Basic Method Validation

Revised, Updated, Expanded! Revised chapter on regulations that reflects the Final CLIA Rule that was published in January 2003. Revised material on reportable range that includes the CAP's new concepts of analytical measurement range (AMR) and clinical report-able range (CRR). New chapter on "statistical sense, sensitivity, and significance" to provide a better understanding of the behavior of different statistics in response to different types of analytical errors. Revised Method Decision Chart that includes the Six Sigma goal for world class quality. Additional discussion of Deming and Passing-Bablock regression. New Internet calculators that perform Deming and Passing-Bablock regression. Reorganization of some of the statistical materials to provide successive "doses" at the right times. New chapter that discusses the new ISO approach of characterizing analytical performance as "uncertainty" rather than the traditional characterization in terms of analytical errors. With the best of the first edition and the new material from the second edition, Basic Method Validation teaches you how to: Perform your method validation experiments quickly, efficiently, correctly! Choose the order of the experiments to save you time! Collect the appropriate data for each experiment - without wasting specimens! Calculate the right statistics! Interpret the method validation results rationally! Judge the acceptability of the method, not the statistics! Establish a practical procedure for validating a method! Basic Method Validation addresses healthcare professionals who perform laboratory tests in central laboratories, clinic or outpatient laboratories, and point-of-care settings. This concise, easy-to-read, 292-page manual contains a comprehensive introduction to method validation in the laboratory, from the conceptual idea of method validation to the bench-level specifics of planning an experiment: The inner, hidden, deeper, secret meaning be