New HIV test gets green light from the FDA

The Food and Drug Administration (FDA) - the nation's pharmaceutical regulator - has accepted the use of a new diagnostic HIV test that promises an earlier and more accurate detection of the virus that causes AIDS.

With a broad range, the test has been approved for use in adults including pregnant women as well as in children as young as 2 years old as an aid in the diagnosis of HIV-1/HIV-2 infection.

The main benefit of the test stems from its ability to detect not just the antibodies but the antigen itself (HIV-1). It can thus help to make the diagnosis faster, even before the antibodies appear.

Dr Karen Midthun, acting director of FDA's Center for Biologics Evaluation and Research, said that the newly approved 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."

She added that "it provides for more sensitive detection of recent HIV infections compared with antibody tests alone."

Called ARCHITECT HIV Ag/Ab Combo, the test is not intended for routine screenings of blood donors, except in urgent situations.