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Issue No. 26 | June 25, 2010

News and Features

FDA Approves First Diagnostic Test to Detect Both HIV Antigen and Antibodies

“The U.S. Food and Drug Administration ... approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old. …

“Since it actually detects the HIV-1 virus (specifically the p24 antigen) in addition to antibodies to HIV, the ARCHITECT HIV Ag/Ab Combo assay can be used to diagnose HIV infection prior to the emergence of antibodies. Most tests used today in the diagnostic setting detect HIV antibodies only. Although direct detection of the virus itself by nucleic acid testing is available, it is not widely used in diagnostic settings. …

“'‘The approval of this assay represents an advancement in our ability to better diagnose HIV infection in diagnostic settings where nucleic acid testing to detect the virus itself is not routinely used,’ said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. ‘It provides for more sensitive detection of recent HIV infections compared with antibody tests alone.’” 

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Join AIDSinfo in Observing National HIV Testing Day

June 27 marks the 16th annual observance of National HIV Testing Day, a day that serves to promote the importance of HIV testing. The Centers for Disease Control and Prevention (CDC) reports that approximately 1.1 million people in the United States are living with HIV and, of these, 21% do not know they are infected. People who receive an early diagnosis are able to begin treatment in the initial stage of the disease, which can lead to better control of the virus and may slow the progression to AIDS.

AIDSinfo has developed a specialty page for National HIV Testing Day with information and resources about HIV testing.

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