What is the Home Access HIV-1 Test System?
The Home Access HIV-1 Test System is a laboratory test sold over-the-counter (OTC) that uses fingerstick blood mailed to the testing laboratory. The test kit consists of multiple components, including materials for specimen self-collection, prepaid materials for mailing the specimen to a laboratory for testing, testing directions, an information booklet (“Things you Should Know About HIV and AIDS”), an anonymous registration system and a call center to receive your test results and follow-up counseling by telephone.
This approved system uses a 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 unique personal identification number (PIN), and are 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.
When should I take a test for HIV?
If you actively engage in behavior that puts you at risk for HIV infection, or your partner engages in such behavior, then you should consider testing on a regular basis. It may take some time for the immune system to produce sufficient antibodies for the test to detect, and this time period can vary from person to person. This time-frame is commonly referred to as the “window period,” when a person is infected with HIV but antibodies to the virus cannot be detected, however, the person may be able to infect others. According to the Centers for Disease Control and Prevention, it can take up to 6 months to develop antibodies to HIV, although most people (97%) will develop detectable antibodies in the first 3 months following the time of their infection.
How reliable is the Home Access HIV-1 Test System?
Clinical studies reported to FDA showed that the sensitivity (i.e., the percentage of results that will be positive when HIV is present) was estimated to be greater than 99.9%. The specificity (i.e., the percentage of results that will be negative when HIV is not present) was also estimated to be greater than 99.9%. Results reported as positive have undergone testing using both a screening test and another test to confirm the positive result.
What about counseling?
The Home Access HIV-1 Test System has a built-in mechanism for pre-test 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.
If the test results are positive, what should I do?
The counselors can provide you with information about treatment options and referrals to doctors who treat HIV-infected individuals in your area.
Do I need a confirmatory test?
No, a positive result from the Home Access HIV-1 Test System means that antibodies to the HIV-1 virus are present in the blood sample submitted to the testing laboratory. The Home Access HIV-1 Test System includes confirmatory testing for HIV-1, and all confirmation testing is completed before the results are released and available to users of the test system.
How quickly will I get the results of the Home Access HIV-1 Test System?
You can anonymously call for the results approximately 7 business days (3 business days for the Express System) after shipping your specimen to the laboratory by using the unique PIN on the tear-off label included with your test kit. This label includes both the unique PIN and the toll-free number for the counseling center.
How are unapproved test systems different?
The manufacturers of unapproved test systems have not submitted data to FDA to review to determine whether or not their test systems can reliably detect HIV infection. Therefore, FDA cannot give the public any assurance that the results obtained using an unapproved test system are accurate.
How can I obtain additional information about the test?
Information on the Home Access HIV-1 Test System can be found on FDA’s website.
Additionally, information can be obtained from the manufacturer, Home Access Health Corporation.