At-home HIV test kit to undergo FDA review
Increasing access to HIV testing is a prevention priority in the United States. Health officials estimate more than 25% of those infected are transmitting HIV to others because they are unaware that they are infected.1
OraSure Technologies of Bethlehem, PA, is aiming at lowering those numbers. It intends to seek Food and Drug Administration (FDA) approval to sell its OraQuick ADVANCE test over the counter (OTC), reports Jennifer Moritz, company spokeswoman. The company made a presentation before the FDA’s Blood Products Advisory Committee in November 2005 regarding such a potential product.
The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is the first and only FDA-approved rapid point-of-care test that provides results for HIV-1 and HIV-2 with greater than 99% accuracy in as little as 20 minutes. It uses an oral fluid, fingerstick or venipuncture whole blood or plasma sample.2 It received a CLIA (Clinical Laboratory Improvements Amendments of 1988) waiver in 2004 that allows the test to be used in a wide variety of settings, including outreach clinics, community-based organizations, and physicians’ offices. The only other CLIA-waived rapid HIV diagnostic test is the Uni-Gold Recombigen (Trinity Biotech, Wicklow, Ireland); however, it is designed to test blood but not oral fluid samples.
There are no rapid at-home self-collection kits available in the United States. One home self-collection kit marketed by Home Access Health Corp. of Hoffman Estates, IL, is available on the U.S. commercial market; however, it calls for self-collection of a blood sample via finger prick, with the specimen mailed to a laboratory for analysis.
The OraQuick ADVANCE over-the-counter test would allow a person to swab his or her gums with a special swab to collect the oral specimen. The swab then would be placed in a holder, with results displayed 20 minutes later. The company does not yet have a projected price for the OTC kit, says Moritz.
More people will know
If rapid self-testing were available, it would greatly improve access to acceptable HIV testing in this country, says Freya Spielberg, MD, MPH, assistant professor in the department of family medicine at the University of Washington in Seattle.
"We need to try different tactics to win the war against AIDS," she says. "The most powerful prevention strategy is knowledge of HIV infection."
Studies have shown that people who learn that they have HIV are much more likely to change sexual and drug use behaviors so that others will not become infected, as compared to studies that provide intensive or brief behavioral interventions to those at risk for acquiring HIV,3,4 Spielberg maintains. Many people at risk do not seek testing in clinical settings because of fear, stigma, and inconvenience; an over-the-counter HIV test would help to overcome some of these barriers, says Spielberg.
According to Spielberg’s research of those at risk for the disease, those who had never tested before were significantly more likely to prefer home self-testing compared with other strategies.5
"People like that home self-tests would be completely anonymous and that they will get results right away; whereas, with home specimen collection, people are concerned that their tests will get lost in the mail, the wait for test results makes people anxious, and people don’t like getting their results from someone on the telephone who could trace their call," she says.
With any advance in HIV testing strategies, concerns are raised about the safety of receiving HIV test results without face-to-face counseling, Spielberg observes. Results from home specimen collection post marketing studies indicate that people may be able to use such tests responsibly. Among 1,494 positive individuals diagnosed with HIV and provided with test results over the telephone, 88% accepted referrals or already had access to medical care.6 The remaining 12% already were getting care for HIV.6
"When implementing over-the-counter HIV testing, it will be necessary to determine educational and counseling strategies that are necessary to ensure the tests are accurate and safe, and to ensure that people who receive preliminary positive results through rapid tests understand the need for confirmatory testing and have ready access to appropriate referrals," says Spielberg. "Advances in communication technologies make this quite feasible; if necessary, it will be possible to offer interactive computer consent and interactive risk-reduction counseling and referrals for people who want to use self-tests for HIV.7"
OraSure plans to work with the FDA to develop directions for using the test, interpreting results, and finding appropriate care, says Moritz.
"We anticipate providing access through multiple channels for counseling, support and linkages to care, as well as counseling on how to properly conduct the test and interpret the results," she notes. "This could be accomplished by providing customers service and support through telephone and a web site, as well as establishing counseling options by telephone, web site, or in person through a local public health clinic."
References
- Centers for Disease Control and Prevention. Advancing HIV prevention: New strategies for a changing epidemic United States, 2003. MMWR 2003; 52:329-332.
- Notice to readers: Approval of a new rapid test for HIV antibody. MMWR 2002; 51;1,051-1,052.
- Janssen RS, Holtgrave DR, Valdiserri RO, et al. The serostatus approach to fighting the HIV epidemic: Prevention strategies for infected individuals. Am J Public Health 2001; 91: 1,019-1,024.
- Weinhardt LS, Carey MP, Johnson BT, et al. Effects of HIV counseling and testing on sexual risk behavior: A meta-analytic review of published research, 1985-1997. Am J Public Health 1999; 89:1,397-1,405.
- Spielberg F, Branson BM, Goldbaum GM, et al. Overcoming barriers to HIV testing: Preferences for new strategies among clients of a needle exchange, a sexually transmitted disease clinic, and sex venues for men who have sex with men. J Acquir Immune Defic Syndr 2003; 32:318-327.
- Branson B. Home sample collection tests for HIV infection. JAMA 1998; 280:1,699-1,701.
- Spielberg F, Kurth A, Fortenberry JD, et al. Computer assisted rapid testing for HIV. Presented at the 2005 HIV Prevention Conference. Atlanta; June 2005.
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