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FDA Panel Backs First Rapid, Take Home HIV Test

samzenpus posted more than 2 years ago | from the privacy-of-your-own-home dept.

Medicine 94

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

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94 comments

If we apply our logic fairly in the US... (2)

gatfirls (1315141) | more than 2 years ago | (#40022169)

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

Re:If we apply our logic fairly in the US... (0)

Anonymous Coward | more than 2 years ago | (#40022465)

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

Re:If we apply our logic fairly in the US... (3, Insightful)

newcastlejon (1483695) | more than 2 years ago | (#40022757)

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

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

Re:If we apply our logic fairly in the US... (2)

cduffy (652) | more than 2 years ago | (#40023915)

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

Because that's the only STD in circulation?

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

Re:If we apply our logic fairly in the US... (-1)

Anonymous Coward | more than 2 years ago | (#40022489)

This breakthrough makes me proud to be an American!

People in Iran and North Korea don't have the freedom to pay for a kit to test for HIV infections in the privacy of their own homes.
Instead, they have no choice but to suffer under the cruel yoke of their unjust oppressors who force them to go out to a clean and attractive neighborhood medical clinic for a free test covered by their universal health insurance coverage.

My heart swells with pride every time I get another medical bill. I'm proud to do my duty to defend freedom by mortgaging my home again!

Re:If we apply our logic fairly in the US... (4, Informative)

vivian (156520) | more than 2 years ago | (#40022775)

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

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

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

Re:If we apply our logic fairly in the US... (1)

vivian (156520) | more than 2 years ago | (#40022827)

cut my own post off short... Continuing...
if your country can't afford to administer these sort of basic tests for free as part of the health services that ultimately protect the whole population, you have to question what's the point of spending billions on trying to build surveillance networks and military defences against theoretical reds/terrorists/whatever, but completely ignoring the medical front line of defence against those little buggers (viruses and contagious diseases) that can just as easily decimate your population if unchecked.

I admit, I don't like going to get tested - it's a bit embarassing and can be inconvenient - but it's a lot better than not knowing, and of course means you and your new partner can have complete peace of mind.

Re:If we apply our logic fairly in the US... (4, Insightful)

mutube (981006) | more than 2 years ago | (#40023547)

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

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

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

I'll calm down now.

Re:If we apply our logic fairly in the US... (1)

dasunt (249686) | more than 2 years ago | (#40025061)

Here in Aus, you can get STI checks free, and they actually encourage you to get one every time you change partners. Not just for AIDS, but for Hepatitis and a couple of other more common diseases I think .

I don't know why they don't don't do the STI tests during a yearly checkup. Even if someone is monogamous, they can't be certain their partner didn't cheat, so it's a good idea.

Re:If we apply our logic fairly in the US... (0)

Anonymous Coward | more than 2 years ago | (#40029399)

I'm not sure how checking your Subaru has anything to do with preventing AIDs, but okay.

Re:If we apply our logic fairly in the US... (-1)

Anonymous Coward | more than 2 years ago | (#40023011)

I've been modded down by a persia-loving, america-hating, godless commie.

Re:If we apply our logic fairly in the US... (0)

Anonymous Coward | more than 2 years ago | (#40024887)

Are u seriously trying to say that there are no free clinics in the USA?
Although they prolly as dirty as the ones in north korea lol
Iran? really dood, u really want to goto an STD clinic in Iran?
Its hot and sweaty there, and the smelly arab woman sitting next to u,
is sweating her yeast infection onto the seat....
Very attractive stuff ;)

-Hashie @ www.trypnet.net

Won't somebody think of the (2)

MRe_nl (306212) | more than 2 years ago | (#40022213)

Unsupervised false positives.

An inaccurate test (2)

imcdona (806563) | more than 2 years ago | (#40022217)

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

Re:An inaccurate test (1)

gatfirls (1315141) | more than 2 years ago | (#40022285)

Yes, there we are. I love that kind of logic. I'm sure the net effect will be a further spread of HIV.

Re:An inaccurate test (1)

zlives (2009072) | more than 2 years ago | (#40022473)

for those who thought putting on a condom was a chore :) just wait till you have to swab and wait 20 minutes before "random sex"

Re:An inaccurate test (1)

Nadaka (224565) | more than 2 years ago | (#40022703)

That is pretty much what I thought.

Re:An inaccurate test (2)

MrEricSir (398214) | more than 2 years ago | (#40022295)

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

Only time will tell what impact this has.

