May 15, 2012
Orasure In-Home HIV Test Gets Unanimous Approval Recommendation
by Tim Horn
Orasure’s oral swab-based rapid in-home HIV test has been recommended for approval by the U.S. Food and Drug Administration’s Blood Products Advisory Committee. If the FDA follows its advisory committee’s recommendation, the Oraquick In-Home HIV Test will be the first complete home-based screening assay for any infectious disease available for purchase over-the-counter (OTC) from pharmacies and internet retailers.
The advisory committee voted unanimously, 17-0, in favor of the test upon being asked two questions: Do the available clinical trial results provide reasonable assurance that the test is safe and effective? And, importantly, do the benefits of in-home HIV testing outweigh the potential risks, notably false negative and false positive results?
The particulars of the second question were hotly discussed throughout the May 15 meeting in Gaithersburg, Maryland. Of concern to the FDA presenters and advisory committee panelists is the test’s reduced sensitivity—its effectiveness at screening for HIV antibodies in those infected with the virus—compared with the professional oral swab OraQuick assay.
However, even with reduced sensitivity, Elliott Cowan, PhD, of the FDA acknowledged, the in-home HIV test is anticipated to have a net public health benefit. "The OraQuick In-Home HIV Test is expected to be associated with a net increase in the number of HIV infections newly identified each year," he said, "with evidence of new infections averted with use of the test."
According to an FDA analysis of available data, nearly 3 million people are expected to use the OTC test if approved and that it may potentially identify 45,000 people living with HIV in the U.S.
Only one OTC HIV testing kit has been approved by the FDA. The Home Access HIV test, approved in 1996, requires blood samples to be collected at home, followed by shipment to a laboratory for analysis—results are provided by a Home Access telephone counselor. The retail price is between $30 and $40.
The OraQuick In-Home HIV Test allows users to collect samples, conduct the test and interpret the results on their own. The test result is read after 20 minutes, but not longer than 40 minutes, after inserting the oral swab device into the vial of developer solution provided with the OTC kit. The price of the test is not yet known, but the company expects it to retail for under $60.
Major talking points at the advisory committee hearing were the test’s sensitivity and specificity. An assay’s sensitivity reflects its ability to prevent false negatives—an HIV antibody-negative result for someone who is infected with the virus. An assay’s specificity reflects its ability to prevent false positives—an HIV antibody-positive results for someone who is not infected with the virus.
The OraQuick In-Home HIV Test has strong specificity (99.98 percent). Whereas the OTC test will yield one false-positive result for every 3,750 true-negative results among people who aren’t infected with HIV, the professional oral swab Oraquick test yields one false-positive for every 462 true-negative results.
The OTC’s sensitivity, however, averaged only 92.98 percent, compared with the 99 percent sensitivity associated with the professional OraQuick oral swab-based assay. For every 13 “true-positive” results using the In-Home OraQuick test, there may be one false-negative test result—or approximately 3,800 false-negative test results per year—an analysis of the Phase III clinical trial data showed.
Of particular concern to the FDA presenters was the lower end of the estimated sensitivity range in the Phase III clinical trial—the “lower bound of the 95 percent confidence interval” in statistical parlance. Accordingly, the sensitivity may be as low as 86.64 percent, which is significantly lower than the 95 percent that has historically been required by the FDA’s Blood Products Advisory Committee.
Looking solely at the “lower bound” analysis, there could be one false negative for every six true-positive results using the OraQuick In-Home HIV Test—approximately 7,000 false-negative test results per year. By comparison, the “lower bound” sensitivity using the professional OraQuick oral-based HIV test would be expected to yield one false-negative for every 62 true-positive results.
“Understanding the public health implications of approving an over-the-counter test that performs at this level of sensitivity and specificity in the hands of lay users is challenging,” the FDA notes in their pre-advisory committee meeting briefing document. “There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status. However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected (false negatives).”
Public testimony at the hearing was overwhelmingly favorable. Roughly 20 agency representatives—including Phill Wilson of the Black AIDS Institute, Cornelius Baker of the Whitman-Walker Clinic in Washington, DC, Dawn Averitt-Bridge of The Well Project, Larry Bryant of Housing Works, C. Virginia Fields of the National Black Leadership Commission on AIDS and Ernest Hopkins of the San Francisco AIDS Foundation—testified that the Oraquick In-Home HIV Test would be a welcome addition to the HIV testing and awareness tool box, particularly for women and people of color living with, and at risk for, HIV who are not being effectively connected to existing testing programs.
