FDA reviews first rapid, take-home HIV test

[deepthroat]

FDA reviews first rapid, take-home test for HIV

The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

The Associated Press

WASHINGTON —

The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

FDA reviewers said Friday the OraQuick In-Home HIV test could play a significant role in slowing the spread of HIV, according to briefing documents posted online. But they also raised concerns about the test's accuracy.

Public health experts estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware of their status. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.

In a trial conducted by the company OraSure Technologies Inc., the test correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimates the test would miss about 3,800 HIV-positive people per year, if approved for U.S. consumers.

The test was more accurate at correctly clearing patients who do not have the disease. In company studies, OraQuick correctly identified HIV-negative users 99 percent of the time.

On Tuesday, the FDA will ask a panel of experts whether the test should be approved for over-the-counter sales in U.S. The agency is not required to follow the group's advice, though it usually does.

In their briefing documents, agency scientists noted both the benefits and risks of expanding HIV testing with the take-home diagnostic kit, a mouth swab which returns results in about 20 minutes.

"There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status," the reviewers state. "However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected."

The FDA has already approved HIV test kits that people take home. However, those kits, which require a blood sample, must be sent to a laboratory for development.

[SLBT]

I suppose it was always gonna come... I just wonder how popular it will be with folks. Also it would have to pretty accurate in its results to be useful to anyone. No real point in getting it if they tell you the test may not be completely accurate and you would also need to get tested again by a recognised lab..

I guess it's a start though..

[rxpharm]

This test still does not get around the latency period for an HIV infection. This test and most others like this are based on the presence of HIV antibodies. There is approximately a 3 week period between the viral infection and the production of measurable antibodies that will cause an antibody test such as the OraQuick to detect a result.

So in that 3 week period, an unknowing punter could blissfully be having bareback sex with his chosen one (gg, lb or guy), and exposing himself to the virus.

In my view this gives a false sense of security to the user(s). There must be a full disclaimer about this so people don't make mistakes.

[SLBT]

Fully agree.. There just isn't a quick fix / test, although that would be great in a perfect world. I think for some time yet to come, folks who are having to do a test for whatever reason will need to wait the prescribed time in order to find out if they are infected or not.. It's still a worrying time for anyone, isn't it.

[deepthroat]

Here's more details. Sounds very interesting - give your ladyboy a cheek swab, then tell her to go hop in the shower. Take your time in the shower, and wala- test is done before you're ready for Prime Time.

Downside: nearly 10% chance that an HIV+ person will show up as HIV-.

Downside: also doesn't take into account anyone infected within the last few weeks (it takes a bit to show up in the bloodstream).

Upside: for those that engage in risky behavior already, it should reduce that risk something like 75-85%.

http://www.nytimes.c...ner=rss&emc=rss

Quick At-Home H.I.V. Test Wins Federal Approval

By DONALD G. McNEIL Jr.

Published: July 3, 2012

A new H.I.V. test for home use that gives quick results was approved on Tuesday by the Food and Drug Administration, giving Americans the first chance in the epidemic’s 30 years to learn in the privacy of their own homes whether they are infected.

The test, made by OraSure and called OraQuick, uses a cheek swab and gives results in 20 to 40 minutes, so it is as easy to use as a home pregnancykit.

A previous over-the-counter H.I.V. test kit allowed users to prick their own fingers, but the samples had to be mailed to a lab.

Dr. Anthony S. Fauci, the longtime AIDS researcher who heads the National Institute of Allergy and Infectious Diseases, called the OraQuick test a “positive step forward.”

Each year about 50,000 Americans become infected with the human immunodeficiency virus, and about a fifth of the 1.2 million Americans who are now infected do not know it, the Centers for Disease Control and Prevention estimates. Getting an infected person onto antiretroviral drugs early lowers by as much as 96 percent the chances that he or she will pass the virus on to someone else, studies have shown, so treatment has become a form of prevention that could shrink the epidemic.

“If this enhances the number of people you can get into care, the advantages outweigh any objections,” Dr. Fauci said in an interview.

Testing for AIDS has been more fraught with controversy than testing for any other disease because of the unique history of the epidemic. It emerged in the 1980s wrapped in a shroud of stigma because it was mysterious, was transmitted through sex, drug injection and blood transfusions, was inevitably fatal, and often afflicted gay men and drug abusers. —

Being tested for AIDS was seen as tantamount to a public disclosure that one was homosexual or a drug addict, so maintaining privacy became paramount and some gay rights groups warned men to avoid testing.

