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Research explores at-home HIV testing
While only one company has received Food and Drug Administration (FDA) approval for an HIV home collection-test system that requires users to collect a blood specimen, then mail it to a laboratory for professional testing, no test kit is available to allow consumers to interpret test results at home. Other companies are seeking FDA approval for such tests for over-the-counter (OTC) use.
The sole home collection test system approved by the FDA is marketed as "The Home Access HIV-1 Test System" or "The Home Access Express HIV-1 Test System." It is manufactured by Home Access Health Corp. of Hoffman Estates, IL. Persons who take the test, approved by the FDA in 1996, receive results in 3-7 days by calling a toll-free number.
Chembio Diagnostics of Medford, NY, has begun studies required for submission of an investigational device exemption to the FDA for its Sure Check Rapid HIV Test as a first step toward over-the-counter product approval. The test is marketed to professional laboratories by Alere of Waltham, MA, as Clearview Complete HIV 1/2, says Lawrence Siebert, Chembio's chief executive officer.
Chembio's test uses a barrel system with a sample port at one end of the barrel that houses a HIV test strip. The blood sample enters the barrel simply by touching the sample port to the fingertip pricked with a provided safety lancet. The barrel technology confines the sample and reagents and, thereby, minimizes potential exposure to the user or other parties.
Chembio must complete two studies to accompany its device exemption request, one which is a market study of the test's intended users. If the FDA approves the investigational device exemption, a Phase II trial will commence in early 2012, says Siebert.
OraSure Technologies of Bethlehem, PA, has begun a clinical trial of its OraQuick Rapid HIV-1/2 test to gain FDA approval for OTC sale. The company received an investigational device exemption from the FDA in November 2010. In the clinical trials, individuals will conduct unsupervised oral fluid self-testing using the investigational OTC version of the OraQuick Advance Rapid HIV-1/2 test.
Home-use kits are now in place for testing fecal occult blood, glucose, cholesterol, and pregnancy. However, there are no tests yet approved to test for infectious diseases in the home environment.
Goal: More will know
At-home testing might be one way to help achieve the one of the major goals of the National HIV/AIDS Strategy: to increase from 79% to 90% the percentage of people living with HIV who know their serostatus by 2015.1
What are the benefits of at-home testing? "About 25% of individuals in North America and Canada and about 70% worldwide, are unaware of their serostatus," says Nitika Pant Pai, MD, MPH, PhD, assistant professor of medicine in the Division of Clinical Epidemiology and Infectious Diseases at McGill University in Montreal, Quebec, Canada. "So those individuals who desire and do not wish to get tested in centers and desire confidentiality can get to know their status in the comfort of their home."
Pai, whose research has focused on point-of-care diagnostics and assessing the impact of treatment regimens in HIV/AIDS and related co-infections, sees at-home testing as a way for people to know their status and then act on it.
What are some of the potential disadvantages of at-home testing? Because rapid tests are antibody-based, they are unable to detect acute infection, notes Pai. In instances in which a patient might suspect a risky exposure but obtains a negative test result, he or she will need to consider additional blood-based confirmatory testing and post-test counseling, she notes.2
Building in a strategy to link at-home testers with post-testing counseling will be an important part of self-testing, says Pai. Post-test counseling provides triage to care, social support, prevention services, prevention of adverse psychological outcomes, and risk of suicide and litigation.2
Testing without the presence of a health care professional or a counselor can prove to be stressful. Developers of at-home tests will need to incorporate links to counseling services to help test users accurately understand and comprehend the implications and interpretations of a test result. Such links will be important in helping at-home testers deal with reactive, false-positive/-negative, or indeterminate test results.2
"Most of these self-tests are preliminary tests; they are accurate, but they do not detect acute infection, so you have to get a confirmatory test if you suspect a recent unprotected exposure," emphasizes Pai. "In cases where you get a positive test, it is extremely important to contact the healthcare provider or the nearest available counselor for seeking confirmatory testing and post-test counseling."