The U.S. Food and Drug Administration’s Blood Products Advisory Committee (BPAC) has recommended the approval of Orasure’s rapid home HIV test in a 17-0 vote. The FDA will consider the committees’ recommendation while making a final decision on the approval of the test.
Supporters of Orasure’s home HIV test site the test as vital in helping to break down barriers to HIV testing. They believe by offering private, in-home access to HIV testing, more people will test which, in turn, means more people will receive treatment and care and will not unknowingly transmit HIV. In the U.S. twenty percent of the 1.2 million people living with HIV do not know they have the virus and only sixty-two percent are linked to healthcare.
Orasure will offer a free, confidential 24 hour hotline for those who need support after receiving a positive HIV test results with their over the counter (OTC) test.
Tom Donohue, Founding Director of Who’s Positive, spoke before the FDA Blood Products Advisory Committee and had this to say” “In order to become the generation which ends AIDS we have to move progressively towards new technology that will put additional tools in the hands of those who seek to know their HIV status”.
Donohue also presented the board with the results of a year long on-line survey of 1,569 people, 74% of which were reported to support the approval of an OTC HIV test. He states that he feels Orasure has addressed many of the concerns regarding this test. Apparently the BPAC agrees, having determined that the benefit of HIV home tests outweigh the potential risks.
In contrast to the BPAC’s recommendation, many, especially within the HIV community who have had the experience of receiving a positive result, fear it would be detrimental to the safety and well being of those who utilize the test and receive a positive diagnosis. One of the main concerns is the level of accuracy of this test.
The level of accuracy is far from that of clinic based tests or even the only presently approved HIV home test. Approved in 1996, The Home Access HIV test, which requires an individual to send a blood sample to a laboratory, maintains a 98.98% accuracy rate compared to 86.64% to 92.98% accuracy for the Orasure home based test. This equates to approximately one false negative test for every thirteen positive test results and one false positive result for every 462 negative result.
A false- negative result may, for some, be viewed as a reason to not use protection during sex with another person they believe to be HIV negative.
Also a substantial concern is the lack of support provided to those who test positive. With HIV tests given outside the home, both pre and post test counseling is provided. If an HIV positive result occurs, the person is counseled by professionals trained to assist in the diagnosis process. Available treatment is explained and they are provided information on how to get connected to care and additional counseling. Although a help line will be established through Orasure to provide assistance following an HIV diagnosis along with a recommendation to be retested in a testing facility, it is likely that many will carry out the testing process without utilizing any outside assistance.
Colin Robinson-Vokoun, a long time HIV advocate and a person living with HIV states: "I knew of people who took their own lives after testing positive". This is a concern that many who do not support the use of this test argue. "...Even an institution as experienced and knowledgeable as the National Institutes of Health was aware of this possibility back in 1993. That's when and where I was diagnosed. They wouldn't allow me to drive my own car after they told me of my HIV-positive status. They had learned from experience that too many people drove off the first bridge they came to after getting their diagnosis. Most people have difficulty coping with an HIV diagnosis in the immediate aftermath, even with a solid support network. Without immediate counseling, receiving this news alone will likely drive some people to take their own lives”.
Other concerns include the potential abuse of this test such as employers illegally utilizing the test to 'weed out' HIV positive employees possibly disguised as a legal drug test. Or as an excuse for unprotected sex which could lead to new infections which may have not yet registered positive, or performing the test incorrectly which could have devastating results.
THE FDA has long stood firm on their rejection of an over the counter HIV home test citing epidemiological reports against the use of such a test. With no new scientific evidence to support the safety of such a test, it is unclear why and if the FDA would follow the committees’ recommendation.