Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Abbott HBV test

This article was originally published in The Gray Sheet

Executive Summary

Firm gains PMA approval for its Architect Core automated hepatitis B test that runs on its Architect i2000 and Architect i2000SR immunoassay testing instruments. Abbott filed the PMA in October (1"The Gray Sheet" Oct. 6, 2008, In Brief). Architect Core is a chemiluminescent microparticle immunoassay for the qualitative detection of the IgG and IgM antibodies to the hepatitis B core antigen in blood serum and plasma. It is indicated for aiding the diagnosis of acute, chronic or resolved hepatitis B virus infection in conjunction with other laboratory results or clinical information. The Centers for Disease Control and Prevention advises individuals needing immunosuppressive therapy to be tested for the hepatitis B core antigen as well as the hepatitis B surface antigen and the antibody to HBsAg, because immunosuppressive therapy may increase the risk for reactivation in patients with resolved hepatitis B infection, according to the company
Advertisement

Related Content

Abbott’s Architect Core

Topics

Advertisement
UsernamePublicRestriction

Register

MT027465

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel