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 for use on
the MODULAR ANALYTICS E170 Immunoassay Analyzer
PMA Applicant: Roche Diagnostics
Address: 9115 Hague Road, Indianapolis, IN 46250
USA
Approval Date: December 14, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110025a.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 these specific IgM-class antibodies
against the hepatitis B core antigen can help determine if a person
is currently infected or has recently been infected with HBV. This
test is designed for use on the MODULAR ANALYTICS E170 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 IgM
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 MODULAR ANALYTICS
E170 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? 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
laboratory 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? The Elecsys
Anti-HBc IgM Immunoassay should not be used for monitoring of HBV
disease or therapy.
Additional information:
Summary of Safety and Effectiveness and labeling are available
online.
Other Resources:
SOURCE