May 15, 1996 in Nation/World

Fda Approves Home Aids Test $40 Kit Assures User Anonymity And Provides For Counseling Over The Phone

From Wire Reports

People worried that they may have HIV, the virus that causes AIDS, will soon be able to test themselves and find out the answer confidentially, from the privacy of their own homes.

The Food and Drug Administration Tuesday approved the first testing kit for HIV that allows users to collect their blood samples at home. The Confide HIV Testing Service was developed by a Johnson and Johnson subsidiary, Direct Access Diagnostics, and includes a telephone counseling and referral service.

“We are confident that this new home system can provide accurate results while assuring patient anonymity and appropriate counseling,” FDA Commissioner David A. Kessler said.

The agency said it was influenced by technological advances in the accuracy of the tests, the availability of more effective therapies for people who are infected but not yet symptomatic, and the public health benefits of having more people know whether they are infected.

“Science and technology have evolved to the point where we believe the benefits of this new product outweigh the risks,” Kessler said.

The federal Centers for Disease Control and Prevention have estimated that more than 60 percent of Americans who engage in high-risk AIDS behaviors have not been tested. Until now, all HIV testing was conducted under the supervision of a health professional, either in a clinic or a physician’s office.

“Too many Americans do not know their HIV status,” said Health and Human Services Secretary Donna E. Shalala. “Knowledge is power, and power leads to prevention.”

The concept - initially rejected by the FDA six years ago has been hotly debated.

Advocates of the home kits have argued that their availability would encourage testing by more people, thus prolonging or saving lives. Many individuals are reluctant to seek testing from clinics or private physicians, particularly in small towns or rural settings.

Opponents have countered that the kits hold the potential for abuse, such as pressure from spouses, employers or insurers, to submit to testing. They are worried that the test might also be used by teenagers or children, who might not understand the implications of test results.

Furthermore, they are concerned about the impersonal nature of the process, which does not involve faceto-face counseling.

The product, known as Confide, will be available over-the-counter only in Texas and through the mail via a toll-free number in Texas and Florida. They will be available nationwide in early 1997.

Jeffrey Leebaw, a spokesman for Johnson & Johnson, said the company “wants to move slowly” in introducing the kits because “it’s a new product, a serious product, and the company wants experience with it before going into a national launch.”

Texas and Florida were selected because “they are manageable size populations, are culturally diverse, and have a significant amount of AIDS and HIV,” he said.

The testing system is as accurate as those used in doctors offices, said FDA Deputy Commissioner for policy Mary Pendergast. The $40 test contains lancets for users to prick their fingers.

The user then blots the blood on a test card with a unique identifying number, and sends it to a certified laboratory for HIV antibody testing. Antibodies are specific proteins produced by the immune system as a response to an infectious agent, such as a virus. If a blood sample tests positive for antibodies to HIV, the laboratory will test it two more times to ensure that the result is accurate.

Results will be ready seven days after sending the test. The patient calls the company’s “Result Center” anonymously, using only the unique identifying number, to get the news.

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