HIV Home-Based Testing: Potential Benefits and Ongoing Concerns

Spring 2014

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HIV Home-Based Testing: Potential Benefits and Ongoing Concerns

The idea of HIV home-based testing has been debated for decades, almost as long as HIV testing has been available, but it has not been widely endorsed. Recently, the debate about home-based testing has been ignited again, with the approval in the United States of the oral testing kit, OraQuick.

This article explores HIV home-based tests (with a focus on OraQuick), how they work, where they are available, their acceptability and accuracy, and the potential benefits and ongoing concerns surrounding home-based testing.

What HIV Home-Based Tests Have Been Approved in the United States?

HIV home-based tests, also known as self-tests, allow people to test themselves for HIV in their home without a healthcare provider present. Currently, two HIV home-based tests have been approved by the Food and Drug Administration (FDA) for use in the United States.


The Home Access HIV-1 Test System is the only finger-prick blood test approved by the FDA (in July of 1996). This test detects HIV antibodies in blood. Before doing the test, the user calls a toll-free number to register for the test using an anonymous code, completes pre-test counselling and provides non-nominal demographic information.

The user draws a blood sample using a finger prick and the sample is then sent away for testing at a lab. The results are obtained by calling the toll-free number and using the anonymous code number to access the results. Positive results are given by a counsellor. Results do not need to be confirmed by an additional test, since confirmatory testing is performed by the manufacturer before results are offered to clients.

OraQuick is an in-home oral swab test that detects HIV antibodies in saliva. This oral test was approved in July 2012 by the FDA and has been available for sale in the United States since April 2013. The test requires users to swab their upper and lower gum line for the saliva sample. The swab is placed in a solution, which allows the test reaction to develop. The test produces a result within 20 to 40 minutes. Unlike blood-test kits, OraQuick can be read at home by the user. Positive results received at home are considered preliminary and must be confirmed by clinic-based testing. OraQuick provides a 24-hour toll-free telephone counselling service and helps link people who test positive to a nearby clinic.

In addition to FDA-approved home-test kits, there are a number of HIV tests available on the Internet that claim to be clinically proven but do not have FDA approval. These kits can't be trusted to offer accurate and reliable test results.

What HIV Home-Based Tests Have Been Approved in Canada?

No home-based tests have been approved for sale in Canada. Although neither OraQuick nor Home Access Health Corporation will accept orders from Canada, it is possible for Canadians to order HIV self-tests (both finger prick and oral swab) online and have them delivered to their homes. Canadians can also cross the border and purchase self-test kits in US pharmacies.

Are Self-Tests Acceptable to Potential Users?

Research has shown that HIV self-tests are acceptable to users. A systematic review published in 2013 on supervised and unsupervised HIV self-testing that included studies of general populations as well as populations at high risk -- gay men and other men who have sex with men (MSM), people who use inject drugs, patients in emergency departments -- found that between 74% and 96% of participants in all populations found HIV self-testing, either with oral swabs or finger-prick blood tests, acceptable.1

Research shows that self-tests are convenient and easy to use. In a study of students seeking care at the McGill University Health Centre, 98% of students rated an oral self-test as convenient.2 In a study of "at-risk" individuals in Singapore, 95% felt that the OraQuick test kit instructions were easy to understand and the kit convenient to use.3 In another study in the U.S., 96% of participants reported that the OraQuick test was "not at all hard to collect."4

Are Oral Swab Tests as Accurate as Blood-Based Testing?

In research studies, the OraQuick test is as accurate (99.9% of the time) at identifying HIV-negative results as blood-based testing done in a lab by trained professionals.5 OraQuick is 91.7% accurate at identifying HIV-positive test results.6 This means that almost 10% of people who test HIV negative using OraQuick are actually HIV positive. Oraquick is not as accurate as blood-based testing in a lab, which has been shown to be 99.7% accurate at identifying positive test results.5

False-negative results -- when the test comes back negative but a person is actually HIV positive -- can occur with OraQuick if a risk event (unprotected sex or borrowing injection equipment, for example) occurs within the three-month window period (as with the standard blood HIV antibody test). This happens because the test relies on the detection of antibodies in the saliva, which may take up to three months to develop. Clients considering self-testing need to be counselled about the window period.

False-negative results may also occur if the test is incorrectly read by the user as negative; if the test instructions are not followed carefully and the user does not swab the gum line; or if the user is wearing a dental product, such as dentures that cover their gums, while they use the swab.6

HIV Home-Based Testing May Improve Access to Testing

HIV self-tests could provide improved access to HIV testing among people who may not otherwise access testing. Research shows that HIV self-testing is acceptable among MSM who have never tested for HIV, a key population to reach for HIV testing.7,8

HIV self-testing could provide convenient and anonymous HIV testing to anyone who wants to test. In particular, depending on cost and availability, self-tests could benefit people who experience significant barriers to health care and people living in rural and remote communities where health care isn't always anonymous or confidential.

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This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication Prevention in Focus: Spotlight on Programming and Research. Visit CATIE's Web site to find out more about their activities, publications and services.

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