STUDY: Procedure detects change in structure of blood protein

JOURNAL: Ischemia Technologies

AUTHORS: FDA

ABSTRACT: Doctors have won federal approval of a new blood test to help them tell which patients suffering chest pain aren’t really having a heart attack.

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COMMENTARY: The FDA approved a simple blood test that, when added to heart checks, could greatly improve doctors’ ability to rule out a heart attack and send those patients home sooner. The $30 test, made by Ischemia Technologies Inc. of Denver, uses the metal cobalt to hunt changes in a blood protein that occur during a heart attack.

Today, two tests are standard for heart-attack detection: an EKG to measure the heart’s electrical activity, and a blood test that detects troponin, a protein present in the blood after a heart attack.



In a study of 200 patients, doctors were 50 percent accurate in ruling out a heart attack using just an EKG and troponin test. But when they added the new test, doctors accurately ruled out a heart attack 70 percent of the time, FDA said.

A blood protein called albumin undergoes changes in its structure during a heart attack and certain other illnesses. In 1995, a Denver emergency room physician discovered that when cobalt was added to a blood sample, more of the metal would bind to normal albumin than to the changed albumin of a heart-attack victim.

The company created a way to measure that cobalt-albumin reaction using chemical-analyzing equipment standard in hospital laboratories.

But the new test must be used with standard heart-attack tests. It’s far from perfect, so using it alone could prove deadly, FDA’s Gutman said.