FDA approves Elecsys HIV combi PT assay for HIV detection- Roche

Roche announced that its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay, has received FDA PMA approval from the U.S. Food and Drug Administration (FDA). The Elecsys HIV combi PT assay is for the in vitro qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1 (HIV-1 groups M and O) and HIV-2 in human serum and plasma. Intended for use as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute and primary HIV-1 infection, this fourth-generation HIV immunoassay is able to detect both antigen and antibodies simultaneously. This can increase the likelihood of early detection of HIV infection, improving disease management and helping to prevent transmission of infection. The assay may be used as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects greater than two years of age and in pregnant women.