FDA Approval for First Fully Automated HIV 1, HIV 2 and HIV 1- Subtype O Antibody Test
Bayer HealthCare Diagnostics Division, has received FDA approval for the first fully-automated test for antibodies for human immunodeficiency virus, called EHIV (Human Immunodeficiency Virus, Enhanced), for use on the ADVIA Centaur® Immunoassay System.
Bayers ADVIA Centaur EHIV test is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to HIV 1, HIV 2 and HIV 1 - sub-type O in human serum and plasma. ADVIA Centaur EHIV is the only fully-automated FDA-approved test that contains a range of recombinant proteins and sub-type O peptide for the detection of antibodies to HIV-1, HIV-2, and sub-type O peptide. This meets the worldwide healthcare standards for detecting all known types of HIV infection.
With its availability on Bayers ADVIA Centaur, the EHIV fully-automated testing process eliminates manual labor and provides advanced features such as: automatic algorithm processing, cascade reflex testing, user-defined panels, and automatic repeats of critical samples. Combined with security and verification features, such as use of sample tips and assay verification processes, ADVIA Centaur EHIV allows laboratorians to increase their HIV testing productivity with enhanced confidence in their HIV results.
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