FDA Approves First Diagnostic Assay to detect both HIV Antigen and Antibodies

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Title: FDA Approves First Diagnostic Assay to detect both HIV Antigen and Antibodies

FDA Approves First Diagnostic Assay to detect both HIV Antigen and Antibodies
Mon, 21 Jun 2010 09:43:00 -0500

The U.S. Food and Drug Administration today 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.


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