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.
- LIAISON® XL MUREX HBsAg Qual
- LIAISON® XL MUREX Control HBsAg Qual
- LIAISON® XL MUREX HBsAg Confirmatory Test
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 HBsAg Qual is used to detect hepatitis B surface antigen (HBsAg) in a patient’s blood. HBsAg is a part of the hepatitis B virus (HBV). When HBsAg is present in blood, it shows doctors that a patient has an active HBV infection, but does not show what kind of infection it is--rapidly developing (acute) or slowly developing (chronic). If someone who previously tested positive for HbsAg now has a test that shows none, it generally means the person is recovering from the infection. The presence of HBsAg should be interpeted together with results of other hepatitis B virus serological markers, particularly the presence of antibodies against hepatitis B surface antigen, in the diagnosis of HBV infection.
This test is used with the LIAISON® XL analyzer which runs the assay and analyzes the results.
The LIAISON® XL MUREX Control HBsAg Qual is used to check that the test is working properly.
The LIAISON® XL MUREX HBsAg Confirmatory Test is used to confirm that HBsAg is present in blood samples after an initial test, the LIAISON® XL MUREX HBsAg Qual, result was positive.
How does it work? A sample of the patient’s blood is sent to a clinical laboratory. The sample is inserted into the LIAISON® XL analyzer where it is mixed with the test chemicals. If there is HbsAg present in the sample, a light signal is produced and measured by the LIAISON® XL analyzer. Samples that are positive for HbsAg then have the result confirmed by the HBsAg Confirmatory Test, that confirms the initial result is correct.
When is it used? A test for HBsAg is often the first laboratory test used for people who may be infected with the hepatitis B virus.
What will it accomplish? Doctors use the test result together with a patient’s medical history and other blood tests to help diagnose HBV infection in adults and pediatric patients who have signs and symptoms of hepatitis B, and in people at risk for hepatitis B infection.
When should it not be used? LIAISON® XL MUREX HBsAg Qual should not be used for screening blood or tissue donors because FDA has not licensed it for this purpose.
Additional information (including warnings, precautions, and adverse events):