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: ADVIA Centaur® HBsAg ReadyPack Reagents, ADVIA Centaur® HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur® HBsAg Quality Control Material
Applicant: Bayer HealthCare, Diagnostics Division
Address: 511 Benedict Ave., Tarrytown, NY 10591
Approval Date: May 26, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030049a.pdf
What is it? These reagents are used with the ADVIA Centaur® instrument to identify certain virus proteins associated with hepatitis B virus (HBV). If these virus proteins are present, then the patient is likely to be infected with HBV.
How does it work?
- A sample of the patient's blood is placed into wells coated with antibodies to HBV.
- If the blood sample contains HBV proteins, they will bind to the antibodies in the wells.
- This reaction is detected by another substance that produces light, which is then measured to determine the presence of HBV in the blood.
- If this first test is positive, the patient's blood is retested to confirm the presence of HBV.
When is it used and What will it accomplish? This test is used to confirm whether or not a person is infected with HBV. It is also used on pregnant women to see if the child may be at high risk for HBV infection.
When should it not be used? This test should not be used for screening blood donors because FDA has not licensed it for this purpose.
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030049