The liaison® xl murex hbeag assay is an in vitro chemiluminescent immunoassay (clia) for the qualitative detection of hepatitis b virus (hbv) e antigen (hbeag) in human adult and pediatric (2-21 years) serum and plasma (lithium and sodium heparin, sodium citrate and k2 edta), including separator tubes, on the liaison® xl analyzer. Assay results in conjunction with other laboratory results and clinical information may be used as an aid 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. The assay is not intended for use in screening blood, plasma, or tissue donors. The liaison® xl murex control hbeag (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the liaison® xl murex hbeag assay. The performance characteristics of liaison® xl murex control hbeag have not been established for any other assays or instrument platforms.
|Device||LIAISON XL MUREX HBeAg, LIAISON XL MUREX Control HBeAg|
|Generic Name||Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)|
|Applicant Address||DiaSorin Inc. 1951 Northwestern Avenue stillwater, MN 55082|
|Supplement Number||Date||Supplement Type|