Palm Test For Skin Cholesterol
The FDA cleared a new laboratory test to
measure skin cholesterol
in adults with severe coronary artery disease. The test can help
determine the amount of cholesterol in skin using the palm of the hand. Other
cholesterol tests currently used by laboratories measure cholesterol from blood
samples.
The test, called Cholesterol 1,2,3, is made by International Medical
Innovations Inc. of Toronto, Canada.
It is for testing people suspected of having severe coronary artery disease
(defined as 50 percent closure of two or more arteries) and those with a history
of heart attack. Cholesterol 1,2,3 is intended to be used along with--not as a
substitute for--the standard blood tests. Nor can it substitute for an
evaluation of other risk factors used to identify coronary artery disease.
FDA's decision to clear the test for marketing was based on a review of the
firm's clinical studies that showed, in patients with severe disease or previous
heart attack, it could provide 4% to 15% more information about risk of severe
coronary artery disease beyond that already available with blood cholesterol and
other risk factors.
Skin contains approximately 11 percent by weight of all body cholesterol.
When severe coronary artery disease is present, the numeric values obtained with
the skin cholesterol test increases.
In a study with 649 patients who each had a known degree of coronary artery
blockages, the skin cholesterol test, combined with a blood cholesterol test,
helped identify patients who had the most severe artery blockages.
For the palm cholesterol test, a band-aid-like applicator pad was placed on
the palm of the hand. Drops of reagent solution were added to the pad, which
remained on the palm for three minutes. A handheld reader attached to a computer
was then used to read the amount of blue color in the pad. The results were
displayed on the computer screen. The deeper the blue, the more cholesterol was
detected.
The Cholesterol 1,2,3 test was not shown to be useful in identifying people
with less severe coronary artery disease. Therefore, it is not intended to be
used as a screening tool to determine risk for coronary artery disease in the
general population.
The test cannot be used on people with skin diseases on the hand or on those
who recently applied skin lotions or topical medications. Also, the test results
may be race and age dependent. Most of those studied were Caucasian, ages 40 to
82.
For more, please visit the following MedicineNet.com areas:
Portions of the above information have been provided with the kind permission
of the U.S. Food and Drug Administration, June 2002. (www.fda.gov)
Last Editorial Review: 2/1/2005
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