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:10/13/2015)... , ... October 13, 2015 , ... ... companies in the United States, today announced the release of its limited edition ... new Cranberry Cocktail Agua Fresca. All feature the unique flavor combinations and delicious ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... announced today their sponsorship of the Microsoft Dynamics AXUG, GPUG and NAVUG Summits ... GPUG Summit and NAVUG Summit are independent user conferences designed and led by ...
(Date:10/13/2015)... ... October 13, 2015 , ... Dr. Poneh Ghasri, dentist ... on September 18, 2015. The research, which was conducted at the Dental Institute at ... colleagues, show connections between stress during pregnancy and future dental health in the child. ...
(Date:10/13/2015)... ... ... Protein is essential to good health. You need it to make the bricks ... does the average man need in order to stay healthy? , The answer ... Harvard Men's Health Watch . Most Americans get about 15% of their calories ...
(Date:10/13/2015)... ... October 13, 2015 , ... Georgia Partnership ... in communities throughout Georgia, along with affiliate organizations, Alabama Partnership for Telehalth (ATP) ... telehealth summits for Fall 2015. , Each of the three conferences share ...
Breaking Medicine News(10 mins):
(Date:10/13/2015)... DIEGO , October 13, 2015 ... today announced the appointment of Harry Lander , PhD ... the Company,s Chairman & CEO David Koos as ... small molecule and immuno-oncological therapeutics. --> Regen ... the appointment of Harry Lander , PhD as its ...
(Date:10/13/2015)...  Yesterday Congresswoman Renee Ellmers (R-NC-02) visited ... located in Holly Springs, NC . ... ® (Influenza Vaccine) using cell-culture technology, a state-of-the-art production ... is not reliant on chicken eggs. 1,2 On ... business of Novartis AG in the US, which for ...
(Date:10/12/2015)... 12, 2015 Given the intricacy of ... challenging to deliver an ophthalmic drug effectively to a specific ... successful ocular drug delivery. These include dilution of a drug ... of conjunctiva and drug permeation issues with respect to the ... topical eye drops, is lost due to the aforementioned barriers. ...
Breaking Medicine Technology: