This chapter provides guidelines on immunoassay pre-selection screening and cost-effective initial assay evaluation.

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.

Jianwen He (M.D. & Ph.D.) is currently the R&D Sr. Manager for BioMerieux Shanghai Biotech with responsibility for managing rapid testing and other immunoassay development. Prior to joining BioMerieux, Jianwen worked as a staff scientist and R&D manager for assay development in the Immunoassay Diagnostics Center of Beckman Coulter, Inc for 10 years, where he helped design and develop many CLIA assays including Access Inhibin A. Jianwen also worked as North Asia commercial manager for DiaSorin S.p.A. for a couple of years, where he managed the RIA, ELISA, and CLIA immunoassay business for a matured market. Jianwen has gone through immunoassay from discovery, research and development to commercialization. Jianwen has a Ph.D. in molecular virology.

Mari Smith. This chapter includes material from the first edition of the Immunoassay Handbook by Mari Smith who has worked in the immunoassay industry for 34 years, in the fields of quality assurance, validation, verification and regulatory affairs, for Amersham International, Eastman Kodak and Johnson and Johnson (Ortho Clinical Diagnostics). She is currently the Regulatory Affairs Manager at Ortho Clinical Diagnostics, at the Vitros ECi reagent manufacturing facility in Wales, UK.

Sensitivity, precision, imprecision, specificity, cross-reactivity, interferences, accuracy, recovery, dilution, linearity, correlation, drift, limit of blank, limit of detection, limit of quantification.