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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 goodmanj (234846) on Wednesday July 04, 2012 @08:19PM (#40546061)

    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.

    • by Anonymous Coward

      Not really clever at all. You'd better use condom, which is 99% safe if you use it properly (test fail in identifying 1 in 12 individuos)

      After all, taking body fluids from someone without his/her consentiment is illegal.

    • 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.

      • AIDS is the only currently incurable life threatening disease you can get that I know of. You may get herpes, which is incurable .. but its not usually life threatening. You may get hepatitis C, which is life threatening but the cure rate is fairly high (and improving) with modern treatment regimens.

        • by arth1 (260657)

          AIDS is the only currently incurable life threatening disease you can get that I know of.

          You have cures for Hepatitis, Creutzfeldt-Jakob, Alzheimer's, Leukaemia, Parkinson's, Huntington's, Polio, Lupus and Diabetes?

          And influenza too - even though the fatality rate is low, the infection rate is so high that it kills an awful lot of people every year.

          • by joaommp (685612)

            I'm pretty sure he was talking about sexually transmitted diseases... Therefore, apart from Hepatitis, which have vaccines and and some very effective treatments, all the other one's become irrelevant in this discussion...

            • by DarkOx (621550)

              Might not stay that way thought. I heard on the radio there is an extremely antibiotic resistant clap from Japan making its way to the west coast.

      • Although the chance of a false negative may be 1 in 12, the actual probability of getting AIDS is less .. because you have to account for the probability of encountering an HIV positive person. Also, many false negatives are for cases where the person may have been recently infected so the immune system has not created enough antibodies. If you have been dating your partner for a while and can be sure he/she hasn't had an HIV exposure within a recent time frame .. the chance of false negative reduces. What

        • by hawguy (1600213)

          Although the chance of a false negative may be 1 in 12, the actual probability of getting AIDS is less .. because you have to account for the probability of encountering an HIV positive person. Also, many false negatives are for cases where the person may have been recently infected so the immune system has not created enough antibodies. If you have been dating your partner for a while and can be sure he/she hasn't had an HIV exposure within a recent time frame .. the chance of false negative reduces. What this test allows you to do is have an added layer of security. It's like this, when you get in a car .. you can reduce your chance of getting seriously hurt in an accident by being a good driver, driving a safe vehicle, and wearing a seatbelt. Does it offer a guarantee of safety? No. I'm pretty sure people have died with their seatbelt on, in fact i recall hearing that some side impact collisions resulted in fatalities BECAUSE the person was wearing a seatbelt. However, seatbelts have saved many lives, so it's a good idea to use one. It reduces the probability of serious injury. That's what this test is about .. it's helping people who can't help but engage in a particular behavior pattern reduce the risk from that behavior -- yes for maximum benefit it must be coupled with other things like not choosing a high risk partner etc. But simply telling people to just plain abstain has not worked for everyone. So in combination with all the other things such as abstinence education, this test is a good thing.

          Note, I am not in blanket favor of testing someone for HIV or anything else without their consent.

          Or does it act like a false layer of security like an airbag. Drivers may think "Oh hey, I don't need a seatbelt, I have an airbag!" even though the seatbelt is what keeps them in place so the airbag is most effective.

          Likewise, is someone who is in a high-risk group for HIV going to take this test, come up with a negative result, and then go out and tell his partners "Don't worry dude, I'm clean, I was tested". While if he'd had a test at a clinic (even if they use the same test), they would have explained

          • Yes it is possible to come up with scenarios where this test results in infection. But how common is that scenario going to be? Overall this test may save lives.

    • by santax (1541065)
      Do not worry son, with your attitude you will never get the AIDS. Here's a new hyper-link and a fresh box of tissues. Carry on son.
    • by fermion (181285)
      It is not a pregnancy test. The setup is quite complex [oraquickhivtests.com] and seems highly susceptible to human error. Latex condoms seem highly effective to reduce the risk of infection when engaging in risky sex, or at least better than a test.

      I remember a time when condoms were considered absolutely unromantic.

    • by Frankie70 (803801)

      Steps
      1) Get partner home from bar
      2) Get them to sleep as soon as they reach your home
      3) Test them for HIV
      4) If they test negative, wake them up and have sex.

  • by Anrego (830717) * on Wednesday July 04, 2012 @08:20PM (#40546069)

    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.

    You need really a lot of information about how to read the test, how to use the test properly.

    That would to me seem the least of the problem. The whole finding out you (might) have a terminal illness while alone in your bathroom might cause some issues. I know I'd probably be a tad upset.

    • 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.

      • 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 dargaud (518470)

          this makes the problem even worse as he continues to get negative results, test after test despite being infected.

          Is this the case ? Or only the 1st time right after contamination when the body hasn't produced enough antibodies yet ? Can someone be (1) a carrier and (2) a spreader while (3) having no antibodies ?

        • by Carnildo (712617)

          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.

