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 IgM Immunoassay and Elecsys ® PreciControl Anti-HBc IgM
PMA Applicant: Roche Diagnostics
Address: 9115 Hague Road, Indianapolis, IN 46256 USA
Approval Date: October 26, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110022a.pdf
What is it? The Elecsys® Anti-HBc IgM 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 IgM can help determine if a person is currently infected or has recently been infected with HBV. This test is designed for use on the cobas e 601 analyzer, which runs the assay and analyzes the results.
How does it work? A sample of the patient’s blood is added to a small glass tube (vial) with the test chemicals. If there are IgM antibodies in the blood, they attach to special microparticles to produce a light signal. The light signal is measured by the cobas e 601 analyzer. The Elecsys PreciControl Anti-HBc IgM is used as a quality control to ensure that the test is working properly.
When is it used? Results of this lab test, as well as other clinical information and blood tests are used in the diagnosis of HBV infection. The presence of anti-HBc IgM, in combination with other clinical information, indicates acute or recent HBV infection.
The ECLIA (electro chemi luminescence Immunoassay) is intended for use on the cobas e 601 immunoassay analyzer.
Elecsys PreciControl Anti-HBc IgM is used for quality control of the Elecsys Anti-HBc IgM Immunoassay on the cobas e 601 immunoassay analyzer.
What will it accomplish? Results of this lab test, as well as other clinical information and blood tests are used in the diagnosis of HBV infection.
When should it not be used? The Elecsys Anti-HBc IgM Immunoassay’s performance has not been established for the monitoring of HBV disease or therapy.
Assay performance characteristics have not been established in patients under the age of 21, pregnant women, or in populations of immunocompromised or immunosuppressed patients.
This assay has not been FDA licensed for the screening of blood, plasma and tissue donors.
Additional information: Summary of Safety and Effectiveness and labeling are available online.
- Centers for Disease Control and Prevention - HBV
- NIH - Medline Plus - HBV
- American Association for the Study of Liver Diseases