CLSI H59 A : 1ED 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.