Basic Method Validation

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