Calibration and commutability assessment of the 1st International Standard for Diphtheria Antitoxin Human

Biologicals. 2013 Nov;41(6):384-92. doi: 10.1016/j.biologicals.2013.08.001. Epub 2013 Sep 5.

Abstract

The 1st International Standard for Diphtheria Antitoxin Human (coded 10/262) was established by the World Health Organization Expert Committee on Biological Standardization in 2012. This paper describes the production, characterization and calibration of the new standard which is intended for use in the standardization of assays used to measure diphtheria antibody responses in human serum. The new standard was calibrated in terms of the International Standard for Diphtheria Antitoxin Equine in an international collaborative study. A total of 8 participants from 8 different countries performed in vivo and/or in vitro toxin neutralization tests and returned data that was used to assign units to the proposed new standard. The new standard has a diphtheria antitoxin potency of 2 IU/ampoule and is predicted to be stable. A follow up study was performed to assess commutability of the new standard. The follow up study was an existing external quality assessment, modified to include the new standard. Results obtained suggest that the new standard is commutable, showing comparable behaviour to native human serum samples in the majority of the assays compared, and is therefore suitable for use as a reference preparation in assays used to measure the level of anti-diphtheria antibodies in human serum.

Keywords: Antibody; Antitoxin; Diphtheria; ELISA; Immunoassay; Serology.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Calibration
  • Chlorocebus aethiops
  • Diphtheria Antitoxin / blood*
  • Diphtheria Antitoxin / immunology*
  • Drug Stability
  • Freeze Drying
  • Guinea Pigs
  • Horses
  • Humans
  • International Cooperation
  • Neutralization Tests / methods
  • Neutralization Tests / standards*
  • Reference Standards
  • Vero Cells
  • World Health Organization

Substances

  • Diphtheria Antitoxin