Assay Development and Evaluation: A Manufacturer's Perspective

Written from the perspective of a manufacturer, this book is intended to help those who develop and evaluate diagnostic assays to apply data modeling and analysis techniques that leverage the vast amount of data collected by manufacturers and by laboratories. Given the financial, technical, and regulatory forces that exist, sophisticated development and evaluation studies are often performed in industry, but these are rarely made public. The key studies are described here. They include not only evaluation studies, but also financial modeling, development of specifications, instrument system reliability, and other applications. Assay Development and Evaluation is also written from the perspective of a consultant. The information is relevant not just for consultants, but for anyone who has an idea and tries to implement it. Just because one is right does not mean that one's solution will be used. This book describes how to identify, understand, and deal with the resistance that often occurs when new solutions are suggested.