This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: ADVIA Centaur Anti-HBe2
PMA Applicant: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Avenue, Tarrytown, NY 10591
Approval Date: July 14, 2021
Approval Letter: Approval Order
What is it?
The ADVIA Centaur Anti-HBe2 is a laboratory test used to detect human antibodies against the hepatitis B virus e-antigen (HBeAg) in a patient’s blood. Detection of anti-HBe antibodies in a patient’s bloodstream indicates e-antigen seroconversion of the hepatitis B virus (HBV). This may occur in patients with recent (acute) or long-term (chronic) HBV infection.
How does it work?
A sample of a patient’s blood is sent to a clinical laboratory. The serum or plasma containing the antibodies is separated from the other parts of the blood and mixed with test chemicals.
When is it used?
The ADVIA Centaur Anti-HBe2 can aid a health care provider in determining HBV e-antigen seroconversion in patients with signs or symptoms of HBV infection or who may be at risk for HBV infection.
What will it accomplish?
Health care providers use the test results, a patient’s medical history, and other blood tests to help determine HBV e-antigen seroconversion; a change from having HBeAg detected in their blood to having anti-HBe antibodies detected. In patients with chronic HBV infection, e-antigen seroconversion often means improved health and improved liver disease.
When should it not be used?
The ADVIA Centaur Anti-HBe2 test should not be used for screening blood, plasma, or tissue donors.