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: Bayer ADVIA Centaur® HAV Total Assay
Applicant: Bayer HealthCare LLC
Address: 511 Benedict Avenue
Tarrytown, NY 10591-5097
Approval Date: March 7, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040017a.pdf
What is it?
The Bayer ADVIA Centaur® HAV Total Assay is a lab test used with the Bayer ADVIA Centaur® System to detect antibodies associated with hepatitis A infection. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as the hepatitis A virus (HAV). Total antibodies to hepatitis A antigen (anti-HAV Total) include anti-HAV IgM antibodies and anti-HAV IgG antibodies. Anti-HAV IgM antibody is an early antibody that normally appears during an HAV infection. Anti-HAV IgG antibody also appears during an HAV infection, but unlike anti-HAV IgM remains detectable years after the HAV infection is resolved. The purpose of this test is to help determine if the patient has a previous or ongoing HAV infection.
How does it work?
- A patient’s blood serum being tested for total antibodies to HAV is incubated with HAV antigen.
- If there are HAV specific total antibodies in the blood, antibody-antigen complexes will form.
- These antibody-antigen complexes are reacted with a detection reagent which produces light.
- The amount of light produced is measured and a determination is made whether there are total antibodies to HAV in the patient’s blood serum.
When is it used? This test is used to help determine if a patient has ever been infected with hepatitis A virus .
What will it accomplish? This test will help determine whether a patient has a previous or ongoing infection by hepatitis A virus. Test results may also be used to help rule out other types of viral hepatitis such as hepatitis B and hepatitis C viruses.
When should it not be used? This test should not be used if it is not ordered by a physician. This test is a prescription device. This test has not been FDA licensed for screening blood donors.
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=p040017