CLSI H47 A2 : 2ED 2008

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 Recommendations
   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