          This is a general screening test intended to be used by the population at large, rather than a diagnostic test. As-is, it's got good positive predictive value [wikipedia.org] and a reasonable negative predictive value [wikipedia.org]: if given to the entire US population (minus tho

      • 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 TheCarp (96830)

      > That would to me seem the least of the problem. The whole
      > finding out you (might) have a terminal illness while alone in
      > your bathroom might cause some issues. I know I'd probably be
      > a tad upset.

      except you probably shouldn't be. The number of people without HIV dwarfs the population with it enough that there are many many more false positives than true positives, even with a very low false positive rate.

      So even if you test positive, you are actually far more likely to be one of the people w

    • by mcgrew (92797) *

      It's no longer terminal with today's antiviral drug regimens. However, it is still incurable, and if you have HIV you'll need to take a very large cocktail of some very dangerous drugs for the rest of your life.

  • 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.
    • 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 multiben (1916126)
        Your logic is fundamentally flawed. Why on earth would you assume that people who are seeking an HIV test are already spreading it around?!? The other (far more likely) scenario is that they are concerned they may have contracted HIV and are looking for confirmation one way or the other *before* engaging in activities that may spread it further. Prior to the existence of this test you could go to the doctor and find out *for sure* if you had it or not. Now with this test people may miss that very important
      • by DarkOx (621550)

        You are making a big assumption this will stop them. Lost of people go around having unprotected sex with multiple partners. They should therefore get tested for a variety of STDs regularly so as not to put others at risk but they don't.

        These are people to embarrassed to ask a medical professional for an HIV test or to narcissistic to bother. Do you really think they are going to either start telling partners, sorry I am HIV positive we should use protection, or change their life style for more than a fe

  • by Anonymous Coward

    Yeah, the error rate is very high, but consider that this test might catch a large fraction of folks who might never get tested. That's a net win.

    • by arth1 (260657)

      Yeah, the error rate is very high, but consider that this test might catch a large fraction of folks who might never get tested. That's a net win.

      Not if it leads to Typhoid Marys who go on infecting a large number of people because tested negative!

  • good thing for the affordable care act or this would of been a easy new way to get on the blacklist aka the per-existing conditions list.

    • Anonymous HIV testing has long been available in the US. And approving OraQuick for OTC sale will make it even easier to be tested without your health insurer, or anyone else, knowing. But yes, in a single-payer system, we wouldn't have to be so guarded about pre-existing conditions, and one would be able to get the treatment(s) they need for preventing and transmitting disease without having to wonder if they could be blacklisted.

  • by Lord Kano (13027) on Wednesday July 04, 2012 @09:25PM (#40546631) Homepage Journal

    in night club/bar bathrooms.

    It's 1:40 and you've hooked up with your last resort, you go back to your place but before you put yourselves at risk, take 5 minutes and show each other that you don't have HIV.

    I say this is all around win!

    LK

  • 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.
    • Re: (Score:2, Informative)

      by Anonymous Coward

      Yes! Never mind that these are all features of the American psyche built over centuries. It is those darn Republicans.

      Never mind that both Republican and Democrats want the government in our (quasi-mandatory public) schools which is specifically what enables "abstinence only" policies to be put into place by Republicans. It's Republicans all the way down!

      Never mind that the Democrats are just as hard on drug users and sellers as the Republicans. It's those darn Republicans at it again!

      Never mind that gays m

      • Um, since when did denigrating Republican policies automatically constitute an endorsement of the Democrats, I must have missed that meeting. Your little libertarian pseudo-intellectual rant is cute, for a 3rd grader, but guess what, in countries where the government has even less power HIV rates are higher, Germany's very highly developed public health system and government sponsored campaigns to distribute condoms and clean needles are a big part of why the HIV rate is so low. So yeah, those pesky facts
    • Re: (Score:1, Insightful)

      by Anonymous Coward

      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 assu

      • First and foremost, stop reading things in my post that are not there. I did not ONCE mention the Democrats, not once. My post wasnt intended to praise their policies per se, but rather praise the policies of countries like Germany who have kept the disease relatively under control. Democratic support for these various policies varies considerably, but unlike Republicans there arent very many Democrats that are downright hostile towards policies that have been EMPIRICALLY PROVEN to reduce HIV rates. That
      • by Hatta (162192)

        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 guess not. Apparently some of them are dumb enough to vote for a party who isn't even interested in making good policy to slow the spread of a terminal disease you suffer from, and whose leaders barely even consider you a citizen. In short, you're even dumber than the average republican.

      • by compro01 (777531)

        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.

        So you're either delusional and think Goldwater and his ilk are still in charge of the Republican Party, you're delusional and think you're going to change the party from within and wrest control back from the religious nuts, you're wealthy and look to benefit from the tax policies the Republicans endorse, or you're delusional and think that IT (The Dream Job, The Lottery Win, The Inheritance, etc.) will happen to you and you'll then benefit from the aforementioned tax policies.

    • by mcgrew (92797) *

      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.

