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First Oral At-Home HIV Test Approved by FDA

First Oral At-Home HIV Test Approved by FDA

For the first time a new test has been approved by the FDA that allows an individual to test for HIV at home without sending the test materials to a lab for results. The Food and Drug Administration approved the test for consumer purchase on Tuesday.

The test, produced by OraSure Technologies, implements a mouth swab which collects saliva. The swab is put into a test tube and the results appear about a half hour later at home. Health officials were originally worried that the test’s margin of error would create too many missed diagnoses.

Currently the test will falsely diagnose one negative result for every 12 negatives. Conversely only about 1 false positive in 5,000 occurs when taking the test. Healthcare professionals are adamant that if a user gets a negative result, it does not guarantee they are HIV-free.

Many unaware of infection

Currently about 20 percent of people in the United States with HIV are unaware they are infected. USA Today points out that about 1.2 million people currently have HIV, which means that about 240,000 people are unaware of the status of their health.

Health care officials are hopeful that the availability of a relatively sensitive and convenient at-home test will detect more cases each year, lowering the risk that the virus will spread. Previously, the test was available in a medical professional’s offices only. The margin of error of the at-home test increases without medical supervision, which concerned some of the experts involved in making the decision to release the product. Professionals urge those with a positive result to follow up at a doctor’s office right away.

The test will not be available until October and will be sold at regular drugstores, such as Walgreens and CVS. The Washington Post reports that the test will most likely sell for less than $60, according to Orasure CEO Doug Michels.

The price is meant to include the toll-free call center which can offer support and counseling for purchasers of the test. Advocates for HIV awareness hail the FDA’s decision as a major step towards detecting and treating more cases in the United States each year  by offering another avenue for ascertaining individuals’ health and curbing the spread of the virus.

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18 comments

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3:32PM PST on Nov 5, 2012

noted

11:30PM PDT on Jul 9, 2012

While it s true that there is a window before one who is exposed to the HIV virus starts producing antibodies and false negative results within the window occur on occassion. The value of the test from a public health perspective may be in diagnosing and alerting people who are HIV positive and unaware of it so that they may abstain from sex, use protection during sexual intercourse, inform their current and former sexual partners of their HIV status and start taking anti-viral medications. The sooner that people are informed of their positive HIV status the sooner high risk behavior might be addressed. The at home test while expensive for some may be less obtrusive than going for a test at an HIV clinic. Normally HIV is a public health reportable disease and the local health department must be notified. It was not pointed out in the post when someone tests positive and does not go for the recommended follow up visit if the OraSure company or the individual is responsible for informing the local health department.

1:38AM PDT on Jul 8, 2012

Thanks for sharing.

7:13PM PDT on Jul 6, 2012

This is a great tool for people who are worried, but this is a major disease, people should maybe told the news from the doctor. I have mixed feelings on this.

2:08PM PDT on Jul 6, 2012

Hello... What is the difference from this one
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091491.htm
approved in 2004!!!
And, by the way, this a good way to get AIDS...

11:54PM PDT on Jul 5, 2012

There are 33,300,000 of AIDS as well as HIV positive single people worldwide. If you are one of them and you are prepared to become a little brave then You may find that PositiveFishes.com is just for you. For you will come across new individuals who will certainly become life long friends or Love of life and achieve a degree of self-belief you never would have believed possible.

7:04PM PDT on Jul 5, 2012

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.

2:05PM PDT on Jul 5, 2012

"First Oral At-Home HIV Test Approved by FDA"....

Designed to send you rushing to your doctor for a very expensive second opinion no doubt.

"the test’s margin of error".......?

"Healthcare professionals are adamant that if a user gets a negative result, it does not guarantee they are HIV-free."......?

I guess that's a bit like a "side effect" huh? Reason to "ask your doctor" anyway!

The lengths these drug companies will go to for a buck!!!!

Save the $60 dollars and just go to your doctor for a regular HIV test if you're concerned....

1:40PM PDT on Jul 5, 2012

i don't know more medical waste with this type of inaccurate tests. made from plastic

10:55AM PDT on Jul 5, 2012

interesting.

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Disclaimer: The views expressed above are solely those of the author and may not reflect those of
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