Tests for flu and cholesterol long ago became routine parts of medical care. Pregnancy kits allowed testing in one’s own bathroom. And tests even for heavily stigmatized sexually transmitted diseases like syphilis were once routine in applying for a marriage license. But testing anyone for AIDS in most states required a separate counseling session and often a signed consent form — all of which added to the air of dread.

Even when lifesaving antiretroviral drugs emerged in the 1990s, states were slow to rewrite laws governing testing, and medical associations took years before suggesting that AIDS tests become part of routine care. The F.D.A. has been considering versions of the home test since 2005.

The new kit will allow anyone who suspects he or she is infected to test in privacy.

Some objections have been raised. When used by average consumers, rather than by health care professionals, the test is accurate 99.98 percent of the time for people who are not infected, but only 92 percent of the time for people who are H.I.V.-positive.

That means about one infected person in 12 would get a false negative, but only about 1 in 5,000 uninfected people would get a false positive.

Any positive test needs confirmation in a doctor’s office, the F.D.A. said. It approved the test not to replace medical testing but because many Americans never get tested at all. The hope is that the home test will encourage infected people to seek medical care earlier, helping save lives and slow the spread of the epidemic.

The home kit “provides another option for individuals to get tested,” said Dr. Karen Midthun, director of the Center for Biologics Evaluation and Research at the F.D.A.

In the past, some advocates have opposed home testing on various grounds: that finding out one is infected is so stressful that it should be done only in the presence of a counselor, that the uncertainty around the test would be stressful, and that getting a false negative could encourage someone to have unprotected sex.

But since the disease is no longer an inevitable death sentence and it is clear from the epidemic’s continuing spread that Americans are having unprotected sex anyway, those objections began to pale.

[pdogg]

Very interesting.

Theoretically, you could tell a ladyboy at the bar that you will be administering this test in your room and she well get paid whether the test shows up positive or negative. If she wants to go with you, up to her.

It would still mean that you should use condoms as the test could falsely show she's negative or was recently infected.

In practice, would you feel comfortable administering this test?

How would you feel if a ladyboy asked you to take the test?

Food for thought.

[deepthroat]

Yes to all above.

[pdogg]

If a ladyboy brought her home testing kit to my room I wouldn't mind taking some sort of swab test such as the one recently FDA approved.. Not a test that draws blood though.

As far as administering...if I could magically pay the money for the test and know the result it'd be worth it. Not sure if I want to give the test and explain in English what it's about though. Not really an issue with me as I'm not sleeping with random ladyboys.

[duke007]

How would you feel if a ladyboy asked you to take the test?

Certainly not the best way to start a "lomance" for me personally

[rxpharm]

The question is if you believe the results of the test will you change your behaviour? So if she tests negative and you test negative, will you ask for bareback sex, and everything else that entails?

Remember there's still a significant chance she may be in the latent period - having the virus - able to transmit it, but not showing antibodies for a +ve test result.

I would say it's not worth it, because if you happened to fall into the zone - you could contract HIV.

The key test is the PCR test - which detects the actual virus - however, there will be no quick do at home test for that anytime at all, as it requires a polymerization chain reaction machine worth a pile of $$$$.

[pdogg]

The question is if you believe the results of the test will you change your behaviour? So if she tests negative and you test negative, will you ask for bareback sex, and everything else that entails?

I hear you RX; being the bottom in bareback sex is still extremely dangerous as one can still have HIV despite testing negative.

However, I think many if not most of us, give and receive unprotected Oral Sex.

Those who do so probably wouldn't do so if they had a strong suspicion that their partner was HIV+.

So even though it would be useful to know if a girl was probably HIV+, it seems the main reason many/most of us would not want to administer this test is that it seems creepy to do so.

[deepthroat]

I guess this is one of the many things that probably turns out to be vastly different in practice than in theory.

In theory, it seems simple enough to ask the girl to let me swab her cheek to see if she's healthy. No big deal, then she bounces off into the shower.

In practice, it might very well turn out to be "creepy" or extremely uncomfortable. What if she says NO, I not take test? What if she not understand and want explanation that I'm unable to provide in a method she can understand and agree with? Her reticence or outright refusal could be a sign that she is aware she's HIV+, or it could simply be a lack of understanding and fear that there's something else nefarious going on, which I would be powerless to truly straighten out once she's got that in her head.

It will be interesting to see how it plays out, as I'm certain other guys will end up trying to use the test in their adventures. We'll see what comes of it.