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FDA Approves HIV Home-Use Test Kit

samzenpus posted about 2 years ago | from the take-home-test dept.

Medicine 186

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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186 comments

Come here baby... (-1)

Anonymous Coward | about 2 years ago | (#40546047)

Lets test if you are clean.

Oh women will love that...

It's only 92% accurate ... (4, Insightful)

Taco Cowboy (5327) | about 2 years ago | (#40546181)

... 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
 

Re:It's only 92% accurate ... (4, Informative)

ColdWetDog (752185) | about 2 years ago | (#40546349)

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.

Re:It's only 92% accurate ... (4, Interesting)

fuzzyfuzzyfungus (1223518) | about 2 years ago | (#40546581)

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...

Re:It's only 92% accurate ... (3, Insightful)

tnk1 (899206) | about 2 years ago | (#40547425)

Yes, in this case, I'd prefer a 1 in 12 false *positive* rate. That way, if it is false, all I did was waste some time and money at a clinic to make sure. With this, if I come up negative, it might just be a false sense of security which is much worse for everyone involved.

Re:It's only 92% accurate ... (4, Informative)

ColdWetDog (752185) | about 2 years ago | (#40548219)

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.

Re:It's only 92% accurate ... (-1)

Anonymous Coward | about 2 years ago | (#40546397)

Or you could (gasp!) stop buttfucking other men, stop using dirty needles for your drug habit, and stop sleeping with everything that walks. Before everyone mods this as a troll, you can also cut down your lung cancer risk by not smoking, lower your risk for diabetes by not eating too much sugar, and lower your risk for obesity by not hitting the buffet line three times. How is this any different?

Re:It's only 92% accurate ... (5, Insightful)

fuzzyfuzzyfungus (1223518) | about 2 years ago | (#40546649)

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.

Re:It's only 92% accurate ... (4, Insightful)

Anonymous Coward | about 2 years ago | (#40546823)

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.

Re:It's only 92% accurate ... (3, Informative)

ooshna (1654125) | about 2 years ago | (#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.

Re:It's only 92% accurate ... (1, Informative)

tnk1 (899206) | about 2 years ago | (#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).

Re:It's only 92% accurate ... (-1)

Anonymous Coward | about 2 years ago | (#40547219)

What a surprise I am more shocked breathing isnt too difficult for your tiny little brain redneck.

Re:It's only 92% accurate ... (-1)

Anonymous Coward | about 2 years ago | (#40547465)

Breathing *is* difficult sometimes. I have asthma, and the good old FDA here in the USA has seen to it that Primatene Mist inhlalers can never harm the environment again with their horrible 1/5th of an ounce of CFCs. Now go forth and fuck another man!

Re:It's only 92% accurate ... (-1)

Anonymous Coward | about 2 years ago | (#40547641)

I've never been happier about the FDA keeping a product from one specific person. Here's hoping you fail to draw breath tomorrow.

Re:It's only 92% accurate ... (-1)

Anonymous Coward | about 2 years ago | (#40547809)

Keep it classy faggot. The world is watching. Now go pork a young boy.

Re:It's only 92% accurate ... (1)

Mr. Freeman (933986) | about 2 years ago | (#40547473)

It doesn't matter who is at the most risk for transmission. Sure, you're more likely to be infected if you shoot up a syringe full of infected blood, but that doesn't mean that having vaginal intercourse is no-risk.

ANYONE can get aids from ANYONE who has aids if you have ANY TYPE of sex. End of story.

Re:It's only 92% accurate ... (1)

grouchomarxist (127479) | about 2 years ago | (#40547787)

"specifically male to male" - actually only in the male to male community. In the lesbian community it is lower than the heterosexual community.

Re:It's only 92% accurate ... (1)

wmac1 (2478314) | about 2 years ago | (#40547197)

In addition to that, during the window period of 1-3 months it might not be detected at all. Not detecting HIV does not mean the person is not infected at all.

Use it on someone else? (5, Interesting)

goodmanj (234846) | about 2 years ago | (#40546061)

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.

Re:Use it on someone else? (1)

Anonymous Coward | about 2 years ago | (#40546285)

Not really clever at all. You'd better use condom, which is 99% safe if you use it properly (test fail in identifying 1 in 12 individuos)

After all, taking body fluids from someone without his/her consentiment is illegal.

