CLSI I/LA2 A2 : 2ED 2006

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
   4.1 Definitions
   4.2 Acronyms/Abbreviations
Part I - Indirect Immunofluorescence Test for Antinuclear
         Antibodies (IF-ANA)
5 Introduction
   5.1 Principles of the IF-ANA Test
   5.2 Patient Specimen and Collection Procedure
6 Substrate and Fixative Variations
   6.1 Fixation of Substrate Tissues
   6.2 SS-A/Ro Antigen
7 Fluorochrome-Labeled Conjugates
   7.1 Working Dilution
   7.2 Polyvalent and IgG-Specific Conjugates
   7.3 Reference Preparation of Fluorochrome-Labeled
        Conjugates
8 Microscope Optics
Part II - The Enzyme Immunoassay Test (ELISA-ANA)
9 Assay Requirements
   9.1 Solid Phase With Adsorbed Nuclear Antigens
   9.2 Enzyme-Labeled (Second Stage) Detection
        Antibody (Conjugate)
   9.3 Standards, Calibrators, and Controls
   9.4 Wash Solutions and Other Reagents
10 Assay Validation
   10.1 Assay Validation From the Manufacturer's Perspective
   10.2 Assay Validation From the User's Perspective
11 ELISA Enzyme-Labeled Conjugates
12 ELISA Detection Methods
13 Technical Considerations
14 Alternative, Emerging Solid-Phase Technologies
Part III - Quantitation of Antibodies, Reference
           Intervals and Reporting of Test Results,
           and Intralaboratory Quality Control
15 Quantitation of Antibodies
16 Reference Intervals and Reporting of Results
17 Intralaboratory Quality Control
18 Reference Preparations for ANA Tests
   18.1 Definitions and Nomenclature
   18.2 WHO/IUIS Reference Preparations
   18.3 AF/CDC Reference Sera for Autoantibodies to Nuclear
        and Intracellular Antigens
   18.4 College of American Pathologists Reference Serum for
        Anti-SS-A/Ro Antibodies
   18.5 ANA Reference Preparations of Association of
        Medical Laboratory Immunologists (AMLI)
19 Summary of Important Quality Assurance Procedures
20 Special Considerations in the Use of Other
   Laboratory Tests for the Detection of ANA
References
Additional References
Summary of Consensus/Delegate Comments and Committee
Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Addresses the criteria for ANA testing by immunofluorescence and by enzyme immunoassay, including test components, quantification of results, and classification criteria.