Diagnostics of gyneacological diseases, especially epithelial ovarian cancer

Abstract

The present disclosure relates to methods and a kit for diagnosing, prognosing and/or monitoring a gynaecological disease, especially epithelial ovarian cancer, on the basis of altered glycosylation pattern of CA125. More specifically, said altered glycosylation pattern relates to that recognizable by MGL.

1 . A kit for a CA125-binding agent-lectin-sandwich assay, comprising:
 a CA125-binding agent, and   MGL,   wherein either said CA125-binding agent or said MGL comprises a detectable label.   
     
     
         2 . The kit according to  claim 1 , wherein the kit is for an assay for determining a gynaecological disease state in a subject, wherein the gynaecological disease is selected from the group consisting of epithelial ovarian cancer (EOC), endometriosis, and endometrial cancer. 
     
     
         3 . The kit according to  claim 1 , wherein said MGL is a nanoparticle-immobilized MGL (MGL-NP), or wherein the kit further comprises nanoparticles for immobilizing said MGL. 
     
     
         4 . The kit according to  claim 1 , wherein said CA125-binding agent is a monoclonal anti-CA125 antibody or mesothelium. 
     
     
         5 . The kit according to  claim 1 , wherein said CA125-binding agent is bound to a solid surface, or a solid substrate selected from glass, silica, aluminosilicates, borosilicates, metal oxides, gold, clay, nitrocellulose and nylon. 
     
     
         6 . The kit of  claim 1 , wherein said CA125-binding agent is bound to a microtiter plate, or wherein the kit further comprises a microtiter plate for binding said CA125-binding agent. 
     
     
         7 . The kit according to  claim 1 , further comprising a control sample for comparing to the measured value of CA125 binding to MGL. 
     
     
         8 . The kit according to  claim 1 , further comprising one or more reagents for assaying CA125 protein concentration. 
     
     
         9 . The kit according to  claim 1 , further comprising a control sample for comparing to the measured value of HE4 concentration. 
     
     
         10 . The kit according to  claim 1 , further comprising one or more reagents for assaying HE4 concentration. 
     
     
         11 . The kit according to  claim 3 , wherein all the dimensions of said nanoparticle are less than about 1000 nm, about 500 nm or less, about 100 nm or less, or about 50 nm or less. 
     
     
         12 . The kit according to  claim 3 , wherein said nanoparticle is selected from the group consisting of protein nanoparticles, mineral nanoparticles, glass nanoparticles, nanoparticle crystals, metal nanoparticles, plastic nanoparticles, polystyrene nanoparticles, poly(ethylene glycol) nanoparticles, polyethylene nanoparticles, poly(acrylic acid) nanoparticles, poly(methyl methacrylate) nanoparticles, polysaccharide nanoparticles, colloidal gold nanoparticles, silver nanoparticles, quantum dots, carbon nanoparticles, porous silica nanoparticles, and liposomes. 
     
     
         13 . The kit according to  claim 3 , wherein the nanoparticles are directly or indirectly qualitatively or quantitatively detectable. 
     
     
         14 . The kit according to  claim 3 , wherein the nanoparticles are upconverting nanoparticles (UCNP), or resonance particles. 
     
     
         15 . The kit according to  claim 3 , wherein the nanoparticles are upconverting phosphorus (UCP) particles. 
     
     
         16 . The kit according to  claim 3 , wherein the nanoparticles are detectable by fluorescent labels, bioluminescent labels, or chemiluminescent labels. 
     
     
         17 . The kit according to  claim 3 , wherein said nanoparticle is doped with a lanthanide chelate. 
     
     
         18 . The kit according to  claim 3 , wherein said nanoparticle is doped with luminescent lanthanide ions with luminescence emission in visible or near-infrared or infrared wavelengths and long fluorescence decay. 
     
     
         19 . The kit according to  claim 3 , wherein said nanoparticle is doped with one or more of europium (III), terbium (III), samarium (III), dysprosium (III), ytterbium (III), erbium (III) and neodynium (III). 
     
     
         20 . The kit according to  claim 3 , wherein said nanoparticle is doped with europium(III). 
     
     
         21 . The kit according to  claim 1 , wherein the kit further comprises a computer readable medium comprising computer-executable instructions for performing said assay. 
     
     
         22 . The kit according to  claim 1 , wherein the kit further comprises agents for assaying one or more biomarkers associated with diseases associated with lower abdominal pain.