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:6/24/2016)... ... 2016 , ... To succeed under value-based payments, healthcare providers ... how to move forward, given the need to sustain current operations. PYA has ... an organization’s specific needs. , PYA Principal Martie Ross states, “Healthcare providers want ...
(Date:6/24/2016)... Brooklyn, New York (PRWEB) , ... June 24, 2016 , ... ... medical marijuana patients optimize the ingestion of their medication by matching users with high ... allows users to compare pieces with no commitment. , Inhale was founded by two ...
(Date:6/24/2016)... ... ... Dr. Seema Daulat, a native Texan and University of Texas at Austin ... July 13, 2016. , Dr. Daulat earned her Doctorate of Medicine (MD) at The ... the Agape Clinic serving Dallas’ underprivileged community. , Following medical school, Dr. Daulat completed ...
(Date:6/23/2016)... Los Angeles, CA (PRWEB) , ... June 23, 2016 , ... ... being conducted that may expose a possible link between head and neck cancer in ... individuals participating in the study were evaluated based on whether they had gum disease, ...
(Date:6/23/2016)... ... ... The Mechille Wilson Agency, a Texas-based insurance company that provides coverage to hundreds ... a charity drive to assist a student to be chosen from the local area. ... be presented to the chosen student to help with the growing costs of tuition, ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
(Date:6/23/2016)... and INDIANAPOLIS , June ... receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is any ... scholarship winners, announced today online at www.diabetesscholars.org ... type 1 diabetes stand in the way of academic ... supported the Foundation,s scholarship program since 2012, and continues ...
(Date:6/23/2016)... 2016 Revolutionary technology includes multi-speaker ... , industry leaders in advanced audiology and hearing aid ... Opn ™, the world,s first internet connected hearing aid ... devices.      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ) ... of ,world firsts,: , TwinLink™ - the ...
Breaking Medicine Technology: