NEW

05/14/1996



<TITLE> FDA APPROVES FIRST HIV HOME TEST SYSTEM </TITLE>

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                                        Lenore Gelb

                                        301-443-3285



             FDA Approves First HIV Home Test System





     The Food and Drug Administration today approved the first HIV

test system that includes collection of blood samples at home. 

Until now, all HIV tests, whether using blood or saliva samples,

were done under the supervision of a health professional at medical

facilities, clinics, physicians' offices or blood establishments. 

 

     The new testing system is comprised of three integrated

components:  an over-the-counter home blood collection kit,  HIV-1

antibody testing at a certified lab, and a test result center that

provides test results, counseling and referral anonymously. 

      The test kit system is called the Confide HIV Testing

Service, developed and marketed by Direct Access Diagnostics, a

subsidiary of Johnson and Johnson, Bridgewater, N.J.   

     More than 60 percent of Americans at risk for contracting HIV

have not been tested, according to estimates by the Centers for

Disease Control and Prevention.  

     "Too many Americans do not know their HIV status.  Knowledge

is power, and power leads to prevention," said HHS Secretary Donna

E. Shalala.  "The availability of a home test should empower more

people to learn their HIV status and protect themselves and their

loved ones."

     "We are confident that this new home system can provide

accurate results while assuring patient anonymity and appropriate

counseling," said Commissioner of Food and Drugs David A. Kessler,

M.D.  "Science and technology have evolved to the point where we

believe the benefits of this new product outweigh the risks."    

       Technological advances in the accuracy of HIV antibody

testing, the availability of treatments for people who are infected

but do not yet have symptoms, and the public health benefits that

would accrue from more people being aware of their HIV status all

contributed to the agency's decision to approve the kit for home

use.  The decision is consistent with advice that FDA received at

a June 1994 meeting of FDA's Blood Products Advisory Committee.  At

that meeting, the committee concluded that the potential benefits

of over-the-counter home specimen collection kits outweighed the

potential risks.   

       After purchasing a kit, a person begins the testing process

by reading a pre-test counseling booklet about HIV and AIDS.  Using

enclosed lancets, the person takes a finger stick blood sample

which is placed on a designated area of a test card precoded with

a unique identification number. 

     The test card is mailed in a protective envelope to a

certified laboratory for HIV-1 antibody testing.  Once instructions

are followed and an adequate sample has been sent, people can

receive results seven days later by calling a toll-free number. 

     The lab testing process is consistent with FDA recommendations

for blood and plasma establishments.  Any initially reactive sample

is retested twice.  Samples reactive in two out of three assays are

further confirmed with a more specific test, such as the Western

blot.  

     To get results, patients call the Confide Test Result Center

and give their identification number from the test kit. 

Professional, certified counselors who speak both English and

Spanish notify callers of the results if they are positive or

inconclusive.  Local medical referrals are provided if needed and

those who test positive are encouraged to seek medical care.  All

conversations are anonymous and confidential.

     Although negative results are provided by an automated

message, everyone has the opportunity to speak to a counselor.  All

negative test results include an explanation of the "window"

period, the time when people may be HIV-infected but still have

negative antibody tests.  The window period, in most cases, lasts

approximately 1 month. 

     FDA's approval was based on data showing that each component

of the test system, as well as the complete system itself, was safe

and effective for its intended use.  Clinical studies showed that

the Confide Test Card was able to correctly identify negative

samples 99.95 percent of the time based on evaluations of over

3,940 samples.  The test also correctly identified 100 percent of

150 known positive samples.  

      Initially, the company will make the kit available for over-

the-counter purchase in the state of Texas.   Residents of Texas

and Florida who would prefer having the kit mailed to their homes

can obtain them through a toll-free number.    

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