The Diagnostics Division of Bayer HealthCare LLC, now have available a Hepatitis A IgM assay on its leading automated immunoassay platform -- the ADVIA Centaur® immunoassay system. This assay is only available outside the United States.
The ADVIA Centaur HAV IgM assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the HAV in human serum or plasma (EDTA or heparinized) using the ADVIA Centaur® system. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with HAV. In addition, this assay can be used in conjunction with other assays for the hepatitis virus including Hepatitis B virus (HBV) and Hepatitis C virus (HCV) for the diagnosis of patients presenting symptoms of acute viral hepatitis.
"With the introduction of this assay, we now have access to a robust panel for infectious disease testing on a single, highly efficient automated immunoassay platform," said Prof. Van Helden from Labor Dr. Stein & Kollegen in Moenchengladbach, Germany. "We are very pleased with the performance of the HAV IgM assay. Clinical trials have shown that the test results in fewer false positives, which reduces unnecessary repeat testing and saves the laboratory time and labor. In addition to providing efficiencies to the laboratory, the superior performance of this automated test allows us to provide the treating physician greater confidence in results in a more timely manner to aid in disease management decisions."
Bayer offers the HAV IgM 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 addition of the HAV IgM assay moves Bayer Diagnostics' infectious disease portfolio one more step forward by expanding our ability to offer customers a comprehensive, fully-automated test menu," said Hans Hiller, PhD, senior vice president, Bayer Diagnostics. "In addition to a fully automated panel for HBV, HCV and HIV, the HAV IgM test will allow laboratories to now routinely provide these specialized test results to aid physicians in making treatment and management decisions."
The HBV, HCV and HIV are currently available in European, Latin American and Asia Pacific countries outside of the United States. The HAV Total assay is currently under development.