January 23, 2001
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 or at clinics. For more information on the HIV test kits approved by FDA, see "Licensed/Approved HIV, HTLV and Hepatitis Tests."
However, 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.
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 or newspaper 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 and marketing in the United States. Some of the HIV home test kits falsely claim to be approved by the FDA or manufactured in a FDA approved/registered/licensed facility. All HIV home sample collection kits approved to date by FDA require laboratory analysis and provide counseling for the consumer.
FDA warned consumers about an unapproved, fraudulently marketed home-use HIV test system labeled "Lei-Home Access HIV test" distributed by Lei-Home Access Care located in Sunnyvale, California in a press release issued on September 26, 1997. The "Lei-Home Access HIV test" was advertised on the Internet as the "Personal HIV Test Kit" and was offered for sale through several Central Valley pharmacies. After an extensive investigation by FDA, the businessman responsible for distributing this fraudulent HIV test kit was recently sentenced to over 5 years in prison for selling the medically useless HIV test kits to consumers in the United States.
The Center for Biologics Evaluation and Research is working with FDA's Office of Regulatory Affairs and Office of Criminal Investigations in investigating firms and persons involved in the sale, distribution, and manufacture of unapproved HIV home test kits in the United States.
The following questions and 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, including materials for specimen collection, a mailing envelope to send the specimen to a laboratory for analysis, and includes pre- and post-test counseling, 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. Proper training to interpret results is not provided with the kits, and they do not have a validated record of precision. This means that they may not be as accurate and that they may yield inconsistent results. Users can get a positive result when they are, in fact, not infected (called a false positive), or the test may indicate that a person is not infected with the virus, when, in fact, they are (called a false negative). Both of these outcomes can have grave consequences in terms of mental anguish, access to proper medical treatment, and on future transmission of the disease.
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. Even if they have been tested by independent laboratories, they have not been analyzed and validated by the FDA to assure that the test results were correct and reliable.
FDA is unaware of any data to confirm the reliability or accuracy of the process used in the unapproved HIV home test kits.
Q. How reliable are approved HIV test systems?
A. Approved HIV test systems, on the other hand, have undergone extensive study and review by the manufacturer of the product to ensure that they work, that the results they provide are specific, meaning that they will accurately detect antibodies to the HIV-1 virus that causes AIDS, and that they are sensitive, meaning that they can detect even low levels of these antibodies, indicating that someone has been exposed to HIV-1.
Clinical studies have shown that the approved HIV test system is able to correctly identify 100% of known positive blood samples, and 99.5% of HIV-1 negative blood samples.
In addition, manufacturer's tests on the approved HIV test system have been carefully reviewed by the FDA to assure that the tests conducted were themselves adequate to demonstrate that the system is capable of yielding accurate, dependable results. FDA review also assures that the system contains adequate directions for proper use, and that the quality standards will be monitored to ensure that each kit is as consistently accurate and sensitive.
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. 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. Is one test better than another?
A. Since the approved HIV home test system has been independently tested, validated, and approved by the FDA for marketing, the consumer can feel confident that the approved HIV test system will provide the most accurate results available from an HIV-1 home test. In addition, the user is provided with counseling and referrals if needed. Use of an approved HIV test system also assures that accurate numbers of infection are reported to public health departments so that adequate services can be provided.
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:
An 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?
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 in doubt about whether an HIV home test kit you are considering using 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 at 301-827-4460.