Bayer HealthCare, Diagnostics Division, a member of the Bayer Group has announced the sixth FDA approval for automated assay for hepatitis on its ADVIA Centaur Immunoassay System.
The US Food and Drug Administration approved Bayer HealthCare Diagnostics' assay for Hepatitis A (HAV) Total, an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to the hepatitis A virus in human serum or plasma. The assay can be used by laboratories to aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination.
The company release says, with this most recent approval, Bayer HealthCare Diagnostics offers one of the most comprehensive test panels for hepatitis testing in United States including two assays for the hepatitis A virus (HAV IgM and Total), three assays for the hepatitis B virus (HBc IgM, anti-HBs and HBc Total), as well as an assay for the detection of the hepatitis C virus (anti-HCV).
Bayer HealthCare Diagnostics offers the HAV Total assay on the ADVIA Centaur immunoassay system, making the hepatitis panel ideal for medium and large volume laboratories. The addition of this assay to the platform allows laboratorians to enhance their level of automation in performing these assays with such features as: software that provides automatic algorithm processing, cascade reflex testing, user-defined panels, automatic repeats of critical samples, and sample and reagent integrity checks, the release claims.
"The approval of the assay for HAV Total brings Bayer HealthCare Diagnostics one step closer to offering the industry's most extensive panel for hepatitis testing. At the same time, this meets our customers' demands for practical assays that enhance the efficiency and value of their laboratories," commented John Nosenzo, Senior VP and general manager of the North America Region for Bayer HealthCare's Diagnostics Division.