Re:An inaccurate test (1)

DanTheStone (1212500) | more than 2 years ago | (#40022381)

I will admit that I could fall into the possible-self-test camp. I have no reason to believe that I have HIV, and there's no practical risk of me spreading it to anyone who wouldn't have already been exposed. If it's inexpensive, why not? It's like the automated blood pressure cuffs at every pharmacy. If it turned out Negative, I'd continue thinking there's very little chance I have it. If it turned out Positive, I'd go get a real test from a doctor.

Re:An inaccurate test (0)

zlives (2009072) | more than 2 years ago | (#40022427)

FTFY "I have no reason to believe that I have HIV (virgin), and there's no practical risk of me spreading it to anyone who wouldn't have already been exposed (hand)"

sorry it was just right there...

Re:An inaccurate test (0)

Anonymous Coward | more than 2 years ago | (#40022329)

You could say that for any test. There is always risks of false positives and false negatives. Plus, you need to use the whole Bayes Theorem in order to properly calculate the probabilities, not just the test results.

This. (1)

bigtrike (904535) | more than 2 years ago | (#40022811)

The test will also produce non-false positives in people that wouldn't have otherwise taken the test. It may also make it more affordable for people to increase their testing frequency for behaviors they were going to engage in anyways.

Re:An inaccurate test (4, Informative)

vistic (556838) | more than 2 years ago | (#40023389)

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

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

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

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

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

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

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

Re:An inaccurate test (0)

Anonymous Coward | more than 2 years ago | (#40026461)

And the window period is especially important folks, because that's the time of the highest level of viral replication. It's when you're most infectious, as infectiousness correlates directly with HIV viral load. It's also a reason why multiple concurrent partner sex is dangerous and increases HIV spread.

Clinical Lab (0)

imamac (1083405) | more than 2 years ago | (#40022253)

In the clinical lab arena we have already had pregnancy-style HIV tests for years. This is nothing new. Good to see it come to the home, though. This will be much cheaper for people.

False positives and false negatives ... (2)

Barbara, not Barbie (721478) | more than 2 years ago | (#40022279)

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

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

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

Re:False positives and false negatives ... (1)

Anonymous Coward | more than 2 years ago | (#40022347)

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

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

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

Design the test to error on the side of more false positives. Then the test result should have 'no result' or a 'negative' . This way the test can reliably exclude people who are true negatives from the rest who should get blood tests.

If the manufacturer can do this. It may not be possible to design the test this way.

Re:False positives and false negatives ... (2)

Barbara, not Barbie (721478) | more than 2 years ago | (#40022455)

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

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

Re:False positives and false negatives ... (3, Interesting)

Belial6 (794905) | more than 2 years ago | (#40022577)

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

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

Re:False positives and false negatives ... (1)

Anonymous Coward | more than 2 years ago | (#40022583)

Detecting the virus in 93% of people who have it is not 93% accurate. You also need to factor in the true negatives and false positives, not just the true positives and false negatives. I couldn't see those rates in the linked article.

Re:False positives and false negatives ... (3, Insightful)

Capt.DrumkenBum (1173011) | more than 2 years ago | (#40022659)

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

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

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40022759)

False dichotomy. I think you'd agree that a third option - requiring that they make the test much more accurate - is a win/win for everyone.

Re:False positives and false negatives ... (0)

Anonymous Coward | more than 2 years ago | (#40023029)

I'm sure it never occurred to them to make the test more accurate.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40023181)

It probably did, but you know how it is - if it costs more to make it more accurate, the extra cost will hurt sales ... so ... let people know it's not all that accurate, and they'll buy twice as many to "test a second time, just to be sure." Marketing 101. Same as home pregnancy tests.

Re:False positives and false negatives ... (1)

retchdog (1319261) | more than 2 years ago | (#40023523)

the error rate is close to clinical oral swabs; a little higher for obvious reasons.

there is no better test, that is this convenient. it's not a conspiracy. that said, i do share your other concerns and hope that the test makes it abundantly clear that "negative" is not a guarantee, and that people take that to heart.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40024293)

the error rate is close to clinical oral swabs; a little higher for obvious reasons.

7x higher (FTFA) is not "close" at all.

Re:False positives and false negatives ... (1)

retchdog (1319261) | more than 2 years ago | (#40024389)

the reported clinical error rate from oral swabs varies by location and has been higher than expected. i don't know exactly what this article is citing, but claiming 1% is cherry-picking. 2x or 3x is probably closer. home users have additional difficulties: they are more likely to be in an early stage, and less likely to perform the test correctly.

would you really be happier with 1% or 3% error rate? doesn't sound a whole lot better to me.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40024517)

Both are better than 7% (even 1% sucks, but it shows that it's possible to reach this level today). A 7% error rate is, for all intents and purposes, worse than no test at all. At least with no test, people aren't going to falsely believe that they're not infected. They can take precautions.

