News
12/23/1994

<TITLE>Statement on FDA Approval of AIDS Virus Test System Based on Oral Fluid Samples</TITLE>
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The Food and Drug Administration today announced that it has
approved the first U.S. HIV test system using oral fluid samples. 
Until now, all approved HIV tests have used blood samples.  

In approving this new HIV test system, FDA approved both a product
for collecting specimens of oral fluid and a specific test used to
analyze the specimens for the presence of antibodies to HIV, the
virus that causes AIDS.  The test system is intended for use in
subjects 13 years of age or older.  Use of the specimen collection
product is subject to several restrictions.  

This new HIV test system is not as accurate as the approved HIV-
antibody tests used on blood.  Studies show that for every 100
people infected with HIV, the oral-fluid-based test will miss one
or two.  For every 100 people who are not infected, test results
will be incorrectly positive for approximately two people.  

The test system includes a specially treated cotton pad on a stick
and a preservative solution in a plastic container.  A trained
collector instructs the subject to place the pad between the lower
gum and cheek to obtain a sample of oral fluid.  The pad is then
stored in the preservative until the sample is processed and
analyzed by a qualified laboratory using an ELISA test specifically
licensed for testing oral fluid samples.  

FDA approved this HIV test system with the following restrictions:

o    The test system is available for purchase and distribution
     only through physicians.

o    The test system may be administered only by individuals
     properly trained in its use.  

o    The test system must not be provided to subjects for home use.

o    Testing of the oral fluid samples for HIV antibodies may be
     carried out only with the Oral Fluid Vironostika HIV-1
     Microelisa System. 

o    The test system may be used for diagnosis only and must not be
     used to screen blood donors.  

o    Before the oral fluid specimen is collected, subjects must be
     given a "Subject Information" sheet.

                             -MORE-


                                        Page 2, Epitope

The information sheet provides information about the reduced
accuracy of testing oral fluid compared with testing blood and
about the alternative of testing blood.  Because there is currently
no confirmatory test for use with oral fluid samples, the sheet
informs subjects that if their oral fluid samples are found to be
positive for HIV antibodies they should have blood samples drawn
and tested with a licensed blood-based test to verify their HIV
status.  It also gives subjects information on how to reduce the
risks of HIV infection.  

The oral fluid sample collection kit for HIV testing is
manufactured by Epitope Corporation of Beaverton, Ore., and is
marketed under the name "OraSure HIV-1 Oral Specimen Collection
Device."  The Oral Fluid Vironostika HIV-1 Microelisa System
approved to test specimens is manufactured by Organon Teknika
Corporation of Durham, N.C.

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