Bayer Diagnostics Receives FDA Approval For Fully-Automated HIV Antibody Test

06/21/06

Bayer HealthCare Diagnostics Division has announced that the first fully-automated test for antibodies for human immunodeficiency virus, called EHIV (Human Immunodeficiency Virus, Enhanced), has received FDA approval for use on the ADVIA Centaur® Immunoassay System.  Bayer’s 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 health care standards for detecting all known types of HIV infection. 

With its availability on Bayer’s 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.

“With the addition of the EHIV test, Bayer offers the most comprehensive fully automated infectious disease portfolio in the United States, thus enabling laboratorians to enhance their level of testing and aid physicians in making treatment decisions,” says Tony Bihl, president, Bayer Diagnostics.  The Bayer automated infectious diseases testing portfolio also includes testing for hepatitis A, B, and C:  HBsAg, HBsAg Confirmatory, HBsAb, HBc-T, HBc-IgM, HCV, HAV-T and HAV-IgM.

The EHIV test is developed, manufactured and sold by Bayer Diagnostics for Ortho Clinical (Ortho) Diagnostics, a subsidiary of Johnson & Johnson, under an agreement entered into with Bayer, Ortho, and Chiron Corporation in 2001.  Under the terms of the agreement, Bayer will not represent the product for blood or plasma screening.