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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Bayer ADVIA® Centaur™ HCV assay
Applicant: Bayer HealthCare LLC
Address: 511 Benedict Avenue Tarrytown , NY 10591
Approval Date: December 22, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030056a.pdf
What is it? The Centaur™ HCV assay is a lab test used to help diagnose people that may be infected with the hepatitis C virus (HCV).
How does it work?
- A sample of the person’s blood serum is placed into wells coated with HCV antigen (proteins from HCV).
- If there is anti-HCV in the blood, it sticks to the antigen.
- The wells are washed to remove excess blood serum.
- Chemicals that cause a fluorescent light reaction (Reagent Pack solutions) are added to the wells.
- If there are antibodies attached to the antigens, they react with the Reagent Pack solutions to produce light.
- The amount of light produced is measured and shows the presence anti-HCV in the patient’s blood serum.
When is it used? This is the initial lab test used for people who might be infected with HCV.
What will it accomplish? Results from the Centaur™ HCV assay may be used with other blood serum (serological) and clinical information to aid in the diagnosis of people with symptoms of hepatitis and in people at risk for HCV infection.
When should it not be used? The Centaur™ HCV assay should not be used to make a final diagnosis of infection with HCV. If this test is positive, more tests will be required to determine if the person is infected.
This test should not be used for screening blood donors, because it has not been proven effective for this purpose. It should be used only when prescribed by a physician.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030056