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April 28, 2010 | History

Basic Method Validation 1 edition

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Basic Method Validation
2nd edition

Published June 30, 2003 by AACC Press .
Written in English.

About the Book

Basic Method Validation, Third Edition
Table of Contents

  1. Is quality still an issue for laboratory tests?
    -Myths of quality
  2. How do you manage quality?
    -The need for standard processes and standards of quality
  3. What is the purpose of a method validation study?
    -MV - The inner, hidden, deeper, secret meaning
  4. What are the regulatory requirements for method validation?
    -MV - The regulations, by Sharon S. Ehrmeyer, PhD
  5. How is a method selected?
    -MV - Selecting a method to validate
  6. What experiments are necessary to validate method performance?
    -MV - The experimental plan
  7. How are the experimental data analyzed?
    -MV - The data analysis tool kit
  8. How are the statistics calculated?
    -MV - The statistical calculations
  9. How is the reportable range of a method determined?
    -MV - The linearity or reportable range experiment
    -Problem set - Cholesterol method validation data
  10. How is the imprecision of a method determined?
    -MV - The replication experiment
    -Problem set - Cholesterol method validation data
  11. How is the inaccuracy (bias) of a method determined?
    -MV - The comparison of methods experiment
    -Problem set - Cholesterol method validation data
  12. How do you use statistics to estimate analytical errors?
    -Statistical sense, sensitivity, and significance
  13. How do you test for specific sources of inaccuracy?
    -MV - The interference and recovery experiments
    -Problem set - Cholesterol method validation data
  14. What is the lowest test value that is reliable?
    -MV - The detection limit experiment
    Problem set - Cholesterol method validation data
  15. How is a reference interval verified?
    -MV - Reference interval transference
  16. How do you judge the performance of a method?
    -MV - The decision on method performance
  17. What's a practical procedure for validating a method?
    -MV - The real world applications
    -MV - The worksheets
  18. How do you use statistics in the real world?
    -Points of care in using statistics in method comparison studies
  19. How can a manufacturer's claims be verified?
    -Verifying a claim for precision and trueness
  20. How can claims be evaluated on the Sigma-scale?
    Translating performance claims into Sigma-metrics
  21. What impact will ISO have on analytical quality?
    -Quality Concepts: is it better to be uncertain or in error?
  22. Self-Assessment Answers
    -Cholesterol Problem Set answers

Appendix 1: CLIA Analytical Quality Requirements

The Physical Object

Format
Paperback
Number of pages
292

ID Numbers

Open Library
OL9523311M
ISBN 10
188695819X
ISBN 13
9781886958197
Library Thing
2961857
Goodreads
6822543

History Created December 11, 2009 · 2 revisions Download catalog record: RDF / JSON

April 28, 2010 Edited by Open Library Bot Linked existing covers to the work.
December 11, 2009 Created by WorkBot add works page