Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 Practical Considerations for Designing a Comparability
Monitoring Protocol
5.1 Causes of Noncomparability of Results
5.2 Scope of Comparisons
5.3 Risk Assessment for Noncomparable Results
5.4 Frequency and Complexity of Comparability Assessment
Protocols
5.5 General Approaches to Comparability Testing
5.6 Triggers for Special Cause Comparability Testing
6 Samples for Comparability Testing
6.1 Commutability
6.2 Analyte Concentrations for Testing
6.3 Storage and Transport
7 Acceptance Criteria for Comparability Testing of Patient
Results
7.1 Evaluation of Comparability Based on Clinical Outcomes
7.2 Evaluation of Comparability Based on Clinician's
Questionnaire
7.3 Evaluation of Comparability Based on Biological Variability
7.4 Evaluation of Analytical Performance Based on Published
Professional
7.5 Evaluation of Analytical Performance Based on Goals Set
by Accrediting Agencies
7.6 Evaluation of Analytical Performance Based on the General
Capability
8 Statistical Evaluation of Comparability Data
8.1 Hypothesis Testing
8.2 Statistical Analysis of Comparability Data
8.3 Fixed Limit Evaluation
9 Point-of-Care Testing (POCT)
9.1 Specimen Selection
9.2 Specimen Acquisition
9.3 Range of Specimen Values
9.4 Multiple Devices of the Same Make and Model
9.5 Statistical Considerations for POC Comparability
Testing
10 Range Test Comparability Protocol
10.1 Select an Analyte for Comparison
10.2 Select the Instruments to Be Compared
10.3 Identify an Approximate Analyte Concentration for
Comparison Testing
10.4 Calculate the Desired Concentration or Activity to Be
Used for Comparison Sample Selection
10.5 Select a Sample for Comparison Testing
10.6 Select the Appropriate Level of Acceptance Criteria
That Can Be Applied to the Comparison Test (from
Section 7)
10.7 Set the Critical Difference for the Comparability
Test at the Recommended Total Error or Bias Limit
Determined in Section 10.6
10.8 Determine the Number of Replicates to Be Run
10.9 Perform the Comparison
10.10 Evaluate the Clinical Relevance of the Comparison
Results
10.11 Troubleshooting Noncomparability
References
Appendix A - Worked Examples
Appendix B - Table of Critical Differences (%) for the
Range Test
Appendix C - Statistical Concepts
Appendix D - Biological Variation
Summary of Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials