HHS NEWS

P97-33                        FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE         Media Press:      (301) 827-6242
September 26, 1997            
                              Consumer Hotline: (800) 532-4440
                         

   FDA WARNS CONSUMERS ABOUT TWO UNAPPROVED HOME-USE TEST KITS

     FDA is advising consumers and pharmacists about two
unapproved, fraudulently marketed home-use test kits distributed
by Lei-Home Access Care, a division of Jin-Greene Biotechnology,
Inc. in Sunnyvale, Calif. One test kit is advertised on the
internet as the "Personal HIV Test Kit" and is labeled the   
"Lei-Home Access HIV Test."  The other test kit is labeled as an
"In-home Hepatitis A Test Kit."  Results from any unapproved tests 
for home use are unreliable. 
     The human immunodeficiency virus (HIV) is the virus that
causes the disease AIDS.  The hepatitis A virus, usually a  
food-borne illness, causes a mild, rarely serious, liver disease. 
     FDA is recommending that pharmacists remove any of these
unapproved test kits from their stores.  
     Currently, the only approved HIV home collection system
being marketed in the United States is the Home Access HIV-1 Test
System (also called the Home Access Express HIV-1 Test System),
manufactured by the Home Access Health Corporation, Hoffman
Estates, Ill.  With this home system, the user mails a dried 
blood sample obtained from a finger prick to a laboratory for
analysis.  Confidential, highly accurate test results are
obtained by telephone, with a trained counselor available.  FDA 
has not approved a hepatitis A home test kit.  
     FDA is advising consumers who purchased the "Lei-Home Access
HIV Test" or the "In-Home Hepatitis A Test Kit" to consult with a
health professional about other available approved tests that
detect antibodies to the HIV virus and the hepatitis A virus.                        ####