Home-Use HIV Test Kits
HIV infection is the leading cause of death in the United States among people 25 to 44 years of age. Up to 1 million Americans are now infected with HIV (human immunodeficiency virus, the virus that causes AIDS), and an estimated 40,000 to 80,000 new infections occur each year.
From the time FDA licensed the first test to detect HIV antibodies in 1985, public health officials have urged people at increased risk of infection with the virus to be tested. Those in whom HIV antibodies are detected (HIV-positive) can receive counseling on how to prevent spreading the infection and seek early treatment. Those whose tests did not reveal antibodies (HIV-negative) can be counseled on how the virus is transmitted and how to prevent infection. Until now, testing was available only through a health professional.
On May 14, 1996, FDA approved the first HIV test system that includes an over-the-counter home-use specimen collection kit, providing a new resource for people to be tested for infection. A recent survey by the national Centers for Disease Control and Prevention showed that only 20 percent of people at increased risk for HIV infection had planned to be tested by a professional within a year's time, but that 42 percent of people at increased risk would likely use a home testing and counseling service.
People at increased risk for HIV infection include:
- men who have had sex with another man even one time since 1977 past or present intravenous drug users
- persons with hemophilia or related clotting disorders who have received clotting factor concentrates
- men and women who have engaged in sex for money or drugs since 1977
- persons who have had sex with anyone meeting the above descriptions during the preceding 12 months
- persons who have had, have been treated for, or have tested positive for syphilis or gonorrhea during the preceding 12 months
- persons who were born in or have emigrated from countries where heterosexual activity is thought to play a major role in transmission of HIV-1 infection and persons who have had sex with any person meeting the latter description.
With the home system, called Confide, the user mails a dried blood sample obtained from a finger prick to a laboratory for analysis. After a week, the person can obtain the test results by telephone. The test is highly accurate; its sensitivity is 99.9 percent, and specificity is almost 100 percent. Sensitivity refers to the test's ability to accurately indicate HIV infection in people who are infected (a true positive result), and specificity refers to its ability to indicate the absence of infection in people who are not infected with HIV (a true negative result). That means that one would expect only one in 1,000 people to falsely test positive, and almost no one to falsely test negative.
Professional counseling and, if indicated, referral for treatment are offered when the person calls for the test results. The system is designed to protect the person's anonymity.
Confide is manufactured by Direct Access Diagnostics, a subsidiary of Johnson & Johnson. It is available in several languages and via a TTY service for people with a hearing impairment. The test kit contains pre-test counseling materials, including information about HIV and AIDS -- such as how the virus is transmitted and how to prevent its spread -- and about legal protection from discrimination.
Other firms have applied to FDA for approval of similar kits, and these applications are being reviewed.
Companies first expressed interest in developing and marketing home-use blood collection kits for HIV testing in 1986. At that time, the agency, as well as AIDS advocacy groups, raised important public health concerns about these kits, especially regarding test accuracy and the way users would be notified of test results.
The technology available when early test kits were developed could not ensure accurate results without careful handling of specimens by a trained, experienced professional. Proper collection, storage and shipping of specimens were critical; samples held too long or subjected to severe temperature changes, for example, could provide inaccurate results.
Other concerns focused on whether a home-use test system could ensure patient confidentiality and provide adequate telephone counseling, particularly for people who tested positive. Effective counseling is crucial to ensure that HIV-infected people understand what HIV infection means and receive vital information about recommended treatments and coping methods.
FDA consulted with other U.S. public health agencies about home test kits for HIV and, in March 1988, notified manufacturers and other interested parties, by letter, that it believed that HIV specimen collection systems should be limited to professional use only. The letter also enumerated the requirements for approval of such systems. The agency published the information in a Federal Register notice Feb. 17, 1989.
In April 1989, FDA held an open public meeting to further discuss home testing. After considering the data and comments from that meeting, the agency published a notice in the July 30, 1990, Federal Register reiterating its position that HIV specimen collection kits should remain for professional use only. The agency did, however, also state a willingness to work with manufacturers on requirements for a premarket approval application and to review data for home collection kits.
Direct Access Diagnostics (then called University Hospital Laboratories) submitted a premarket approval application for its home collection system. On July 19, 1990, FDA's Blood Products Advisory Committee recommended against approval because the application lacked sufficient data. Questions remained regarding possible problems with such issues as confirmatory testing of positive samples, adequacy of telephone counseling, and compliance with state notification requirements while maintaining patient confidentiality.
In the years following the meeting, FDA discussed over-the-counter HIV home specimen collection kits extensively with other U.S. public health agencies and with several product sponsors. During those years, circumstances had altered considerably. Advances in technology offered significantly greater potential for achieving acceptable test accuracy. The nature of the HIV epidemic and treatment methods -- including availability of therapy for asymptomatic individuals -- changed drastically over the years.
In view of these changes, and the public's increasing desire for greater involvement in personal health-care decisions, FDA renewed discussion of issues regarding HIV home test kits. In June 1994, FDA convened its Blood Products Advisory Committee for a comprehensive examination of HIV testing, including a discussion of home-use specimen collection systems. At the meeting's conclusion, most committee members, consultants, and guests agreed that the benefit of having an alternative means of reaching previously unreachable populations for HIV testing outweighed potential risks. Members expressed concerns about how accessible -- both economically and physically -- a home-use kit would be to target groups; whether the system could provide appropriate counseling while maintaining confidentiality; and whether education and follow-up would be effective. The committee recommended pilot studies to evaluate these issues.
FDA published revised guidance Feb. 23, 1995, stating that over-the-counter home specimen collection kit systems for HIV testing may be approvable. The Federal Register notice outlined the specific kinds of data sponsors should include in a premarket approval application submitted for agency review of safety and effectiveness.
Confide kits will initially be sold in Texas over the counter in pharmacies, through college health centers, and at public health clinics. The kits will also be sold through a toll-free number for people in Texas and Florida who wish to have them mailed confidentially to their homes.