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FDA Approves Roche's HIV Assay

NEW YORK (360Dx) – Roche today said that the US Food and Drug Administration has approved the firm's fourth-generation HIV combination antigen-antibody assay for marketing.

The Elecsys HIV combi PT assay is for the in vitro qualitative assessment of HIV-1 p24 antigen and antibodies to HIV-1 (HIV-1 groups M and O) and HIV-2 in human serum and plasma. It can be used to help in the diagnosis of HIV-1 and/or  HIV-2 infection, including acute and primary HIV-1 infection. The assay detects antigen and antibodies simultaneously, increasing the likelihood of early detection of HIV infection, and improving disease management, as well as prevention of infection transmission, Roche said.

"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," said Roche Diagnostics President and CEO Jack Phillips in a statement.