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Medicine Science

FDA Approves HIV Home-Use Test Kit 186

Posted by samzenpus
from the take-home-test dept.
Hugh Pickens writes "The LA Times reports that the Food and Drug Administration has approved the first over-the-counter HIV test kit, allowing people to test themselves in private at home and get preliminary results in less than 30 minutes. The test, which works by detecting antibodies in a swab from the gums, should not be considered final — in trials, the test failed to detect HIV in 1 in every 12 patients known to be infected, and returned false positives in 1 in 5,000 cases. The new at-home test, called OraQuick, will be sold in supermarkets and pharmacies and manufacturer, OraSure, has not said how much the test will cost, only that it will be more than the $18 cost for the professional kit. The federal Centers for Disease Control and Prevention estimates that of the 1.2 million people in the U.S. with HIV, 1 in 5 is not aware of the infection and that a disproportionate number of the 50,000 new cases of HIV each year is linked to people who have not been tested. Chip Lewis, a spokesman for Whitman-Walker Health, which provides AIDS care in Washington, says at-home testing could reach some people who didn't want to go to a clinic but removing medical professionals from the process could cause problems. 'It's not like a home pregnancy test,' says Lewis. 'You need really a lot of information about how to read the test, how to use the test properly.'" Back in May, we reported that a panel of FDA experts recommended approval of an over-the-counter HIV test.
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FDA Approves HIV Home-Use Test Kit

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  • by multiben (1916126) on Wednesday July 04, 2012 @08:26PM (#40546113)
    1 in 12 failure rate is absolutely *far* too high. It's marginally better than rolling a die to see if you have HIV. People (as a group), who have proven themselves to be not the best logicians time and time again, will take this as proof they are in the clear and start spreading it around. It is a very irresponsible product. If you think you have HIV then go to a doctor and find out for sure.
  • Re:Good and bad (Score:5, Insightful)

    by LordLucless (582312) on Wednesday July 04, 2012 @08:31PM (#40546151)

    This seems like a really good idea in that a lot of people who really should get tested never will due to the stigma of going to a clinic.

    On the other hand, it seems like now 1 in 12 will never go to a clinic because the home test gave them a clean bill of health when really, they were carrying the virus. I understand that a false positive is going to be hugely upsetting to the individual, but on a society-wide level, such a massive false negative rate is really much more concerning. In my opinion, it makes the test not only useless (as a high false-positive rate would) but counter-productive.

  • by Taco Cowboy (5327) on Wednesday July 04, 2012 @08:33PM (#40546181) Journal

    ... lest you guys start thinking that this kit is a heavenly sent, that you guys will be 100% protected ...

    This test kit is only 92% accurate

    While 8% does not seem to be a big number, it still matters in this case for AIDS is still incurable
     

  • by ShanghaiBill (739463) on Wednesday July 04, 2012 @08:39PM (#40546223)

    People (as a group), who have proven themselves to be not the best logicians time and time again, will take this as proof they are in the clear and start spreading it around.

    People who feel they need to use this test are already spreading it around. If this stops 11 of 12, that is a good thing. Just because something isn't perfect, doesn't make it worthless. Life is not black and white.

  • by Anonymous Coward on Wednesday July 04, 2012 @09:09PM (#40546495)

    What i like about this is the possibility of social pressure :-)

    and being "at home" possibly some who would never get tested will take one (for curiousity or due to this pressure) and if that catches a few positives (even a few false positives) that go get checked up at the doctor, that should be an overall win to society.

  • by hawguy (1600213) on Wednesday July 04, 2012 @09:22PM (#40546603)

    Nobody seems to have noticed the "best" thing about this test: it should be possible to use it on your partner. With or without their consent. So you can invite that random girl at the bar home for a drink and a swab, or secretly swab your boyfriend while he's sleeping, just in case he's lying to you about being clean.

    Unethical? Yes. Unromantic? Yes. False sense of security? Yup. But potentially lifesaving? Also yes.

    If you distrust this partner so much that you're willing to give them an HIV test without their consent, do you really want to bet your life on the 1 in 12 chance that the test will give a false negative result?

    Besides, there are lots of other diseases you can pick up from this partner even if he/she is not infected with HIV. Better to be safe than sorry.

  • by fuzzyfuzzyfungus (1223518) on Wednesday July 04, 2012 @09:28PM (#40546649) Journal
    Eh, this isn't the 1980s anymore. Are hard-partying homosexual intravenous drug users still a high risk demographic? Sure.

    Has AIDS become something of a crossover hit, especially but not exclusively in the developing world, with substantial uptake among behaviorally prosaic demographics? Oh yes, yes it has...

    At the risk of sounding blunt to the point of crassness, if the 'AIDS = Ass Cancer' theory of epidemiology were actually accurate, we wouldn't still be talking about it. It's hard for a virus that has no significant animal vectors and can't survive outside the body worth a damn to hang on if it can only burn its way through crazy-high-risk demographics. There just aren't that many of those, and they tend to die.
  • Re:Good and bad (Score:4, Insightful)

    by hawguy (1600213) on Wednesday July 04, 2012 @09:34PM (#40546677)

    This seems like a really good idea in that a lot of people who really should get tested never will due to the stigma of going to a clinic.

