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FDA Approves Siemens HIV Combo Assay

Siemens Healthineers
23 Jun 2015
Lois Manton-O'Byrne, PhD
Executive Editor

Product news

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.

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HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.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 ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. 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.Antibody ProductionAntibody production is essential for a wide range of applications in biochemistry and immunology. Ensuring high-quality monoclonal and polyclonal antibodies are produced is key. Explore antibody production tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Infectious DiseasesInfectious diseases are caused by pathogens such as bacteria, viruses, and fungi. Effective detection, prevention, and treatment are crucial to control outbreaks and improve public health. Diagnostic tools, vaccines, and antimicrobial treatments are essential components of managing these diseases. Research into emerging pathogens and resistance patterns continues to evolve. Browse our peer-reviewed product directory to find the best diagnostic tools, prevention solutions, and treatment options; compare products, read customer reviews, and get pricing directly from manufacturers.

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FDA Approves Siemens HIV Combo Assay