Quality assurance/quality control of foot and mouth disease solid phase competition enzyme-linked immunosorbent assay--Part I. Quality assurance: development of secondary and working standards.

Abstract

International movement in animals and animal products has urged organisations like the World Organisation for Animal Health (OIE) to draw up guidelines to regulate and facilitate trade between Member Countries. However, as the global market continues to grow, further standardisation and harmonisation of antibody detection assays for infectious diseases are needed, especially regarding the development and use of reference materials. For OIE notifiable diseases for which primary or international reference standards are available or under development, National or Regional Reference Laboratories are encouraged to establish their own secondary and/or working standards. This paper describes the development of standards for the foot and mouth disease (FMD) solid phase competition enzyme-linked immunosorbent assay using positive serum obtained from calves vaccinated against the FMD virus. The procedure outlined in this manuscript can easily be extrapolated to similar serological assays and should lead to further international harmonisation of assays and test results.