Product News: Siemens Submits Premarket Approval Application to FDA for HIV Combo Assay

08 May 2014


Siemens Healthcare announced that it has submitted a Premarket Approval (PMA) application for its ADVIA Centaur HIV Ag/Ab Combo assay to the U.S. Food and Drug Administration (FDA) for review. The assay is designed to simultaneously detect the presence of HIV p24 antigen (produced by the HIV virus) and antibodies (proteins produced by the body against HIV antigens), which could allow for earlier detection of HIV infection than antibody tests.

The Centers for Disease Control and Prevention (CDC) estimates that there are 50,000 new cases of HIV in the United States annually.1 In 2011, UNAIDS, the Joint United Nations Programme on HIV/AIDS, estimated that 2.5 million people throughout the world are newly infected with HIV each year, and 50% of people living with HIV do not know their status.2 Leading risk factors for HIV infection include male-to-male sexual contact, high-risk heterosexual contact and intravenous drug use.3

The Siemens-developed ADVIA Centaur HIV Ag/Ab Combo assay, which is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection, has been available for use in Europe since 2010.

1. The ADVIA Centaur HIV Ag/Ab Combo assay is designed for the simultaneous detection of HIV p24 antigen and antibodies to HIV Type 1, including Group O (HIV-1 + “O”) and/or Type 2 (HIV-2) in serum and plasma.
2. CDC. HIV/AIDS. HIV Basics. Available at http://www.cdc.gov/hiv/basics/statistics.html. Accessed 3/3/13
3. UNAIDS World AIDS Day Report 2012. Available at http://www.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2012/gr2012/jc2434_worldaidsday_results_en.pdf. Accessed 3/3/13
4. CDC. HIV Surveillance in Injection Drug Users. Available at http://www.cdc.gov/hiv/pdf/statistics_surveillance_HIV_injection_drug_users.pdf Accessed 3/3/13