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CLSI EP26 A Ed. 1 User Evaluation Of Between-Reagent Lot Variation

Standard Number:  CLSI EP26 A Ed. 1
Title:  User Evaluation Of Between-Reagent Lot Variation
Language:  English
Status:  Current
Publisher:  Other Standards
Price:  
Number of Pages:66  

Description:Specifies guidance for laboratories on the evaluation of a new reagent lot, including a protocol using patient samples to detect significant changes from the current lot.  
Catalog:Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Performing Reagent Lot-to-Lot Comparisons
6 Samples for Reagent Lot Comparability Testing
7 Process For Evaluation of Lot-to-Lot Differences
8 Procedural Issues
9 Examples of Evaluating Between-Lot Shifts
Using Patient Data
References
Appendix A - Tables to Determine Number of Samples
Needed and Rejection Limit
Appendix B - Statistical Considerations
Appendix C - Determining the Number of Patient
Sample Differences
Appendix D - Using Biological Variations to Establish
Critical Difference
The Quality Management System Approach
Related CLSI Reference Materials  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  325KB
Tile in English:  User Evaluation Of Between-Reagent Lot Variation

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