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 anti-HBe, LIAISON® XL MUREX Control anti-HBe
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 anti-HBe is a laboratory test used to detect human antibodies against the hepatitis B virus e antigen (Anti-HBe) in a patient’s blood. Anti-HBe may be detectable in patients with a recent (acute) hepatitis B virus (HBV) infection and in some patients with long-term (chronic) HBV infection.
The test is used with the LIAISON XL analyzer which runs the assay and analyzes the results.
The LIAISON XL MUREX Control anti-HBe is used as a quality check to ensure that the test is working properly.
How does it work? A sample of a patient's blood is obtained and sent to a clinical laboratory where the blood is inserted into the LIAISON XL analyzer and mixed with the test chemicals. If there are Anti-HBe in the sample, a light signal is produced and measured by the LIAISON XL analyzer.
When is it used? The LIAISON XL MUREX anti-HBe is intended to be used to aid doctor’s in the diagnosis of HBV infection in adult and pediatric patients and to assess improvement in patients previously shown to have hepatitis B virus e (HBeAg).
What will it accomplish? Doctors use the test results together with a patient’s medical history and other blood tests to help diagnose HBV infection in patients with signs and symptoms of hepatitis or in patients at risk for hepatitis B infection. In patients with chronic HBV infection, transition from having HBeAg detected in their blood to having a positive anti-HBe antibody is usually associated with clinical improvement, reduced infectivity, and better prognosis.
When should it not be used? The LIAISON XL MUREX anti-HBe test should not be used for screening blood, plasma or tissue donors.
Additional information (including warnings, precautions, and adverse events):