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FDA Approves New Antigen Based HIV Testing

By Andrew M. Gibson | July 29, 2010

The FDA (Food and Drug Administration) recently approved the use of a new method for performing HIV testing that has the ability to detect infections several days earlier than existing tests currently approved in the United States.

Currently, most HIV tests are limited in that they cannot be performed until sixty (60) to ninety (90) days post infection.  This is because they rely upon the ability to identify key antibodies produced over that period of time.  Instead, this new method can look for HIV antigens, which are proteins that are produced by the virus itself and show up much earlier.

Says Peter Leone, director of North Carolina HIV/STD Prevention and Control Branch. “A significant percentage of new HIV infections are transmitted by someone with an undetected acute infection, so identifying more people earlier offers a significant opportunity for counseling, which can reduce high-risk behaviors.”

He also added that knowing your HIV status that much earlier can have significant impacts upon the spread of the disease.  Most individuals are not aware that the disease is at its most infectious stage during the time period immediately after it is contracted.  A much needed benefit would be a decrease in the rate of transmission.

For years this new test has been available in Europe, and FDA officials have noted that it has shown very positive results.  By making this new testing available immediately, the FDA is hopeful that declines in transmission rates overseas can be replicated here in the states. As of yet, it is unclear if this new type of testing will be made readily available to county, state, and other free health clinics.  They have generally used standard testing due to it being readily available and affordable.  However, with the release of more federal stimulus money throughout the rest of 2010, there are hopes that some of those funds can be allocated towards making more advanced testing that has only been available for private testing, available to those who cannot afford it.

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