Re:Use it on someone else? (-1)

Anonymous Coward | about 2 years ago | (#40546419)

In what way is your sleazy, deceitful, unethical, and probably illegal behavior more life-saving than simply requesting the woman take the test? Hell, she'll probably thank you because she gets to see you take it, too. Never mind that it is a really stupid way to use this test. This test should be used to give yourself piece of mind before you go see a doctor to actually get tested. That's really the only thing such an unreliable test can do for you.

Don't even get me started on the twisted thinking that sees one side of it as "a false sense of security" and the other side "potentially lifesaving". The words you were looking for are "potentially fatal."

And try to remember there are other STDs out there that, while not as deadly, are permanent and life-altering.

Re:Use it on someone else? (3, Insightful)

Anonymous Coward | about 2 years ago | (#40546495)

What i like about this is the possibility of social pressure :-)

and being "at home" possibly some who would never get tested will take one (for curiousity or due to this pressure) and if that catches a few positives (even a few false positives) that go get checked up at the doctor, that should be an overall win to society.

Re:Use it on someone else? (4, Insightful)

hawguy (1600213) | about 2 years ago | (#40546603)

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.

Re:If you distrust this partner so much (0)

Anonymous Coward | about 2 years ago | (#40547169)

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.

Re:If you distrust this partner so much (1)

Belial6 (794905) | about 2 years ago | (#40548259)

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.

Re:Use it on someone else? (2)

backslashdot (95548) | about 2 years ago | (#40548093)

AIDS is the only currently incurable life threatening disease you can get that I know of. You may get herpes, which is incurable .. but its not usually life threatening. You may get hepatitis C, which is life threatening but the cure rate is fairly high (and improving) with modern treatment regimens.

Re:Use it on someone else? (0)

Anonymous Coward | about 2 years ago | (#40546611)

Wow, you sound like a tremendous asshole.

Re:Use it on someone else? (1)

santax (1541065) | about 2 years ago | (#40546789)

Do not worry son, with your attitude you will never get the AIDS. Here's a new hyper-link and a fresh box of tissues. Carry on son.

Re:Use it on someone else? (0)

Anonymous Coward | about 2 years ago | (#40547123)

Hey, he's just looking out for your best interests. No saying what the fag you brought home from the Linux users group has. So while he's shooting in your ass as you scream "Oh Linus!" you can have some peace of mind.

Re:Use it on someone else? (2)

santax (1541065) | about 2 years ago | (#40547359)

You are mistaken sir, you are referring to Linus User Groups and not Linux User Groups.

Re:Use it on someone else? (0)

Anonymous Coward | about 2 years ago | (#40547633)

>>Unethical

Terrible spelling. You got most of the letters in ILLEGAL wrong.

Seriously? You think that doing invasive medical tests on somebody without their consent is only "unethical"?

Re:Use it on someone else? (2)

fermion (181285) | about 2 years ago | (#40547679)

It is not a pregnancy test. The setup is quite complex [oraquickhivtests.com] and seems highly susceptible to human error. Latex condoms seem highly effective to reduce the risk of infection when engaging in risky sex, or at least better than a test.

I remember a time when condoms were considered absolutely unromantic.

Re:Use it on someone else? (1)

Frankie70 (803801) | about 2 years ago | (#40547905)

Steps
1) Get partner home from bar
2) Get them to sleep as soon as they reach your home
3) Test them for HIV
4) If they test negative, wake them up and have sex.

Good and bad (2)

Anrego (830717) | about 2 years ago | (#40546069)

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.

Re:Good and bad (0)

Anonymous Coward | about 2 years ago | (#40546117)

yes but you're already half expecting to get it. its not like you just randomly contract it

Re:Good and bad (4, Insightful)

LordLucless (582312) | about 2 years ago | (#40546151)

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.

Re:Good and bad (3, Insightful)

hawguy (1600213) | about 2 years ago | (#40546677)

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.

And it's not just the fact that they won't go to a clinic for themselves, but now those 1 in 12 will proclaim to future partners "Don't worry, I'm clean, I was just tested". And if there's a biological reason that makes an individual more likely to get a false negative, this makes the problem even worse as he continues to get negative results, test after test despite being infected.

I'd feel better about this test if the false positive and false negative rates were reversed. Sending 1 out of 12 people to the doctor because they got a false positive (and missing just 1 out of 5000 actual HIV infections) sounds a lot better than the reverse.

