Evaluation of the Stratus® CS Acute Care™ D-dimer assay (DDMR) using the Stratus® CS STAT Fluorometric Analyzer: A prospective multisite study for exclusion of pulmonary embolism and deep vein thrombosis
| Autor: | Jogin R. Wu, Robert C. Gosselin, Heidrun Muth, Dirk Peetz, Kandice Kottke-Marchant, Douglas J. Christie, Edward A. Panacek |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
medicine.medical_specialty Deep vein Gastroenterology D-dimer assay Fibrin Fibrinogen Degradation Products Young Adult Internal medicine Acute care medicine Humans Fluorometry Prospective Studies cardiovascular diseases Prospective cohort study Aged Aged 80 and over Immunoassay Venous Thrombosis business.industry Hematology Heparin Middle Aged medicine.disease Thrombosis Pulmonary embolism Surgery medicine.anatomical_structure Pulmonary Embolism business Venous thromboembolism medicine.drug |
| Zdroj: | Thrombosis Research. 130:e274-e278 |
| ISSN: | 0049-3848 |
| DOI: | 10.1016/j.thromres.2011.12.015 |
| Popis: | Background D-dimer testing is an integral part of the diagnostic algorithm in excluding patients with venous thromboembolism. In this study, we prospectively evaluated the Stratus DDMR D-dimer test in patients suspected of pulmonary embolism (PE) and deep vein thrombosis (DVT). Methods Patients suspected of venous thromboembolism were prospectively enrolled at four different clinical sites, with sodium citrate and lithium heparin plasma was tested using the DDMR D-dimer test on the Stratus CS analyzer. Results 1,012 patients were enrolled for analysis, with 85/603 (14.1%) patients with PE and 80/443 (18.1%) with DVT, and four of the patients (0.4%) with PE and DVT. For the samples collected in 3.2% sodium citrate, the DDMR method had a sensitivity, specificity, and negative predictive value for VTE of 98.0%, 38.1%, and 99.1%, respectively. For the samples collected in lithium heparin, the DDMR method had a sensitivity, specificity, and negative predictive value (NPV) for VTE of 98.9%, 28.8%, and 99.4%, respectively. In PE, DDMR testing on citrate plasma had a sensitivity, specificity, and NPV of 98.8%, 39.5%, and 99.6%, respectively, while heparin samples had a sensitivity, specificity, and NPV for PE of 98.0%, 28.4%, and 99.1%, respectively. In DVT, citrate plasma had a sensitivity, specificity, and NPV for DVT of 97.5%, 32.0%, and 98.3%, respectively, while heparin samples had a sensitivity, specificity, and NPV for DVT of 100%, 27.8%, and 100%, respectively. Conclusion The Stratus CS DDMR D-dimer can be used in those patients with non-high clinical pre-test probability for the exclusion of PE. |
| Databáze: | OpenAIRE |
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