Mouse monoclonal antibodies to Hepatitis E virus and methods for using same

A hybridoma cell line which secretes a monoclonal antibody which specifically binds to hepatitis E virus (HEV) orf-3-encoded protein, wherein said cell line is ATCC deposit number HB 11522.

A competitive assay method for determining the presence of Hepatitis E Virus (HEV) antibody which may be present in a test sample, comprising:

• a. contacting a test sample suspected of containing HEV antibodies with a solid phase coated with at least one HEV orf-3 antigen and an indicator reagent comprising a signal generating compound which generates a measurable signal and a monoclonal antibody which specifically binds to said HEV orf-3 antigen, for a time and under conditions sufficient to form antigen/antibody complexes of the test sample and solid phase and/or indicator reagent and solid phase;
• and
• b. determining the presence of HEV antibody present in the test sample by detecting the reduction in binding of the indicator reagent to the solid phase as compared to the signal generated from a negative test sample to indicate the presence of HEV antibody in the test sample, wherein said monoclonal antibody which specifically binds to said HEV orf-3 antigen is secreted by the cell line ATCC deposit number HB 11522.

An assay kit for determining the presence of HEV antigen or antibody in a test sample comprising a container containing at least one monoclonal antibody or fragment thereof which specifically binds to HEV orf-3 antigen, wherein said monoclonal antibody is secreted by cell line ATCC deposit number HB 11522.

An immunoassay for detecting hepatitis E virus (HEV) antigen which may be present in a test sample comprising (a) contacting said test sample suspected of containing HEV antigen with a solid phase to which an HEV specific antibody is attached to form an antigen-antibody complex, (b) contacting said complex with an indicator reagent comprising an antibody attached to a label capable of generating a detectable signal wherein said indicator reagent specifically binds to said HEV antigen and (c) detecting the presence of HEV antigen in said test sample by detecting the signal generated by said indicator reagent, wherein the improvement comprises utilizing in either the solid phase of step (a) or the indicator reagent of step (b) a monoclonal antibody or fragment thereof, said monoclonal antibody secreted by the cell line ATCC deposit number HB 11522, wherein said monoclonal antibody or fragment thereof specifically binds to HEV orf-3 antigen.