Testing Yourself for the HIV Virus

Getting tested for the Human Immunodeficiency Virus-1 (HIV-1), the virus that causes AIDS, by testing for the presence of antibodies to the virus as you know is very important. Testing can be done at home.

The tests that are approved by the United States Food and Drug Administration (FDA) for detecting whether or not you are infected with HIV are available through your doctor at clinics, or public health clinics.

There is one HIV-1 Home Collection Test System that is currently approved by the FDA in which a sample for testing is collected in the privacy of your home and then sent to a laboratory for analysis. The “Home Access Express HIV-1 Test System” manufactured by Home Access Health Corporation is the only HIV-1 Home Collection Test System approved by FDA and legally sold in the United States. It is available in most drug stores and even in Walmart, Walgreens, CVS, etc.

Be aware that there are a number of different HIV home test systems and kits that are being marketed on the Internet and through magazine promotions that claim to detect antibodies to HIV in blood or saliva samples and provide results in the home in 15 minutes or less. The FDA has not approved these rapid HIV-1 home test kits being promoted on the Internet for use in the United States. All HIV home sample collection kits approved to date by FDA require laboratory analysis and provide counseling for the consumer.

The following Questions & Answers may help to explain how HIV-1 home tests differ, and how to select a test that you can trust.

Q. How many different kits are available, and how do they work?

A. There are more than a dozen different HIV home test kits being advertised on the market today. Only the Home Access test system is FDA approved and legally marketed in the United States. Because the Home Access test consists of multiple components, it is considered a testing system.

This approved system uses a simple finger prick process for home blood collection which results in dried blood spots on special paper. The dried blood spots are mailed to a laboratory with a confidential and anonymous personal identification number (PIN), and analyzed by trained clinicians in a certified medical laboratory using the same procedures that are used for samples taken in a doctor’s office. The results are obtained by the purchaser through a toll free telephone number using the PIN, and post-test counseling is provided by telephone when results are obtained.

The advertisers of the unapproved HIV home test kits claim that the presence of a visual indicator, such as a red dot, within 5 to 15 minutes of taking the test shows a positive result for HIV infection. These unapproved test kits use a simple finger prick process for home blood collection or a special sponge device for saliva collection. The blood or saliva sample is then added to a plastic testing device containing a special type of paper. A developing solution is added to determine if the sample is positive for HIV. The samples are not sent to a laboratory for professional analysis. Although this approach may seem faster and simpler, it may provide a less accurate result than can be achieved using an approved test, which is analyzed under more controlled conditions than is possible in the home.

Q. How reliable are the unapproved HIV home test kits?

A. Diagnostic testing depends on precise science. Unapproved HIV home test kits do not come with any guarantee of the accuracy of the test, or the sensitivity of the reagents used in the analysis. Nor do they have a documented history of delivering dependable results. None of the unapproved tests have undergone the intense scrutiny and validation required for FDA marketing approval. Although unapproved tests might be promoted as sensitive and reliable, the consumer has no guarantee that the results produced by the test are, in fact, accurate. The FDA is unaware of any data to confirm the reliability or accuracy of the process used in the unapproved HIV home test kits.

Q. What about counseling?

A. The unapproved HIV home test kits do not provide direct counseling to help the user understand results, answer questions about the test or about HIV infection, or to discuss available options. The approved HIV test system has a built in mechanism for pre-and post-test counseling provided by the manufacturer.

Counseling is an important part of HIV testing. It is anonymous and confidential. Counseling, which uses both printed material, and telephone interaction, not only provides the user with an interpretation of what positive or negative results really mean, but provides information on how to keep from getting infected if you are negative, and how to prevent transmission of disease if you find you are infected.

Counseling also provides you with information about treatment options if you are infected, and can even provide referrals to doctors that treat HIV-infected individuals in your area.

Q. Are approved HIV test systems really confidential?

A . Yes. The approved HIV home test system is anonymous. It can be purchased anonymously at pharmacies, or by mail order from the manufacturers. The mail-in system uses a confidential code number that is unrelated to the identity of the buyer or user. Although some states require that new cases of HIV infection be reported to the health department, only the number of cases detected with home test systems can be reported. The identity of the user remains anonymous.

The number of cases reported allows local or state public health officials to assess the extent of infection to properly budget, plan and administer programs for people with HIV. The lack of reporting of the number of new cases in a geographic area also means that adequate services for people with HIV infection may not be available in your area.

Q. Are there other ways I can be tested for infection with HIV-1?

A. There are several kinds of tests available through your doctor to determine if you are infected with HIV-1, the virus that causes AIDS. In addition to blood tests, there is a test that uses oral fluid, collected from between the cheek and gum of the mouth, and a urine test. All of these tests have been thoroughly tested and reviewed, and provide the highest possible level of confidence in determining HIV infection. All are collected in the doctor’s office, and analyzed in a medical laboratory. Only a doctor or clinic can administer these tests.

So, ask yourself what is the best choice for you:
A HIV home test system that has been approved by the FDA for marketing after extensive review and in which you can feel confident about the results? Or, an HIV home test kit that has not even been reviewed by the FDA and may not provide accurate results about whether you are HIV positive or negative?

Is it worth your time, money, mental anguish and your life to gamble on an unapproved HIV home test kit? Only you can answer that question.

If you are doubting that the HIV home test kit you are considering is approved, or if you have other questions related to HIV home test kits, you may call the HIV/AIDS Program of the FDA, in the Office of Special Health Issues for further information about this topic. The Office can be reached in the United States at: 301-827-4460.

Useful Telephone Resources:

• Centers for Disease Control (CDC) National AIDS Hotline (toll-free, Eastern time):
• English service: 1-800-342-2437 (7 days a week, 24 hours a day)
• Spanish service: 1-800-344-7432 (daily 8 a.m. to 2 a.m.)
• TDD service for the deaf: 1-800-243-7889 (10 a.m. to 10 p.m., M-F) August 2004