CLSI EP15 A2 : 2ED 2006

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

Specifies the demonstration of method precision and trueness for clinical laboratory quantitative methods utilizing a protocol designed to be completed within five working days or less.