The Food and Drug Administration on Monday announced its approval of the first diagnostic test for both HIV antigens and antibodies.
"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," FDA said in a statement. "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," FDA said.
"This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women," 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 two years old."
The new test will be used in clinical as well as public health laboratories. Although not intended for routine blood donor screening, the assay is approved for such testing "in urgent situations where licensed blood donor screening tests are unavailable or their use is impractical," FDA noted.
"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, MD, 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."
Abbott Laboratories of Abbott Park, Ill., manufactures the Architect test.
To access FDA's full statement, visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216375.htm.
06/21/10
UNITED STATES: FDA OKs New HIV Antigen, Antibody Test
Source: United Press International; Courtesy of the CDC National Center for HIV, STD, and TB Prevention