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Thromboembolic Diseases
Pulmonary embolism, or PE, a blockage of one or more of the pulmonary arteries by blood clot, is a common and highly lethal condition that is a leading cause of death in all age groups in the United States. PE is the third most common cause of death in the United States, with 650,000 cases each year. It is the first or second most common cause of unexpected death in most age groups. Because of its vague and non-specific symptoms, more cases of PE are missed than actually diagnosed.1
Symptoms of PE can include shortness of breath, restlessness, chest pain, fainting, or light headedness. Weakness and swelling of the legs or ankles can develop progressively for weeks, months or even years. Symptoms in the lower extremities are due to deep vein thrombosis (DVT), which is the leading precursor to PE.
A recent single center study published in the Annals of Emergency Medicine, highlighted the benefits a point-of-care clinical protocol for the evaluation of PE. The study showed that using a commercially available rapid, whole-blood immunochromatographic test for D-dimer doubled the number of patients evaluated for PE and decreased length of stay in the emergency department, without increasing the need for vascular imaging.2
In June 2004, Biosite® announced that the U.S. Food and Drug Administration (FDA) issued the Company clearance to market the Triage® Profiler Shortness of Breath Panel. The diagnostic symptom panel is intended to aid in the evaluation of patients who present to the emergency department with shortness of breath, a symptom of PE. The panel simultaneously measures the levels of five biomarkers: B-type natriuretic peptide (BNP), D-dimer, myoglobin, CK-MB and cardiac troponin I, to aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including PE, and the risk stratification of patients with acute coronary syndromes.
In December 2004 the Company announced the FDA granted it clearance to market the Triage D-Dimer Test. The diagnostic test is intended to be used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including PE.
Portable and easy-to-use, both point-of-care diagnostic tests provide results in approximately 15 minutes and can be used in the emergency department or at a patient’s bedside. The tests use highly sensitive immunoassay technology and the highly specific 3B6 D-dimer antibody.3,4,5 The Triage D-Dimer Test and the Triage Shortness of Breath Panel are run on the widely used Triage Meters.
1Feied CF: Pulmonary embolism. In: Rosen and Barken, eds, Emergency Medicine Principles and Practice, 4th ed. 1998; 3: Chapter 111.
2J. Kline, et al. Ann Emerg Med. 2004; 44:490-502.
3Dempfle, C-E, Zips S, Ergul H, Heene D and the FACT Study Group, The Fibrin Assay Comparison Trial (FACT), J Thromb Haemost 2001: 85: 671-8.
4Stein and Hull et al, D-dimer for the Exclusion of Acute Venous Thrombosis and Pulmonary Embolism, Ann Intern Med. April 2004
5Philip S. Wells, Evaluation of D-dimer in the Diagnosis of Suspected Deep-Vein Thrombosis, NEJM, 2003
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