Methods and materials for amplification of a signal in an immunoassay

Abstract

Ultrafine particles are provided having a core region that has a signal amplifying molecule and a shell region that surrounds the core region. The shell region has at least one antibody affixed to its surface that is specific for at least one antigen. Alternatively, the ultrafine particles may entrap the signal amplifying molecule within its matrix and may also have antibodies affixed to its surface for molecular recognition. Ultrafine particles are also provided having a matrix component that includes a signal amplifying molecule and at least one antibody specific for the antigen or biomaterial. The ultrafine particles of the present disclosure may be used in assays for the detection, including quantification, of one or more antigens present in a biological sample.

1 . An ultrafine particle for detection of an antigen or biomaterial, the particle comprising a matrix component, wherein the matrix component comprises a signal amplifying molecule and at least one antibody specific for the antigen or biomaterial. 
     
     
         2 . The ultrafine particle of  claim 1 , wherein the antibody is embedded in the matrix. 
     
     
         3 . The ultrafine particle of  claim 1 , wherein the antibody is attached to a surface of the matrix. 
     
     
         4 . The ultrafine particle of  claim 1 , wherein the particle comprises a shape selected from the group consisting of substantially spheroidal, substantially tubular, substantially ellipsoidal, and combinations thereof. 
     
     
         5 . The ultrafine particle of  claim 4 , wherein the particle has a diameter of about 10 to about 50,000 nanometers. 
     
     
         6 . The ultrafine particle of  claim 1 , wherein the matrix comprises magnetic nanoparticles. 
     
     
         7 . The ultrafine particle of  claim 1 , wherein the signal amplifying molecule is a quantum dot. 
     
     
         8 . The ultrafine particle of  claim 1 , wherein the signal amplifying molecule is selected from the group consisting of magnetic, radioactive, ultra violet sensitive, infrared sensitive, ultrasound sensitive, and combinations thereof. 
     
     
         9 . The ultrafine particle of  claim 1 , wherein the signal amplifying molecule is an enzyme. 
     
     
         10 . The ultrafine particle of  claim 1 , wherein the signal amplifying molecule is selected from the group consisting of horseradish peroxidase, 13-D-galactosidase((-DGal), alkaline phosphatase, and combinations thereof. 
     
     
         11 .- 69 . (canceled) 
     
     
         70 . An immunoassay kit for detection of at least one antigen in a biological sample, the kit comprising:
 a. a container comprising at least one ultrafine particle comprising a matrix component, wherein the matrix component comprises a signal amplifying molecule and at least one antibody specific for the antigen; and   b. instructions for detecting the at least one antigen.   
     
     
         71 . The kit of  claim 70  wherein, the ultrafine particles comprise a core region and a shell region, wherein the core region comprises a signal amplifying molecule and the shell region surrounds the core region and comprises at least one secondary antibody affixed to a surface of the shell region that is specific for the at least one antigen. 
     
     
         72 .- 74 . (canceled)