Purpose: To determine the negative predictive value of a rapid semiquantitative assay for the detection of circulating D-dimer in whole blood (SRDD assay). The SRDD assay (Simpli RED D-dimer test [SRDD], Amgen, Inc., Brisbane, Australia) is a bedside assay employing 10μL of whole blood. The presence of D-dimer results in visble agglutination appearing within 2-3 minutes. Methods: Prospective, blinded, single center study. The first 98 patients of an ongoing 1-year study are reported. All patients undergoing an evaluation for suspected thromboembolism (i.e., deep vein thrombosis, pulmonary embolism, line-associated thrombosis) were prosepectively evaluated with the SRDD assay. The main outcome evaluated was the occurrence of clinically significant thromboembolism defined as either deep vein thrombosis, pulmonary embolism, or line-associated thrombosis requiring treatment with anticoagulation, thrombolytic agents, inferior vena cava interruption, or some combination of these modalities. Results: Among the initial 98 study patients, 25 (25.5%) had a diagnosis of clinically significant thromboembolism requiring medical treatment. The occurrence of clinically significant thromboembolisms according to the rapid D-dimer assay is shown below. SRDD Reading 0 1 2 3 4 Clinically significant 0/18 7/37 10/24 4/12 4/7 thromboembolism/n: % with (+) SRDD 0 18.9 41.7 33.3 57.1 assay: Conclusions: The SRDD assay has excellent negative predictive value for excluding the diagnosis of clinically significant thromboembolism. Clinical Implications: Based on our study, a negative SRDD assay can be used to exclude the diagnosis of clinically significant thromboembolism in the ICU setting. This assay may improve the cost-effectiveness of evaluating critically ill patients for a diagnosis of suspected thromboembolism.
|Issue number||4 SUPPL.|
|State||Published - Oct 1 1998|