| U.S. Clears New Test to Help Rule Out Heart Attacks |
| 来源:Reuters;添加日期:2003-2-17;编辑:ark |
February 14, 2003 02:35:28 PM PST,
US health officials on Friday approved a new blood test that can help doctors rule out a heart attack in patients with severe chest pain.
An estimated 3 million to 5 million Americans show up at emergency rooms each year with heart attack symptoms, but only about 22% of them actually have had a heart attack, the Food and Drug Administration ( news - web sites) said in announcing the approval.
The new test measures blood levels of modified albumin, an altered version of a protein. Studies have shown the amount of modified albumin rises in heart-attack patients . "If it's a negative test, it increases the likelihood it is not a heart attack," said Dr. Steve Gutman, director of the FDA's Office of In Vitro Diagnostics. The FDA said doctors should not rely on the new test alone to tell if someone has had a heart attack. The modified albumin test should be used with an electrocardiogram--a measure of electrical activity in the heart--and a test for troponin, a protein found in the blood after a heart attack.
A study of more than 200 patients with severe chest pain found physicians were 70% accurate in ruling out a heart attack using all three tests, the FDA said. With an electrocardiogram and troponin test alone, they correctly ruled out a heart attack 50% of the time."The real advantage is that many patients can be sent home much, much earlier," said Peter Crosby, president and chief executive of test maker Ischemia Technologies Inc., a private company based in Arvada, Colorado.
The company will sell the new test, called the Albumin Cobalt Binding Test, to hospitals for $30 each, Crosby said. The test already is available in Canada and Europe.
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