This is a brief overview of information related to FDA’s approval to market this product. See the link below and product labeling for more complete information on this product. The Summary of Safety and Effectiveness Data (SSED) and the basis for FDA’s approval will be published subsequently.
Product Name: LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
PMA Applicant: DiaSorin Inc.
Address: 1951 Northwestern Avenue, Stillwater, MN 55082-0285
Approval Date: August 29, 2020
Approval Letter: Approval Order
What is it? The LIAISON XL MUREX HBc IgM is a laboratory test used to detect human immunoglobulin (IgM) antibodies against the hepatitis B virus (HBV) core antigen in a patient’s blood. The presence of IgM antibodies against HBV core antigen can help determine if a person has been exposed to HBV but will not be able to tell if a person is acutely infected, chronically infected, or has recovered from HBV infection.
The test is used with the LIAISON XL analyzer which runs the assay and analyzes the results.
The LIAISON XL MUREX Control HBc IgM is used as a quality control to check that the test is working properly.
How does it work? A sample of a patient's blood is sent to a clinical laboratory where the blood is inserted into the LIAISON XL analyzer and mixed with the test chemicals. If there are IgM antibodies against the hepatitis B core antigen in the sample, a light signal is produced and measured by the LIAISON XL analyzer.
When is it used? The LIAISON XL MUREX HBc IgM is intended to be used when doctors have symptoms consistent with HBV infection and might be infected with HBV, or who may be at risk for HBV infection.
What will it accomplish? Doctors use the test results together with a patient’s medical history and other blood tests to help determine if a patient is actively infected with HBV or previously had an HBV infection.
When should it not be used? The LIAISON XL MUREX HBc IgM should not be used for screening blood, plasma, or tissue donors for HBV infection.
Additional information (including warnings, precautions, and adverse events):