CLSI H60 A : 1ED 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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LABORATORY TESTING FOR THE LUPUS ANTICOAGULANT
28-11-2019
04-04-2014
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.
DocumentType |
Miscellaneous Product
|
PublisherName |
Clinical Laboratory Standards Institute
|
Status |
Superseded
|
SupersededBy |
CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
CLSI H21 A5 : 5ED 2008 | COLLECTION, TRANSPORT, AND PROCESSING OF BLOOD SPECIMENS FOR TESTING PLASMA-BASED COAGULATION ASSAYS AND MOLECULAR HEMOSTASIS ASSAYS |
CLSI H57 A : 1ED 2008 | PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
CLSI EP12 A2 : 2ED 2008 | USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
CLSI EP24 A2 : 2ED 2011 | ASSESSMENT OF THE DIAGNOSTIC ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC CURVES |
CLSI EP9 A3 : 3ED 2013 | MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
CLSI GP41 A6 : 6ED 2007 | PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE |
CLSI H47 A2 : 2ED 2008 | ONE-STAGE PROTHROMBIN TIME (PT) TEST AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST |
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