FDA approves first rapid, at-home HIV test, in-store availability this October

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    Jul 04, 2012 12:58 AM GMT
    An ongoing story reported here before, a home HIV test is now officially US FDA-approved as of today. This is the OraQuick bloodless mouth swab test you may have taken before, often free or low-cost at clinics, in mobile vans and at gay events. With results at home in 20 minutes, no need to mail anything back as with some previous home tests.

    Also the ultimate in confidentiality, since no one sees the results but you. Gets around those US States that require health care providers to submit positive results to State health agencies, with your name. But also a source of some medical ethics concerns, since a person testing HIV+ gets no immediate in-person counseling, at the time of diagnosis when they likely need it most, although company OraSure will be providing a hot-line.

    http://vitals.msnbc.msn.com/_news/2012/07/03/12545743-fda-approves-first-rapid-at-home-hiv-test?lite

    http://www.orasure.com/products-infectious/products-infectious-oraquick.asp
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    Jul 04, 2012 5:20 AM GMT
    I'm gonna bump this, important news for gay men, another HIV testing option that reduces resistance to doing it, by greatly increasing privacy and confidentiality. Also looks like these tests will be available for online purchase and home delivery, for those who might not want to buy them openly in a pharmacy.
  • FRE0

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    Jul 04, 2012 5:50 AM GMT
    I have mixed feelings about it. It's good that one can be tested conveniently and confidentially, but I'm concerned that it bypasses the counseling for people who test positive. That could be a serious problem.
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    Jul 04, 2012 11:28 AM GMT
    It definitely is a step in the right direction...but it needs more competition to bring the price down. (It's expected to cost more than the version that has send-in samples)
    On the other hand, it took thousands of years until we had pregnancy tests at home. It only took like 20-something years for the first HIV test at home. icon_lol.gif
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    Jul 04, 2012 11:37 AM GMT
    I just started a new thread about this not realizing that AD already had. Here's today's NYT article about it.

    http://www.nytimes.com/2012/07/04/health/oraquick-at-home-hiv-test-wins-fda-approval.html?_r=1&partner=rss&emc=rss&src=igw

    No price is listed except "...higher than the $17.50 now charged to medical professionals...".
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    Jul 04, 2012 12:31 PM GMT
    I think this is great. I wonder how
    Much they are going to charge for these
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    Jul 04, 2012 12:46 PM GMT
    A factor in cost is usually production volume, plus marketing and distribution. No doubt there are slight differences between these and the "professional" version, if only with individual packaging rather than bulk, and in different instructions to users, with the volume to individual consumers perhaps much less at first than to health care professionals and organizations. The cost of a US-wide public advertising campaign would also have to be covered by the retail price they ask.

    And I don't know how the distribution system works. The home kits are gonna be at retail stores and online, which can add store profit and costs that are higher than to professionals, especially if these test kits have previously been available directly from the OraSure company. So while the manufacturing expense for the individual mouth swab devices could be identical, whether for professional or home use, the cost of getting the complete kits into the hands of consumers could account for a higher product cost.
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    Jul 04, 2012 12:58 PM GMT
    FRE0I have mixed feelings about it. It's good that one can be tested conveniently and confidentially, but I'm concerned that it bypasses the counseling for people who test positive. That could be a serious problem.


    I agree with FRE0 here.icon_neutral.gif
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    Jul 04, 2012 1:17 PM GMT
    Buddyboy938 said
    FRE0I have mixed feelings about it. It's good that one can be tested conveniently and confidentially, but I'm concerned that it bypasses the counseling for people who test positive. That could be a serious problem.


    I agree with FRE0 here.icon_neutral.gif

    I agree this is a concern, as mentioned in my OP, and the linked article. Some medical ethicists are raising this issue.

    At the same time, a home test can lead to more people being screened, and the lack of HIV detection, estimated to be about 20% of those infected in the US, is also of serious concern. OraSure says they'll have a toll-free hot-line number for people with poz results to call, to provide immediate counseling and attempt to direct them to local resources.

    When I was a volunteer receptionist at the local gay pride center I'd get calls from distraught guys recently diagnosed with HIV. They'd have been tested the conventional way, and they had either not been offered counseling at the testing site they used, or they had declined it. Now a little while later the reality was setting in and they needed guidance and support. It shakes you up to hear guys crying on the other end of the phone, or in one call I took, the young man's mother.

    So even the traditional testing methods left some people without proper follow-up. And the politically-motivated requirement in some States for inclusion of HIV+ results into a data base at State level was both intimidating, and also unethical on a different level, in my opinion. Most medical professionals oppose these reporting laws, and this home test is a way around them that gets more people tested, an essential goal in dealing with HIV.
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    Jul 04, 2012 1:17 PM GMT
    I already see the hookup of 2013: stop at the CVS, get two HIV tests, go home, drink a glass of chablis while the test "develops."

    Scary new world.
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    Jul 04, 2012 1:34 PM GMT
    themachine saidI already see the hookup of 2013: stop at the CVS, get two HIV tests, go home, drink a glass of chablis while the test "develops."

    Scary new world.