Re:Good and bad (3, Insightful)

lessthan (977374) | about 2 years ago | (#40547675)

I don't get it. Yours is the third or fourth comment I've seen lamenting the failure rate. If you are sexually active, with multiple partners, you should be getting tested every 6 months minimum. With an over-the-counter version for about $20, I'm probably going to do it every month. (I'm a bit of a hypochondriac, but I do get laid occasionally.) I like to think of myself as unusually unlucky, but 6 times in a row? That is rather improbable.

Re:Good and bad (-1)

Anonymous Coward | about 2 years ago | (#40546237)

The whole finding out you (might) have a terminal illness while alone in your bathroom might cause some issues.

HIV is not the death sentence it once was. In fact in the gay community it's almost a badge of honor.

The pharmaceutical companies have gotten real good at <strike>keeping these people alive</strike> sucking money out of desperate people and insurance companies.

Re:Good and bad (1, Troll)

spike hay (534165) | about 2 years ago | (#40546379)

Haha, no it's not a badge of honor in the gay community. There's a huge stigma that actually keeps people from getting tested.

Re:Good and bad (1)

amiga3D (567632) | about 2 years ago | (#40547017)

I doubt living with a ticking time bomb is that much of an honor. Survival rates are up but not everyone does as well as Magic Johnson.

Re:Good and bad (0)

Anonymous Coward | about 2 years ago | (#40547241)

HIV is not a terminal illness anymore with modern antivirals. It's manageable similar to herpes. People with HIV are living old now and dying of other causes. Not to diminish the seriousness of the disease, but it's not the death sentence it was in the 1980's..

Seriously? (-1)

Anonymous Coward | about 2 years ago | (#40546077)

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 don't know what the FDA is thinking about releasing this. Sure it sounds nice if you think about it, its VERY convenient but there is a REASON why people have to go through medical professionals to get tested. Because they will know what to do to TREAT a person who is infected, both with medication and therapy to get over the very obvious, very dark taboo that society itself pinned on HIV positive people and their own fears and emotional baggage as well.

Re:Seriously? (0)

Anonymous Coward | about 2 years ago | (#40546153)

That's what mail order is for...

Re:Seriously? (1)

Georules (655379) | about 2 years ago | (#40546233)

So, you do know there's a thing called the internet where you can order products and have them shipped to your house right?

Re:Seriously? (4, Funny)

Osgeld (1900440) | about 2 years ago | (#40546263)

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

Re:Seriously? (1)

hawguy (1600213) | about 2 years ago | (#40546713)

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.

This will end badly... (2, Insightful)

multiben (1916126) | about 2 years ago | (#40546113)

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.

Re:This will end badly... (5, Insightful)

ShanghaiBill (739463) | about 2 years ago | (#40546223)

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.

Re:This will end badly... (0)

Anonymous Coward | about 2 years ago | (#40546333)

^^ this

Re:This will end badly... (0)

Anonymous Coward | about 2 years ago | (#40546365)

Why would they stop doing that behavior? Do they have HIV-Positive swinger parties? Do you get f ree needles when you get HIV?

Re:This will end badly... (0)

Anonymous Coward | about 2 years ago | (#40546385)

Because if you knowingly transmit HIV without consent, you can be charged with murder.

Re:This will end badly... (0)

Anonymous Coward | about 2 years ago | (#40546459)

But it wasn't me who gave them hiv.... I figured with such a high false positive rate, I didn't have it.

Re:This will end badly... (0)

Anonymous Coward | about 2 years ago | (#40547143)

Either way, you're explaining that to a judge, for a murder trial. Which means even if you're successful, you have months (years?) of lost work opportunity, lawyer fees, and your name permanently tarnished if, in fact, you go with the defense you suggested. You'll be ruined financially.

Re:This will end badly... (0)

Anonymous Coward | about 2 years ago | (#40547409)

I'm not convinced the people who most need this test will take it. Tests are already available and for whatever selfish reason they'd rather risk sentencing someone else to death than find out for sure.

Re:This will end badly... (1)

multiben (1916126) | about 2 years ago | (#40548171)

Your logic is fundamentally flawed. Why on earth would you assume that people who are seeking an HIV test are already spreading it around?!? The other (far more likely) scenario is that they are concerned they may have contracted HIV and are looking for confirmation one way or the other *before* engaging in activities that may spread it further. Prior to the existence of this test you could go to the doctor and find out *for sure* if you had it or not. Now with this test people may miss that very important step. Follow this:

Scenario 1
A person is worried they have HIV. They go and purchase a home test kit. The test turns up negative. Then they release there is a chance the test is not right and go to the doctor to find out for certain.
Scenario 2
A person is worried they have HIV. They go and purchase a home test kit. The test turns up positive. Then they release there is a chance the test is not right and go to the doctor to find out for certain.