The error rate can be brought down. We did it for other types of home testing. Sure, part of it involves taking the time to teach people how to do it. In this case, there's no reason not to go beyond the simple instruction sheet - we can have videos on the net showing the right and wrong way, for example. That's a lot better than "displaying a phone number prominently" that the user can call. The typical user is going to want privacy. Same as a pregnancy test. Same as pretty much any other test - it's their body.

Bandwidth is cheap - a lot cheaper than a funeral.

What's a 1 gig usb key cost in bulk? Throw a video on it and stuff it in the box, and make it worth a $5 credit on the next purchase.

We can do better. We *need* to do better. HIV affects everyone.

Re:False positives and false negatives ... (1)

mattiaza (2567891) | more than 2 years ago | (#40026473)

A 7% error rate is, for all intents and purposes, worse than no test at all. At least with no test, people aren't going to falsely believe that they're not infected. They can take precautions.

You make a huge, and in my opinion wrong assumption that most people believe "I could potentially be infected" or take precautions if they have not taken a test.

People are terrified of the thought that they may be infected, and for many the bliss of ignorance is more comfortable than testing. Many people think that there is no way they could be exposed, because it's something that only homosexuals and drug addicts get, and sleeping around with "nice random people from parties" is just fine. Some are even assholes who think that testing is a bad thing, because they suspect having something, but can always claim ignorance to new partners if they haven't been tested. Some are major assholes who will outright lie about this.

Perhaps these opinions are not universal, but they are the majority what I've heard expressed in college environments. A quick home test, even with a 7% error rate is much better than nothing: for people who might not take the effort of going to a clinic otherwise, and as given as a request to new partners.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40026743)

So part of the problem is the need for greater awareness. For example, that 1 in 4 people who contract HIV are women. That using a condom is the best way to guard against infection [cdc.gov] (because abstinence is neither natural nor realistic, and just sets people up for a fall).

HIV infection is, by far, the most deadly STD, and considerably more scientific evidence exists regarding condom effectiveness for prevention of HIV infection than for other STDs. The body of research on the effectiveness of latex condoms in preventing sexual transmission of HIV is both comprehensive and conclusive. The ability of latex condoms to prevent transmission of HIV has been scientifically established in "real-life" studies of sexually active couples as well as in laboratory studies.

... and of course it also reduces the incidence of other STDs.

We need to do things like giving people both the self-assurance and the almost automatic reflex to say "cut the crap" when a guy says he doesn't want to use a condom because "it will get between us" or "it takes the spontaneity out of it" or "it's like wearing a raincoat" or "if you loved me you'd let me". (in other words, a working "b.s. detector"). And not just in high schools and colleges - this should start in grade school.

It's the parents who don't want their "little precious" to be exposed to "such smut" who end up with kids raising kids, so the fools who preach abstinence need to be exposed for what they are.

A society that won't encourage their kids to attend sex ed classes to get the information they need that could save their life but lets them watch gruesome simulated murders and rapes in high-def as a part of their daily ration of entertainment is messed up.

Re:False positives and false negatives ... (1)

retchdog (1319261) | more than 2 years ago | (#40030563)

yes, it can be brought down... by developing a new test. your desired test doesn't exist yet. the tests which do consistently better than this require a clinical lab and training. even if they could somehow sell the lab (it'd cost a lot), the user error rate would end up being much higher than 7%.

i do wonder how you figured out what error rate is good enough... i suspect that if this test achieved 1%, you'd want it to be 0.1%, and so on.

anyway, you're providing nothing but pure speculation. here is an apposite opposite: it's entirely likely that people will understand the uncertainty of this test, and that this itself will increase the general level of concern about hiv. people may say, "well, this test was very easy, but it says it's uncertain. maybe i should go to a clinic to be sure."

HIV transfer. (3, Informative)

queazocotal (915608) | more than 2 years ago | (#40023297)

Your case raises the interesting issue of transmissibility.

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

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

Re:HIV transfer. (2)

Capt.DrumkenBum (1173011) | more than 2 years ago | (#40024147)

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

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

Re:HIV transfer. (2)

BlueParrot (965239) | more than 2 years ago | (#40026801)

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

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

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

Re:HIV transfer. (1)

queazocotal (915608) | more than 2 years ago | (#40027531)

I believe I may have misremembered what I believe was a WHO paper on this.
http://ije.oxfordjournals.org/content/39/4/1064.full [oxfordjournals.org] - for example - gives the figure as 20* more risky for anal than vaginal sex - 30* with the figures given seems entirely plausible for a study to have found, and for me to have remembered.

Re:False positives and false negatives ... (0)

Anonymous Coward | more than 2 years ago | (#40024621)

Well, for now it's the best we have, and it's much better than nothing. When I was young, there were many opportunities when I could have contracted HIV. I wondered about it from time to time, but never really thought I could have it, so never bothered to get tested. If I had caught it, I never would have known and would have went right on anyway. If a home test existed, I might have at least used that. Not perfect, but at least there would have been a pretty good chance of catching it.

So a false negative might harm a few people, but in the absence of this test, most of them would have just had the false negative of assuming they were negative. The number of people truely harmed by a false negative (vs no test) is probably going to be small next to the number of people saved by a true positive who would otherwise never have been tested.

Re:False positives and false negatives ... (4, Interesting)

TWX (665546) | more than 2 years ago | (#40022357)

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

Re:False positives and false negatives ... (1)

DanTheStone (1212500) | more than 2 years ago | (#40022405)

Now that is an interesting point.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40022631)

If you RTFA, for every 100 actual cases, it misses 7. That's 7 people who will think that they're HIV-free, and possibly spread it to others.

7% false negatives is a *terrible* number.

a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimated the test would miss about 3,800 HIV-positive people per year,

The test in a clinical setting has a 1% false negative number, and if you're engaged in high-risk behaviour/in a high-risk situation, you'll be asked to go back for a second test later, further lowering the false negatives to a much smaller number (quick math: what's 1% of 1%? 1 in 10,000. Real-life is not going to be that good, but it will still be much, MUCH lower than 7%).

Re:False positives and false negatives ... (1)

tinkerton (199273) | more than 2 years ago | (#40025991)

I don't know if it will be much lower than 7%. On one end of the spectrum, the test will show a false negative for a reason (a certain stage of the disease, or a variant)and repeating the test will give a failure for the same reason. on the other hand, the failure is random and a repeated test has 0.05% failure. And then the prescribed test procedure would indeed be to repeat it.

Re:False positives and false negatives ... (1)

BlueParrot (965239) | more than 2 years ago | (#40026869)

If you RTFA, for every 100 actual cases, it misses 7. That's 7 people who will think that they're HIV-free, and possibly spread it to others.

7% false negatives is a *terrible* number.

No it isn't. If everybody used this test, and the people who tested positive seek treatment, then you just reduced the transmission rate among the people who would not otherwise get tested by 93%.

I often run in to arguments like this when it comes to vaccinations as well. Many vaccines don't offer perfect protection. They just reduce the probability that a disease will spread in the population by a sufficient amount that you don't get major outbreaks, and thus the illness eventually dies out since it cannot spread effectively. More specifically, if new infections occur at a rate that is lower than the rate at which infected people are discovered and treated, the the total number of infections decrease. Since untreated HIV will eventually start showing symptoms, people will eventually get diagnosed, so the trick is to bring the overall infection rate down enough that you're more likely to be diagnosed and treated than you are to spread it to others.

Thus while highly preferable, it need not be perfect. If your measures to combat the illness cause a persistent decrease in the number of people infected, then the disease will eventually die out simply because it cannot spread.

As it happens that is also one of the reasons why you want everybody to have access to healthcare.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40027135)

False dichotomy alert!

if everybody used this test, and the people who tested positive seek treatment, then you just reduced the transmission rate among the people who would not otherwise get tested by 93%.

Your argument is based on people either using this test or no test at all. This (inaccurate) test will drive down the number of people who get the more accurate test, resulting in increased numbers of false negatives, which is the real risk.

The second false dichotomy inherent in your position is that people will only have one partner. Multiple partners over the course of a year will increase the transmission rate due to false negatives impacting multiple people.

Simplification - 10 people, all test negative (including 1 false negative). If each person only has sex with 2 other people over the course of a year, it's conceivable that within a year they can all be infected. This scenario is especially likely given that infections are much harder to detect at an early stage.

