Validation of Single Radial Haemolysis assay: A reliable method to measure antibodies against influenza viruses

J Immunol Methods. 2015 Jul:422:95-101. doi: 10.1016/j.jim.2015.04.009. Epub 2015 Apr 22.

Abstract

The Single Radial Haemolysis (SRH) assay is a serological method widely used for measuring antibodies against influenza viruses. Despite the broad application and recommendation by licensing authorities, the SRH assay has not been standardized. The aim of this study is to demonstrate how the SRH assay satisfies validation parameters of regulatory agencies in terms of specificity, precision, repeatability, intermediate precision, linearity, accuracy and robustness. This study shows that the SRH is a rapid, simple, reliable and reproducible assay, which requires only small volumes of serum samples and can be easily standardized.

Keywords: SRH assay; Validation parameters..

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / blood*
  • Antibodies, Viral / immunology
  • Hemolytic Plaque Technique / methods
  • Humans
  • Immunoglobulin G / blood
  • Immunoglobulin G / immunology
  • Influenza A Virus, H1N1 Subtype / immunology*
  • Influenza A Virus, H3N2 Subtype / immunology*
  • Influenza A Virus, H5N1 Subtype / immunology*
  • Influenza B virus / immunology*
  • Middle Aged
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Antibodies, Viral
  • Immunoglobulin G