FDA approves Siemens HIV Combo assay
Jun 19, 2015
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.1 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.
For further information on the ADVIA Centaur HIV Ag/Ab Combo assay please visit http://www.usa.siemens.com/hiv.
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Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world's largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of combined cycle turbines for power generation, a major provider of power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2014, which ended on September 30, 2014, Siemens generated revenue from continuing operations of €71.9 billion and net income of €5.5 billion. At the end of September 2014, the company had around 343,000 employees worldwide on a continuing basis. Further information is available on the Internet at http://www.siemens.com.
1The ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay is an in vitro diagnostic immunoassay for the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group “O”) and type 2.
The ADVIA Centaur HIV assays are developed, manufactured and sold by Siemens for Ortho-Clinical Diagnostics, Inc. and Novartis Vaccines and Diagnostics, Inc.