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FDA Approves HIV Home-Use Test Kit

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.

15 of 186 comments (clear)

  1. Use it on someone else? by goodmanj · · Score: 5, Interesting

    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.

    1. Re:Use it on someone else? by hawguy · · Score: 4, Insightful

      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.

  2. Re:Good and bad by LordLucless · · Score: 4, Insightful

    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.

    --
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  3. It's only 92% accurate ... by Taco+Cowboy · · Score: 4, Insightful

    ... 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
     

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    Muchas Gracias, Señor Edward Snowden !
    1. Re:It's only 92% accurate ... by ColdWetDog · · Score: 4, Informative

      No test is 100% accurate. Even ones done in a lab setting. In particular, these HIV tests require the body to produce antibodies to the virus. No antibodies, no positive test. You don't make antibodies instantly - it takes on the order of 10 - 14 days. So, if you were in contact with an HIV positive person and then ran out and got tested you would test negative. A couple of weeks later, the story might be different.

      Wrap the rascal.

      --
      Faster! Faster! Faster would be better!
    2. Re:It's only 92% accurate ... by fuzzyfuzzyfungus · · Score: 4, Interesting

      Unless the 1 in 12 figure includes some large number of "zOMG, I might have been infected, I'm going to get tested immediately, days before I could conceivably actually show what the tests look for!" morons(who really need to get to somebody qualified to tell them why that is stupid, now...), that is a dreadful false-negative rate...

    3. Re:It's only 92% accurate ... by fuzzyfuzzyfungus · · Score: 5, Insightful

      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.

    4. Re:It's only 92% accurate ... by Anonymous Coward · · Score: 4, Insightful

      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.

    5. Re:It's only 92% accurate ... by amiga3D · · Score: 4, Insightful

      It's not politically correct to mention that.

    6. Re:It's only 92% accurate ... by ColdWetDog · · Score: 4, Informative

      The test kit comes with a booklet that the manufacturer and the FDA spent quite a bit of time going back and forth about. It attempts to clearly delineate what the test can and cannot do and impresses the need to get repeat testing. Remember, this took years to get cleared and not because of the technology itself - that's pretty cut and dried.

      The hard part was setting the false positive and negative rates and trying to educate the general public on how to approach this issue. Whether or not their decisions were correct remains to be seen.

      The big issue, IMHO, is the fact that you're only testing for one disease. If you went into a doctor's office or an STD clinic, you would typically get tested for the other communicable diseases that tend to ride along with HIV (gonorrhea, chlamydia and to a lesser extent, syphilis and Herpes). While these won't kill you right off the bat, they are important enough in their own right.

      --
      Faster! Faster! Faster would be better!
    7. Re:It's only 92% accurate ... by darkshadow88 · · Score: 5, Informative

      ... 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

      The test's accuracy is much higher than 92%. The test has 92% recall (it will correctly detect 92% of the true positives). In determining the accuracy, you need to take into account all the people who don't have HIV (which it will correctly detect 99.98% of the time). Based on the CDC's numbers, about 1 in 250 people in the U.S. have HIV, so the accuracy of this test would be (249/250)*99.98% + (1/250)*92% = 99.95%. The precision here (the probability that a positive returned by the test is a true positive) is the probability of a true positive detection over the total probability of a positive test result, or (1/250)*92% / ((1/250)*92% + (249/250)*0.02%) = 95%. In other words, if the test says you have HIV, there's a 95% chance it's correct. Doing the same for a negative result, you'll find that a negative result is correct 99.6% of the time.

      Your point that the test fails to correctly detect 8% of the true positives is a reasonable one, but accuracy is not the metric you should be using to evaluate. To better illustrate why accuracy is a terrible metric to use, consider a test that always returns "no". Since 99.6% of people do not have HIV, the test is 99.6% accurate, yet totally useless (0% recall and undefined precision due to no positive results). Precision and recall are what you should care about.

      TL;DR:

      • Accuracy: 99.95%
      • Precision (positive): 95%
      • Precision (negative): 99.6%
      • Recall: 92%
  4. Re:This will end badly... by ShanghaiBill · · Score: 5, Insightful

    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.

  5. Re:Seriously? by Osgeld · · Score: 4, Funny

    oh yea thats even better, rather than the local pharmacy know, now google, facebook and every single one of their ad whores know. a few hours later their friends start noticing "HIVStick" ad's on every page

  6. Re:The solution to the AIDS problem is simple: by AlphaWolf_HK · · Score: 4, Informative

    I know he's trolling, but there's actually a ring of truth to it. Approximately half of all black homosexuals have HIV.

    One study of five major cities found that nearly 50 percent of all Black gay and bisexual men were HIV-positive

    Pretty staggering number.

    source: (it's a PDF)

    http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf

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  7. Republican policies at work by antifoidulus · · Score: 4, Insightful

    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.