Hepatitis A Total Assay

The assay has been cleared by the U.S. Food and Drug Administration (FDA).

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 assay was developed by Bayer Healthcare, Diagnostics Division (Tarrytown, NY, USA).

Bayer offers the HAV assay on its Advia Centaur immunoassay system, making the panel ideal for medium- and large-volume laboratories. The addition of this assay to the Advia 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 approval of the assay for HAV Total brings Bayer Diagnostics one step closer to offering the industry's most extensive panel for hepatitis testing,” noted John Nosenzo, senior vice president and general manager of the North American Region for Bayer HealthCare's Diagnostic Division. In addition to the new assay, Bayer also offers 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).

Hepatitis A infects up to 200,000 people each year in the United States alone. It is a highly contagious virus that attacks the liver. The virus is spread by the fecal-oral route through close person-to-person contact or by ingesting contaminated food or water.




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