Abbott Laboratories has introduced its second fully automated hepatitis A test in the United States for its widely used AxSYM automated immunoassay instrument system.

Used to aid in the laboratory diagnosis of previous or ongoing hepatitis A viral infection, the AxSYM HAVAB 2.0 assay detects the total antibody to hepatitis A (anti-HAV) in human serum or plasma. Though primarily used to determine previous exposure to hepatitis A (HAV), the test can also be used to identify HAV-susceptible individuals for vaccination. This introduction marks the completion of Abbott's hepatitis A menu for the AxSYM system in the United States. Abbott will be introducing additional AxSYM tests for other types of hepatitis in the US throughout 2004 and continuing into 2005, a release from Abbott said.

Michael J Collins, vice president, US Diagnostic Commercial Operations, Abbott Laboratories says, "The addition of the AxSYM HAVAB test demonstrates our ongoing commitment to completing AxSYM's viral hepatitis panel in the United States. Within a few months, this panel will include the addition of AxSYM Anti-HCV, a test for hepatitis C. Abbott has also submitted applications to the US Food and Drug Administration for its AxSYM hepatitis B tests, which are currently available outside of the United States," he added.

"Our AxSYM HAVAB assay has excellent correlation to Abbott's other well-known hepatitis tests which are run on other systems-the IMx HAVAB assay and EIA HAVAB assay," William Brown, vice president, Diagnostic Assays and Systems Development, Abbott Laboratories said adding, "Sensitive and specific, the AxSYM HAVAB test also features the added benefit of automation from our AxSYM immunoassay system. This gives laboratories the ability to process a variety of immunodiagnostic tests simultaneously."

In July, Abbott introduced the AxSYM HAVAB-M 2.0 assay which aids in the diagnosis of an acute or recent hepatitis A viral infection by detecting the IgM antibody to hepatitis A. In most cases, IgM antibody response usually peaks within the first month of illness and persists throughout the first three to six months of infection, the release said.

According to the World Health Organization, an estimated 1.5 million clinical cases of hepatitis A occur each year.