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