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Testing Yourself for HIV-1

AIDS is a serious disease that can be fatal. The United States Food and Drug Administration (FDA) regulates the tests that detect infection with Human Immunodeficiency Virus-1 (HIV-1), a virus that causes AIDS. Up until 1996, the only way to get tested for HIV was to be tested under a doctor's supervision. However, in 1996 FDA approved the first home collection HIV testing systems. 

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How many different home tests are available in the United States, and how do they work?

Only one HIV home collection test system is approved by FDA and legally sold in the United States. This test, sold as either "The Home Access HIV-1 Test System" or "The Home Access Express HIV-1 Test System" is manufactured by Home Access Health Corporation and allows blood samples to be taken at home, which people then send to a laboratory for testing. This test system may be purchased on the Internet.  However, there are many non-FDA approved tests kits illegally marketed over the Internet and in newspaper and magazine advertisements.

What is an HIV home collection test system and how does it work?

An HIV home collection test system, such as the Home Access test system, consists of multiple components, including materials for specimen collection, a mailing envelope to send the specimen to a laboratory for analysis, and pre- and post-test counseling.

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 laboratory using the same tests that are used for samples taken in a doctor's office or clinic. Test results are obtained through a toll free telephone number using the PIN, and post-test counseling is provided by telephone when results are obtained.

What is the difference between a test, a rapid test, test system and a home-use test kit?

A test is the actual device used to determine whether a sample of blood or other body fluid is HIV positive or not. The sample may be collected in a doctor's office or other clinical setting and sent to a laboratory for analysis. Alternately, a consumer may use a home collection test system to collect a sample, which is then sent anonymously to a laboratory for testing. The consumer, still anonymous, is able to contact the testing facility to obtain their test results.

For a rapid test, a health care worker usually collects the sample. Instead of sending the sample to a laboratory, the test is run at the site where the sample is collected. Rapid tests can produce results within 20 minutes.

With all types of FDA approved testing, the consumer has access to trained health care workers who can help consumers understand their test results.

Home-use test kits are HIV tests kits that require consumers to collect the sample, run the test and interpret the results. There are currently no FDA approved home-use test kits.

How reliable are approved HIV home collection test systems?

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Very reliable. Manufacturers of approved test systems have demonstrated that the test system can accurately detect antibodies to the HIV virus that causes AIDS. Approved tests have also demonstrated and that they can detect even low levels of HIV antibodies.

Clinical studies have shown that the FDA approved HIV home collection test system is able to correctly identify 100% of known positive blood samples, and 99.5% of HIV negative blood samples.

What about counseling?

The approved HIV home collection test system has a built-in mechanism for pre-and post-test counseling provided by the manufacturer. This counseling is anonymous and confidential. Counseling, which uses both printed material and telephone interaction, provides the user with an interpretation of the test result. Counseling also provides information on how to keep from getting infected if you are negative, and how to prevent further transmission of disease if you are infected. Counseling provides you with information about treatment options if you are infected, and can even provide referrals to doctors who treat HIV-infected individuals in your area.

The unapproved HIV home test kits do not provide interactive counseling to help the user understand the test results, answer questions about the test or about HIV infection, or discuss options available to the user, such as medical follow-up.

Are approved HIV collection test systems really confidential?

Yes. The approved HIV home collection test system is confidential. It can be purchased at pharmacies or by mail order from the manufacturer. You mail in your specimen anonymously. Consumers obtain their test results by phone using a confidential code number that is unrelated to the identity of the consumer.

Although some states require testing labs to report new cases of HIV infection to the health department, with the approved test systems the testing lab can report only the number of cases detected with home test systems. The testing lab cannot report the name of the infected person, since the lab does not have that information. The identity of the user remains anonymous.

Is one test better than another?

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FDA approved tests have demonstrated their reliability; unapproved tests have not been reviewed by FDA. Therefore, FDA cannot state that unapproved tests are reliable. Since the approved HIV home collection test system has been independently tested, validated, and approved by FDA, the consumer can feel confident that the approved HIV test system will provide accurate results available from an HIV home test. In addition, the user is provided with counseling and referrals if needed.

How are unapproved test systems different?

The manufacturers of unapproved test systems have not submitted data to FDA to review to determine whether their test systems can reliably detect HIV infection or not. Therefore, FDA cannot give the public any assurance that the results obtained using an unapproved test system are accurate.

How reliable are test kits that are not FDA approved?

FDA cannot ensure the reliability of any test kit that has not undergone FDA review. Diagnostic testing depends on precise science. FDA approved tests have demonstrated that they are reliable. Tests that are not FDA approved have not demonstrated to FDA that they are reliable. Unapproved HIV home test kits do not come with any guarantee of the accuracy of the test. The kits do not train a home user on how to interpret results and they have not demonstrated that home users can use them without that training.

None of the unapproved tests has undergone the review required for FDA marketing approval. Although unapproved tests might be promoted as sensitive and reliable, the consumer has no assurance that test results are accurate.

Simply put, you just can't trust the results of an unapproved test to be correct. Users may get a positive result when they are, in fact, not infected (called a false positive). Or the test may indicate that users are 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, delays in obtaining medical treatment, and transmission of the disease to additional persons.

FDA is unaware of any data to confirm the reliability or accuracy of unapproved HIV home test kits.

What action has FDA taken against unapproved test systems?

Consumers should be aware that there are numerous HIV home testing systems that are marketed on the Internet, in newspapers and in magazines that are NOT FDA approved. These tests 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 for use and marketing in the United States. Some of these HIV home test kits falsely claim to be approved by the FDA or manufactured in an FDA approved/registered/licensed facility. The only approved HIV test collection system is the "Home Access HIV-1 Test System" manufactured by Home Access Health Corporation. 

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 sentenced to over 5 years in prison for selling the unapproved HIV test kits to consumers in the United States.

FDA has also warned consumers about unapproved HIV home test kits marketed by Globus Media. These kits were sold over the Internet and shipped via overnight delivery services. FDA has not reviewed the tests marketed by Globus Media. Without FDA review and approval, such tests are illegally distributed. Consumers are not assured of getting reliable test results.

CBER will work 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.

Are there other ways I can be tested for infection with HIV?

There are several kinds of tests available through your doctor or other trained health care professional to determine if you are infected with HIV, the virus that causes AIDS. In addition to blood tests, there are tests that use oral fluid, collected from between the cheek and gum of the mouth, and a urine test. All of these tests have been reviewed and approved by FDA.

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Source
U.S. Food and Drug Administration
http://www.fda.gov/

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