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 HBeAg, LIAISON® XL MUREX Control HBeAg
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 HBeAg is a laboratory test used to detect human hepatitis B e antigen (HBeAg) associated with hepatitis B virus (HBV) infection. Detection of HBeAg in a patient’s bloodstream indicates active replication of HBV. This may occur in patients with recent (acute) or chronic (long-term) HBV infection.
The test is used with the LIAISON XL analyzer which runs the assay and analyzes the results.
The LIAISONXL MUREX Control HBeAg is used as a quality control to ensure 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 is HBeAg in the sample, a light signal is produced and measured by the LIAISON XL analyzer.
When is it used? The LIAISON XL MUREX HBeAg Assay can aid a doctor in the diagnosis of hepatitis B virus (HBV) infection in patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection.
What will it accomplish? Doctors use the test results to aid in determining infectivity of certain paetitns who are hepatitis B virus (HBV) carriers and for monitoring the infection status of individuals with chronic hepatitis B. In patients with chronic HBV infection, transition from having HBeAg detected in their blood to having anti-HBe antibodies in the blood is usually associated with clinical improvement, reduced infectivity, and better prognosis.
When should it not be used? The LIAISON XL MUREX HBeAg Assay should not be used for screening blood, plasma, or tissue donors for HBV infection.
Additional information (including warnings, precautions, and adverse events):