FDA OKs New HIV Antigen, Antibody Test

WASHINGTON, June 21 (UPI) — The U.S. Food and Drug Administration announced approval Monday of the first diagnostic assay to detect both HIV antigens and antibodies

Officials said the newly approved test advances science’s ability to detect human immunodeficiency virus infections earlier than before possible.


“This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults, including pregnant women,” the FDA said. “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 2 years old.”

Officials said the highly sensitive 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. And since it actually detects the HIV-1 virus (specifically the p24 antigen) in addition to antibodies to HIV, the test — called the Architect HIV Ag/Ab Combo Assay” — can be used to diagnose HIV infection prior to the emergence of antibodies, unlike most tests used today that detect only HIV antibodies.

HIV is the virus that can lead to the development of AIDS.

The test is manufactured by Abbott Laboratories of Abbott Park, Ill.

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