FDA Approves Siemens HIV Combo Assay

The U.S. Food and Drug Administration (FDA) has approved the Siemens ADVIA Centaur HIV Ag/Ab Combo (cHIV) assay. This latest addition to the ADVIA Centaur infectious disease menu from Siemens Healthcare Diagnostics, which also includes tests for hepatitis A, B, C; eHIV, syphilis and other infectious disease assays, enables laboratories to further consolidate their testing to enhance efficiencies.

The ADVIA Centaur HIV Ag/Ab Combo assay is designed to simultaneously detect the presence of the HIV viral protein (p24 antigen) and the antibodies produced in response to the HIV (HIV-1 or HIV-2) viral infection. The ability to detect both the antigen and the antibody may enable earlier detection of acute infection, allowing both clinical management and behavior modification that may reduce transmission.

“Siemens continues to invest in the development of new solutions that allow clinical laboratories to improve both patient care and workflow efficiency,” said Franz Walt, CEO, Chemistry, Immunoassay, Automation and Diagnostics IT Business Unit, Siemens Healthcare Diagnostics. “We are proud to offer our U.S. customers a broad range of high performance, fully automated infectious disease tests, which now includes the ADVIA Centaur HIV Ag/Ab combo assay.”

The ADVIA Centaur HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of both acute and established HIV-1/HIV-2 (including HIV-1 Group O) infection, and has been available for use in Europe since 2010. The third generation HIV test (eHIV) will also remain available on the ADVIA Centaur systems.