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1993.03.02 :  Home Cholesterol Test
           
Contact: Sharon Snider--(301) 443-3285 (Home) -- (301) 622-0977
March 2, 1993

    The Food and Drug Administration today announced that it has
cleared for marketing the first cholesterol test available for home
use by consumers without a prescription.
    Previously, cholesterol tests, which are used to help determine
the risk of heart disease, were available only for use by medical
professionals.
    The test--the Accumeter Cholesterol Self-Test, made by Chem
Trak Inc. of Sunnyvale, Calif.--comes in a kit and allows the user
to find the level of cholesterol in the blood in about 15 minutes.
    "This test can help give consumers greater opportunity to
monitor their health and take steps to prevent disease," said
Health and Human Services Secretary Donna E. Shalala.  "Making it
more convenient to check on cholesterol can help ensure that people
are aware of the level so they can see a doctor before serious
problems develop."
    High cholesterol is only one factor that leads to heart
disease.  Others include high blood pressure, smoking, obesity and
family history of heart disease before age 55.  An estimated 17.6
million Americans have heart disease, which claims some 734,000
lives in the United States annually.
    The agency's decision to allow the test to be sold over-the-
counter is based on results of a multi-center clinical trial
involving nearly 500 adults.  The firm's study showed the test to
be as accurate as cholesterol tests used by doctors and medical
laboratories.
    "Accuracy is crucial," said David A. Kessler, M.D.,
Commissioner of Food and Drugs.  "It is also important, as the
study showed, that participants were able to read and understand
the instructions and perform the test without assistance," he
noted.
    To perform the test, the user pricks his finger, squeezes blood
into a cassette that contains a test strip and then waits 10 to 15
minutes for results.  The strip changes color as the cholesterol
rises on it.  When the time is up, the user compares the height of
color shown on the cassette with an accompanying conversion chart
to get the cholesterol reading.
    The test measures total cholesterol.  It does not measure
individual components, such as LDL or HDL cholesterol.  A reading
of less than 200 is desirable; 200 to 239 is borderline high; and
240 or above is high, meaning the user may be at a greater risk for
heart diesase.  People whose cholesterol is borderline or high
should see a doctor.
    The National Institutes of Health's National Cholesterol
Education Program recommends that people with a reading in the
desirable range have their cholesterol checked once every five
years, and that those whose cholesterol is borderline or high
follow the recommendation of their doctor for frequency of   
testing.
    The home test should not be used by hemophiliacs or by people
who take medicine to thin blood because of the possibility of the
finger prick.  Those individuals should have their cholesterol
checked by their doctors.
    The package labeling for the test includes detailed
instructions for proper use and a discussion of the test's limits. 
It also includes information on cholesterol, heart disease, diet
and exercise and lists a toll-free number consumers can call for
additional information.  The number is 1-800-927-7776.
    Other home tests approved by FDA include tests for ovulation,
pregnancy, blood glucose, hidden fecal blood, blood pressure and
urinary tract infections.  FDA and NIH are among the eight Public
Health Service agencies within the Department of Health and Human
Services.
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