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