Comparing HIV to, say, the flu, is a bad example. We're not talking about an HIV vaccine here. Also, simple hand washing and teaching people not to pick their noses will greatly reduce transmission, you can tell when someone has had the flu after a few days just by looking at them or listening to them hacking away, and the flu isn't for life - you're only able to infect someone for a short period of time, then flu season burns itself out as most of the people who can get infected are either infected or over it.

Re:False positives and false negatives ... (0)

Anonymous Coward | more than 2 years ago | (#40026001)

"the expensive regimen of drugs is prescribed to PROLONG life"...

You might want to read this:

http://www.virusmyth.com/aids/hiv/abnvp.htm

Re:False positives and false negatives ... (0)

Anonymous Coward | more than 2 years ago | (#40027667)

And can also intentionally transmit it to other people, without a record of being tested positive.
But I think it will save ore people from infecting than the opposite.

Re:False positives and false negatives ... (1)

ClintJCL (264898) | more than 2 years ago | (#40022711)

It must suck to live in a backward world where progress is considered bad.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40022841)

It must suck to live in a backward world where progress is considered bad.

It must suck to live in a backword mind where the only alternatives are to either let a flawed test go on the market or not , and where improving the tests accuracy is not even considered an option.

Enjoying your false dichotomy?

Re:False positives and false negatives ... (1)

ClintJCL (264898) | more than 2 years ago | (#40022897)

Wow. Create a false dichotomy, stick it in my mouth, attack it as a strawman, and call me the one who created it. You are truly fucked. By the FDA's own calculation it will have a net loss of 4,000 infections a year. If you don't like that, maybe you can be one of them and go die.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40023049)

You're the one who considers a 7% false negative rate progress, and says that I must be backward to think otherwise. The false dichotomy (either accept a 7% failure rate or not) is the basis for your attack. Nowhere do you consider that there's a 3rd alternative - make a better test.

As for "a net loss of 4,000 infections a year" - that's over an order of magnitude worse than current tests. That's 4,000 people (and their partners) who will think they're safe when they're not.

To quote your own words, but with the "don't" removed "If you like that, maybe you can be one of them and go die."

This test is a death sentence for thousands of people a year. Of course, if you have a right-wing fundy holy-roller attitude, you'll just love that, won't you? What's it like being on the same side as the self-righteous proud-to-not-knows in Jeebus-land?

Re:False positives and false negatives ... (1)

ClintJCL (264898) | more than 2 years ago | (#40023089)

..... net less of new infections. Less new infections. 4,000 fewer new infections. 46,000 new infections next year instead of 50,000. Clearly you did not read the article.

Now, someone's at a bar on a friday night, and they've decided to hook up. What is your alternative? There is none. So they die instead. I'm talking about when this is released, not a hypothetical future years from now when a better test is released.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40023285)

I read the article. You should read it again.

a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimated the test would miss about 3,800 HIV-positive people per year

The FDA estimate of preventing ~4,000 new infections is from the people who got the positive results. However, the number of new infections from the 3,800 who got a false negative and then infect others is left out, and is potentially MUCH greater, never mind that these people will not be starting treatment earlier since they wrongly believe they're HIV-free, and any early symptoms must be from something else, like "the flu" or "over-work" or whatever.

Now, someone's at a bar on a friday night, and they've decided to hook up. What is your alternative? There is none. So they die instead.

Under your scenario, they test, and 7% of those couples where one who has HIV but gets a false negative think "hey, we're okay - no need to take any extra precautions."

It's as stupid, moronic, and backwards as fundies telling their kids to practice abstinence rather than giving them access to effective birth control. The end result is the same in both cases - unsafe unprotected sex.

Or do you not see a problem with that?

Re:False positives and false negatives ... (1)

ClintJCL (264898) | more than 2 years ago | (#40023427)

You just equated this as being the same as unprotected sex. Because anyone who gets a negative result would then have unprotected sex? You're thinking just like the fundies! No wonder you have your ridiculous conclusion. (It's also funny that you think they didn't consider your scenario in their numbers.)

Uh, no. For any prudent person, A negative result would mean going through with the protected sex would be safer. A positive result would mean it would not be worth even having safe sex. You assume the worst then extrapolate that out to everyone. You make fun of fundies while thinking like them.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40024285)

No - because a prudent person wouldn't be doing your scenario - to quote:

Now, someone's at a bar on a friday night, and they've decided to hook up

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

If you're going to troll, you'll have to do a lot better than that. Stupid amateur.

Re:False positives and false negatives ... (3, Funny)

Time_Ngler (564671) | more than 2 years ago | (#40025123)

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

Exactly! Tuesday nights are ladies night.

