Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc on the Elecsys® 2010 Immunoassay Analyzer – P100032
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: Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc on the Elecsys® 2010 Immunoassay Analyzer
Manufacturer: Roche Diagnostics
Address: 9115 Hague Road, Indianapolis, IN 46256 USA
Approval Date: June 27, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/
What is it? The Elecsys® Anti-HBc Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of these specific antibodies against the hepatitis B core antigen can help determine if a person is currently infected or has previously been infected with HBV. This test is designed for use on the Elecsys® 2010 Immunoassay Analyzer, which runs the assay and analyzes the results.
How does it work? A person’s blood sample is added to a tube (vial) with the test chemicals. If there are antibodies to the hepatitis B core antigen in the blood, they attach to special microparticles to affect the production of a light signal. The light signal is measured by the Elecsys® 2010 Immunoassay Analyzer. The Elecsys PreciControl Anti-HBc is 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 diagnosis of individuals with signs and symptoms of hepatitis, or in individuals at risk for hepatitis B infection.
What will it accomplish? Results of this lab test, in combination with other clinical information and laboratory blood tests, may be used by the clinician to aid in the diagnosis of patients with the symptoms of hepatitis or who may be at risk for HBV 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 has not been FDA-licensed for screening blood, plasma, tissue donors, or immunocompromised or immunosuppressed persons or for testing children under the age of 21 years.
Additional Information: Summary of Safety and Effectiveness and labeling are available online.
- Centers for Disease Control and Prevention – HBV
- American Association for the Study of Liver Diseases – New/Updated Guidelines – Chronic Hepatitis B: Update 2009