This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
ADVIA Centaur® HBeAg Assay
ADVIA Centaur® HBeAg Quality Control Material
PMA Applicant: Siemens Healthcare Diagnostics Inc.
Address: 511 Benedict Ave, Tarrytown, NY 10591-5097
Approval Date: October 11, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/p090024a.pdf
What is it? ADVIA Centaur HBeAg Assay is a laboratory test used to detect human hepatitis Be antigen (HBeAg) in a person with a hepatitis B virus (HBV) infection. HBeAg is found in the blood only when the HBV virus is active. The presence of HBeAg in the blood often disappears after the HBV virus is cleared. Detection of HBeAg in the blood can determine if a person is chronically infected with HBV or if the infection is cleared. This test is designed for use on the ADVIA Centaur and ADVIA Centaur XP systems, which run the assay and analyze the results.
How does it work? A sample of the patient’s blood is added to a small glass tube (cuvette) with the test chemicals. If there is HBeAg present in the blood, they attach to special anti-HBe antibodies to produce a light signal. The light signal is measured by the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur HBeAg Controls are used as a quality control to ensure that the test is working properly.
When is it used? The lab test result, as well as other clinical information and blood tests, is used in the diagnosis of chronic HBV or confirm recovery from HBV infection.
What will it accomplish? The lab test result will aid in the diagnosis of chronic HBV or confirm recovery from HBV infection.
When should it not be used? This assay has not been FDA-approved for the diagnosis of individuals with acute Hepatitis B infection.
This assay should not be used to test cord blood samples.
Assay performance characteristics have not been established for testing of children less than 17 years of age or in populations of immunocompromised or immunosuppressed patients. Users are responsible for establishing their own assay performance characteristics in these populations.
This assay has not been licensed for the screening of blood, plasma, and tissue donors.
Additional information: Summary of Safety and Effectiveness and labeling are available online.