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FDA approves HIV diagnostic assay that detects antigens and antibodies
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The FDA recently approved the fourth generation of the Architect HIV Ag/Ab Combo assay from Abbott Laboratories. The assay is the first to detect HIV antigen and antibodies, and it is also the first test approved by the FDA for use in children younger than 2 years.
The device is a single, automated test that is a highly sensitive chemiluminescent microparticle immunoassay. It is to be used to diagnose HIV-1 or HIV-2 infection, including acute or primary HIV-1, and has specificity for the detection of the HIV-1 p24 antigen, antibodies to HIV-1 groups M and O and antibodies to HIV-2.
Because the assay has the capacity to detect the p24 antigen and antibodies to both types of HIV, it can extend the window of diagnosis to the period of the acute phase of infection by up to 7 days (range 0 to 20 days) compared with the third generation enzyme immunoassay antibody tests, according to findings in an FDA press release.
FDA officials said although the assay is not intended for routine screening of blood donors, it is approved as a donor screening assay for HIV-1 and HIV-2 in situations in which licensed blood donor screening tests are unavailable or the use of such tests is impractical.