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
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