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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.
That's what mail order is for...
... 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 !
So, you do know there's a thing called the internet where you can order products and have them shipped to your house right?
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 agree. 1 in 12 failure rate is far too high. I'd also call the 1 in 5000 far too high.
What I want to know is who was bribed to allow this product to be brought to the market?
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.
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
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.
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
... into pharma. Looks like there'll be a lot more people recruited into HIV "treatments" ;-)
Muhahahaha the slashdot 'lameness' filter doesn't let me laugh as much online as I am
laughing at you gullible sheeple offline. Anyhow its a good idea, disease is a growth industry.
That is absolutely ridiculous...they want to do the test themselves? Its like a huge neon sign going "HI I MAY BE HIV POSITIVE!!!". EVERYONE is going to want to do that now and they will know what it means, just like a pregnancy test, so the whole "do it at home to not feel ashamed" thought process goes right out the window. Not to mention that without the proper treatment, the people who are infected will have a bad life expectancy, won't live normal lives...just so many issues with this.
I think that's the problem this test is supposed to solve - one out of 5 people with HIV don't realize it, so the sooner they take the test, the sooner they can begin treatment since the longer they wait the harder it is to treat.
I don't know why you think that picking up a home test "for a friend" from the pharmacy or ordering it through mail order is more of a stigma than making an appointment at a clinic or with your doctor for the test.
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
I met a woman recently who claimed to have HIV. Her virus load was "undetectable", and I think the hepatitis C and depo-provera-induced osteoporosis (that's the 3-month birth control injection) was much more significant in her daily life than HIV ever will be.
Majic Johnson is still alive, afaik... So what else is going on with people who test positive for HIV? What is the difference between someone who dies, and someone whose body successfully keeps the virus in check?
HIV never blew up like it was supposed to. /methinks we are being lied to.
If you go around doing stupid things, you are likely to die. Werther it is playing with explosives, driving carelessly or having unsafe sex. Just make sure you know who you are with and don't be stupid enough to get into drugs. Then you will be fine.
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.
http://www.youtube.com/watch?v=_p-ttLfkZHQ
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.
Hell yeah, though maybe not while asleep, but if you just wanna hook up, this is miles away better than just taking their word for it or if they even agree, waiting weeks for a test.
I think you're a slut's butt probe. We all have our thoughts.
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.
HIV does not define who you are or what type of person you are. HIV does not rob you of your desires, your goals, or your personality. 70 million are afflicted with STD in the U.S. alone and an estimated over 400 million worldwide. www.positivechats.com is a warm STD dating site for 680,000+ singles with hiv and other STDs. 100% anonymous.
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 shopping at a thrift store.
If you want to be tested at home, the Home Access brand kits will run about $50, and offer 99.9% reliability. The catch being the 72 hour turnaround time. I'm not thrilled with OraSure's reliability. 1 false positive in 5,000 isn't too bad, while 1 false negative out of 12 is kind of terrible. This isn't testing for high cholesterol, it's literally "Hey baby, no need to use a condom, I'm clean!"
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.
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); and HSV, which often leads to becoming a lifelong carrier. (2) Most everyone knows that there is a window in which one could be HIV-positive but the concentration of antibodies is below the detection threshold. (3) People who are responsible enough to bother getting tested AT ALL are also generally responsible enough to know better than to consider a potentially unreliable test as definitive justification for unprotected sex--that is, the ones who never get tested because of avoidant coping are the real high-risk group.
Basically, I'm not entirely convinced that the people who would go and purchase OraQuick OTC are the kind of people who would see a negative result as an excuse to subsequently engage in high-risk behavior. In any population, yes, you'll have some idiots. But to be able to test them at all is far more preferable than no test. The benefit of being able to reach those 11 out of 12 who do correctly test positive far outweighs missing the extremely small proportion of the population who might get a false negative, and the even smaller proportion of those who think a negative result is a license to become reckless.
Ultimately, frequent, widespread, and regular testing is the single best approach to HIV detection, even if the test has low sensitivity, because the more often you can test, the better chance you have at catching infection early enough to limit further transmission. And the easiest and safest test to administer at present is the oral swab--drawing blood through the arm is difficult, time-consuming, and carries risk of injury. Combined with prevention through education, widespread testing is the ONLY way we are going to reduce infection rates. Vaccines and cures are just too far off; we've been battling HIV for nearly 30 years now, and despite all the drug advances, all we have managed to do is to turn HIV into a chronic condition with lifelong complications, with the potential for multidrug resistance.
