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The Triage^® BNP Test is the first objective measurement for CHF. 

The Triage BNP Test is the first blood test to be cleared in the United States as an aid in the diagnosis of congestive heart failure (CHF). Already available and gaining acceptance in European hospitals and heart failure clinics, the Triage BNP Test measures circulating levels of B-type natriuretic peptide (BNP) which are elevated during heart dysfunction in both symptomatic (late-stage) and asymptomatic (early-stage) CHF patients.

The Triage BNP Test can be used in hospital emergency departments and heart failure clinics to facilitate efficient and accurate diagnosis of patients who are experiencing shortness of breath or other symptoms associated with CHF. The FDA has deemed the test appropriate for use on patients of age 55 years and older. The 15-minute test assesses a patient’s status by measuring BNP, which is released by the left ventricle of the heart when it experiences ventricular overload and ventricular stretch. The resulting loss in pumping action is viewed as an important clinical determinant in diagnosing congestive heart failure.

Patients exhibiting shortness of breath and other symptoms of CHF account for millions of emergency department (ED) visits in the United States each year," said Richard Nowak, vice chairman of the department of emergency medicine at the Henry Ford Health System. "Many are elderly individuals affected with several conditions, making it difficult to determine which is the source of the problem. In a situation where the patient is in distress, you do not have hours to spare. A rapid, quantitative test could help us quickly and objectively determine whether the problem is attributable to CHF, thereby leading us to begin treatment or continue the diagnostic process."

The Triage BNP Test has been evaluated in pre-submission clinical studies at eight sites involving more than 1,200 patients. The BNP test identified patients with CHF, as compared to patients without CHF, with a specificity of greater than 95 percent. Patients suffering from chronic obstructive pulmonary disease who had symptoms similar to patients with CHF did not have elevated BNP concentrations. Additionally, patients with hypertension, diabetes and renal insufficiency do not have significantly higher levels of BNP as compared to a normal population.

"In the clinical studies, we found BNP to be both highly sensitive and specific in differentiating CHF from other medical problems encountered in the emergency room setting," according to Alan S. Maisel, MD, director of the coronary care unit at the San Diego Veterans’ Affairs Health Care System and professor of medicine at the University of California, San Diego. "Furthermore, data from our studies suggest that BNP could be useful in identifying diastolic dysfunction, a type of CHF that can be challenging to detect. For this reason, we look forward to continuing our work with this important marker."

The Triage BNP Test
The Triage BNP Test is a rapid, point-of-care immunoassay that measures levels of BNP from approximately six drops of whole-blood or plasma. BNP, a naturally occurring hormone in the body that aids healthy functioning of the heart, is secreted by the ventricles of the heart as one of the body’s natural responses to heart failure. When the heart is unable to pump blood efficiently, BNP is produced to ease its workload. BNP appears to relax blood vessels (vasodilation), increase the excretion of sodium (natriuresis) and fluid (diuresis) and decrease neurohormones that lead to vessel constriction, fluid retention and elevated blood pressure. Biosite secured a semi-exclusive license to BNP from Scios Inc. in 1997. The license covers technology and patents for use in developing a test that aids in the diagnosis of CHF by measuring levels of BNP.

Congestive Heart Failure
A potentially life-threatening disorder that has no cure, heart failure is a chronic pathophysiologic condition in which the heart functions inefficiently and circulation is reduced to the body's organs. In congestive heart failure, fluid accumulates in the tissues, including lung tissue, causing such symptoms as difficulty breathing, swelling of the hands and feet, difficulty sleeping, dry cough, fatigue and rapid weight gain. CHF may result from an acute event (e.g., heart attack) or may develop gradually over time.

During an acute episode of CHF, the heart's inability to adequately circulate blood throughout the body worsens beyond its already compromised state, causing symptoms to become so pronounced that hospital treatment is required to stabilize the patient's condition. A sudden increase in dietary sodium (salt), failure to take medications for managing CHF, or the development of a new heart arrhythmia can precipitate an acute attack.

Roughly five million Americans suffer from heart failure, and there are approximately one million hospitalizations each year in the United States for CHF which cost the healthcare system $8 - 15 billion. This figure is nearly twice the amount spent on treating all forms of cancer. In 1995, CHF treatments were the largest annual expenditure for Medicare, costing nearly $3.4 billion. Another two million Americans are hospitalized each year with CHF as the secondary diagnosis. In the United States, CHF accounts for the largest cause of hospitalizations for patients over age 65. Virtually all CHF patients will have at least one acute episode, where the symptoms are so severe that often only intravenous (IV) medications administered in the hospital can improve patients' health.

Cost is $725 dollars for 25 tests or 29 dollars a test.  The Meter costs $4750 dollars and is available on a lease program.  For more info www.biosite.com

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