Home testing for HIV: Hopefully, a step forward
ABSTRACTAn over-the-counter at-home test for human immunodeficiency virus (HIV) infection has been approved and will likely be available soon. It is intended to decrease the percentage of HIV-infected people unaware of their infection (estimated at 18% of the 1.2 million people infected in the United States). Since early and continued treatment prevents disease progression and reduces HIV transmission, testing is the first step toward effective care.
KEY POINTS
- The new test is highly (99.9%) specific for HIV but is not quite as reliable at ruling out infection (93% sensitivity). Therefore, it may miss some cases of HIV, especially during the 90-day window after initial infection.
- False-positive test results may occur, especially in people at low risk. A positive result must be confirmed with a laboratory-based third- or fourth-generation blood test.
- It is important to continue to assess and counsel patients on how to modify their risk of HIV infection.
- Providers are urged to offer HIV testing to all patients ages 13 to 64 at least once, regardless of their risk.
- At least once a year, patients at high risk should get one of the more sensitive laboratory blood tests.
- People who choose to test themselves at home should seek medical care for verification of the test result and for HIV counseling, and, if the result is confirmed positive, access to HIV care.
In July 2012, the US Food and Drug Administration approved the first over-the-counter test kit for human immunodeficiency virus (HIV) infection, the OraQuick In-Home HIV Test (OraSure Technologies, Bethlehem, PA). This test is a variation of the currently available OraQuick ADVANCE Rapid HIV-1/2 Antibody Test used in clinical settings by trained personnel for rapid detection of HIV.
The home HIV test is expected to become available in the fall of 2012 from the company’s Web site and at retail drugstores. This will put the power of HIV testing into the hands of anyone able to afford the estimated $60 price and willing to purchase the item online or in stores.
GOAL: TO REDUCE THE NUMBER OF INFECTED PEOPLE WHO ARE UNAWARE
How home testing will change the demographics of HIV testing is not clear, but the intention is to reduce the number of HIV-infected people who are unaware of their infection and to get them in for care. Anthony Fauci, MD, the director of the National Institutes of Allergy and Infectious Diseases, has called the new test a “positive step forward” in bringing the HIV epidemic under control.1
Recent figures from the US Centers for Disease Control and Prevention (CDC) indicate that, of the 1.2 million HIV-infected people in the United States, up to 220,000 are unaware of their infection.2,3 Since antiretroviral therapy is now considered beneficial even in the early stages of HIV infection, those who are unaware of their infection are missing an opportunity for the most effective therapies.
They may also be unknowingly transmitting the virus, thus perpetuating the HIV epidemic. Awareness of one’s HIV infection may lead to behavioral changes that can reduce the risk of transmission. It has also become clear that antiretroviral therapy can dramatically reduce transmission rates, a concept known as “treatment as prevention.” 4 Thus, access to care and initiation of antiretroviral therapy have the potential to prevent progression to acquired immunodeficiency syndrome (AIDS) in the individual and to interrupt the spread of the virus in the community.
There are several steps between awareness of HIV infection and full engagement in HIV care that require attention from the health care community.5 Only a quarter of those with known HIV infection are in care and adherent to antiretroviral therapy, leaving much work to be done on removing barriers to effective treatment.5 The first step is still to identify those infected. The effort to increase the percentage of HIV-infected individuals who know their HIV status is one of the goals of the National HIV/AIDS Strategy and HealthyPeople2020.6
HOW THE TEST IS USED
The OraQuick In-Home Test consists of the device and reagents, instructional materials, information on interpreting the results, and contact information for the OraQuick Answer Center for information, support, and local medical referral.7 The overall time needed for testing is 20 to 40 minutes.
To perform the test, an oral fluid specimen is collected by swabbing the upper and lower buccal mucosa along the gum line. Once inserted into the developer solution the swabbed sample is carried onto a membrane strip containing HIV-1/2 antigens.
The device has two windows, one labelled “T” (for test) and the other labelled “C” (for control). If the patient has sufficient antibodies to HIV proteins, the “T” window indicates a positive result if a band is visible. The “C” (control) window displays a band to indicate if the device and reagents are working. If the control window does not show a band, then the kit has not functioned properly and the test result is not reliable.
SOME PEOPLE MAY STILL NEED HELP
For the test to succeed in informing people of their HIV status, it must be used effectively and the results must be interpretable. Of 5,662 participants in phase III investigational-device studies, 99% were able to use the kit and determine a result.7 While the test’s simplicity is similar to that of pregnancy test kits, it is possible that some people (at least 1% of those using the kit) may seek guidance from medical practitioners because they are unable to understand the test results.
For a test result to have the desired outcome of leading to HIV care, individuals must act on a positive result. When home test results are positive, the instructions indicate that “you may have HIV” and provide contact information for the OraQuick Answer Center. It is unclear how reliable the counseling, information, and referral process from OraSure will be and if people will use the service.
Individuals may access medical care at a variety of levels for further assistance if they have a positive test result. These may include primary care offices, emergency and urgent care settings, health departments, and HIV clinics.