Re:False positives and false negatives ... (1)

compro01 (777531) | more than 2 years ago | (#40024237)

You're not really going to get a better test short of phlebotomy.

This exact same test is used clinically today.

The question they're looking at here is whether to allow it to be bought by anyone in any random drugstore rather than only by doctors/NPs/etc.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40024475)

Or they can do more research to find out why the false negative rate is 7x higher outside of clinics, then eliminate the factors that cause the problems.

Things like improper storage and handling, not getting a decent sample, etc. We've managed to mitigate most of these issues for other tests, such as blood sugar. For example, (technological improvements) the monitors are now self-calibrating. If you don't get a decently-sized sample, the machine won't give a result rather than give a wrong result. If the test strips are stored wrong, they deactivate. And (human training) the user is told that if a result is really unexpected, take a second sample. An error rate of even 1% would be considered unacceptable.

And yet, for HIV they want to market a test that doesn't detect 7% of all HIV patients? They can do better.

Re:False positives and false negatives ... (0)

Anonymous Coward | more than 2 years ago | (#40022989)

Jesus (wo)man. If you're going to beat and kill the person who may have given you aids, perhaps you shouldn't be having sex with them. Or with anyone at all. Part of safe sex is making sure you're getting tested, and even the professional tests have a margin of error. If you play the game, you have to be ok with the chance at getting burned, and a relatively accurate, errors on the testing-positive side test would be huge. Hopefully it will help remove the (idiotic) stigma of getting tested in the first place. STDs happen, they suck, but people shouldn't be afraid to find out the truth, and if they did, maybe we'd see a decrease in the overall number of cases.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40023149)

This is an "errors on the testing-negative side" - 7% of subjects with HIV test negative.

It's a fact that some people lose it when they think someone has given them HIV: [dreamindemon.com] From last November:

Guy meets girl. Girl and guy meet for drinks and nookie. Girl tells guy she gave him AIDS. Guy shoots girl in head. Girl says, "Daaamn! Just kiddin'!"

According to authorities, that's basically what happened between 49-year-old Lloyd Wilkins and his girlfriend on the evening of April 23, 2011. The two had hooked up that evening, and after a few drinks, ended up swapping spit and other bodily fluids. After the lovin' was over, Wilkins' girlfriend apparently said something along the lines of, "Oh, snap! You got the AIDS!"

Wilkins responded by walking into his bedroom and retrieving a 12-gauge, single-shot shotgun from his closet. He pointed it in the general direction of the woman's head. The gun went off, striking the jokester in the brain space. No word on whether he jokingly replied, "Oh, snap! You got the dain bramage!"

Wilkins then called 911 to report that he shot someone. At the same time, the woman called a friend to take her to the hospital. When police arrived on scene, the victim was already on her way to the hospital and Wilkins was waiting for them outside, hands in the air.

"She gave me AIDS," Wilkins told the officer.

Wilkins said he pointed the gun at the woman, but the gun "just went off."

The woman survived, but is deaf in her right ear as a result of the shooting and has undergone several surgeries to mend her scalp. According to her medical records, which were presented as evidence in the case against Wilkins, she does not have AIDS. Authorities said she was joking when she told Wilkins that she had infected him.

On Tuesday, Wilkins pleaded guilty to aggravated assault, possession of a firearm during a crime of violence and possession of an unregistered firearm. He will be sentenced in February.

The clinical test has only 1% false negatives. This test has 7% false negatives. The FDA estimates that 3,800 people per year will think they're not at risk of giving someone HIV when they are. Do you like those numbers? I think the company should be required to make their test much more accurate.

Re:False positives and false negatives ... (0)

Anonymous Coward | more than 2 years ago | (#40023621)

Spoken just like someone who isn't in a high-risk group, and doesn't really need a test.

Try being gay and living in one of those "abstinence-only" conservative areas where most Planned Parenthood type funding has been cut, and "gay outreach" testing programs are non-existent. This option is better than nothing; it may be the ONLY option available for some people.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40024341)

Spoken just like someone who isn't in a high-risk group, and doesn't really need a test.

Try being gay and living in one of those "abstinence-only" conservative areas where most Planned Parenthood type funding has been cut, and "gay outreach" testing programs are non-existent. This option is better than nothing; it may be the ONLY option available for some people.

Riiiight .... because condoms aren't an option [avert.org] - even though studies show they're the best way to prevent the spread of HIV to a partner. Gee, it's too bad that they're so hard to get. It's not like you can pick them up without a prescription, or anonymously from a vending machine, or at WallyWorld or the corner drugstore.

