CLSI EP15 A2 : 2ED 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
09-11-2014
01-12-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 Performance Standards
6 Overview of the Protocol
6.1 Device Familiarization Period
6.2 Precision Evaluation Experiment
6.3 Trueness Evaluation Experiment
6.4 Measuring Interval and Reference Interval
7 Familiarization Period
7.1 Operator Training
7.2 Quality Control Procedures
7.3 Materials for Precision Experiments
8 Verification of Precision Performance
8.1 Experimental Design - Numbers of Days and
Replicates
8.2 Specific Procedures
8.3 Recording the Data
8.4 Calculation of Precision Estimates
8.5 Comparison of Estimated Repeatability to
Manufacturer's Claims
8.6 Comparison of Estimated Within-Laboratory Precision
to Manufacturer's Claims
9 Demonstration of Trueness
9.1 Comparison of Patient Sample Results to Those of
Another Procedure
9.2 Recovery of Expected Values From Reference Materials
With Assigned Values
References
Appendix A. Sample Data Recording Sheet - Precision
Experiment
Appendix B. Example of a Completed Sample Data Recording
Sheet - Precision Experiment
Appendix C. Additional Statistical Explanations and
Considerations - Precision Experiment
Appendix D. Sample Data Recording Sheet - Comparison of
Patient Samples Experiment
Appendix E. Example of a Completed Sample Data Recording
Sheet - Comparison of Patient Samples Experiment
Appendix F. Power Calculation for the Procedure for
Verification of Trueness by Comparison of Patient
Samples
Appendix G. Sample Data Recording Sheet - Demonstration of
Trueness With Reference Materials
Appendix H. Example of a Completed Sample Data Recording
Sheet - Demonstration of Trueness With Reference
Materials
Appendix I. Flow Sheet for Experiments for User Demonstration
of Performance for Trueness and Precision (Accuracy)
Summary of Consensus Comments and Committee Responses
Summary of Consensus/Delegate Comments and Committee Responses
The Quality System Approach
Related CLSI/NCCLS Publications
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