AEGiS-FDA: FDA Approves First HIV Home Test System

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

FDA Approves First HIV Home Test System

Food and Drug Administration, U.S. Department of Health and Human Services - May 14, 1996
Lenore Gelb; (301) 443-3285

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. The kits will also be sold through a toll-free number in two states, Texas and Florida, for people who would prefer having the kits mailed confidentially to their homes.
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SOURCE: Food and Drug Administration (FDA).

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