The Body: The Complete HIV/AIDS Resource Follow Us Follow Us on Facebook Follow Us on Twitter Download Our App 
Professionals >> Visit The Body PROThe Body en Espanol
HIV/AIDS Blog Central

FDA Advisory Panel Approves Truvada and Home HIV Tests

By Candace Y.A. Montague

May 16, 2012

Oral HIV tests are almost at your doorstep. Photo credit:

Oral HIV tests are almost at your doorstep. Photo credit:

The Food and Drug Administration's Blood Panel Advisory Committee has approved both Truvada PrEP and the OraSure Rapid HIV test for home use. The panel voted yesterday after deliberation and testimonies in support and against both products. Truvada, a pill with a combination of tenofovir and emtricitabine, has been recommended for use as a pre-exposure prophylaxis (PrEP) for HIV-negative partners in serodiscordant relationships. The OraSure Rapid HIV test is an oral-swab based test that can give results in about 20 minutes. The FDA does not have to accept the recommendations from the committee but it usually does.

Truvada has been proven to be generally safe and effective in preventing new HIV infections in clinical trials. It has a 75 percent success rate of reducing infections when used as directed. The concerns from the trials were that it wasn't proven to be as effective in women, a patient can develop a resistance to the drug over time, side effects that could harm an otherwise healthy person, and that if a person doesn't adhere to the strict regimen their chances for infection will rise again. And while a prescription is a great start there has to be a balanced approach to ending the epidemic.

The OraSure in-home HIV test was unanimously voted 17-0 in favor of approval. The over-the-counter test is predicted to identify as many as 45,000 people living with HIV in the US who didn't know they were infected. The test will allow users to collect their own oral sample, place it in a vial of developer solution, and interpret their own results in as little as 20 minutes after sample collection. Concerns about this test were that the test would not be sensitive enough to pick up on HIV anti-bodies in the sample and could produce false-negatives.

Local AIDS Service Organizations are already showing support for the in-home test. Stephen Bailous Executive Vice President of NAPWA and Chair of the EMA Ryan White Planning Council stated, "We welcome in-home testing. We know there are risks in allowing people to test themselves for HIV without counseling, but we also know we are still seeing more than 50,000 new HIV infections every year, and a large majority of them come from sexual contact with people who do not know they have the virus. In-home testing is one of many new testing and treatment options that promise to bring the end of AIDS in America."

The agency is expected to announce its decision on or before June 15th.

Recommended reading: HIV Testing Comes Closer to Home

Send Candace an email.

Get email notifications every time this blog is updated.

See Also
Quiz: Are You at Risk for HIV?
10 Common Fears About HIV Transmission
More on Home HIV Testing

Reader Comments:

Comment by: Worried (USA) Thu., May. 24, 2012 at 6:10 pm UTC
Ok, since no one will respond to my comment, I will add that after googling this, it is shown that the at home trials show a 93% sensitivity, but I am still unsure if this is due to testing inside the window period or simply because the test failed. Any clarification on this would be appreciated.
Reply to this comment

Comment by: Worried (USA) Fri., May. 18, 2012 at 12:53 pm UTC
Could you please clarify something. When you state the concerns about the orasure test were that it would produce false negatives, who were the ones voicing these concerns? I thought that this test was FDA approved and had a sensitivity of more than 99%. Thanks.
Reply to this comment

Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read's Comment Policy.)

Your Name:

Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:
D.C. HIV/AIDS Examiner

Candace Y.A. Montague

Candace Y.A. Montague

Candace Y.A. Montague has been learning about HIV since 1988 (and she has the certificates from the American Red Cross to prove it). Health is a high priority to Candace because she believes that nothing can come of your life if you're not healthy enough to enjoy it. One of her two master's degrees is in Community Health Promotion and Education. Candace was inspired to act against HIV after seeing a documentary in 2008 about African-American women and HIV. She knew that writing was the best way for her to make a difference and help inform others. Candace is a native Washingtonian and covers HIV news all around D.C. She has covered fundraisers, motorcycle rides, town hall meetings, house balls, Capitol Hill press conferences, election campaigns and protests for The DC and emPower News Magazine.

Follow Candace on Twitter

Friend Candace on Facebook

Subscribe to Candace's Blog:

Subscribe by RSSBy RSS ?

Subscribe by Email

Recent Posts:

View All Posts

A Brief Disclaimer:

The opinions expressed by's bloggers are entirely their own, and do not necessarily reflect the views of itself.