Better to give people a false sense of security with a test that will let 7% of people who are HIV positive think that they're not going to infect someone that they might care about.

7% false negatives is too high. Let them fix the bug in their product, because otherwise the alternative is going to be a lot more people catching a different bug - one that kills - because they think it's safe to forego protection.

Re:False positives and false negatives ... (1)

xigxag (167441) | more than 2 years ago | (#40024697)

Any drug store where they sell this test would have condoms as well, so yes they are still an option. Obviously GP meant "may be the only TESTING option available for some people." And there's not one person on this thread suggesting (other than you) that getting a negative result on this test means it's okay to go have unprotected sex, or that somehow the fact that you have tested negative means you're required to go bareback. In fact, others have mentioned that HIV or no, unprotected sex is risky and shouldn't be practiced in the sort of situation that you'd find yourself in if you're using this test.

Furthermore, you're consistently making the assumption that 100% of the people who take a home test are idiots who can't read warnings that state that the test only has a 93% success rate. Certainly if a test like this were marketed, that fact would be required to be part of the advertising. 93% may seem low but as far as medical diagnoses go, it's fairly good. It would surprise me if even a good doctor had a 93% accuracy rate in terms of overall diagnostic skill. Should we stop using physicians as well?

The appeal of this test is that there is a population of people who would not otherwise get tested at all but would still engage in sexual activity. Those people are still going to want to have sex, except that now, out of the ones who are HIV infected, 93% of their partners will be able to make an informed decision. And yes, the remaining 7% won't. But they would not have made an informed decision anyway, because they would not have been tested anyway.

Re:False positives and false negatives ... (-1)

Anonymous Coward | more than 2 years ago | (#40025063)

Just stop being a faggot. That way, you won't have to worry about AIDS and what-nots.

Re:False positives and false negatives ... (0)

Anonymous Coward | more than 2 years ago | (#40023657)

Since the problems you describe stem from possible human reactions to the results of the test rather than anything about the test itself, they must logically apply to the tests that are performed in a clinical setting.

Therefore, according to your reasoning, literally ALL possible HIV tests are "just a money grab by some drug co".

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40024369)

A 7x higher false negative rate outside of clinics is not the same. According to YOUR stupid "logic", a 100x higher false negative rate would also be just as defensible.

They should find out why the test fails by almost an order of magnitude outside of clinics, and fix the problem. We're talking about something that is preventable, and can save lives, not put them at risk by giving people who get a false negative an equally false sense that there's no risk.

This test, as it stands now, IS a money grab. And the people pushing it are hoping that everyone will be so gosh-darn politically correct to overlook that the test, as it stands now, is flawed and unnecessarily puts people at risk. The FDA's figures are that, annually, 3,800 people who have HIV will believe they don't - how many people will they unnecessarily infect?

Re:False positives and false negatives ... (1)

reversible physicist (799350) | more than 2 years ago | (#40024065)

The test is 99% reliable when performed correctly. Also, since condoms typically break or slip about 3% of the time, and don't cover the entire penis, the test will be a more effective method of preventing exposure to HIV for many people than a condom.

Re:False positives and false negatives ... (1)

Barbara, not Barbie (721478) | more than 2 years ago | (#40024437)

Cut the bs.

First, the test has been PROVEN to have a false negative rate of 7% outside of clinics. They need to address this issue, identify the causes, and fix them. The FDAs projections are that every year, 3,800 people who use this test and have HIV will wrongly believe that they don't. Want to do a body count projection?

Second, condoms work [avert.org] .

The male latex condom is the single, most efficient, available technology to reduce the sexual transmission of HIV and other sexually transmitted infections.UNAIDS, WHO and UNFPA6

Also, you might want to buy condoms from outside the US. Other countries such as Canada have much stricter standards for breakage resistance. The FDA water test (10 ounces of water) is lame.

Re:False positives and false negatives ... (0)

Anonymous Coward | more than 2 years ago | (#40025069)

I have never worn a condom.

Re:False positives and false negatives ... (0)

Anonymous Coward | more than 2 years ago | (#40026827)

I have never touched a girl.

FTFY

Re:False positives and false negatives ... (1)

seeker_1us (1203072) | more than 2 years ago | (#40024675)

When you design tests, there are two rules.
  1. You can have a false positive.
  2. You must not have a false negative.

    The reasoning is this: If you have a false positive, you just take another, more expensive, slower test to confirm. If you have a false negative, someone will die.

