Access Medical Systems, Ltd.

Pu Li

Robert F Zuk

Hong Tan

Heng Wu

Qing Xia

Haode Chen

Indrani Chakraborty

Jackie Shek Kei Chan

The present invention is directed to methods for increasing sensitivities of immunoassays. The invention utilizes an acid elution condition that preferentially elute specifically bound immune complexes over non-specifically bound complexes from a solid phase, and designs immunoassay protocols that improve the ratio of specific binding to non-specific binding and thereby improving assay sensitivity. The protocol determines the signal of the labeled immunocomplexes eluted from a solid phase.

Immunoassay with enhanced sensitivity

The present invention is directed to biochemical assay methods, which re-use a hapten-immobilized test probe and reagents for quantitating an analyte or measuring kinetic binding in different samples, anywhere from about 3 to 20 times, while maintaining acceptable assay performance. The methods use a conjugate solution either comprising (i) an anti-hapten antibody and a capture antibody against an analyte, or (ii) an anti-hapten antibody and streptavidin, in each cycle and regenerate the hapten-coated test probe by dipping the test probe in an acidic solution having pH about 1-4, optionally further dipping in a DMSO solution, after the completion of each cycle of reaction. The robustness of the hapten-immobilized solid phase allows utilization of denaturation reagents for efficient elution of the immune complexes after each cycle without compromising the binding activity of the hapten on the solid phase.

Method for re-using test probe and reagents in biochemical assay based on interferometry

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Pu Li