CLSI EP9 A3 : 3ED 2013

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Measurement Procedure - Familiarization Period
6 Measurement Procedure Comparison Studies
7 Considerations for Clinical Laboratories
8 Visual Data Review
9 Quantitative Analysis
10 Comparisons Within a Measurement Procedure
11 Interpreting Results and Comparing to Performance Criteria
References
Appendix A - Confidence Interval of a Median Estimate of Bias
             Between Measurement
Appendix B - Detecting Aberrant Results (Outliers)
Appendix C - Ordinary Linear Regression
Appendix D - Weighted Least Squares Regression (Weighted
             Ordinary Linear Regression)
Appendix E - Deming Regression
Appendix F - Constant CV (Weighted) Deming Regression
Appendix G - Passing-Bablok Regression
Appendix H - Jackknife Approach for Estimating Standard Errors
             for Bias and Regression Parameters
Appendix I - A Practical Example Illustrating Bias Estimation and
             Measurement Procedure Comparison Techniques
Appendix J - Example Datasets
The Quality Management System Approach
Related CLSI Reference Materials

Specifies the design of measurement procedure comparison experiments using patient samples and subsequent data analysis techniques used to determine the bias between two in vitro diagnostic measurement procedures.