“We are concerned by the data indicating that when administered by consumers the accuracy of the rapid HIV tests drops to 93 percent as compared to 99 percent when conducted by professionals,” testified Kimberly Crump, policy officer at the HIV Medicine Association. Yet, Crump noted, “we still believe the rapid test holds great promise as a self-directed tool for individuals to learn their HIV status. We also urge continued research and education in heavily impacted areas and with the low income and minority populations disproportionately affected by HIV infection to determine how the instructions and accompanying support materials can raise the assurance of the test results closer to the level obtained by professionals.”
A particularly crucial issue is the test's "window period"—the time between possible exposure to HIV and the assay's ability to detect antibodies to the virus. Study volunteers who used the OTC test during the test's window period, coupled with human error, likely contributed to the assay's reduced sensitivity results.
Orasure says it takes approximately two months post-exposure for the test to produce reliable results. In draft test instructions reviewed by the advisory committee, Orasure indicates users should perform the test at least three months, or 90 days, after engaging in behavior associated with HIV transmission.
Amy Lansky, MPH, PhD, of the U.S. Centers for Disease Control noted that professional fourth-generation tests, designed to look for both antibodies and HIV antigens in blood samples, are the most effective at detecting HIV infection in the first few weeks following potential exposure to the virus. These tests become sensitive and specific within 15 days following high-risk behavior.
The advisory committee panelists noted, on several occasions, the need for strong, clear and concise information in the educational materials that will accompany the test to minimize human error and testing during the window period, spell out the risks of false-negative test results and, importantly, to link those who do test positive to licensed health care providers for follow-up testing and care.
“There has been a lot of talk about the false-negative test results,” said Steven Pipe, MD, of the University of Michigan and a member of the panel. “But I still can’t get over the fact that a quarter of a million people living with HIV haven’t been tested. If the in-home test helps to reduce this number, its benefits ultimately outweigh its risks.”
Search: hiv, oraquick, orasure, home, hiv test, oral, fda, blood products advisory committee, approval
Scroll down to comment on this story.
comments 1 - 15 (of 19 total) next
Frederick Wright, Coachella Valley, 2012-06-13 13:39:57
Sam, again this is a screening process not a threatmen option it is not chemo therapy, where thousands atimes a day a Doctor states we do not really know if this treatment will work ,unless we try it. Ocourse a screening process like diabetes at a health fair with blood has only direct people into care and has nothing to do with a fecal transplant,nor does a HIV home screening kit,other than it could save a child in the womb or protect many from HIV because one doesn know they are HIV.
Caitlin, New Jersey, 2012-06-13 12:48:54
Unless the test comes with a personal counselor/social worker educated on providing initial HIV testing support, I have difficulty supporting something of this nature.
Sam, , 2012-06-11 17:05:44
One of the most terrifying catchphrases we see in a lot these debates is "We won't know until we do it". Well, yes, I suppose that is true. How does this reasoning sound when the terror of AIDS doesn't hover above it and AIDS Inc isn't lobbying? "There's an obesity epidemic amongst america's youth. Lets perform fecal transplants with thin people to see what happens!" What, bad idea? Why not, we won't know until we try it! Fecal transplants for all!
Frederick Wright, Coachella Valley, 2012-06-07 09:52:45
Larry, these are great questions of concerns. What is the truth about the reactions of in home HIV screening and we will never known if this concept will stop new HIV infections by 50 percent or more or will it increase HIV infections with harm to the consumer, if we do not move forward. Some are hopefully that, parents,teachers,pastors will keep a couple of screening kits in their desk to help with this process. I beleive it could allow the community to take ownership of this HIV pandemic.
Larry Frampton, Knoxville, 2012-06-05 12:37:11
As a person living with HIV and a certified HIV tester I am 100% against this at home test for many reasons. First realistically if someone gets a positive result how many of them are going to call the 800 number and self report. 2. Denial is a huge factor here and it will let the person continue their risky behaviors and spread the virus even more.3. The counseling that comes with the test is vital to make them understand the virus and that it is not a death sentence.