    On the other hand, it seems like now 1 in 12 will never go to a clinic because the home test gave them a clean bill of health when really, they were carrying the virus. I understand that a false positive is going to be hugely upsetting to the individual, but on a society-wide level, such a massive false negative rate is really much more concerning. In my opinion, it makes the test not only useless (as a high false-positive rate would) but counter-productive.

    And it's not just the fact that they won't go to a clinic for themselves, but now those 1 in 12 will proclaim to future partners "Don't worry, I'm clean, I was just tested". And if there's a biological reason that makes an individual more likely to get a false negative, this makes the problem even worse as he continues to get negative results, test after test despite being infected.

    I'd feel better about this test if the false positive and false negative rates were reversed. Sending 1 out of 12 people to the doctor because they got a false positive (and missing just 1 out of 5000 actual HIV infections) sounds a lot better than the reverse.

  • by antifoidulus (807088) on Wednesday July 04, 2012 @09:42PM (#40546725) Homepage Journal
    The HIV rate in the US is a microcosm of everything that is wrong with the country. The HIV infection rate is massive compared to pretty much every other rich country on the planet, for instance in Germany there are about 3,000 new cases per year, and considering Germanys population is roughly 1/4 of the USs, we can see that the US rate is over 3x as high as Germanys per capita. Why the huge disparity? Probably has something to do with the fact that in the US there are a large # of people who secretly want "sinners" to get infected as punishment for their "deviancy", we call these people Republicans.

    We can see it in the massive farce that is "abstinence only" education, turns out kids are having sex anyway and since they cannot get, or do not have access to condoms(and have been told that they fail most of the time anyway) they are going about it without them. Results? Highest STDs and teen pregnancy rates in the rich world.

    And lets not forget our hardon for "justice" that results in a massive # of people(mostly men) in prison at any given time, where, surprise surprise, HIV runs rampant. And perhaps related refusal to admit that people are going to shoot up, and if they do they should have clean needles ends up in a lot of drug users contracting HIV(a very large % of those infected with HIV in the US are also infected with hep-C, indicating that needle-born HIV infections in the US are much more common than other first-world countries)

    And of course lets not forget the massive amount of homophobia that basically ensures a large # of homosexuals will be ostracized from their family and community, and thus have a very low level of self-worth. This translates into many gays engaging in self-destructive behavior in the US, including but not limited to risky sex.

    Congrats Republicans, largets HIV infection in the rich world, you worked hard to get to this point, might as well celebrate.
  • by Anonymous Coward on Wednesday July 04, 2012 @09:55PM (#40546823)
    It's beyond me why people cannot grasp that AIDS is behaviorally transmitted, and in the USA its incidence is multiples higher in the homosexual-- specifically male to male-- community, and in people who shoot up, than heterosexuals. This is not debatable; you can go to the CDC website and see for yourself.
  • by amiga3D (567632) on Wednesday July 04, 2012 @10:16PM (#40546969)

    It's not politically correct to mention that.

  • by tnk1 (899206) on Wednesday July 04, 2012 @11:24PM (#40547425)

    Yes, in this case, I'd prefer a 1 in 12 false *positive* rate. That way, if it is false, all I did was waste some time and money at a clinic to make sure. With this, if I come up negative, it might just be a false sense of security which is much worse for everyone involved.

  • by Anonymous Coward on Wednesday July 04, 2012 @11:34PM (#40547513)

    Posting anon since there is still a huge stigma with being HIV positive...

    I am HIV positive. I am a registered Republican. And I am an atheist.

    Not all Republicans are religious nutjobs in the same way that not all Democrats are hippie nutjobs.

    I am getting sick and tired of the "my team = good, your team = bad" divisiveness which is tearing this country apart. We can't even have intelligent debates on ideas anymore if one person discovers the other is a "libtard" or a "teabagger".

    The above post contains assumptions and sweeping generalizations and is just one more example of the desired squabbling in what appears to be the ruling-class' plan of divide and conquer. It seems to me that the swine who call themselves Democrats and Republicans in government want the people to blame the "other side" for all the ills in the world--and the only way it can be fixed is to grant them more power (be it Republican or Democrat).

  • Re:Good and bad (Score:4, Insightful)

    by lessthan (977374) on Wednesday July 04, 2012 @11:54PM (#40547675)

    I don't get it. Yours is the third or fourth comment I've seen lamenting the failure rate. If you are sexually active, with multiple partners, you should be getting tested every 6 months minimum. With an over-the-counter version for about $20, I'm probably going to do it every month. (I'm a bit of a hypochondriac, but I do get laid occasionally.) I like to think of myself as unusually unlucky, but 6 times in a row? That is rather improbable.

  • by ooshna (1654125) on Thursday July 05, 2012 @03:34AM (#40548713)

    I do wonder if part of that has to do with the fact that gay men also are more likely to get tested for AIDS regularly than straight guys. I live in Lakewood Ohio that has a huge openly gay community that probably rivals San Fransisco on a per capita basis. In fact the nursing home I work in has twice as many gay male employees than straight. While talking to them there seems to be a trend of being very open about multiple partners or sharing partners while they were young and usually settling down in monogamist relationships around their late 30's early 40's. But even with all the promiscuous sex there is a get tested and get tested often mentality in the community.

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