Whatever happens, the patient has to go to the doctor at some point. The test is worse than useless because of the potential that people will not make that final step and go to the doctor!

Who was bribed? (0)

Anonymous Coward | about 2 years ago | (#40546347)

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?

Re:Who was bribed? (1)

backslashdot (95548) | about 2 years ago | (#40548133)

Uh nobody was bribed, I am sure the packaging will explain the failure rate. This will save more lives than those it may result in infections with. It is a safeguard for people who might otherwise engage in risky sex. It's like using a condom. Condoms are not 100% either. The 1 in 12 failure rate is because new/recent infections wont show up. So if you are really paranoid about htat you can wait for a 6 months period. Also, the 1 in 12 failure is not that high in the context of the probability of encountering an HIV positive partner .. which is fairly low unless you are in a high risk group.

Re:This will end badly... (0)

Anonymous Coward | about 2 years ago | (#40546391)

Agreed. A Type 2 Error [wikipedia.org] rate of 8 percent is unacceptable. Maybe its ok if it's only supposed to be an initial screen and you have to get another slower test afterwards.

you .. you ... (-1)

Anonymous Coward | about 2 years ago | (#40546129)

DOUBLE NIGGER!

The solution to the AIDS problem is simple: (-1)

Anonymous Coward | about 2 years ago | (#40546283)

Don't have sex with niggers.

Re:The solution to the AIDS problem is simple: (4, Informative)

AlphaWolf_HK (692722) | about 2 years ago | (#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]

Re:The solution to the AIDS problem is simple: (1)

Anonymous Coward | about 2 years ago | (#40546779)

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.

Re:The solution to the AIDS problem is simple: (0)

Anonymous Coward | about 2 years ago | (#40547229)

I think you're a slut's butt probe. We all have our thoughts.

Re:The solution to the AIDS problem is simple: (1)

AlphaWolf_HK (692722) | about 2 years ago | (#40548267)

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.

Re:The solution to the AIDS problem is simple: (-1)

Anonymous Coward | about 2 years ago | (#40546465)

Unless you're a nigger.

50,000 new cases of HIV each year (-1)

Anonymous Coward | about 2 years ago | (#40546337)

That's a lot of buttsex.

Error Rate High, but Still Useful (1)

Anonymous Coward | about 2 years ago | (#40546381)

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.

good thing for the affordable care act or this wh (1)

Joe_Dragon (2206452) | about 2 years ago | (#40546583)

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.

Re:good thing for the affordable care act or this (2)

wickerprints (1094741) | about 2 years ago | (#40547115)

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.

They should sell these (3, Interesting)

Lord Kano (13027) | about 2 years ago | (#40546631)

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

cool I think I'm going to invest some money (0)

Anonymous Coward | about 2 years ago | (#40546665)

... 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.

Republican policies at work (4, Insightful)

antifoidulus (807088) | about 2 years ago | (#40546725)

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.

Re:Republican policies at work (-1)

Anonymous Coward | about 2 years ago | (#40546993)

Yes, I modded your worthless oversized-anus ass "overrated." George Bush gave more money to AIDS relief for Africa than Obama has. You want to take it in the pooper, that's fine. Get out of my face, and stop whining about how your own stupid behavior got you infected. I don't know about your self-worth, but I don't value you very highly at all. You want to smoke? Accept the risk of lung cancer. You want to engage in self-destructive behavior? Then accept the consequences.

Re:Republican policies at work (-1)

Anonymous Coward | about 2 years ago | (#40547273)

Truth hurts so you mod it down eh asshole? Just another pathetic american redneck it seems.

Re:Republican policies at work (-1)

Anonymous Coward | about 2 years ago | (#40547517)

I modded you down too. I have three points left from the original 15. Now go suck a cock.

Cool exactly what i wanted! (-1)

Anonymous Coward | about 2 years ago | (#40547921)

Did you asshole well whoop de do,glad I wasted your point, care to mod this down, and waste another one. If you had any fucking balls you wouldnt post such drivel as an AC. (: Sorry but unlike yourself I dont suck cocks and lick asses.

Re:Republican policies at work (-1, Troll)

antifoidulus (807088) | about 2 years ago | (#40547971)

And your shithead reasoning that giving money is the same as helping is why you are a Republican, i.e. a shithead. Money if spent on the wrong things can not only be useless, it can be harmful. But then again, arguing facts and logic with a Republican won't do any good, shitheads will be shitheads.

