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FDA Panel Backs First Rapid, Take Home HIV Test

Posted by samzenpus on from the privacy-of-your-own-home dept.

TheGift73 writes in with news about an over-the-counter HIV test getting the backing of a panel of FDA experts. "American consumers may soon be able to test themselves for the virus that causes AIDS in the privacy of their own homes, after a panel of experts on Tuesday recommended approval of the first rapid, over-the-counter HIV test. The 17 members of the Food and Drug Administration advisory panel voted unanimously that the benefits of the OraQuick HIV test outweigh its potential risks for consumers. While the test, which uses a mouth swab to return a result in 20 minutes, does not appear to be as accurate as professionally-administered diagnostics, panelists said it could provide an important way to expand HIV testing. The FDA will make its final decision on whether to approve the product later this year, weighing the opinion of the panel."

18 of 94 comments (clear)

  1. If we apply our logic fairly in the US... by gatfirls · · Score: 2

    IV use and Bareback anal sex should go through the roof.

    1. Re:If we apply our logic fairly in the US... by newcastlejon · · Score: 3, Insightful

      You must be lacking in logic. This is only an HIV *test*, not a vaccine or cure.

      It needn't be a cure for HIV; if people believe a prospective partner is clean they're more likely to go bare.

      --
      If God forks the Universe every time you roll a die, he'd better have a damned good memory.
    2. Re:If we apply our logic fairly in the US... by vivian · · Score: 4, Informative

      Nailed it.
      Here in Aus, you can get STI checks free, and they actually encourage you to get one every time you change partners. Not just for AIDS, but for Hepatitis and a couple of other more common diseases I think .
      This also means there is a better chance of tracking down your partners and stopping whatever diseases you might have getting spread further. It also means if you do have a life threatening disease, you can get counselling to help you deal with this traumatic news and help stop you totally flipping out.

      Overall it helps the community, because it prevents the further spread of disease, which would otherwise cost a lot more in the long term.

      Having a test you do at home for this sort of life threatening disease, instead of getting a professionally administered one with appropriate counselling backup is the stupidest thing I ever heard of. If your coun

    3. Re:If we apply our logic fairly in the US... by mutube · · Score: 4, Insightful

      Nailed it. Here in Aus, you can get STI checks free, and they actually encourage you to get one every time you change partners.

      Same in the UK - although they don't shout about it enough in my opinion, they have started doing testing in student bars etc. which is great move. I've been checked regularly over the past few years and make a point of being open about it. Sure you get the standard 'ha ha you dirty bastard' response to begin with. But who is dirtier? It's the equivalent of being proud for never washing your hands.

      The frustrating thing is these are all absolutely preventable diseases. The religious anti-sex brigade are causing considerable pain and suffering -how moral- by perpetuating the lie that "sex is bad m'kay" and that where you stick your bits is somehow something to be ashamed of - not to mention someone else's business.

      I'll calm down now.

      --
      Python coder | PyQt Applications | Writer
    4. Re:If we apply our logic fairly in the US... by cduffy · · Score: 2

      It needn't be a cure for HIV; if people believe a prospective partner is clean they're more likely to go bare.

      Because that's the only STD in circulation?

      Incidents of AIDS may go down (and hurrah for that), but I don't really want HSV, HPV, and all the rest to become more common in turn. My significant other and I may be extremely cautious when sleeping with anyone else (heck, we're extremely cautious with each other, despite having current, clean across-the-board results), but a higher-risk environment is just that, precautions or no.

  2. Won't somebody think of the by MRe_nl · · Score: 2

    Unsupervised false positives.

    --
    "Kill 'em all and let Root sort 'em out"
  3. An inaccurate test by imcdona · · Score: 2

    This has the potential to further the spread of HIV. Someone who might otherwise get tested by a professional may opt for this test and consider themselves negative and proceed to have unprotected sex.

    1. Re:An inaccurate test by MrEricSir · · Score: 2

      But then again, someone who wouldn't have gotten tested by a doctor (out of embarassment, or perhaps financial reasons) now might be likely to self-test.

      Only time will tell what impact this has.

      --
      There's no -1 for "I don't get it."
    2. Re:An inaccurate test by vistic · · Score: 4, Informative

      If you go to a lot of clinics, this is the exact same test they will give you there (OraQuick).

      I've had this test done a few times and it always seems pretty brainless to do it. I don't think there's much risk of someone getting a false positive or false negative from something they did wrong. It's similar to a home pregnancy test I think... there's a thing that shows up whether its negative or positive, and if its positive then another thing would show up in addition to that.

      In terms of accuracy and all that, they say it's like 99% as effective as the old way where they drew blood and shipped it off to a lab for 2 weeks.

      Of course if someone did get a false positive, then they would probably go to a doctor for a more careful test.

      And of course if someone is really obsessive compulsive about it and worried they have a false negative, they can buy a bunch and test themselves daily if they really wanted to.

