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.
Product Name: ADVIA Centaur XP/XPT HBc Total 2 (HBcT2)
ADVIA Centaur XP/XPT HBc Total 2 Quality Control (HBcT2 QC)
ADVIA Centaur CP HBc Total 2 (HBcT2)
ADVIA Centaur CP HBc Total 2 Quality Control (HBcT2 QC)
Atellica IM HBc Total 2 (HBcT2)
Atellica IM HBc Total 2 Quality Control (HBcT2 QC)
Applicant: Siemens Healthcare Diagnostics Inc.
Address: 511 Benedict Ave. Tarrytown, NY 10591
Approval Date: April 28, 2023
Approval Letter: Approval Order
What is it?
The ADVIA Centaur Anti-HBc Total 2 tests for antibodies to a viral protein within the hepatitis B virus, also known as the core antigen (HBc).
How does it work?
A sample of the patient’s blood is sent to a clinical laboratory. At the laboratory, the blood sample is processed to separate the plasma or serum. The sample is then mixed with test chemicals and tested on the instrument. The instrument reports the results as antibodies to HBc are detected or are not detected. A laboratorian reviews the results and sends a report to the healthcare provider.
When is it used?
Results from this test are used together with clinical information and other laboratory results to help health care providers determine a person’s hepatitis B infection status.
What will it accomplish?
Knowing the HBV infection status will help the health care provider determine if the patient needs additional testing and/or should be considered for treatment.
When should it not be used?
There are no known reasons not to use this test.
Additional information (including warnings, precautions, and adverse events):