FDA approves rapid diagnostic test for HIV antigen, antibodies

August 9, 2013
FDA approves rapid diagnostic test for HIV antigen, antibodies
The first rapid test to detect the HIV-1 antigen, as well as blood antibodies for the HIV-1 and HIV-2 strains, has been approved by the U.S. Food and Drug Administration.

(HealthDay)—The first rapid test to detect the HIV-1 antigen, as well as blood antibodies for the HIV-1 and HIV-2 strains, has been approved by the U.S. Food and Drug Administration.

The Alere Determine HIV-1/2 Ag/Ab Combo test can detect these markers for the virus in human serum, plasma, and blood specimens, the agency said in a news release.

Detection of the HIV-1 antigen may allow doctors to diagnose the viral infection earlier than detection of the antibodies alone, the FDA said.

Some 50,000 people are infected with HIV each year in the United States, the agency said, citing statistics from the U.S. Centers for Disease Control and Prevention. Of the more than one million people living with HIV in the United States, about 20 percent haven't been diagnosed, the FDA added.

The new test is produced by Orgenics Ltd., whose parent, Alere Inc., is based in Yavne, Israel.

Explore further: New microsphere-based methods for detecting HIV antibodies

More information: More Information

Related Stories

New microsphere-based methods for detecting HIV antibodies

May 23, 2013

Detection of HIV antibodies is used to diagnose HIV infection and monitor trials of experimental HIV/AIDS vaccines. New, more sensitive detection systems being developed use microspheres to capture HIV antibodies and can ...

New test IDs genotype of hepatitis C

June 20, 2013

(HealthDay)—A new test to help doctors identify the genotype of a person's hepatitis C infection has been approved by the U.S. Food and Drug Administration.

FDA reviews first rapid, take-home test for HIV

May 11, 2012

The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

FDA rejects two HIV drugs from Gilead Sciences

April 29, 2013

Gilead Sciences Inc. says that the Food and Drug Administration rejected two marketing applications for HIV treatments, citing quality control problems at the company's manufacturing facilities.

Recommended for you

S.Africa launches major new trial of AIDS vaccine

November 29, 2016

South Africa on Wednesday launched a major clinical trial of an experimental vaccine against the AIDS virus, which scientists hope could be the "final nail in the coffin" for the disease.

HIV survives in our chromosomal DNA

November 17, 2016

It has been said that HIV cannot be cured since the virus propagates in places beyond the reach of antiviral agents. New research from Karolinska Institutet suggests, however, that this view is incorrect.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.