      The only effect I can see from this being made available is a LOT more people will know their status now. Or at least have a 99% clear indication.

      The only downside really is that they won't get to talk to a doctor. A doctor would inform them about the time "window" between time of infection and the time it would show up on a test. If there are false negatives, that's where it would be from: People mistakenly thinking they can test for HIV the day after they might have been infected.

  4. False positives and false negatives ... by Barbara,+not+Barbie · · Score: 2

    False positive - someone could get seriously beaten, even killed. After all, if you figure you're going to die anyway, why not take it out on the person who you thought gave it to you?

    False negative - you're going to spread it to others, plus delay getting treatment yourself.

    In both cases, you're still going to need to re-do the test if you're at all sane, so this is just a money grab by some drug co.

    --
    Let's call it what it is, Anti-Social Media.
    1. Re:False positives and false negatives ... by TWX · · Score: 4, Interesting

      On the other hand, false positive or real positive, one can possibly seek our medical insurance without having a documented pre-existing condition, and might actually qualify before the expensive regimen of drugs is prescribed to prolong life.

      --
      Do not look into laser with remaining eye.
    2. Re:False positives and false negatives ... by Barbara,+not+Barbie · · Score: 2

      The test is only 93% accurate in home use when detecting people wiht HIV. In other words, it misses 7 out of every 100 cases ... people who will then go on to assume they've dodged the bullet, and can unknowingly give it to others.

      For something that is literally going to be involved in making life and death decisions, such a large error rate is unacceptable.

      --
      Let's call it what it is, Anti-Social Media.
    3. Re:False positives and false negatives ... by Belial6 · · Score: 3, Interesting

      With a 20 minute outcome. I would require every new partner I have sex with to take the test. A cheek swab and 20 minutes of none penetrating fooling around is simply not that much to ask. For those that have lots of partners, a 93% error rate would pinpoint them pretty darn quick. For those that are monogamous, they are no worse off than before, and can still retest.

      I see this as more useful for testing those that you will be having sex with than for testing yourself. Keep in mind, by the time the test comes up, most people would have already decided to have sex with the other person. Not having the test at all would result in the exact same activity as having the test and getting a false negative. Now, if they could just get the same kind of test for herpes, we would be set to go.

    4. Re:False positives and false negatives ... by Capt.DrumkenBum · · Score: 3, Insightful

      For something that is literally going to be involved in making life and death decisions, such a large error rate is unacceptable.

      As compared to the error rate inherent in, "Well, I feel healthy."
      As someone who has had the experience of having my GF tell me she had just tested positive. Then having to go see the doctor, then the blood test, then wait for results. I had the first Dr. appointment of the day and the doctor was running late. I nearly lost my mind waiting.
      I think a test like this would have saved me a lot of stress.
      In case anyone cares, my test came back negative, and again 6 months later.
      This was almost 20 years ago and testing HIV+ was pretty much a death sentence back then.

      --
      If I were God, wouldn't I protect my churches from acts of me?
    5. Re:False positives and false negatives ... by Time_Ngler · · Score: 3, Funny

      Prudent people don't go in for casual "hook ups" in a bar on a Friday night.

      Exactly! Tuesday nights are ladies night.

  5. HIV transfer. by queazocotal · · Score: 3, Informative

    Your case raises the interesting issue of transmissibility.

    It's been found through studies of cases like yours that 'vanilla' couples sex, where the partners are otherwise healthy apart from one being HIV+ have well under a percent (.3% IIRC) rate per act of transmitting HIV.
    For anal, this rises to 30%.

    The reproductive system - in the absence of sores or other problems due to other diseases - is remarkably good at protecting itself from disease.

    1. Re:HIV transfer. by Capt.DrumkenBum · · Score: 2

      It's been found through studies of cases like yours that 'vanilla' couples sex, where the partners are otherwise healthy apart from one being HIV+ have well under a percent (.3% IIRC) rate per act of transmitting HIV.

      I can tell you that we were quite vigorous, and on more than one occasion I did see a hint of pink afterwords. On at least one occasion I know I was a bit rubbed raw.
      Honestly I was a bit surprised when the doctor told me I was negative. In fact I didn't really believe it until after the second test.

      --
      If I were God, wouldn't I protect my churches from acts of me?
    2. Re:HIV transfer. by BlueParrot · · Score: 2

      It's been found through studies of cases like yours that 'vanilla' couples sex, where the partners are otherwise healthy apart from one being HIV+ have well under a percent (.3% IIRC) rate per act of transmitting HIV.
      For anal, this rises to 30%.

      Your numbers are WAY off. The figures are closer to 0.1% and 1% respectively. See this study for details:
      http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1881672/?tool=pmcentrez

      Other studies have been done for Gay couples and various groups, and the numbers come off similar. They may be off by a a small factor depending on exactly how the study was done, but that 30% figure you quote is nonsense.