Basic Method Validation, 4th Edition
Westgard QC is proud to announce the new 4th edition of our popular textbook, Basic Method Validation and Verification.
Basic Method Validation and Verification, 4th Edition
Training in Statistical Quality Control for Medical Laboratories
2020, 312 pages, 9" by 6" paperback
List price: $80.00
[Special pre-order discount: Save $10 off the cost of the book with the coupon code GETVERIFIED.
The fine print: Online store only, cannot be combined with other offers. One coupon per order, per customer. Expires August 31st, 2020.]
BASIC METHOD VALIDATION AND VERIFICATION: REVISED, EXPANDED AND UPDATED!
- THE BEST EXPLANATION OF HOW TO CHECK OUT A NEW METHOD IN YOUR LAB
- OVER 100 CHARTS, GRAPHS, TABLES and ILLUSTRATIONS!
- THE DEFINITIVE BOOK ON LABORATORY QUALITY FOR MORE THAN TWO DECADES
- NOW INCLUDES A CHAPTER ON QUALITATIVE TEST VALIDATION AND VERIFICATION - CRUCIAL FOR PCR, SEROLOGY AND LATERAL FLOW TESTS USED IN THE COVID19 PANDEMIC
- DISCUSSES THE STRENGTHS AND WEAKNESSES OF CHOOSING VALIDATION OR VERIFICATION FOR YOUR METHODS
- EXPLAINS HOW ISO STANDARDS INTEGRATE WITH CLIA, CAP AND OTHER REGULATIONS
Thousands of medical technology professionals have made the Basic Method Validation and Verification their roadmap to implementing new methods in their laboratory.
In the fourth edition, Dr. James O. Westgard and colleagues have updated their coverage:
- Updated Verification and Validation regulations, guidelines, and recommendations from around the world.
- New explanations about practical approaches to validate Qualitative methods
- Expanded discussion of the multiple ways to compare methods, from Difference plots to Scatter plots, from Deming regression to Passing-Bablok
- Exclusive access to online content that supplements and tests your knowledge of the material
Basic Validation and Verification is the plain language, common sense guide to the studies and statistics that govern the evaluation, validation and verification of a laboratory method. For healthcare pratictioners who want to implement and operate valid QC procedures, this manual is an essential reference.
Table of Contents
|1. Is Quality still an issue for laboratory tests?||1|
|2. How do you manage quality?||13|
|3. What is the purpose of a method validation study?||31|
|4. What are the regulatory requirements for basic method validation?||41|
|5. How is a method selected?||65|
|6. What experiments are necessary to validate or verify method performance?||75|
|7. How are the experimental data analyzed?||89|
|8. How is the reportable range of a method determined?||101|
|9. How is the imprecision of a method determined?
|10. How is the inaccuracy (bias) of a method determined?||133|
|11. What’s another way to determine accuracy?
|12. How do you test for more specific sources of inaccuracy?||171|
|13. What is the lowest test value that is reliable?||179|
|14. How is a reference interval verified?||189|
|15. How do you judge the performance of a method?||199|
|16. What’s a practical plan for validating/ verifying?||213|
|17. How do you validate a qualitative method?||233|
|18. How can claims be evaluated on the Sigma scale?||251|
|19. Self-Assessment Questions and Answers and Example Datasets||259|
|The Statistical Appendix