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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 ColdWetDog (752185) on Wednesday July 04, 2012 @08:51PM (#40546349) Homepage

    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.

  • by AlphaWolf_HK (692722) on Wednesday July 04, 2012 @08:58PM (#40546411)

    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 [whitehouse.gov]

  • by ooshna (1654125) on Wednesday July 04, 2012 @10:50PM (#40547159)

    A big part of that was the lack of condom use among homosexuals in the 70s and 80s. Who is going to wear a condom when there is no risk of anyone getting pregnant. Another risk was the fact that the homosexual community was so small and hidden back then. If one guy caught AIDS it wouldn't take long for it to make the rounds in that area due to lack of choice in partners.

  • by Anonymous Coward on Wednesday July 04, 2012 @11:14PM (#40547339)

    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 make their own decisions and that any sense of self worth derived from external sources isn't "self" worth at all. Obviously only Republicans are religious and against homosexuality, so it's the Republicans again!

    Here's a hint: Any power you want for your precious Democrat overlords to "fix" things can also be used by Republicans to "unfix" them. Maybe you live in a fantasy world where you believe everything will be alright as long as the "right people" are in charge, but surely you realize that the Republicans still manage to get elected and do stuff. So maybe the solution isn't to try to find the "right people" but to limit the government's ability to make things worse. After all, if the government has less power, those "Republican" policies can't hurt anybody. And if those policies aren't "Republican" at all, you'll be killing two birds with one stone.

    Oh, and just for the record, I'm pretty much on your side about the actual issues (but your hate is something else entirely). Abstinence only education is stupid. Access to clean needles and condoms is a must (though not necessarily at taxpayer expense). Homophobia is stupid (but that's their choice). But the anti-cheerleading against the Republicans isn't helping and it's not even accurate.

  • by tnk1 (899206) on Wednesday July 04, 2012 @11:58PM (#40547697)

    CDC figures still indicate that half of all new HIV infections are in men having sex with men (gay or bi). From what I can tell, the factors that you mention are actually still in effect and did not end in the 70s and 80s. While there is more knowledge of risk factors, that appears to be offset by the complacency of younger gay or bi men to the risks, as AIDS is no longer front page news, nor necessarily a death sentence.

    2009 CDC Fact Sheet
    http://www.cdc.gov/nchhstp/Newsroom/docs/FastFacts-MSM-FINAL508COMP.pdf [cdc.gov]

    From the summary:

    * MSM account for nearly half of the approximately 1.2 million people living with HIV in the United States (49%, or an estimated 580,000 total persons).
    * MSM account for more than half of all new HIV infections in the United States each year (61%, or an estimated 29,300 infections).
    * While CDC estimates that only 4 percent of men in the United States are MSM, the rate of new HIV diagnoses among MSM in the United States is more than 44 times that of other men (range: 522 – 989 per 100,000 MSM vs. 12 per 100,000 other men).

  • by ColdWetDog (752185) on Thursday July 05, 2012 @01:42AM (#40548219) Homepage

    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.

  • by darkshadow88 (776678) on Thursday July 05, 2012 @02:13AM (#40548345)

    ... 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%
  • by FrootLoops (1817694) on Thursday July 05, 2012 @04:51AM (#40549003)

    you can go to the CDC website and see for yourself.

    Indeed, here's a summary from the CDC [cdc.gov] from the end of last year. The most relevant part to your point:

    While CDC estimates that only 4 percent of men in the United States are MSM, the rate of new HIV diagnoses among
    MSM in the United States is more than 44 times that of other men (range: 522 – 989 per 100,000 MSM vs. 12 per
    100,000 other men).

    I have that link somewhat handy since I'm a gay male. For any other gay guys, to protect yourself...
    1. Be monogamous; if you can't,
    2. Skip anal and go for oral, which has a much smaller HIV transmission risk to both partners (basically 0 to the guy who's getting head); it's safest not to get cum in your mouth; if you can't,
    3. Always use a condom and top--bottoming has a far higher transmission risk; if you can't,
    4. Never fucking bareback with a guy you're not absolutely certain is HIV negative no matter what you asshole. You make us all look bad. If you can't,
    5. Test yourself often (1-3 months). When you become positive, only have sex with other positive guys. There is no more "if you can't".

    It should be noted that condom usage is highly effective but also imperfect. Depending on the study, they reduce exposure risk by only around 80%. For more precise transmission statistics, the Transmission [wikipedia.org] section of the HIV/AIDS Wikipedia article has a good summary and good sources (though you usually need journal access to read them). The Prevention section is also worth reading.

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