      As much as I dislike Newt, Rush, and Mitt, I just don't see any evidence of that. More liikely, the reason we have so much more AIDS is that poor prople simply don't go to the doctor; they can't afford it. They go to the ER when they're at death's door, and by then have likely infected

  • by wickerprints (1094741) on Wednesday July 04, 2012 @10:35PM (#40547071)

    To review, sensitivity is the probability of a positive result given that the tested individual is actually positive; specificity is the probability of a negative result given that the tested individual is actually negative. The OraQuick swab test has a rather low sensitivity, meaning that there is a roughly 1 in 12 chance that an HIV-positive individual incorrectly tests negative (type II error). But it has a relatively good specificity, meaning that there is a roughly 1 in 5000 chance that an HIV-negative individual incorrectly tests positive (type I error).

    The value in granting FDA approval for OTC sales of OraQuick, then, is to address the need for the vast majority of the population, which is HIV-negative, to feel reassured that they are in fact negative. Historically, one of the biggest challenges in HIV education has been overcoming the fear and stigma of testing. Making testing available OTC greatly improves the likelihood of getting regularly tested.

    But what of those pesky type II errors? Yes, given that an individual is actually HIV-positive, the chance that the test fails to detect is is 1 in 12. But that is NOT the same thing as saying that given a negative test result, the chance the person is actually HIV-positive is 1 in 12. For the general population, that probability is much smaller. In fact, I leave it as an exercise for the reader to calculate the negative predictive value (which would require the prevalence of HIV in the US population). Now, if we were talking about using OraQuick on a very high-risk group, we would expect many more false negatives, so a more appropriate test would be the standard ELISA blood test, followed by a confirmatory Western Blot. But remember, FDA approval of OTC OraQuick is targeted at the general population. If you know you're in a high-risk group, you presumably would be getting regularly tested at a public health clinic, and OraQuick isn't necessarily your best choice. But it's still better than not getting tested at all.

    Finally, remember that any reasonable person who tests positive with OraQuick would want a follow-up test to be sure. (Someone who tests negative, however, is much more unlikely to want a follow-up test.) So we don't really need to worry about type I errors, except for the panic and anxiety such a rare outcome might cause.

    • by Hatta (162192)

      If you know you're in a high-risk group, you presumably would be getting regularly tested at a public health clinic, and OraQuick isn't necessarily your best choice.

      If you know you're in a high-risk group, you're probably not making the best decisions anyway. In fact, you're probably looking for an excuse to continue your destructive behavior. Why would such a person go to a clinic instead of popping one of these in their mouth just before hooking up with a new partner?

    • Here's the maths.

      From Wikipedia, the background rate of HIV in the USA is 0.375%: 1,200,000 people are HIV+ and 310,800,000 are HIV-.

      From the sensitivity: of those 1,200,000 who are HIV+, 100,000 (1 in 12) would test -ve, and 1,100,000 will test +ve. And from the specificity: of the 310,800,000 who are HIV-, 310,737,840 would test -ve, and 62,160 (1 in 5000) would test +ve.

      This means that of those 310,837,840 who test +ve, 94.7% would actually be HIV+. And of those 1,162,160 who test -ve, 99.97% wou

      • by Carnildo (712617)

        If you remove the people who are HIV-positive and know it from the groups, the numbers shift: of the 240,000 people who are HIV-positive and don't know it, 20,000 will test negative. The positive predictive value drops from 94.7% to about 78%, while the negative predictive value rises from 99.97% to about 99.99%.

  • I would caution people to pay Cash only for these tests.

    I remember a while back on /. there was an article on how Credit Card companies would offer people better rates if they bought some obscure combination of items at least yearly (showing they cared for their household, etc .... bird seed I seem to recall was one of the items).

    Food for thought anyways.

    • Huh, good point. I didn't think that credit card companies would adjust your credit score based on what you buy but I guess there's not reason they can't and they have an incentive to do so.

  • But many people can't bear to ask someone to perform the test on them.

    If you want to find out your HIV status, there's really no substitute for having it performed by someone trained to do it, and trained to privately answer every random question you have with zero judgement. For those of you who haven't done it, it's literally the most banal, undramatic process ever. HIV testing is absolutely routine and doesn't make anyone think less of you.

    I mean, in some places, you can even get it done for free while s [outofthecloset.org]

  • Given basic human psychology, releasing an HIV test with admittedly low false positive rate, but such ridiculously high false negative (type II error), is borderline criminal.

    Let's not forget that the target demographic for such a test is people who are not very keen (for any sort of reason) on taking the test in the first place, otherwise they would just get tested for free at one of the many locations that do it.
    Giving these people a false positive (with attached warning regarding reliability of the t
    • by zedrdave (1978512)
      Damn, posted too quickly: 8.3% type II error does not mean 8.3% undetected HIV... Obviously the number would be much lower for an even moderately at-risk population. That is still a rather unacceptable compromise imho.
    • Granted, you have a point in that people who test negative are unlikely to seek further confirmation that they are in fact HIV-negative, whereas designing a test with a high sensitivity but low specificity would result in many more follow-ups with more specific tests.

      But where I think your argument treads on somewhat shaky ground is that (1) HIV is not the only STD out there, and there are lots of other very things you could catch through unprotected sex, such as hepatitis (which may lead to liver cancer);

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