Medical Breakthrough: Over-the-Counter HIV Tests Could Hit Stores Soon

May 16th, 2012 - By Brande Victorian

Pretty soon there will be no excuse for not knowing your status—not that there’s much of one now.

A 17-member FDA panel just voted unanimously that OraSure Technologies’ over-the-counter, at-home HIV test is reasonably safe and effective for determining whether someone has the AIDS virus. In saying so, the panelist agreed that the test’s ability to prevent new HIV infections and provide HIV-positive people with access to medical care and social services outweighed the risks of potential false results. The panel’s recommendation will now be taken into consideration by the agency’s regulators as they decide whether the OraQuick Advance In-Home HIV Test should be approved as the first over-the-counter, completely in-home HIV test.

The new product is an oral swab rapid test that produces results within 20 minutes and shouldn’t be taken until 90 days after an individual’s last risky behavior. If approved and marketed over the next several months, the company said it would expect the product to retail for less than $60. That price tag could still be a bit much for those who need it most which is why panel members urged OraSure to undertake post-marketing studies to ensure that the test is available to under-served populations and that those who use the kit receive follow-up healthcare services including confirmatory tests in professional settings.

One caveat of this breakthrough is that some research data suggested the test lacked sufficient sensitivity to avoid false negative results. This could be particularly dangerous if individuals who are actually HIV-positive receive a negative result and engage in risky behavior. For that reason, panel members are pushing for strongly worded labeling about false results and procedures to link those who telephone a company hotline with questions with healthcare professionals.

This news on top of the FDA panel’s recommendation of regulatory approval for Gilead Sciences Inc’s HIV drug, Truvada, as the first pill treatment for protecting uninfected individuals last week, shows promise for reducing HIV infections in the future, which is definitely overdue.

What do you think about this at-home test? Would you use it?

Brande Victorian is a blogger and culture writer in New York City. Follower her on Twitter at @be_vic.

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  • Can_I_Livv

    plus there is a ton of stigma surround HIV/AIDS testing in the community this way people are comfortable in their own homes.

  • Can_I_Livv

    I serve as Health Chair for my University’s chapter of the NAACP and i think this is exactly what our community needs along with more free clinics so people can make sure the results are accurate.

  • Candacey Doris

    I thin this could be a really good thing. Some people will use it not for themselves, but for people they’re thinking about getting serious about. Knowing your potential partner is safe will be very helpful. Maybe NY will lose its status of second highest HIV population with more awareness,

  • http://www.facebook.com/RosarioRed Rosario Stefania Scarsci

     I’m really not sure if I want to find out whether or not I am HIV positive while sitting on my toilet seat or in my bedroom. I feel like if anything I’d rather be in a clinic. I’ve always had a side eye reaction to HIV tests as it is as I have my own opinions about the disease, but I’ll keep it simple.

  • Mls2698

    Bad idea. You can get tested free at local clinics. When you ask people to do test at home, it becomes an idiot magnet. The CDC needs to have the info for the sake of everyone else. If people were allowed to just take test at home, there will be more incidents of people knowingly spreading disease. Anyone who is embarassed about their own health, or the mention of sex and condoms is ignorant.

  • FromUR2UB

    If people begin testing at home, then how will the CDC keep track of HIV/AIDS cases?

    • Miss Anonymous

      The same way they keep up with abortion stats from white women who go to their “private doctors”.

  • mochaaa

    that sounds good. more people would be willing to get tested but then again there would be some people are too embarrassed to purchase them smh. just like some are embarrassed to buy condoms. 

  • november rain

    I would definitely use it.  I get tested every year (going in on Monday, actually, even though I haven’t had sex since October 2011) I’m a licensed professional massage therapist so, I get tested often just because of the nature of my job and how much contact I have with other individuals.  Even before I was an MT, I still got tested on regular basis because I am sexually active (even though it’s been a while).

    • Mls2698

      TMI

      • November Rain

        TMI? How?  Please explain…

        • Mls2698

          “Going on Monday” “haven’t had sex since October 2011″

          • November Rain

            If you say so…it’s not like I told you the sex was with my best friend’s husband, sheesh, what’s the problem???? LOL…just kidding….What I said is no different than you talking about your son and some hoodrat who tried to pin a baby on him.

            • Mls2698

              I don’t know when or how long they were having sex. You remembered that post….how sweet.

              • November Rain

                Good for you. Now act like you don’t see my posts or at the very least ignore them since I’ve given you TMI. 

  • HONEYLOVE

    i honestly think all test such as STIs should be something done at home. Its much better to get it at the nearest Walgreens than to sit and wait and wait at the clinic/hospital. Some ppl may find going to the clinic/hospital to be humiliating and PLUS, for those who work, may not have the time to take off and wait. Just a thought.

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