BOOK REVIEWS
Enzyme Immunoassays: From Concept to Product Develop-evaluation of assay precision, sensitivity, accuracy, specificity, tolerance to variations in procedure (ruggedness), and assay validation. ment. S. S. DESPHANDE. Chapman and Hall, New York, 1996. 464 pp., (hardcover).
The last three chapters consider product formulation, data analysis, requirements for documentation and registration, and business This book states its goal clearly in the preface and introductory aspects of starting up a diagnostics company. Considerable emphasis chapter: ''to provide useful information for the development of a sucis given to principles involved in freeze-drying reagents, including cessful commercial immunodiagnostic product based on enzyme imthe physics of water phase transitions. Again, other sources would munoassay technology.'' It is not intended to be a text on general be required for a thorough understanding of that physics, but the immunotechnology (it does not include Western blotting with ensection does present major factors to be considered in reagent prozyme-labeled detecting antibodies), but does present some of the iscessing. There is a useful description of the many possible shapes of sues that arise with analyses other than immunoenzyme methods, calibration curves and short descriptions of curve fitting procedures such as radioimmunoassays.
that may be applied to immunoassay data. The section on business The initial chapters on history, antibody structure, and antigenaspects lists many concerns, agencies, and forms that enter into prodantibody reactions are written in clear language but are very brief uct development. and sweeping and not likely to be a primary source of that informa-
The value of the book is that it serves as a flow diagram of the tion for the reader. More detail is presented on hapten-protein consteps involved in diagnostic kit development, identifying the availjugation, antibody production, enzyme labeling of antibodies, sysable approaches to achieving them. The reader will probably find tems for separating free and bound antigen, and assay formats useful the extensive list of analytes for which diagnostic tests have (Chapters 4-8). In these sections, extensive lists of reagents and been prepared, relative binding of various immunoglobulins to proavailable methods are assembled and the author discusses the merits teins A and G, cross-linking reagents for hapten conjugation, labels or disadvantages of the various methods. However, the user will have used in immunoassays, enzyme conjugation procedures, and assay to refer to other sources for protocols, and may find it difficult to use formats. Its bibliography points the way to sources for more detail this catalogued presentation as a basis for choosing among the large and for required protocols. number of possibilities. Chapter 9 becomes more of a working document for assay development. It focuses on fewer choices of assay