Basic Method Validation
Edition: 2nd edition
Publisher: AACC Press; Westgard QC
Published: June 30, 2003
Language: eng
Format: Paperback
Number of pages: 292
ISBN-13: 9781886958197
Subjects: Medical / Nursing; Medical; Health Care Delivery; Laboratory Medicine; Quality Control
Description: 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