NAME AND INTENDED USE
The MONOLISA™ Anti-HBc IgM EIA is an enzyme immunoassay intended for use in the qualitative detection of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma (potassium EDTA, sodium citrate, ACD [acid citrate dex- trose], lithium heparin and sodium heparin). Assay results may be used with other HBV serological markers for the laboratory diag- nosis of HBV disease associated with HBV infection.
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.
MONOLISA™ Anti-HBc IgM EIA is for the detection of IgM antibodies to hepatitis B core antigen (HBc) in human serum or plasma. The MONOLISA™ Anti-HBc IgM is intended for manual use and for use with the Bio-Rad EVOLIS™ Automated Microplate System in the detection of IgM antibodies to hepatitis B core antigen.
Bio-Rad offers a full range of sensitive and specific hepatitis B microplate assays to detect every stage of hepatitis B virus (HBV) infection. All Bio-Rad hepatitis B enzyme immunoassays (EIA) feature common reagents and procedures for use with other Bio-Rad assays, fast incubation time (2.5 hours), and easy automation. Advanced safety features include: barcoded reagents, color-coded reagents and reagent labels, microplate strip identification, color monitoring for sample and conjugate addition steps, and color changes during protocol steps.