METHODS AND COMPOSITIONS FOR ASSAYING BLOOD LEVELS OF LEGUMAIN

摘要

In one aspect, a homogenous assay method for determination of blood levels of legumain molecules (an asparaginyl endopeptidase) is disclosed. In one aspect, the assay utilizes specific sizes of nanoparticles that are coated with antibody or antibodies specifically towards legumain molecule or its fragment(s). In one aspect, the assay is designed in a homogenous manner with a dynamic range from 0.2 to 160 ng/mL. In another aspect, disclosed herein is a kit for assaying blood levels of legumain comprising two parts of reagents (R1 and R2), which kit is adaptable to be used on clinical chemistry analyzers. In one aspect, the cut-off values for differentiating normal from high risk of cancers such as breast cancer, colorectal cancer and stomach cancer are 18±3 ng/mL.

主权项

1. A method for determining the level of legumain in a sample, comprising:
(a) (i) contacting a sample containing or suspected of containing legumain with a microparticle coated with an antibody or fragment thereof that specifically binds legumain or a degradation fragment thereof; (ii) detecting the optical or signal change of the sample contacted with the microparticle; and (ii) determining the level of legumain in the sample by comparing the optical or signal change with a calibrator of a known level of legumain.