Abbott has announced that it has received premarket approval (PMA) from the U.S. Food & Drug Administration for ARCHITECT® CORE™, an automated hepatitis B test for use on its ARCHITECT i 2000 and i 2000SR immunoassay testing instruments.
Hepatitis is an inflammation of the liver caused by a number of agents, including viruses, bacteria, drugs, toxins and excess consumption of alcoholic beverages. There are at least five types of hepatitis caused by different hepatitis viruses.
ARCHITECT CORE is intended as an aid in diagnosis of acute, chronic or resolved hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information.
ARCHITECT CORE will build upon the current ARCHITECT menu of hepatitis A, hepatitis B and hepatitis C diagnostic tests. The ARCHITECT i
is designed to be seamlessly integrated with the ARCHITECT c8000 clinical chemistry analyzer. The benefit of integration is that laboratories have the ability to perform common hepatitis tests and associated liver enzyme panels from one patient sample.
The Centers for Disease Control and Prevention currently recommends that individuals needing immunosuppressive therapy be tested for hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc) because immunosuppressive therapy may increase the risk for reactivation in persons with resolved hepatitis B infection. Individuals found to be positive for anti-HBc should be monitored closely for signs of liver disease.
With today's announcement, the ARCHITECT now offers all three recommended tests.
"This approval provides an important test with excellent clinical performance for our laboratory customers and the patients they serve," said Mike Warmuth, senior vice president, diagnostics, Abbott.
Abbott's AxSYM and ARCHITECT assays listed are restricted to sale and distribution by or on the order of a physician, or to a clinical laboratory, and use is restricted to, by or on the order of a physician.
ARCHITECT and AxSYM hepatitis assays are not intended for use in screening blood, plasma or tissue donors. Assay performance characteristics have not been established for immunocompromised and immunosuppressed patients, it is warned.