Navigation Links
FDA Panel Backs At-Home HIV Test

By Randy Dotinga
HealthDay Reporter

TUESDAY, May 15 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Tuesday approval of the first HIV test that would give people the results in the privacy of their own home.

The 17 panel members were unanimous in voting that the benefits of the test were greater than any possible risks. The test kit, known as Oraquick, detects the presence of HIV -- the virus that causes AIDS -- within 20 minutes, the Associated Press reported.

If the FDA heeds the recommendation of its advisory panel, the decision could pave the way toward a new era in HIV testing. The agency typically follows the recommendations of its advisory groups.

OraSure Technologies Inc., which makes the over-the-counter test, already sells a version of it to doctors and other health professionals. Studies have shown the test was less accurate when used by consumers, but the panelists said Tuesday that the benefits of expanding HIV testing outweigh a small drop in test accuracy, according to the AP.

"There is huge global momentum in support of over-the-counter testing for HIV. People desire private, discreet options that protect their confidentiality," said Dr. Nitika Pant Pai, an assistant professor of medicine at Montreal's McGill University who co-authored an analysis of the effectiveness of an at-home HIV test earlier this year.

The test, which looks for signs of HIV in oral fluid, is already used at hospitals and doctors' offices where medical professionals administer it. The FDA first approved its use in 2004.

To take the OraQuick test, people swab their outer gums and put the swab into a vial. After about 20 minutes, the test device will reveal two reddish-purple lines in a small window if there are signs that the body's immune system has geared up to battle HIV.

The test uses oral fluid, which is not the same as saliva. Its results are considered preliminary, and should be confirmed by a blood test.

OraSure had nearly 5,700 people take the at-home version of the test. The tests found that 114 thought they were HIV-positive; 106 of them actually were. That means that positive results were accurate 93 percent of the time. Negative results were accurate 99.98 percent of the time, the company said.

Pant Pai said the oral test's overall accuracy is similar to that of a blood test, although it's slightly less accurate. The oral test, in particular, may miss HIV infection in its early stages, she said.

Also, "the sensitivity of the test appears lower when administered in the home setting rather than a medical setting, so some of the people who are HIV-positive will get a test result that they are negative," said Jane Rotheram-Borus, director of the Center for HIV Identification Prevention & Treatment Services at the University of California, Los Angeles. "However, if they would otherwise not have gotten the test at all, they may also have believed they were negative."

Experts have expressed concern for people who learn at home, possibly alone, that they are probably infected with the virus that causes AIDS.

"The arguments against the at-home test focus on the absence of a counselor who could provide support and link the newly identified HIV-positive individual to medical care," said Rotheram-Borus, who supports over-the-counter sales of the OraQuick test.

She pointed out that "over-the-counter pregnancy tests are widely used, and pregnant women do find their way into prenatal care."

Orasure has said it will offer a 24-hour toll-free number that people can call to get support regarding their test results.

The comnpany has not determined the over-the-counter price of the test yet.

More information

For more on HIV and AIDS, try the U.S. National Library of Medicine.

SOURCES: Nitika Pant Pai, M.D., Ph.D., M.P.H., assistant professor, medicine, McGill University, Montreal; Mary Jane Rotheram-Borus, Ph.D., Bat-Yaacov Professor of Child Psychiatry and Biobehavioral Sciences, and director, Global Center for Children and Families, and director, Center for HIV Identification Prevention & Treatment Services, University of California, Los Angeles

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Panel to Consider At-Home HIV Test
2. FDA Panel Gives Blessing to New Weight-Loss Drug
3. U.S. Panel Rejects Ovarian Cancer Screening
4. Panel of serum biomarkers may reduce number of lung biopsies needed
5. FDA Panel Cites Clot Risk From Contraceptive Patch
6. Panel endorses active monitoring and delay of treatment for low-risk prostate cancer
7. Expert Panel Pinpoints Environmental Culprits in Breast Cancer
8. FDA Panels to Weigh Safety of Newer Forms of the Pill
9. Panel of melanoma mutations opens door to new treatment possibilities
10. Many on Medical Guideline Panels Have Conflicts of Interest: Study
11. Panels Rejection of PSA Test Spurs Mixed Reaction From Experts
Post Your Comments:
Related Image:
FDA Panel Backs At-Home HIV Test
(Date:6/27/2016)... ... June 27, 2016 , ... The ... OSHA Training Institute Education Center headquartered in Northern California, has issued an important ... heat at their worksites. Employers with workers exposed to high temperatures should ...
(Date:6/27/2016)... ... ... "FCPX editors can now reveal their media with growing colorful split screen ... - CEO of Pixel Film Studios. , ProSlice Color brings the split screens ... reveal the media of their split screens with growing colorful panels. , ProSlice Color ...
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, ... today its affiliation with Tennessee Counseling Association. This new relationship allows ... the Tennessee Counseling Association, adding exclusive benefits and promotional offers. , "TCA is ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... industry today announced its strategic partnership with Connance, a healthcare industry leader ... two companies’ proven, proprietary technology combine to provide health systems, hospitals and ...
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... ... cutting edge technology to revolutionize the emergency ambulance transport experience for the millions ... aware of how Uber has disrupted the taxi industry through the use of ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
(Date:6/23/2016)... , June 23, 2016 , ... Thursday, July 7, 2016 , , , , LOCATION: , ... , , , , EXPERT PANELISTS:  , , , Frost ... Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh ... The global pharmaceutical industry is witnessing an exceptional era. Several ...
(Date:6/23/2016)... 2016  Guerbet announced today that it has been ... Award . One of 12 suppliers to ... its support of Premier members through exceptional local customer ... commitment to lower costs. ... our outstanding customer service from Premier," says Massimo ...
Breaking Medicine Technology: