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Siemens Submits Premarket Approval Application to FDA for HIV Combo Assay

Siemens Healthineers
7 May 2014
Sarah Thomas
Associate Editor

Product news

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

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ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.HIV and AIDSBlood tests are the most common way to identify and monitor HIV and AIDS. Current methods include ELISA, Western blot, RT-PCR viral load and CD4/8 testing. Areas for development include point-of-care assays for use in developing countries, and self-testing ‘at home’ HIV kits.

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Siemens Submits Premarket Approval Application to FDA for HIV Combo Assay