Testing Critical to Reducing HIV, FDA Approves Test for Home Use

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July 6, 2012

UPDATE: On July 3, 2012, the Food and Drug Administration (FDA) approved for marketing the first HIV test for home use. In the announcement that came a little more than a month after an advisory panel unanimously recommended it for approval, the FDA noted that the test is targeted to those individuals who might be reluctant to visit a doctor or clinic for testing. Although the test is not as accurate when used at home as it is when performed in a clinic or laboratory, the FDA felt that the potential benefit of increasing the number of people tested for HIV outweighs the drawbacks of possible errors when the test is performed at home. According to the CDC, testing for HIV is critical to preventing the spread of the virus and, along with appropriate medical care, can help prolong the lives of those infected.

Original article published June 29, 2012: Testing Critical to Reducing HIV, FDA Panel Recommends Approving Test for Home Use

In a recent Vital Signs report, the U.S. Centers for Disease Control and Prevention (CDC) emphasized that testing for HIV is critical to preventing the spread of the virus and, along with appropriate medical care, can help prolong the lives of those infected. The CDC estimates that there are 1.2 million people in the U.S. who have HIV, but up to 20% of them do not know that they are infected. Each year, 50,000 people become infected with HIV in this country. The CDC recommends that those at risk for infection, such as people who have more than one sexual partner, use injection (IV) drugs, or are men who have sex with other men, should get tested for HIV at least once a year. They also recommend that every person between the ages of 13 and 64 be tested at least one time for HIV.

Currently, a few different options are available for HIV screening. A sample can be collected at a clinic or doctor's office and then sent to a laboratory for testing, with results generally available within a day or so. Rapid tests may sometimes be performed on site in these settings and can provide results in about 20 minutes. Another type of test allows an individual to collect a sample at home and then send it to a laboratory for testing.

Now, an advisory panel of the Food and Drug Administration (FDA) has recommended that one HIV test be approved for marketing for home use. The kit would allow individuals to collect an oral sample and perform the test in the privacy of their homes, receiving the results in about 20 minutes. The panel expects the added convenience would encourage those who have been reluctant to get tested for various reasons to learn their HIV status.

The testing kit for the home test is the same as that used in many clinics and doctors' offices. It has two limitations. First, testing on oral fluid is less sensitive than testing on blood, meaning this test misses some cases of HIV that a blood test would detect. Secondly, research conducted by the manufacturer has shown that when the testing is performed by a lay person, some cases of HIV are missed compared to when it is performed by a trained health care professional. An FDA official estimated that performance of the test in a home setting using oral fluid might miss about 3,800 HIV cases annually.

In general, home tests can provide convenience and privacy, but mistakes can be made that lead to inaccurate results. Errors can range from storing the kit inappropriately to collecting the sample improperly to imprecise timing of the test—not waiting long enough or waiting too long before noting the result. (For more on this, read the article on Home Testing.)

Nevertheless, the FDA panel felt that the potential benefit of increasing the number of people tested for HIV outweighs the drawbacks of a less-than-perfect test. FDA projections noted that the test has the potential to detect an additional 45,000 new HIV cases and prevent spread of more than 4,000 infections each year. As with all positive HIV screening test results, supplemental testing is required before a diagnosis is established. There is concern that people who test positive at home outside of a health care setting will not have follow-up testing or seek necessary treatment. If the test is to be truly effective, those who test positive need to be motivated to seek help. Toward that end, the testing kit would include a number for a 24-hour hotline that would provide testing support and referrals for medical counseling.

It remains to be seen if the FDA will follow the panel's advice and approve the test. A decision is expected as early as this summer. Meanwhile, those who do not know their HIV status should get tested. Information on HIV testing is available on this web site (see Related Pages below). To find a testing site, visit the National HIV and STD Testing Resources.

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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used.

Centers for Disease Control and Prevention. New Hope for Stopping HIV. Vital Signs. December 2011. Available online at http://www.cdc.gov/vitalsigns/HIVtesting/index.html through http://www.cdc.gov. Accessed May 2012.

Lena H. Sun. Home HIV Test Should Be Approved, FDA Panel Rules. The Washington Post. May 15, 2012. Available online at through http://www.washingtonpost.com. Accessed May 2012.

Emily P. Walker. FDA Panel Says Yes to HIV Home Test. Medpage Today. May 15, 2012. Available online through http://www.medpagetoday.com. Accessed May 2012.

U.S. Food and Drug Administration. FDA Consumer Health Information: First Home-Use HIV Kit Approved for Self-Testing. July 2012. Available online at http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM310563.pdf through http://www.fda.gov. Accessed July 2012.