Exactly, and if the failure rate is per test, and not per person, if that infected person has multiple partners, the chances of them finding out and ending their promiscuity goes way up.
HIV is still as deadly as it ever was. The only thing that changed in the 90's is big pharma produced some drugs that inhibit the HIV virus from reproducing. Trouble is, no one drug works indefinitely. The virus adapts to the drug the patient is currently taking, and once it does, they have to switch to a new one. The side effects of these drugs are terrible, and they aren't completely effective; you still have a significantly diminished immune system.
When the virus mutates to resist drugs, it does lose some of its potency of being able to reproduce. However this is ultimately a losing battle. Some strains of the virus have recently shown up that are resistant to multiple drugs, and retain their ability to spread every bit as effectively as the wild form of the virus (that is, the one that hasn't been exposed to drugs that killed everybody in the 80's.)
Some people think that having sex with another HIV infected person is harmless, but they're dead wrong. You're liable to end up with two strains of the virus; one resistant to one drug, and one resistant to another. Or worse, you could end up with the multi-drug resistant variant.
Sure, HIV hasn't blown up....yet.
Careful with names containing L slashdot.org/~AiphaWolf_HK slashdot.org/~AlphaWoif_HK slashdot.org/~AiphaWoif_HK
Stay out of Sweden.
One of the first long term survivors of AIDS figured this out on an intuitive level. Instead of taking the "I've got it, I might as well screw around with other people who've got it" approach, he instead became celebate. He ended up being studied by researchers to find out why he lived so long. There may have been some genetic advantage. There are people running around who have nearly complete immunity; but I don't think he was one of those guys. The name escapes he.
Anyway, from what I recall having studied this a number of years ago, the drugs are not perfect. You can end up with weird fat deposits and other problems. HIV might not be a death sentance, but it will still tie your body down like diabetes or asthma. Oh, and let's not forget that the drugs aren't cheap. So yeah, I'm SoooooO eager to get a chronic condition and another financial hassle. Not!
... and 99% of you don't even know what 'AIDS' is.
Read this book:
http://www.amazon.com/Science-Sold-Out-Really-Cause/product-reviews/1556436424/ref=dp_top_cm_cr_acr_txt?ie=UTF8&showViewpoints=1
Read this article:
www.tig.org.za/The%20trouble%20with%20nevirapine.pdf
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.
"When information is power, privacy is freedom" - Jah-Wren Ryel
Might as well bring up a new BackTrack release at an Amish town meeting...
"When information is power, privacy is freedom" - Jah-Wren Ryel
If you do this in Sweden
There is a reason why 1 in 12 tests fail to detect it. From what I have been told in the past (which may have changed over the years), the HIV virus has a period of time in which it cannot be easily detected. This window can be a few months long. If somebody finds out that their partner has the virus and immediately takes the test, then it may not detect it if they have not been with that person long.
Also, I saw an interview about this a few nights ago. The doctor repeatedly stated that most people should go to a doctor's office to get the test. However there is a small group that do not go to a doctor's office (it may be out of embarrassment or fear of stigma or something else). This test is aimed at that small group... doctors and the makers of the test figure that a test like this (that may not be as informative as a consultation with a doctor) is better than not test at all. The doctor also stressed that the makers of the test will have a hotline to provide information on how to find a real doctor and get immediate treatment.
Yes, you are indeed being lied to. Read the book 'Science Sold Out', or just Google 'HIV does not cause AIDS' and start READING.
The reason so many gay men died in the 80s was because they were either taking so many recreational drugs and partying so much that they ruined their immune systems, OR they were being poisoned to death by AZT and the other 'life saving' drugs which the pharmaceutical industry foisted on them.
Magic Johnson is still alive because HIV does not cause AIDS, and he is on a low enough dose of the toxic drugs that they don't kill him.
Read the article 'The trouble with Nevirapine', freely available online.
There is a stigma associated with being a male gay/bisexual that still exists and this is higher in the south and in black and hispanic communities. Men who are gay must still have a wife and kids to fit in. Men who are bisexual cannot admit it or they will be excluded by both gay and straight communities since they cannot be trusted. This leads to a lot of dishonesty and less communication since you cannot discuss what is going on with others until perhaps it is too late.
Don't think that's true - go to one of the hook-up sites and see how many single women or couples are ok with you being a male bisexual. Suddenly everyone is straight with nary a male bisexual in sight.
Same goes for drug users. On a hook-up site everyone is drugs/disease free. Amazing how that can be true. It's almost as if someone were being less than truthful so they are not excluded.
