This chapter explains the theory and practice of immunoassay standardization and calibration. For standardization, the role of External Quality Assessment Schemes (also known as Proficiency Testing) is explained, as are international standards and definitive and reference methods. The practical challenges related to immunoassay standardization are reviewed, including method-related differences due to matrix effects, interference and cross-reactivity. There are short sections on how to ensure accurate standardization through good design of buffers, antibodies, labeled analyte or antibody, and the separation method. The additional challenges related to methods that test for antibodies are described. The next major section is on calibration of the assay and the use of calibrators in commercial immunoassays, including reduced and stored calibration curves.

David Wild’s career spans 40 years in diagnostics, medical devices, pharmaceuticals and biotechnology. As a University of London undergraduate, he won the Driver Prize for Biochemistry after discovering an extra electron transfer step in photosynthesis. As leaders of the University Biochemistry Society, he and his girlfriend Cindy (now wife) hosted lectures by Sir Hans Krebs and Roger Ekins. After graduation, he worked first as a molecular biologist at a pharmaceutical company R&D laboratory, then, for 25 years, in immunodiagnostics, managing product development and industrial engineering projects. More recently he managed large medical device R&D and operational projects. He worked for Amersham, Kodak, Johnson and Johnson, Bristol-Myers Squibb and ConvaTec. His Director level positions include Research and Development, Design Engineering, Global Manufacturing, and Strategy. He indulges his passion for immunoassays as Managing Editor of The Immunoassay Handbook and lectures, trains and consults on development, manufacturing and marketing strategies, and how to integrate and execute them.

Chris Sheehan is an experienced and effective Healthcare Commercial Coach/Consultant/Interim, with a strong Sales and Marketing track record in large corporate, international, diagnostics and capital markets. He is expert in all aspects of sales processes and CRM implementation and has coached high growth companies in planning for and achieving strong sales in business-to-business markets. Has worked with pre-start and SMEs (small to medium sized enterprises) in healthcare and has carried out several assignments at incubators internationally mentoring start-ups, creating business and marketing plans and project managing commercialization. Chris enjoys motivating and persuading people, whether in international project teams, as line manager or in customer and opinion leader consultative selling settings to achieve business results and people development. Previously with Johnson and Johnson, Chris works with Oxford Innovation as well as leading a breast cancer start-up and work for Fleet Bioprocessing.

Standardization, calibration, standard, calibrator, external quality assessment, proficiency testing, international standard, international unit, World Health Organization, National Institute for Biological Standards and Control, definitive method, reference method, matrix, interference, human anti-mouse antibodies, blocking agents, calibration curve, cross-reactivity, recovery, dilution.