CLSI H59

Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease, 1st Edition

This document provides 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.

This document is available in electronic format only.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2016. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: John D. Olson, MD, PhD

Date of Publication: March 31, 2011

Order Code PDF: CLSI H59AE
ISBN Number: 1-56238-747-2

Order Code Print: print not available

Edition: First

Pages: 44

CLSI H59 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI H59 Abstract

D-dimer is a product of fibrinolysis that is assayed in the blood. It is elevated following intravascular thrombosis, disseminated intravascular coagulation, and other conditions that can cause fibrin generation. Assay of D-dimer is a useful tool when evaluating patients with possible venous thromboembolism (VTE), as the absence of D-dimer is helpful in excluding VTE. Clinical and Laboratory Standards Institute document H59-A—Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline provides guidance regarding the use of D-dimer in exclusion of 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. The guideline is provided for use by laboratorians, manufacturers of D-dimer assays, clinicians who use the D-dimer for VTE exclusion, and accrediting and regulatory agencies.