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OraQuick  (Source: Chuck Zovko)
OraQuick is expected to hit stores this October

The U.S. Food and Drug Administration (FDA) approved a home HIV test for the first time ever earlier this week.

The HIV test, called OraQuick, was created by a medical company called OraSure. The test can be taken at home, providing results in approximately 30 minutes. The idea behind OraQuick is to make testing accessible to those who do not have the means to see a doctor.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

While the new home test is a great start to providing results to those who may not be able to receiving testing otherwise, OraQuick shouldn't be the final word on the matter. According to OraQuick trials, the home test was unable to detect a positive in 1 in every 12 patients that were infected. In addition, the test provided a false positive in 1 in every 5,000 cases.

Despite these drawbacks, the FDA approved the home test kit because it felt the advantages outweighed the disadvantages. According to the federal Centers for Disease Control and Prevention, about 1.2 million people in the U.S. have HIV and approximately 1 in 5 are unaware of it. With a new home test kit, those who are infected can seek early medical attention for treatment and also reduce the transmission rate.

Testing for HIV has certainly come a long way since the 1980s, when testing first began. In 2002, the FDA approved on-the-spot tests for clinics, and in 2005, the FDA started looking into the possibility of a home test for HIV.

The price for an OraQuick test is unknown, but reports estimate that it will cost more than $18. A call center is coupled with the test for those who need support when finding they have an HIV positive test.

OraQuick is expected to hit stores this October.



Source: FDA



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RE: How will that work?
By geddarkstorm on 7/5/2012 12:29:33 PM , Rating: 4
I'm more concerned about that high 1 in 5000 false positive rate, along with a staggering 1 in 12 false negative. No one to be sure with that kit, one way or the other.

A false positive could certainly hurt a person's health insurance, and getting that reversed would be a headache. The consequences of a false negative speak for themselves.


RE: How will that work?
By Lord 666 on 7/5/2012 12:37:18 PM , Rating: 2
One in 100 infected is still too high with it being one in 75 for NYC. At least this levels the playing field a bit.


RE: How will that work?
By Jeffk464 on 7/5/2012 5:43:32 PM , Rating: 2
one in 75, you sure that seems way high


RE: How will that work?
By Jeffk464 on 7/5/2012 5:45:45 PM , Rating: 2
Nationwide its got to be more like one in 300 people.


RE: How will that work?
By geddarkstorm on 7/6/2012 12:31:01 AM , Rating: 2
You're right http://www.cdc.gov/hiv/topics/surveillance/basic.h...

It is about 1/300 nationally.


RE: How will that work?
By Boze on 7/5/2012 3:29:21 PM , Rating: 3
Buy more than one test?

Just an idea... If you're concerned you have HIV, it might be a good idea.


RE: How will that work?
By geddarkstorm on 7/6/2012 12:22:36 AM , Rating: 2
How does that help? If one test says you're negative and another says positive, you've just wasted a bunch of money for nothing, as you can't trust either now. And why buy x number of tests to give you statistical confidence in a result, when you can go to a doctor to get a single definitive test?


RE: How will that work?
By Jeffk464 on 7/5/2012 5:42:25 PM , Rating: 3
I'm thinking anyone that got a positive result would be making an immediate appointment with a doctor, who would then retest.


RE: How will that work?
By geddarkstorm on 7/6/2012 12:24:47 AM , Rating: 1
So why waste the money on this and not just go to the doctor in the first place?


RE: How will that work?
By abzillah on 7/6/2012 3:52:20 PM , Rating: 2
Yes, but labs don't just run one test. This test can be used and then a second and third ELISA tests can be run to confirm a patient is HIV positive or negative. If this test is cheaper and quicker, then it can save money and time on the first test that is normally used.


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