Re:Republican policies at work (2, Informative)

Anonymous Coward | about 2 years ago | (#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.

Re:Republican policies at work (1)

antifoidulus (807088) | about 2 years ago | (#40548011)

Um, since when did denigrating Republican policies automatically constitute an endorsement of the Democrats, I must have missed that meeting. Your little libertarian pseudo-intellectual rant is cute, for a 3rd grader, but guess what, in countries where the government has even less power HIV rates are higher, Germany's very highly developed public health system and government sponsored campaigns to distribute condoms and clean needles are a big part of why the HIV rate is so low. So yeah, those pesky facts and logic getting in the way again.

Re:Republican policies at work (0)

Anonymous Coward | about 2 years ago | (#40548073)

Yeah, I'll try not to let your "logic" get in my way.

Re:Republican policies at work (1, Insightful)

Anonymous Coward | about 2 years ago | (#40547513)

Posting anon since there is still a huge stigma with being HIV positive...

I am HIV positive. I am a registered Republican. And I am an atheist.

Not all Republicans are religious nutjobs in the same way that not all Democrats are hippie nutjobs.

I am getting sick and tired of the "my team = good, your team = bad" divisiveness which is tearing this country apart. We can't even have intelligent debates on ideas anymore if one person discovers the other is a "libtard" or a "teabagger".

The above post contains assumptions and sweeping generalizations and is just one more example of the desired squabbling in what appears to be the ruling-class' plan of divide and conquer. It seems to me that the swine who call themselves Democrats and Republicans in government want the people to blame the "other side" for all the ills in the world--and the only way it can be fixed is to grant them more power (be it Republican or Democrat).

Re:Republican policies at work (1)

antifoidulus (807088) | about 2 years ago | (#40548083)

First and foremost, stop reading things in my post that are not there. I did not ONCE mention the Democrats, not once. My post wasnt intended to praise their policies per se, but rather praise the policies of countries like Germany who have kept the disease relatively under control. Democratic support for these various policies varies considerably, but unlike Republicans there arent very many Democrats that are downright hostile towards policies that have been EMPIRICALLY PROVEN to reduce HIV rates. That is solely the domain of the radical right in the US.

Theres conservatism, and then there being a Republican, you don't have to be the latter to be the former. The problem isnt conservatism per se(though like any ideology it can become problematic when you ignore any empirical data that contradicts your ideology), but the Christian facism of the modern Republican party is not conservatism, its facism pure and simple. Whatever tax plan or economic ideas they have dont really matter in light of the fact that they are trying to force Americans to adopt Christianity against their will.

Are you positive this will work? I'm not just po.. (-1)

Anonymous Coward | about 2 years ago | (#40546857)

Are you positive this will work?

I'm not just positive, I'm HIV positive.

Common sense.... (0, Troll)

InspectorGadget1964 (2439148) | about 2 years ago | (#40546891)

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.

Re:Common sense.... (0)

Anonymous Coward | about 2 years ago | (#40546955)

I am sure those who were infected via transfusions, rape or medical accidents would disagree.

Sensitivity is only part of the story (3, Interesting)

wickerprints (1094741) | about 2 years ago | (#40547071)

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.

Hmm...HIV remains 99% in its original risk groups (0)

Anonymous Coward | about 2 years ago | (#40547087)

http://www.youtube.com/watch?v=_p-ttLfkZHQ

quarantine (-1)

Anonymous Coward | about 2 years ago | (#40547231)

Why is it... When it a disease is sexually transmitted. Suddenly we forget all about our quarantine procedures that stop shit from being transmitted....

Stuff can kill people and oh.. you got it with your fun parts? we're gonna pretend it's your problem only.

People should be careful how they pay for the test (1)

Anonymous Coward | about 2 years ago | (#40547451)

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.

you are such a baby (0)

Anonymous Coward | about 2 years ago | (#40547471)

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.

It's stupidly easy to get tested (for free) (1)

Y-Crate (540566) | about 2 years ago | (#40547719)

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 [outofthecloset.org].

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!"

Who needs specificity, with such poor sensitivity? (2)

zedrdave (1978512) | about 2 years ago | (#40547959)

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.

Re:Who needs specificity, with such poor sensitivi (1)

zedrdave (1978512) | about 2 years ago | (#40547979)

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.

Re:Who needs specificity, with such poor sensitivi (1)

wickerprints (1094741) | about 2 years ago | (#40548097)

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.

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