July 3, 2012
FDA Approves In-Home, Do-It-Yourself Rapid HIV Test
by Tim Horn
OraSure’s OraQuick In-Home HIV Test, the first do-it-yourself HIV test kit to detect the presence of antibodies to HIV, has been approved by the U.S. Food and Drug Administration, according to news announcements by the company and the agency. It is the first rapid diagnostic test for any infectious disease to be approved by the FDA for sale over the counter.
According to OraSure, the test will be available for purchase this October at more than 30,000 retail outlets throughout the country and online. Though its price has not be disclosed, the company announced on a July 3 conference call with investors that it would cost "slightly more" than the $17.50 currently be charged for the oral-based rapid assay used by professionals.
“Approval of the OraQuick In-Home HIV Test represents a major breakthrough in HIV testing,” said Douglas A. Michels, president and chief executive officer of OraSure Technologies. “For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed. This new in-home rapid test—the same test doctors have used for years—will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting.”
The test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside their mouths. The sample is then placed into a developer vial, with results available within 20 to 40 minutes.
A positive result with this test does not mean that an individual is definitely infected with HIV, the FDA stresses, but rather that additional testing should be done in a medical setting to confirm the test result.
Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months.
Clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92 percent for test sensitivity, the percentage of results that will be positive when HIV is present. This means that one false negative result would be expected out of every 12 test results in people who are actually HIV positive.
Clinical studies also have shown that the OraQuick In-Home HIV Test has an expected performance of 99.98 percent for test specificity, the percentage of results that will be negative when HIV is not present. This means that one false positive would be expected out of every 5,000 test results in people who are actually HIV negative.
Once the in-home test is available to the public, OraSure will have a consumer support center that is available via phone 24 hours a day, seven days a week. The center will educate users with information about HIV/AIDS, the proper method for administering the test and guidance on what to do once results have been obtained. Information about the consumer support center and contact information is included in the test kit.
When used correctly, the test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods.
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”
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comments 1 - 15 (of 20 total) next
Bruce, New York, 2012-09-26 16:24:39
It it my opinion that a HIV home test kit is a BIG mistake. As a trained certified tester, I found that there are some cases when testing right then can create drastic problems without the proper counseling.
Frederick wright, Coachella valley, 2012-07-21 09:31:46
Mitch I am sorry for the past and loosing your job. You sound a bit upset . I am on my 23 year and keep pulling myself up from my boot straps to get another job and joy in my life, hey man forgive the mean people and find your happiness. I have a young nephew who is half white and half black, no father and he is very handsome nelly young manheath a12 grade education and 20 years old,now.Has be sexing on the net at 15 years old, no social skill,no employment and the weakest in the pack, PREP?
Mitch, , 2012-07-20 00:11:10
Wow, so if that teen did seroconvert anyways, you'd gladly doom him to a life of isolation and unemployement too, huh? No wonder you place such an imperative on prevention. Death is better than the hell you've got planned for us.
Frederick Wright, Coachelle, 2012-07-16 22:18:32
i too have been dismissed from a job,where the owner stated no one would come do business because they know I am HIV , plus have been shuned fromHIV groups because of free thinking and the best dam thing in my life ,hurt a bit but freeier,stronger and forgiving more. Mitch this Still is not a reason for no over the counter for one new teen that doesn't become Hiv is worth the sacrifice to me.Truly sorry for some mean people,however I believe most are caring and can change ,it is my hope.
Mitch, , 2012-07-16 15:26:51
Frederick, do you even live in the real world? The ADA is impotent unless you can prove your termination was specifically because of your HIV status. To do so, you literally have to produce a paper trail or witnesses. If they can dredge ANYTHING else up...and in a performance setting they can usually dream up something, thats all they need. I know this because I was fired for driving up healthcare costs and consulted with a lawyer. Its a joke in all but the most egregious cases.
