CLSI H60 A : 1ED 2014

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Equipment
6 Validation of Assay Systems
7 Preexamination Issues (Criterion A)
8 Preliminary Examination Issues
9 Principles of Lupus Anticoagulant Assays
10 Assays to Screen for the Presence of Lupus
   Anticoagulant (Criterion B)
11 Assays of Confirm the Presence of Lupus
   Anticoagulant (Criterion C)
12 Mixing Test as Applied to Screening, Confirmatory, and
   Integrated Assays (Criterion D)
13 Post examination Issues
14 Quality Control and Quality Assurance
15 Harmonization of CLSI Lupus Anticoagulant Guideline With
   Other Guidelines
References
Appendix A - Algorithmic Approach to Lupus Anticoagulant
             Testing
Appendix B - Establishing Reference Intervals and Cutoff Values
Appendix C - Lupus Anticoagulant Testing in Relationship to
             Coagulation Pathways
Appendix D - Diagrammatic Principles for Lupus Anticoagulant
             Test
Appendix E - Table of Interferences and Limitations for Specific
             Lupus Anticoagulant Tests
Appendix F - Formulas and Examples for Calculating Test Results
Appendix G1 - Interpretive Comments and Rationale for Comments
              Based on Patient Examples (Data)
Appendix G2 - Interpretive Comments and Rationale for Comments
              Based on Patient Examples (Comments)
The Quality Management System Approach
Related CLSI Reference Materials

Gives guidance and recommendations regarding the proper collection and handling of the specimen; descriptions and limitations of screening and confirmatory assays, and mixing tests used to identify lupus anticoagulant (LA); determination of cutoff values and calculations associated with the various assays; and interpretation of test results in an LA panel.