Quality Standards for Immunoassay Kits

Abstract

The environmental immunoassay kit industry is growing rapidly with both new kits and new companies entering the market. While the industry is still young, it is an opportune time to develop industry standards for immunoassay kits. The Analytical Environmental Immunochemical Consortium (AEIC) is comprised of agrichemical and immunochemical companies that use or provide immunochemical methods and associated equipment for environmental chemical analysis. One of the goals of the AEIC is to establish performance standards. This paper discusses current programs and potential future activities of the AEIC aimed towards developing quality standards for immunoassay kits.The rapid increase in the availability of immunoassay kits for detection and quantitation of analytes such as pesticides, environmental contaminants, food and waterborne pathogens, and toxins is now enabling a diverse user group to perform analyses within a variety of laboratory and field environments. One of the objectives of the Analytical Environmental Immunochemical Consortium (AEIC) is to help assure that high quality performance and appropriate interpretation of results are obtained from immunoassay kits used in various applications by operators with varying degrees of experience. To help achieve this goal, the AEIC is developing recommended standards for manufacturers of immunoassay kits. As a model, the AEIC is using the medical diagnostic immunoassay kit industry which has a 25 year history. Initial recommended standards under development include establishing standardized package inserts, sources of immunoassay kit calibrators and quality control samples, and quality control guidelines for users to employ for monitoring kit performance. The AEIC is also developing standardized definitions to enable clear communication within the immunoassay kit industry for both the manufacturers and users.This paper discusses current programs and potential future activities of the AEIC directed towards establishing uniform quality standards for immunoassay kits.