Analysis of the proficiency of single radial immunodiffusion assays for quality control of influenza vaccines in Korea

Abstract

Influenza vaccine potency, which is determined by quantitatively measuring the content of Hemagglutinin (HA), is an essential index representing the efficacy of the vaccine. Standardization of the single radial immunodiffusion (SRID) assay, a method for measuring HA content, and proficiency of the testing institutions are crucial for influenza vaccine quality control. Herein, we assessed the proficiency of SRID assays at the National Control Laboratory (NCL) of Korea and several vaccine manufacturers. Eight laboratories participated in this study, and the proficiencies of all laboratories yielded satisfactory results in overall SRID assays. In contrast, there were some unsatisfactory results in measuring with different types of agarose gel plates produced by other laboratories. Overall, our findings demonstrated that the proficiency of SRID assay in the tested laboratories is acceptable for quality control of influenza vaccines and that detailed review on the validation reports regarding the test methods will be helpful for better control.

Detection methods for influenza A H1N1 virus with special reference to biosensors: a review

“…It can detect antigenic differences in HA that cannot be detected by DI. It is reproducible, simple and sensitive for antigenic composition and used for antigeniclly active antigen detection [49].…”

Sources of variance in the results of a commercial bovine immunoglobulin G radial immunodiffusion assay

“…Errors in obtaining the same precipitin ring diameter for a sample may be the result of poor delineation of the ring, which has been noted in previous RID assay studies. 6,19 Although each serum was vortexed, lack of thorough mixing of antibodies within the vial might have contributed to the observed variability. However, research is lacking related to the length of time and type of mixing required to reach complete IgG suspension in serum.…”

Development and characterization of standard reagents for cell-based prepandemic influenza vaccine products

“…The current standard method for HA quantification, the SRID assay, has been accepted by national regulatory agencies. 27 The HA standard antigen and antiserum used for SRID assays are provided by Essential Regulatory Laboratories (ERLs). In this study, an SRID reagent was prepared with a cell-based platform and used to clarify whether reference reagents derived using egg-based platforms can precisely quantify cell-derived products.…”