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: VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls
PMA Applicant: Ortho-Clinical Diagnostics, Inc.
Address: 100 Indigo Creek Drive, Rochester, New York 14626-5101
Approval Date: May 11, 2011 Approval Letter:
Approval Letter:http://www.accessdata.fda.gov/ cdrh_docs/pdf9/p090028a.pdf
What is it? VITROS® Immunodiagnostic Products HBeAg Immunoassay is a laboratory test used to detect hepatitis B e antigen associated with the hepatitis B virus (HBV) infection. Hepatitis B e antigen is an antigen of hepatitis B virus sometimes present in the blood during an acute infection, usually disappearing afterward but sometimes persisting in chronic disease. The presence of the hepatitis B e antigen can help determine if a person is acutely infected or chronically infected with HBV, or is recovered from HBV infection. This test is designed for use on the VITROS® ECi/ECiQ Immunodiagnostic System, which runs the assay and analyzes the results.
How does it work? A person’s blood sample is mixed with the test chemicals. If there are hepatitis B e antigens in the blood, they attach to special anti-HBe antibodies to generate a light signal. The light signal is measured by the VITROS® ECi/ECiQ Immunodiagnostic System. The VITROS® Immunodiagnostic Products HBeAg Controls are used as a quality control to ensure that the test is working properly.
When is it used? The test result is used in combination with other clinical information and blood tests to aid in the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection.
What will it accomplish? Tests results, in combination with other clinical information and laboratory blood tests, may be used by the clinician to aid in the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection.
When should it not be used? This test should not be used to determine the final diagnosis of HBV infection or to determine the stage of infection. This test should not be used to test umbilical cord blood specimens. This test has not been FDA-licensed for screening blood, plasma, tissue donors, or FDA-approved for testing immunocompromised or immunosuppressed persons or for testing children under the age of 2 years.
Additional information: Summary of Safety and Effectiveness and labeling are available online.
- Centers for Disease Control and Prevention – Hepatitis B
- American Association for the Study of Liver Diseases – New/Updated Guidelines – Chronic Hepatitis B: Update 2009