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Abbott Says ARCHITECT HIV Ag/Ab Combo Assay Gets FDA Approval - Quick Facts

(RTTNews) - Abbott Laboratories (ABT) Monday said that the U.S. Food and Drug Administration has approved its ARCHITECT HIV Ag/Ab Combo assay, an innovative new diagnostic tool, which can simultaneously detect both HIV antigen and antibodies. Studies have demonstrated that the test may detect HIV days earlier than antibody-only tests, which is important in controlling the spread of the virus.

Studies conducted by the Centers for Disease Control and Prevention show that current antibody-only tests miss up to 10% of HIV infections in some high- risk populations because they do not detect antigens. However, Abbott's new assay detects the HIV p24 antigen, or the direct presence of HIV, allowing for diagnosis of early infections days before antibodies emerge.

The company noted that ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pregnant women.