Navigation Links
FDA Panel to Consider At-Home HIV Test
Date:5/15/2012

By Randy Dotinga
HealthDay Reporter

TUESDAY, May 15 (HealthDay News) -- Should Americans be able to buy a test at the drugstore and use it to determine whether they're infected with the virus that causes AIDS?

A U.S. Food and Drug Administration advisory panel plans to debate this question Tuesday, and the answer the panel arrives at could pave the way toward a new era in HIV testing.

FDA advisory panel recommendations are not binding, but they are often followed by the agency.

"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 test, known as OraQuick, patients 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.

At its meeting this week, the panel is expected to discuss the fact that the test is not as accurate as HIV blood tests.

OraSure, the company that manufactures OraQuick, 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."

In addition to talking about its accuracy, the FDA panel may also examine the support that's available 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."

The company that makes the test says it will offer a 24-hour toll-free number that people can call to get support regarding their test results.

OraQuick 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 Gives Blessing to New Weight-Loss Drug
2. U.S. Panel Rejects Ovarian Cancer Screening
3. Panel of serum biomarkers may reduce number of lung biopsies needed
4. FDA Panel Cites Clot Risk From Contraceptive Patch
5. Panel endorses active monitoring and delay of treatment for low-risk prostate cancer
6. Expert Panel Pinpoints Environmental Culprits in Breast Cancer
7. FDA Panels to Weigh Safety of Newer Forms of the Pill
8. Panel of melanoma mutations opens door to new treatment possibilities
9. Many on Medical Guideline Panels Have Conflicts of Interest: Study
10. Panels Rejection of PSA Test Spurs Mixed Reaction From Experts
11. Osteoporosis Drugs Safety Subject of FDA Panel
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel to Consider At-Home HIV Test
(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)... NY (PRWEB) , ... June 27, 2016 , ... ... using cutting edge technology to revolutionize the emergency ambulance transport experience for the ... are aware of how Uber has disrupted the taxi industry through the use ...
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in ... ways they remain in the eye of the beholder, according to experts who offered ... The American Journal of Managed Care. For the full issue, click here . ...
(Date:6/26/2016)... , ... June 26, 2016 , ... Pixel Film Studios ... X. , "Film editors can give their videos a whole new perspective by using ... - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 Different ...
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016 According to a new ... Pen Needles, Safety Pen Needles), Needle Length (4mm, 5mm, ... Mode of Purchase (Retail, Non-Retail) - Trends & Global ... the market for the forecast period of 2016 to ... Billion by 2021 from USD 1.65 Billion in 2016, ...
(Date:6/23/2016)... , June 23, 2016 Research ... Devices Global Market - Forecast to 2022" report to ... the treatment method for the patients with kidney failure, it ... excess fluid from the patient,s blood and thus the treatment ... potassium and chloride in balance. Increasing number ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... Analysis 2016 - Forecast to 2022" report to their ... contains up to date financial data derived from varied research ... trends with potential impact on the market during the next ... which comprises of sub markets, regional and country level analysis. ...
Breaking Medicine Technology: