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

Robert C. Gosselin, Jogin R. Wu, Kandice Kottke-Marchant, Dirk Peetz, Douglas J. Christie, Heidrun Muth, Edward A Panacek

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3 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalThrombosis Research
Volume130
Issue number5
DOIs
StatePublished - Nov 2012

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Pulmonary Embolism
Venous Thrombosis
Prospective Studies
Sensitivity and Specificity
Heparin
Venous Thromboembolism
Lithium
Citric Acid
fibrin fragment D

ASJC Scopus subject areas

  • Hematology

Cite this

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. / Gosselin, Robert C.; Wu, Jogin R.; Kottke-Marchant, Kandice; Peetz, Dirk; Christie, Douglas J.; Muth, Heidrun; Panacek, Edward A.

In: Thrombosis Research, Vol. 130, No. 5, 11.2012.

Research output: Contribution to journalArticle

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title = "Evaluation of the Stratus{\circledR} CS Acute Care™ D-dimer assay (DDMR) using the Stratus{\circledR} CS STAT Fluorometric Analyzer: A prospective multisite study for exclusion of pulmonary embolism and deep vein thrombosis",
abstract = "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.",
author = "Gosselin, {Robert C.} and Wu, {Jogin R.} and Kandice Kottke-Marchant and Dirk Peetz and Christie, {Douglas J.} and Heidrun Muth and Panacek, {Edward A}",
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T2 - A prospective multisite study for exclusion of pulmonary embolism and deep vein thrombosis

AU - Gosselin, Robert C.

AU - Wu, Jogin R.

AU - Kottke-Marchant, Kandice

AU - Peetz, Dirk

AU - Christie, Douglas J.

AU - Muth, Heidrun

AU - Panacek, Edward A

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N2 - 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.

AB - 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.

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