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CLSI EP9 A3 : 3ED 2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES

Superseded date

03-12-2020

Published date

10-09-2013

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.

DevelopmentNote
Supersedes CLSI EP9 A2. (09/2013)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

CLSI EP19 : 2ED 2015 A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES
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CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
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CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
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CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI I/LA28 A2 : 2ED 2011 QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS
CLSI I/LA21 A2 : 2ED 2008 CLINICAL EVALUATION OF IMMUNOASSAYS
CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY

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