HIV home test kits: are all created equal?
by Jill M. Shuman, M.S., R.D., E.L.S.
Home medical tests of all kinds have become popular with consumers because they are convenient and provide some measure of privacy. Testing for HIV, the virus that causes AIDS, is no exception. Although there are at least a dozen different HIV home testing kits advertised in magazines and on the Internet, only one is approved by the U.S. government.
According to the U.S. Centers for Disease Control and Prevention, many of the estimated 1 million HIV-infected people in the U.S. remain unaware of their infection, and fewer than 40% of people in the U.S. who are potentially at risk for HIV infection have been tested. Barriers to testing include fear of test outcome, fear of discrimination, potential loss of insurance benefits, negative social stigma attached to the diagnosis, and the inability or unwillingness to go for testing and counseling.
For those people who are unable or resist going to a clinic for testing, there is another option—home testing. Convinced by clinical trials that showed an accuracy rate of 99%, the U.S. Food and Drug Administration (FDA) approved the Home Access Express HIV-1 Test System for national distribution in June, 1996. Manufactured and distributed by Home Access Health Corporation (HAHC), this is the only FDA-approved system for HIV testing at home.
What are the pros and cons of home testing?
There are benefits and drawbacks to home testing for HIV. A few considerations:
PROS
- Can be done in the privacy of your home.
- Can be purchased by mail or at a local retailer and performed at your convenience
- The FDA-approved test is as accurate as tests performed in any certified laboratory in the country.
CONS
- Home testing is more expensive than conventional hospital or clinic-based tests. Testing through local health departments is often free, while home tests cost between $40 and $50.
- Home testing is not covered by insurance, either. If you test at home and your results are positive, it is much harder to notify your previous partners. This very important public health measure is routinely done by local health departments around the country.
- Obtaining test results over the phone can be traumatic, especially if the results are positive. If you were to leave your PIN around the house or office, anyone could call the toll-free number and use the PIN to obtain your result.
- You maintain a greater level of anonymity if you are tested at a clinic or health department, because they release your results only if you show up in person with your assigned number and if you match the profile that was taken at the time of testing.
How does the FDA-approved home test work?
You first call a toll-free number to register the 11-digit number that is included in the Home Access test kit. You're then asked a series of questions designed to gather general demographic information about gender, age, ethnicity, geographic region and risk of HIV infection. This information is collected for research to support public health initiatives; your identity remains completely anonymous.
To do the actual test, you prick your finger and collect a small blood sample, which will be analyzed by a laboratory for the presence of antibodies to the HIV virus. The blood sample is mailed to the lab in the special leak-proof envelope provided in each kit along with the anonymous personal identification number (PIN) that you registered by phone. The samples are analyzed using national certification standards and the results are available in either 3 days (express kit) or 7 days (standard kit). The results are obtained by calling a toll-free number and punching in your PIN for identification.
But aren't all the tests the same?
Other home HIV-tests on the market claim that they can detect antibodies to HIV-1 in blood or saliva in 15 minutes or less—right in your own home, without a lab. You either prick your finger for a blood sample or use a special sponge device to collect a saliva sample. Rather then sending the samples to a lab, you simply add the blood or saliva to a testing device and add a developing solution. If the test is positive, you will see a red dot or some other marker. Although fast and relatively easy to perform, these tests do not provide the accuracy achieved by a laboratory. Therefore, they are not approved by FDA.
Other issues to be aware of
Accuracy
Clinical studies have shown that the Home Access testing system is able to correctly identify 100% of known positive blood samples, and 99.5% of HIV-1 negative samples within the time frame considered appropriate by CDC. FDA has also determined that each kit is as consistently accurate, sensitive, and sterile as the next. These are all important factors in obtaining an accurate result from a home test.
Sterility
Unapproved HIV home testing kits come without any guarantee that they are sterile or disease free, nor do they have a history of producing reliable results. They have not gone through the rigorous FDA marketing approval. The kits don't provide proper documentation to interpret the results, and FDA has not been able to scientifically validate the reliability of the results obtained. You may get a false positive result, or the test may indicate that you are not infected when you really are (false negative). Both of these outcomes can have grave consequences in terms of mental anguish, access to proper treatment, and future transmission of the virus.
Counseling
Pre- and post-result counseling is an important part of the HIV diagnostic process. Unapproved tests provide neither. HAHC offers pre-test counseling for clients who are anxious about taking the test, need help with blood collection, or simply need someone to help them walk though the process. When you want the results, you phone the toll-free number and provide your PIN for identification. Negative results are provided via an interactive voice response system. Positive or indeterminate results are provided via a counselor.
Counselors have received extensive training in both HIV-related illnesses and counseling technique. In fact, many of the counselors are licensed social workers, according to Jill Spooner, Director of Counseling and Client Services at HAHC. Clients with negative results can speak with a counselor as often as three times in a 30-day period, and clients with positive results have access to a counselor six times over a 12-month period. Negative results stay on file for 30 days. Positive results are available for up to one year, after which they are archived and are accessible by the medical director if necessary.
Anonymity
Clients are known at HAHC only by their PIN, which is associated with the zipcode provided at registration. When HAHC receives results back from the laboratory they are logged into a computer. If a sample has tested positive, then the result is coded with at least three local (based on the zipcode) referrals for physicians, social service agencies, clinics, or health departments. Because phone counseling cannot replace the depth of a face-to-face contact, HAHC counselors offer initial support in helping a client with the overwhelming news of a positive result, and then provide these additional referrals for further, more directed followup.
At home or at a clinic, get tested
Be aware that some unapproved tests use the phrase "home access" in their names. Don't be fooled, though; the FDA-approved test is the only one carrying a label to that effect.
Home testing for HIV is not for everyone. You may want the support of a clinic or agency. Maybe you're squeamish about handling your own blood. And whether you choose to test at home or not, remember that CDC recommends that any negative test should be considered valid only if it occurs at least six months since your last exposure to HIV-risk. In other words, if it's been six months since the last time you were exposed to the HIV virus and your test is negative, you can feel confident that this is an accurate result.
Resources
Division of HIV/AIDS Prevention
Centers for Disease Control and Prevention (CDC)
http://www.cdc.gov/nchstp/hiv_aids/dhap.htm
CDC National AIDS Hotline
+1-800-342-AIDS
Office of Special Health Issues: HIV/AIDS
U.S. Food and Drug Administration (FDA)
+1-301-827-4460
http://www.fda.gov/oashi/aids/hiv.html
HIVpositive.com
http://www.hivpositive.com
Provides links to information about AIDS testing, counseling, treatment, etc.
Last reviewed August 1998 by Medical Review Board
