Advertisement
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
  
  • Email Email
  • Comments Comments
  •  (1)
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

Medical News

Rapid HIV Test Approved by U.S. FDA

August 13, 2013

The U.S. Food and Drug Administration (FDA) has approved the Alere Determine HIV-1/2 AF/Ab Combo test that can detect an HIV infection and distinguish between an early infection and an established HIV infection from "human serum, plasma, and venous or fingerstick whole-blood specimens." Developed by Alere's Israel-based Orgenics subsidiary, the Alere Determine rapid HIV test not only would provide faster HIV diagnosis, but also would be relatively simple to use in remote high-incidence areas such as sub-Saharan Africa.

The Alere Determine rapid test is able to detect simultaneously the HIV-1 p24 antigen, a signal of HIV-1 infection, and the presence of HIV-1 and HIV-2 antibodies usually present in established infections. Most worldwide AIDS cases developed from HIV-1 infections, and HIV-2 infections have occurred mostly in West Africa. The Alere Determine test is not useful for screening blood donors because it does not distinguish between HIV-1 antibodies and HIV-2 antibodies.

FDA's Center for Biologics Evaluation and Research Director Karen Midthun predicted the test could help in identifying HIV earlier in "outreach settings." Early detection could help newly infected people receive medical care sooner and potentially could prevent HIV transmission.

CDC estimated that more than a million U.S. residents are HIV-positive, although approximately 20 percent are unaware of their infection. The United States records approximately 50,000 new HIV infections annually.

Back to other news for August 2013

Adapted from:
Medical News Today
08.12.2013; Nick Valentine


  
  • Email Email
  • Comments Comments
  •  (1)
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
 
See Also
Quiz: Are You at Risk for HIV?
10 Common Fears About HIV Transmission
More on Rapid HIV Testing

 

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 TheBody.com's Comment Policy.)

Your Name:


Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:

Tools
 

Advertisement