CLSI I/LA23 P : 1ED 2003

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
   3.1 Definitions
   3.2 Acronyms and Abbreviations
4 Primary Components for Immunoassays
   4.1 Antibody
   4.2 Antigen
   4.3 Separation Procedures
5 Sample Collection, Handling, and Storage
   5.1 Sample Collection
   5.2 Sample Requirements
   5.3 Sample Handling
   5.4 Sample Storage
6 Radioimmunoassays
   6.1 Radioisotopic Systems
   6.2 Reagents
   6.3 Assay Description
   6.4 Detection and Quantitation
   6.5 Limitations and Precautions
   6.6 Radiolabeled Waste Products
7 Enzyme Immunoassays
   7.1 Enzyme Systems
   7.2 Reagents
   7.3 Assay Description
   7.4 Detection and quantitation
   7.5 Limitations and Precautions
8 Fluorescent Immunoassays
   8.1 Fluorescent Systems
   8.2 Reagents
   8.3 Assay Description
   8.4 Detection and Quantitation
   8.5 Limitations and Precautions
9 Luminescent Immunoassays
   9.1 Luminescent Systems
   9.2 Reagents
   9.3 Assay Description
   9.4 Detection and Quantification
   9.5 Limitations and Precautions
10 Assay Performance Characteristics
   10.1 Accuracy, Trueness, and Precision
   10.2 Sensitivity and Specificity
   10.3 Comparison of Quantitative Tests
   10.4 Reference Intervals
   10.5 Reference Values (Expected Values)
   10.6 Results in Test Comparisons
11 Quality Assurance
   11.1 General
   11.2 Quality control enhancement parameters
   11.3 Technical Considerations
12 Necessary Product Insert Information for Immunoassay
   Systems
References
Additional References
The Quality System Approach
Related NCCLS Publications

Gives guidelines for immunoassays of macromolecular analytes. The factors likely to be important in achieving and reproducible results are emphasized.