And right now there's an even bigger advantage: After testing positive, you can then proceed to buy health insurance. ;)
And as for 'stigma'...yeah, that's dumb. It's not a prescription, it doesn't even require ID. Just drive a few towns over and buy it with cash. Or, of course, buy it online.
If I were this company, I'd have mail-order forms in the box, with a way for people to set up a 'subscription' where they got sent a new test every three months.
Incidentally, I think instead of trying to figure out ways 'around' the 'stigma' of AIDS, we should, you know, stop it from having one. What is this, 1986?
Hell, I had plenty of surgeries in the mid-80s, right when it was coming into the public eye and not yet being tested for in blood. I could have gotten AIDS from blood transfusion. I didn't, but I could have.
And, you know what, it's time we stop using the 'they could have gotten it without sex' excuse, anyway. Even people who got it via unprotected sex...well, they engaged in risky behavior and hit a landmine. That does not mean they are, in any way, bad people, or we should think worse of them. Until I see the same critizism of people injured in car accidents (Driving is pretty risky also), I'm forced to assume this is some sort of homophobia bullshit. (The fact the other thing mentioned was pregnancy test is, I think, telling. Homophobia _and_ misogynistic slut shaming, hand in hand, as God intended.)
Not that I'm suggesting the GP is those things. I'm suggesting he's listening to people who are, that he lives in a place where gossiping about other people is reasonable. Next time that happens, he should just punch them in the face and tell them to mind their own business about medical conditions of others.
If corporations are people, aren't stockholders guilty of slavery?
That is a damn good observation. I could easily imagine risk models that would cut someone's credit lines off right quick after a purchase like that.
I'm like that - I got raped in a bad incident and got infected that way. Pretty much gave up on dating after that (for loads of psychological reasons, but I got over that). Pretty much had three short term partners in the last 17 years. I don't want to be responsible for randomly infecting someone, especially without their knowledge. Is being celibate the way I saw my life? Nope, but there might be something to it. I've had it for 17 years now and you wouldn't know it to look at me. Oh yeah - no meds in years. Posting AC for the usual reasons. I wish I was brave enough to post under my real /. id, but I'm not. Maybe someday :) I've been on /. too long to have my rep ruined by some idiot :(
HIV is still as deadly as it ever was. The only thing that changed in the 90's is big pharma produced some drugs that inhibit the HIV virus from reproducing. Trouble is, no one drug works indefinitely. The virus adapts to the drug the patient is currently taking, and once it does, they have to switch to a new one. The side effects of these drugs are terrible, and they aren't completely effective; you still have a significantly diminished immune system.
When the virus mutates to resist drugs, it does lose some of its potency of being able to reproduce. However this is ultimately a losing battle. Some strains of the virus have recently shown up that are resistant to multiple drugs, and retain their ability to spread every bit as effectively as the wild form of the virus (that is, the one that hasn't been exposed to drugs that killed everybody in the 80's.)
Some people think that having sex with another HIV infected person is harmless, but they're dead wrong. You're liable to end up with two strains of the virus; one resistant to one drug, and one resistant to another. Or worse, you could end up with the multi-drug resistant variant.
Sure, HIV hasn't blown up....yet.
What is frightening is going on to those amateur porn sites like xtube and youporn and seeing most of the gay men their having raw, unprotected sex.
The environment for creating a super-strain of HIV is already in place and percolating away.
of their HIV status being positive in the US, why is it that we aren't seeing the kid of crisis we saw back in the 80's, or the half of all Americans infected that Oprah promised us, back in the early 90's ?
On thing Americans can be counted on for is our remarkable selective amnesia.
Or could the estimates that a million and a half people in the US are HIV positive, but don't know it wrong. Again.
I wonder what has changed which makes it a good idea to hand-out HIV tests to anybody without any kind of screening or support.
Used to be, you couldn't even get your test results over the phone, without going in to talk to somebody.
This will make another drug company with FDA ties some big bucks, but it will do so at the cost of lives. I wonder why it is all those HIV/AIDS not for profits are not in an uproar over this - then again, they get the bulk of THEIR funding and perks from the drug companies, too.
So who is it that's doing real patient advocacy nowadays in the US, because it's sure not the not for profits, the government, or our doctors.
The only people that benefit by the flurry of false positives tests like these create are the people that insist that AIDS funding in all it's manifestations in the US is justified, even though it represents WAY more spending per person affected than with ANY other disease.
These tests are a scam, but not anything new, when it comes to the scam that is HIV/AIDS.