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FDA Approves First 4th-generation Rapid HIV Diagnostic Test


Alere Determine HIV-1/2 Ag/Ab Combo test, a fourth-generation rapid diagnostic test manufactured by Orgenics Ltd., won FDA approval on Thursday for use as an aid in the diagnosis of HIV-1 and HIV-2 infection.

There are two types of human immunodeficiency virus namely, HIV-1 and HIV-2. HIV-1 is the most common type while HIV-2 is found primarily in West Africa, although cases of HIV-2 infection have been reported in North America and Europe.

The Alere Determine Combo test becomes the first rapid HIV test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma or whole blood, and the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test, said the regulatory agency in a statement.

Since the HIV-1 p24 antigen can be detected early, before antibody appears, the test also permits earlier detection of HIV-1 infection than is possible by testing for HIV-1 antibodies alone.

Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research said, "This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner. Earlier diagnosis may also help to reduce additional HIV transmission."

by RTTNews Staff Writer

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