Creative Biolabs's primary serological assay allows our laboratory to test multiple strains of a single pathogen in combination with system and sample suitability controls to increase sensitivity and accuracy. Serological techniques commonly used for quantification include hemagglutination inhibition (HI), single radial hemolysis (SRH) and virus neutralization (VN) assays.
The HI assay is based on the ability of antibodies (if present in serum) to prevent agglutination between red blood cells and viral hemagglutinin. We use standard HI titers as a protective immune correlation according to FDA guidelines for vaccines.
Virus Neutralization (VN) is a useful diagnostic and basic research analysis that enables observation of humoral immune responses to viral vaccines. Compared to HI, the VN assay identifies multiple neutralizing antibodies, while HI only detects antibodies to viral hemagglutinin, which acts by preventing red blood cell agglutination.
Single tibial hemolysis (SRH) combines the advantages of single radial diffusion (SRD) and HI testing. This technique utilizes antibody diffusion within the gel to determine antibodies that may present in the serum of the assay. Hemolysis mediated by complement and induced by antibody-antigen complexes produces an easily identifiable "hemolysis zone" whose size is proportional to the concentration of anti-influenza antibodies present in serum.
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