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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, are no exception.
Barriers to testing in a clinic include fear of test outcome, fear of discrimination, concern for 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.
The Pros and Cons of Home Testing
There are benefits and drawbacks to home testing for HIV. A few considerations:
- Can be done in the privacy of your home using a mail-in test or a rapid, in-home test
- Can be purchased online or at a local retailer
- Can be done at your convenience
- Testing through local health departments is often free, while home tests may cost between $45 and $60. Home testing is not covered by insurance, either.
- If you test at home and your results are positive, it is up to you to notify your previous partners. This important public health measure is routinely done by local health departments around the country.
- Obtaining test results can be traumatic, especially if the results are positive and a healthcare provider is not there to provide counseling.
- 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 the results of a mail-in test. There are greater steps to ensure your privacy if you are tested at a clinic or health department.
Approved Home Test Kits
The FDA has approved 2 HIV home test kits. One uses a blood sample while the other uses an oral sample.
The FDA has approved an at home test that uses a blood sample. You begin by calling a toll-free number to register the PIN number that is included in the test kit. You may be 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 lab 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 PIN number that you registered by phone. The samples are analyzed using national certification standards, and the results are usually available within a week. The results are obtained by phone, fax, or online by giving your PIN number.
The FDA has approved an at home test that uses fluid from your mouth. To do the actual test, you swab your upper and lower gums for an oral fluid sample. The sample is placed in a tube with a solution. After 20 to 40 minutes, 1 line will appear if the test is negative. 2 lines indicate that HIV antibodies were detected and you may be positive. Follow-up testing is then needed.
Other Issues to Be Aware Of
Clinical studies have shown that mail in test kits are able to correctly identify 100% of known positive samples, and 99.9% of HIV-1 negative samples. The FDA has also determined that each approved kit is accurate, sensitive, and sterile. These are all important factors in obtaining an accurate result from a home test.
Clinical studies have shown that the rapid, in-home tests are less accurate may result in some false negative test results. When HIV is present only 92% of the test results are positive, meaning 8% of cases will not be detected. When HIV is not present 99.9% of the results are negative, similar to the mail in tests.
Unapproved HIV home testing kits come without any guarantee that they are sterile or disease free. They have not gone through the rigorous FDA marketing approval.
They also may not have a history of producing reliable results. 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—called a false negative. Both of these outcomes can have grave consequences in terms of mental distress, access to proper treatment, and future transmission of the virus.
Pre- and post-result counseling is an important part of the HIV diagnostic process. The FDA-approved blood sample home kits offer pretest counseling for clients who are anxious about taking the test, need help with blood collection, or simply need someone to help walk them 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 trained counselor.
Clients using the FDA-approved blood sample home test kits are known only by their PIN, which is associated with the zip code provided at registration. When the testing company receives results back from the lab they are logged into a computer. If a sample has tested positive, then the result is coded with at least three local referrals for doctors, social service agencies, clinics, or health departments. Because phone counseling cannot replace the depth of a face-to-face contact, 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
Home testing for HIV is not for everyone. You may want the support of a clinic or agency. Maybe you are 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 6 months after your last exposure to HIV-risk. In other words, if it has been 6 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.
Centers for Disease Control and Prevention
Food and Drug Administration
Canadian AIDS Society
Canadian HIV/AIDS Information Centre
About HIV/AIDS. Centers for Disease Control and Prevention website. Available at: http://www.cdc.gov/hiv/basics/whatIshiv.html. Updated January 25, 2017. Accessed April 6, 2017.
Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2010. MMWR. 2010;59(No. RR-12):1-110.
First rapid home-use HIV test kit approved for self-testing. US Food and Drug Administration website. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm310545.htm. Updated September 27, 2016. Accessed April 6, 2017.
HIV home test kits. US Food and Drug Administration website. Available at: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/HIVHomeTestKits/default.htm. Updated June 25, 2013. Accessed April 6, 2017.
Home access HIV-1 test system. US Food and Drug Administration website. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091475.htm. Updated March 26, 2015. Accessed April 6, 2017.
Information regarding the Home Access HIV-1 test system. US Food and Drug Administration website. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm311903.htm. Updated October 2, 2012. Accessed April 6, 2017.
Information regarding the OraQuick in-home HIV test. US Food and Drug Administration website. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm311895.htm. Updated June 18, 2014. Accessed April 6, 2017.
Testing for HIV. US Food and Drug Administration website. Available at: http://www.fda.gov/biologicsbloodvaccines/safetyavailability/hivhometestkits/ucm126460.htm. Updated August 8, 2013. Accessed April 6, 2017.
- Reviewer: Michael Woods, MD, FAAP
- Review Date: 04/2017
- Update Date: 04/07/2015