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: LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs, LIAISON XL MUREX Anti-HBs Verifiers
PMA Applicant: DiaSorin Inc.
Address: 1951 Northwestern Avenue, Stillwater, MN 55082-0285
Approval Date: February 21, 2020
Approval Letter: Approval Order
What is it? The LIAISON XL MUREX Anti-HBs is a laboratory test used to detect human antibodies against the hepatitis B virus (HBV) in a patient's blood. The presence of antibodies to a part of the HBV can help determine if a patient has been exposed to HBV or is immune to HBV, but will not be able to tell if a patient has a recent or a long-term HBV infection, or if a patient has recovered from HBV infection.
This test is used with the LIAISON XL analyzer which runs the assay and analyzes the results.
The LIAISON XL MUREX Control Anti-HBs and the LIAISON XL MUREX Anti-HBs Verifiers are used 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 HBV antibodies in the blood sample, a light signal is produced and measured by the LIAISON XL analyzer.
When is it used? The LIAISON XL MUREX Anti-HBs test is used when doctors suspect a patient may be infected with the hepatitis B virus. The test may also be used when doctors need to know if the person was vaccinated to HBV.
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 adult and pediatric patients with signs and symptoms of hepatitis or in persons at risk for hepatitis B infection. It can also be used to decide if the patient needs to be vaccinated to prevent HBV infection.
When should it not be used? The LIAISON XL MUREX Anti-HBs test should not be used:
- As the only test for diagnosis of an HBV infection
- As the only test to determine the stage of HBV infection
- For screening blood donors because FDA has not licensed it for this purpose
Additional information (including warnings, precautions, and adverse events):