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.
LIAISON XL MUREX HCV Ab
LIAISON XL MUREX Control HCV Ab
PMA Applicant: DiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 55082-0285
Approval Date: October 18, 2019
Approval Letter: Approval Order
What is it? The LIAISON XL MUREX HCV Ab is a laboratory test used to detect antibodies to the hepatitis C virus (HCV) in a patient’s blood. The presence of antibodies against HCV can help determine if a patient has been exposed to HCV but will not be able to tell if a patient has a recent or chronic HCV infection, or if a patient has recovered from HCV infection.
The LIAISON XL MUREX HCV Ab is used with the LIAISON XL analyzer to conduct the test and analyze the results.
The LIAISON XL MUREX Control HCV Ab is used to check that the test is working properly.
How does it work? A sample of a patient’s blood is sent to a lab. At the lab, the blood is inserted into the LIAISON XL analyzer where it is mixed with the test chemicals. If there are HCV antibodies in the blood sample, a light signal is produced.
When is it used? The LIAISON XL MUREX HCV Ab is the initial laboratory test used to determine if patients might be infected with the hepatitis C virus. The test is used in combination with other clinical information and blood tests to help diagnose hepatitis C infection in adults and children.
What will it accomplish? Results of this test, in combination with other clinical information and laboratory blood tests, may be used by the doctor to help to determine if a person has been infected with HCV.
When should it not be used? The LIAISON XL MUREX HCV Ab test should not be used:
- As the only test to determine whether somebody has an HCV infection.
- To determine the stage of HCV infection.
Additional information (including warnings, precautions, and adverse events):