Jeton Ademaj, Harlem, NYC, 2012-05-24 12:44:12
overall, i am happy about the test becoming available. there will be abuses of it, certainly...i fear for sex workers "disposed of" by their pimps, especially. the fear of a rash of suicides is overstated, as for many "counseling" proves a ham-handed, overbearing joke. ironically, the Market is taking over where disclosure laws could not...i expect many neg partners to use this test on poz partners who havent disclosed. eventually poorer people will want the same ability to test their partners.
michael, AndrewsTexas, 2012-05-23 17:55:48
The only thing is if you do not get someone to talk too you could become depressed and kill your self we here in my area we have free one on one conceling at www.ribbonsoflight.org and support group meeting if you want them the group also goes out to eat 2 times a mo. and meet in private 2 time a mo. every thing is paid for free free free Christimas party ,Thanksgiving feast. back to testing so many people are infected and not tested so so crazy
SoulAsylum, Minneapolis, MN, 2012-05-21 21:06:40
When I got my test result, I had not even asked for one - I heard syphilis was on the rise and went in to get tested. A few minutes later, I am told I am positive and other people I have never met are bum-rushing me to be this 'support group'. I felt like the lab rat in an emotional trauma study. I think a well-done CD or DVD to address -/+ results and resources to turn to would better prepare singles AND couples for dealing with the magnitude of such news in the most comfortable way possible.
SoulAsylum, Minneapolis, MN, 2012-05-21 20:58:48
Andy, I understand, you don't like testing, and have no hope for any home-based testing. We get it. Truth is, current testing is inhibitive- not every state has anonymous testing. If you don't believe in the 'national database' ask any HIV testing center and they will tell you, they have to report positive results. This provides people the choice to get tested in the most comfortable surroudings they can make for themselves. No promises on their reaction, but it gives them choice of when/where.
frederck wright, plam desert, 2012-05-20 14:04:36
Remember it is a screening home kit, and I hope this kit can educate the consumer that a screening must be followed up by a another test. Our heath systems are set up on screenings and tests. I for one when tested for HIV had the common sense to get another test hoping the first was wrong. I still not getting what is the fear about HIV screening kits,for the kit doesn't give one Hiv for it is an education tool to help determined a truth and empower the consumer I believe,truth to the end.
Andy, , 2012-05-18 10:21:04
If someone is so afraid of a "national database" that they won't get an anonymous test at a center, how are they supposed to find the gumption to seek out medical care, where there really is state reporting? It might reassure the seronegative that this test exists, so they can hope + people will depart the dating pool, but how does this actually help those + people? Or, as I've suggested, do their lives just no longer matter? And what's to say someone with a + result will react as desired?
SoulAsylum, Minneapolis, MN, 2012-05-17 21:30:24
I am thrilled for this test - now people will be able to test themselves, without ending up on some national database because they went to a doctor or free clinic that is required to disclose. It would be helpful if the kits contained contact info for unaffiliated support services that would help anyone with a positive test result, while preserving their privacy. I personally won't date anyone negative, and this is a good way for me to advocate testing while preserving my integrity in disclosure
Andy, , 2012-05-17 20:11:17
Before anyone comes rushing to the defense of this test saying it offers counseling, I want to volunteer that I had a traditionally administered indeterminate followed by a home access positive, and there is most assuredly NOTHING resembling adequate counseling with the current home test. I was lucky to have received counseling after my first ELISA. I feel terrible for those whose first indication of seroconversion is a home test.
Keith, Portland, OR, 2012-05-17 15:15:32
I agree that this test is not a good idea. If I am home alone and take the test and find out I'm positive, who is there to counsel me or tell me what the next step is? When I tested positive I was at least told to go to Cascade Aids Project and they helped me by giving me a lot of information and helped find a Dr. that specializes in HIV. I would not have received any assistance from a home test. I think that the testing and treatment of HIV should left up to the professionals.
Andy, , 2012-05-17 12:27:43
comments 1 - 15 (of 19 total) next
This is great news if you're an employer who wants to screen out people who will drive up health costs or a serophobic barebacker. Not such great news if you're suddenly unemployable or someone who finds out that they're poz when some maniac with a home test and an overblown sense of preservation starts accusing them of "lying". Actually, its really bad for anyone who turns up poz. This is part of an ongoing trend where the value of one's life ends abruptly at "your test came back positive".
[Go to top]