Test for Congestive Heart Failure Cleared by FDA

A blood test for use as an aid in the diagnosis of congestive heart failure (CHF) has been cleared by the U.S. Food and Drug Administration (FDA). Called Triage BNP, the test is an immunoassy that 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 is designed for use in hospital emergency departments and heart failure clinics to provide an accurate diagnosis of patients who are experiencing shortness of breath or other symptoms associated with CHF. The FDA says the test is appropriate for use on patients 55 and older. The 15-minute test measures 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 an important clinical determinant in diagnosing CHF.

In clinical studies involving more than 1,200 patients at eight sites, the BNP test identified patients with CHF with a specificity of more than 95%. Patients suffering from chronic obstructive pulmonary disease who had symptoms similar to patients with CHF did not have elevated BNP concentrations. The BNP test is the product of Biosite Diagnostics Incorporated (San Diego, CA, USA), which notes that the test is the first blood test to be cleared in the United States as an aid in the diagnosis of congestive heart failure.

"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,” said Alan S. Maisel, M.D., 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.



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