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CLSI H59 A : 1ED 2011

Current

Current

The latest, up-to-date edition.

QUANTITATIVE D-DIMER FOR THE EXCLUSION OF VENOUS THROMBOEMBOLIC DISEASE

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-03-2011

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Overview of D-dimer Testing
6 Patient Evaluation and Pretest Probability
7 Specimen Collection and Processing
8 Assay Methodologies
9 Assay Characteristics, Reference Interval, and Threshold
   for Exclusion of Venous Thromboembolism
10 Interpretation of Results
References
Appendix - US Food and Drug Administration Clinical Study
           Design: An Example
The Quality Management System Approach
Related CLSI Reference Materials

Gives guidelines regarding the use of D-dimer in exclusion of venous thromboembolism (VTE) including a description of the value of clinical determination of the pretest probability of VTE; the proper collection and handling of the specimen; assays used for D-dimer analysis; determination of the threshold for exclusion of VTE; interpretation of test results; and aspects of regulatory and accreditation requirements.

DevelopmentNote
Supersedes NCCLS H59 P. (04/2011)
DocumentType
Standard
ISBN
1-56238-747-2
Pages
44
PublisherName
Clinical Laboratory Standards Institute
Status
Current
Supersedes

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 EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI I/LA30 A : 1ED 2008 IMMUNOASSAY INTERFERENCE BY ENDOGENOUS ANTIBODIES
CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY

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