CLSI H59 A : 1ED 2011
Current
The latest, up-to-date edition.
QUANTITATIVE D-DIMER FOR THE EXCLUSION OF VENOUS THROMBOEMBOLIC DISEASE
Hardcopy , PDF
English
03-31-2011
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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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