Test Principle: The method for qualitative determination of IgM anti-HAV is an
antibody capture chemiluminescence immunoassay (CLIA). IgG to human IgM
(mouse monoclonal) is used for coating magnetic particles (solid phase). A mouse
monoclonal antibody to HAV is linked to an isoluminol derivative (isoluminol
antibody conjugate). During the first incubation, IgM antibodies present in
calibrators, samples or controls bind to the solid phase. During the second
incubation, the antibody conjugate reacts with HAV antigen and the immune
complex thus formed reacts with the IgM already bound to the solid phase. After
each incubation, the unbound material is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence
reaction is thus induced. The light signal, and hence the amount of isoluminolantibody
conjugate, is measured by a photomultiplier as relative light units (RLU)
and is indicative of IgM anti-HAV present in the calibrators, samples or controls.