Bio-Rad Laboratories has secured approval from the US Food and Drug Administration (FDA) for its Bio-Rad BioPlex 2200 HIV Ag-Ab assay.
The assay is designed to differentiate between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.
Specifically, the test assists in the diagnosis of infection with HIV-1 and / or HIV-2, including acute HIV-1 infection in adults, children two years of age and older, as well as in pregnant women.
FDA Center for Biologics Evaluation and Research director Karen Midthun said: "Today’s approval provides healthcare professionals another option for the diagnosis of HIV infections.
"The ability to diagnose HIV infection early and differentiate between types of infection is important in the care of individuals, as both diseases exhibit the same symptoms but progress at different rates."
The BioPlex 2200 HIV Ag-Ab assay allows results of antigen and antibody detection to be reported separately, enabling differentiation between acute and established HIV infection respectively.
Intended for use with the BioPlex 2200 System, which was cleared by the FDA in 2004, the assay can also be used to screen organ donors for HIV-1/2 when the blood specimen is collected, while the donor’s heart is still beating.
However, the assay is not approved for use in screening blood or plasma donors, except in urgent situations where legacy licensed blood donor screening tests are unavailable or their use is impractical.
Both the HIV-1 and HIV-2 are similar, but distinct viruses.
The HIV-1 is responsible for majority of HIV infections worldwide, while HIV-2 is found primarily in West Africa, with some cases of the HIV-2 infection also being identified in the US.
Image: A scanning electron micrograph of HIV-1 budding from cultured lymphocyte. Photo: courtesy of C. Goldsmith.