CLSI C28 P3 : 3ED 2008

Abstract
Committee Membership
Foreword
1 Scope and Introduction
2 Standard Precautions
3 Definitions
   3.1 IFCC/ICSH Definitions
   3.2 Clarifications
4 Use of Systhme International d'Unitis (SI Units)
5 Protocol Outline for Obtaining Reference Values and
   Establishing Reference Intervals
   5.1 New Analyte or Analytical Method
   5.2 Multicenter Reference Interval Studies
   5.3 Previously Measured Analyte
6 Selection of Reference Individuals
   6.1 Introduction
   6.2 Exclusion and Partitioning
   6.3 Sample Questionnaire
   6.4 Selection of Reference Individuals
7 Preanalytical and Analytical Considerations
   7.1 Subject Preparation
   7.2 Specimen Type, Collection, Handling, and Storage
   7.3 Analytical Method Characteristics
8 Analysis of Reference Values
   8.1 Minimum Number of Reference Values
   8.2 Treatment of Outlying Observations
   8.3 Partitioning of Reference Values
   8.4 Examples
   8.5 Confidence Intervals for Reference Limits
9 Transference
   9.1 Transference: Comparability of the Analytical System
   9.2 Transference: Comparability of the Test Subject
        Population
10 Validation
   10.1 Validation: Subjective
   10.2 Validation: Using Small Numbers of Reference Individuals
   10.3 Validation: Using Larger Numbers of Reference Individuals
11 Presentation of Reference Values
   11.1 Introduction
   11.2 Laboratory Presentation
   11.3 Manufacturer Presentation
12 Other Issues
   12.1 Qualitative Analysis
   12.2 Therapeutic Drug Levels
   12.3 Time-Dependent/Challenge Tests
   12.4 Individual Variation
   12.5 "Critical Values"
13 Summary
References
Appendix A. Effectiveness of Several Statistical Tests in
            Validating Transference of Reference Intervals
Appendix B. Robust Calculation
Summary of Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials