Roche Receives FDA Approval for Fourth-Generation HIV Combination Antigen-Antibody Assay

Roche announced 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 approval of this highly sensitive and specific assay demonstrates our ongoing commitment of expanding Roche's already broad testing menu for infectious diseases on the cobas e 602 analyzer, including Hepatitis and ToRCH assays," said Jack Phillips, President and CEO, Roche Diagnostics Corporation. "With the addition of this assay, laboratories will be able to screen for common co-infections, such as Hepatitis C and Syphilis, which can be tested simultaneously with HIV, reducing the need for sample splitting and additional analyzers."

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.