NAME AND INTENDED USE
The Bio-Rad MONOLISA™ Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody to hepatitis B surface antigen in human serum and EDTA, heparin, or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The MONOLISA™ Anti-HBs EIA is intended for manual use and for use with the Bio-Rad EVOLIS™ Automated Microplate System in the detection of antibody to hepatitis B surface antigen.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
Federal law restricts this device to sale by or on the order of a physician.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.
Calibrators to be used for quantitative determination of hepatitis B surface antibody (Anti-HBs) in human serum and EDTA or citrated plasma. Set of 20 calibrators.