    It became a scary world when HIV made its first widespread appearance in the 1980s. BTW, though I realize your hookup scenario is a bit tongue-in-cheek, speaking of cheeks, this is a mouth swab test. Not sure if drinking wine before would spoil the test. Afterwards wouldn't matter, of course.

    And second BTW, the OraQuick method is an antibody test, not a viral load test, which would be a much more expensive blood-draw method, taking over a week. Antibodies to HIV don't reach detectable levels in the body for 3-6 months after exposure, despite the viral load being high following initial exposure, high enough to infect others.

    So in your imaginary 2013 hookup scene, an OraQuick result of negative shows the guys were negative not less than 3 months ago or even longer. It does NOT mean, it cannot mean, that they are guaranteed negative tonight.

    They could have become infected within the most recent 3 months prior, and be fully infectious, but the test shows negative. But that's always been a misunderstanding with HIV tests, that guys think they've negative the day of the results, when that's not what the test indicates.

    I saw it myself at our pride center, where guys testing negative are issued a wallet card with their negative result and date. The slang term for it is a "get out of jail card" and guys would rush right over to their favorite gay bar and start flashing the thing, incorrectly claiming they were negative and safe for sex. But the card said nothing of the sort - it meant he was negative 3 MONTHS AGO, but no proof he's been since then.

    So any HIV testing can actually be misleading and dangerous, if the individual lacks the understanding of what information it really provides.
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    Jul 04, 2012 9:42 PM GMT
    This is a great idea, since one could also use it to test their potential hookup partners. icon_wink.gif
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    Jul 04, 2012 9:44 PM GMT
    themachine saidI already see the hookup of 2013: stop at the CVS, get two HIV tests, go home, drink a glass of chablis while the test "develops."

    Scary new world.


    Sounds like the path to safer sex to me.
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    Jul 04, 2012 9:52 PM GMT
    Ariodante said
    themachine saidI already see the hookup of 2013: stop at the CVS, get two HIV tests, go home, drink a glass of chablis while the test "develops."

    Scary new world.


    Sounds like the path to safer sex to me.


    Actually, if the test is falsely negative (e.g. in the window before antibodies have developed), people can be lulled into a false sense of security and do risky things like barebacking. So some statistics will need to be done (i.e. does the 1:5000 false negative rate overcome the risk of getting HIV through barebacking, and do it in a population with high propensity for such high risk activity) to see if it's going to be "safer" sex. icon_lol.gif
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    Jul 04, 2012 9:58 PM GMT
    I love this idea. I think a LOT of people skip the HIV testing business because they're too embarrassed/anxious about doing it with a stranger (health professional) they've never met, or not being able to contain themselves if they get a positive reading, etc.

    this is a good thing! it has some drawbacks but overall the privacy built into this is such a step forward. too often the discussion about HIV completely disregards the "personal" aspect... some people really need that privacy
  • BuggEyedSprit...

    Posts: 920

    Jul 04, 2012 10:02 PM GMT
    Cheap, if this is it:

    http://www.oraquickhivtestkit.com/order.php
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    Jul 04, 2012 10:34 PM GMT
    Does it accurately indicate whether it is safe to forgo protection?

    I'm gravely concerned this might cause an increase in HIV infections as its accuracy rate for a false negative is one in twelve.

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    Jul 04, 2012 10:42 PM GMT
    RobertF64 said
    I'm gravely concerned this might cause an increase in HIV infections as its accuracy rate for a false negative is one in twelve.



    where did you see that?
  • metta

    Posts: 39167

    Jul 05, 2012 5:48 AM GMT


    Clinical studies for self-testing have shown that the OraQuick 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 HIV-infected individuals," the FDA said."

    ........


    "Similar testing indicates that one false positive would be expected out of every 5,000 test results in uninfected individuals, according to the FDA, which is responsible for regulating medication in the United States."

    http://news.yahoo.com/us-approves-over-counter-hiv-home-testing-kit-182619672.html
  • Posted by a hidden member.
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    Jul 05, 2012 5:51 AM GMT
    Just go to a testing center, folks, have the blood work done.
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    Jul 05, 2012 3:17 PM GMT
    Cuts both ways but it may be the best option for people who are promiscuous and just want to have one night stands..obviously they should always be safe but this makes taking someone's word out of the picture
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    Jul 05, 2012 4:47 PM GMT
    Everyone will start Bare Backing now?
  • metta

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    Jul 05, 2012 4:50 PM GMT
    SportyGuy_1 saidEveryone will start Bare Backing now?


    I hope that people understand this test better than that.
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    Jul 05, 2012 4:59 PM GMT
    Basically, this product can avoid a false negative only after enough time has passed for them to circulate antibodies as they fight off the infection. It will not detect the virus itself like a lab/blood test will.

    Now I'm becoming less concerned about a false negative and more concerned about the counseling aspect.
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    Jul 05, 2012 5:33 PM GMT
    Buddyboy938 said
    FRE0I have mixed feelings about it. It's good that one can be tested conveniently and confidentially, but I'm concerned that it bypasses the counseling for people who test positive. That could be a serious problem.


    I agree with FRE0 here.icon_neutral.gif


    I'll pile on with further agreement.

    When people test HIV+, they may also need counseling not only for the more immediate emotional issues, but also to connect with resources for treatment and other support.