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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.
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.
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.
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.
... 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
Muchas Gracias, Señor Edward Snowden !
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
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
Careful with names containing L slashdot.org/~AiphaWolf_HK slashdot.org/~AlphaWoif_HK slashdot.org/~AiphaWoif_HK
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
"Hi. This is my friend, Jack Shit, and you don't know him." - Lord Kano
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.
Monstar L
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.
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.
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 test) would result in a bit of anxiety and a visit to their local clinic, wherein they'd be told they are actually fine: not much harm done.
Giving them a false negative: the vast majority will breath a sigh of relief and never ever consider going for a real test.
You can tell people "this test is not final, it has a high error rate" all you want (forget even trying to explain the concept of false negatives to the average user): people see what they want to see... In this case, they see a big blinking "you are fine, don't worry", followed by small print they won't bother reading. Meanwhile (for 8.3% of them), their HIV goes untreated.