Good news! (1, Funny)

NoSleepDemon (1521253) | more than 2 years ago | (#40022281)

Well this is certainly some...
*puts on glasses*
positive news!

YEEEEEEEEEEEEEEEEEAAH!!

Re:Good news! (-1)

Anonymous Coward | more than 2 years ago | (#40022715)

Dude, don't lie. None of you Slashtards will ever have sex or touch a breast that's not attached to your own flabby cheeto filled body. Ever.

Re:Good news! (1)

busyqth (2566075) | more than 2 years ago | (#40022949)

Dude, don't lie. None of you Slashtards will ever have sex or touch a breast that's not attached to your own flabby cheeto filled body. Ever.

Well I do like KFC extra crispy every now and then as a splurge.

Alternative headline (-1)

Anonymous Coward | more than 2 years ago | (#40022297)

FDA Bends The Rules To Appease Gay Community

There are drugs and treatments waiting to be approved that will take many more years of foot-dragging by the FDA, and this test gets the green light by a unanimous vote. Yep, headline is correct.

Re:Alternative headline (0)

Anonymous Coward | more than 2 years ago | (#40022323)

FDA Bends The Rules To Appease Gay Community

Exactly which community is the gay community?
Is everyone there gay? Are non-gay people allowed to visit?

Re:Alternative headline (0)

Anonymous Coward | more than 2 years ago | (#40022947)

Exactly which community is the gay community?

This one [wikipedia.org] :-J

Re:Alternative headline (1)

TWX (665546) | more than 2 years ago | (#40022349)

A drug, a treatment, and a swab test.

<singing>One of these things, is not like the others... One of these things, does not belong.</singing>

Seriously. A test is not a treatment. It's diagnostic procedure. Those should be fast-tracked if they're reasonably reliable, and so noninvasive as to not require a professional to accurately administer.

Re:Alternative headline (0)

Anonymous Coward | more than 2 years ago | (#40022495)

You have tested positive for being a homophobe, congratulations!

Quickly followed by ... (1)

rhysweatherley (193588) | more than 2 years ago | (#40022337)

And how many milliseconds until this happens:

A new law was passed today by both houses of Congress making it illegal for pharmacies to sell over the counter HIV tests. The author of the bill, congressman John Q. Religinut, Jr (R) welcomed the passage of the law saying "Today we have taken a stand against promiscuity and the homosexual agenda".

Re:Quickly followed by ... (0)

Anonymous Coward | more than 2 years ago | (#40022461)

And dozens of Republicans rush to defend the new law saying "it's constitutional! Just like how your back yard is in another state, your mouth is in another state, so the pot you grow in the back yard and the swab you stick in your mouth are absolutely interstate trade!"

Kathleen Fent should order one quick. (0)

Anonymous Coward | more than 2 years ago | (#40022813)

Considering the stories floating around about her Cmdr. Taco, she should find out the truth ASAP.

That's one way to get them to go in for testing (1)

ourlovecanlastforeve (795111) | more than 2 years ago | (#40022907)

What if it was designed so that whether or not you had the HIV virus it showed a positive result? That would be one way to get people to go in for testing.

This has been around since the early 1990's. (0)

Anonymous Coward | more than 2 years ago | (#40023091)

I worked for the company when it was called Epitope. Management was sure that people would throw money at them when their in-home HIV test became available. FDA approval came in 1996, but it required you to mail off the swab for analysis. Strangely, it didn't make the billions they were hoping for. The business model was as follows:

1. Come up with a single unique device.
2. Get investors to pony up lots of cash.
3. When stock prices plummet, lay off 1/3 of employees (mostly scientists) to show "cost reduction."
4. When stock prices recover, hire back employees at reduced salaries.
5. Repeat 2 - 4 as many times as necessary.
6. Profit?

darkly amusing (1)

retchdog (1319261) | more than 2 years ago | (#40023415)

X and Y take the test, and get negatives. X (only) has a false negative. Y blows X and the virus enters through the mouth abrasion caused by the swab.

Required for Government Offices (1)

sycodon (149926) | more than 2 years ago | (#40024867)

This should be freely available at every counter, station, desk, etc. across which citizens interact with the Federal Government. Because regardless of what your business is, you will always come away having been fucked in the ass.

The Law... (0)

Anonymous Coward | more than 2 years ago | (#40031795)

The real reason for clinical HIV tests is not to find out you have HIV, but so that someone other than you knows you have HIV. This allows infections to be counted and can also be used in criminal cases against you.
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