Frederick Wright, Palm desert, 2012-07-16 14:43:19
i feel your pain brother stay strong,here in the states we have a treatment for your condition concerning lipoatroy and if you like this Poz army reservist to ring on the telephone the nation aids trust leader to advocate for this treatment, just give me the ok and I wiifm bird dog your leader to hoefullly bring action. At first I thought a progress Uk would be the first on over the counter,however learned your leaders can be a bit stuffie and likes to sweep some issues under the rug.
roberto85, manchester, 2012-07-16 11:29:48
I find this to be most distressing news. I work in an environment of young adults who are not the professional type and see their workplace as a "playground". If these tests become available in stores in the uk i can guarantee that a coworker would bring one in and make it like a "game" to test each other. I have mild lipoatrophy in my face and im very sure people suspect i have HIV. People do not want to be around potentially infectious colleagues, HIV is NOT like diabetes, we can kill!
Frederick Wright, Coachelle Valley, 2012-07-15 11:50:57
Mitch, I understand your position however the American disabity act puts very stiff penities on this kind of behavior, and if any employer discriminates to save money, it could back firier in millions of dollars in fines. I am not sure if you know but Diabetes can lead to a kind of AIDS called Kidney failure and before that stage big buck for Dyalisis for Diavita and Baxter Inc. I amsorry,for I am not buying your agrument however do believe stigma needs to be addressed in unity with zeal
Mitch, , 2012-07-13 02:32:06
Darling, costs for diabetes medicine are 300-900 a month. Costs for HIV start at 2500. You can tell me workplace disclosure is no big deal, stigma is all in our head and the only thing we need to overcome is a culture of silence the moment those numbers approach each other. Until that point, our employers have a vested interest in weeding out poz people just like they blatantly weed out people over a certain age; because it saves them money, which is why everyone shows up to work.
Frederick Wright, Coachelle Valley, 2012-07-11 23:46:31
Mitch, when have you read,hear or seen a boss test a person on the job for diabtees,pregency,or high colesteral ,dude it is a self test and one can ask for suport and help! II for one do not discuss my person business with my boss,but not afraid to address HIV with any boss iif they wish to know,it is called courage .Mitch. I have know problem protecting privacy and know,other HIV people will pave the way. HIV and Diabtees are alike to me for these people alll like a lot of surgar. LoL kiss
Mitch, , 2012-07-10 15:24:32
Oh, yeah, testing in prisons, I'm sure that won't cause any problems! We can't get them condoms, but we can force them to live with the consequences. Hey Frederick, why stop with nursing homes and our families? Maybe our jobs could help us test, where our bosses are there to provide us with "emotional support"! Nothing says "just like diabetes" like gross privacy violations and complicated medical tests done in church basements by antisex pastors. Just get it over with and tattoo us!
Andy, , 2012-07-07 17:41:27
1. "accountability"? I'm sorry, but the accountability vacuum has been coming from the seronegative for more than a decade.
2. Terrible, terrible idea. This is the worst possible news, delivered in the worst possible way, to the people who are least able to handle it. Does anyone actually give a s**t about what happens to people who test positive, or is any price acceptable for the prospect that they might remove themselves from the dating pool?
3. Kiss our privacy, and our jobs, goodbye.
Frederick Wight, Coachelle valley, 2012-07-06 18:34:04
The cool part I think about sellf testing is that you can invite a friend or the buddy testing and one doesn't, have to be alone or better yet parents can assit in the process or nursing homes can help the elder with this test. Maybe Snookie can get her cure to do a hiv testing reality show. It would be great if faith groups would offer hiv testing within prison ministries to help the prisoners get follow up care, so when they leave prison may not infect unknowing women as much.
Frederick wright, Choachelll Valley, 2012-07-06 12:27:56
Andrew this test was developed 20 years ago and tested in Africa where they were given to women to take home and test themsleves during the Clinton adminisration and kept in a secret for years, My question is why has it taken so long, for during those 20 years millions have became HIV. The only way stigma is going to reduce is that the HIV people plus the PWAs standing tall and the community starts to address HIV openlly to reframe or brand HIV as treatable, like diabetes.
Andrew, , 2012-07-05 16:30:12
comments 1 - 15 (of 20 total) next
Back in 2006, I ordered a hiv kit off the net-so, they have been around for awhile. Since this is apparently big news-Im guessing what I ordered back N the day wasnt FDA approved. If I had found out I was positive thru that test at home-not sure if I wouldve handled it better. I was broken when the doc told me-i couldnt imagine finding out on my own.
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