HIV Home Test Kits: Are All Created Equal?
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HIV Home Test Kits: Are All Created Equal?

Home medical tests of all kinds have become popular with consumers because they are convenient and provide some measure of privacy. Home medical tests for HIV, the virus that causes AIDS, is no exception.

Barriers to testing in a clinic 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 people who are unable or reluctant to go to a clinic for testing, home testing is an option.

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
  • If used correctly, the FDA-approved test (see below) can be 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 home 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. There are greater steps to ensure your privacy if you are tested at a clinic or health department. 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.

An FDA-Approved Home Test

The Home Access Express HIV-1 Test System is the only HIV-1 test system approved by the US Food and Drug Administration (FDA). It has demonstrated an accuracy rate of 99% in clinical trials.

Here is the way this test works:

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. The sample 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 three days (express kit) or seven 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 the 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 the Center for Disease Control and Prevention (CDC). The 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, and they may not have a history of producing reliable results. They have not gone through the rigorous FDA marketing approval. The kits may not provide proper documentation to interpret the results, and the 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. The Home Access Express HIV-1 Test System offers pretest 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.

These 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 Home Access Health Corporation (HAHC), makers of the Home Access Express HIV-1 Test System. 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 zip code 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 zip code) 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 follow-up.

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 might have been 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/hiv

HIVpositive.com
http://www.hivpositive.com

Office of Special Health Issues: HIV/AIDS, US Food and Drug Administration (FDA)
http://www.fda.gov/oashi/aids/hiv.html

CANADIAN RESOURCES:

Canadian AIDS Society
http://www.cdnaids.ca/

Canadian HIV/AIDS Information Centre
http://www.aidssida.cpha.ca/



Last reviewed May 2008 by Rosalyn Carson-DeWitt, MD

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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