CLSI I/LA26 P : 1ED 2003

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
   3.1 Definitions
   3.2 Acronyms and Abbreviations
4 Specimen Collection
   4.1 Anticoagulant Used in Collection
   4.2 Venipuncture Technique
   4.3 Labeling of Specimen
   4.4 Storage
5 Specimen Transport
   5.1 Handling Specimens
   5.2 Transport
   5.3 Storage and Handling
6 Sample Precaution
   6.1 CFC
   6.2 MHC Tetramers
   6.3 ELISPOT Assay
7 Assessment of Cellular Immune Response Using Cytokine
   Flow Cytometry (CFC)
   7.1 Principle
   7.2 Apparatus and Equipment
   7.3 Materials
   7.4 Reagents
   7.5 Specimen and Sample Acceptability
   7.6 Procedure
   7.7 Acquisition and Analysis of Samples
   7.8 limitations
8 Assessment of Cellular Immune Response Using Class I
   MHC Oligomers
   8.1 Principle
   8.2 Apparatus and Equipment
   8.3 Materials
   8.4 Reagents
   8.5 Specimen and Sample Acceptability
   8.6 Procedure
   8.7 Acquisition and Analysis of Samples
   8.8 Limitations
9 Assessment of Cellular Immune Response Using ELISPOT
   Technology
   9.1 Principle
   9.2 Apparatus and Equipment
   9.3 Materials
   9.4 Reagents
   9.5 Specimen and Sample Acceptability
   9.6 Procedure
   9.7 Acquisition and Analysis of Samples
   9.8 Limitations
10 Quality Assurance and Test Validation
   10.1 Preanalytical
   10.2 Analytical
   10.3 Postanalytical
11 Data Reporting
   11.1 Worksheet
   11.2 Supervisory Check
   11.3 Reporting of Data
   11.4 Reference Intervals
   11.5 Interpretation of Data
   11.6 Notation of Out-of-range Control Samples
References
Appendix A Cryopreservation of Viable Cells
Appendix B Troubleshooting Table for Antigen-Specific
           CFC Assay
Appendix C Troubleshooting Table for Class I MHC Oligomer
           Analysis
Appendix D Troubleshooting Table for ELISPOT Assays
Appendix E ELISPOT Worksheet
The Quality System Approach
Related NCClS Publications

Gives guidance for the performance of single cell immune response assays in the clinical areas including infectious disease cancer, transplantation, autoimmune disease, and allergy.