Novel poct diagnostic system for cancer

Abstract

The present invention relates to a POCT diagnostic system for cancer that can quickly identify early cancer, can diagnose the prognosis of cancer to enhance the therapeutic effects of anticancer agents, etc. on the cancer, and can accurately determine cancer with high sensitivity. The present invention provides magnetic particles including a core including a magnetically responsive metal, a shell layer surrounding the core and having a uniform thickness, and capture probes introduced onto the shell layer to capture biological materials. Each of the capture probes includes an antibody against a biomarker for cancer diagnosis as an antigen.

1 . Magnetic particles comprising a core comprising a magnetically responsive metal, a shell layer surrounding the core and having a uniform thickness, and capture probes introduced onto the shell layer to capture biological materials, wherein each of the capture probes comprises an antibody against a biomarker for cancer diagnosis as an antigen. 
     
     
         2 . The magnetic particles according to  claim 1 , wherein the cancer is breast cancer, lung cancer, liver cancer, gallbladder cancer, ovarian cancer, renal carcinoma, leukemia or glioblastoma. 
     
     
         3 . The magnetic particles according to  claim 2 , wherein the biomarker comprises GP88. 
     
     
         4 . The magnetic particles according to  claim 1 , wherein the magnetic particles have a limit of detection of 1 ng/ml or less and a dynamic range of at least log 3. 
     
     
         5 . The magnetic particles according to  claim 1 , wherein the magnetic particles have two or more different lengths and diagnose two or more types of biomarkers simultaneously. 
     
     
         6 . The magnetic particles according to  claim 1 , wherein the shell surface has 1 to 80 hydrophilic functional groups per unit area (nm 2 ). 
     
     
         7 . The magnetic particles according to  claim 6 , wherein the hydrophilic functional groups are silanol groups or carboxyl, amino, hydroxyl, thiol or aldehyde groups derived from silanol groups. 
     
     
         8 . The magnetic particles according to  claim 6 , wherein the capture probes are linked to the hydrophilic functional groups on the surface of the shell layer. 
     
     
         9 . The magnetic particles according to  claim 1 , wherein the core occupies 60% or more of the total volume of the magnetic particles. 
     
     
         10 . The magnetic particles according to  claim 1 , wherein the shell layer has an average surface roughness (Ra) of 15 nm or less. 
     
     
         11 . The magnetic particles according to  claim 1 , wherein the shell layer may have a thickness of 1 to 100 μm. 
     
     
         12 . The magnetic particles according to  claim 1 , wherein the magnetic particles are obtained by cutting glass-coated metal micro wires. 
     
     
         13 . The magnetic particles according to  claim 1 , wherein the magnetic particles have a size and specific gravity such that they are not suspended in water. 
     
     
         14 . The magnetic particles according to  claim 1 , wherein the magnetic particles are in the form of micro rods. 
     
     
         15 . The magnetic particles according to  claim 14 , wherein the micro rods have a length of 10 to 1,000 μm. 
     
     
         16 . The magnetic particles according to  claim 14 , wherein the micro rods have an aspect ratio of at least 2. 
     
     
         17 . The magnetic particles according to  claim 1 , wherein the biomarker is one present in a sample solution derived from a living organism. 
     
     
         18 . A method for preparing magnetic particles, comprising (i) preparing magnetic micro rods consisting of a shell made of glass and a core comprising a magnetic material, (ii) treating the surface of the magnetic micro rods with an acidic solution to form silanol groups, (iii) immersing the surface-treated magnetic micro rods in a silane-based solution to bind a silane compound to the silanol groups, (iv) converting the terminal groups of the silane molecules to terminal groups capable of binding to probes, and (v) attaching probes to the terminal groups of the silane molecules, wherein each of the probes comprises an antibody against a biomarker for cancer diagnosis as an antigen. 
     
     
         19 . The method according to  claim 18 , wherein step (iv) is carried out by immersing the magnetic micro rods in a silane-based solution for 6 to 24 hours. 
     
     
         20 . The method according to  claim 18 , wherein the acidic solution is a mixture of sulfuric acid and hydrogen peroxide. 
     
     
         21 . A method for detecting biological materials, comprising (1) providing the magnetic particles according to  claim 1  to a first well, (2) transferring the magnetic particles from the first well to a second well using a magnetic force, (3) providing detection probes capable of specific binding to biological materials and conjugated with a luminescent material emitting light in response to an external stimulus to the second well and allowing the capture probes, the biological materials, and the detection probes to react with one another to form complexes of the magnetic particles, the biological materials, and the detection probes, and (4) transferring the magnetic particle-biological material-detection probe complexes to a third well using a magnetic force and measuring luminescence signals generated from the luminescent material present in the complexes in response to the external stimulus to detect the biological materials. 
     
     
         22 . The method according to  claim 21 , wherein the formation of the complexes comprises promoting the reactions in the presence of an external magnetic force. 
     
     
         23 . The method according to  claim 21 , wherein the method is intended for multiplexed detection of two or more types of biological materials using two or more types of magnetic particles. 
     
     
         24 . The method according to  claim 21 , wherein the multiplexed detection comprises reading the magnetic particles labeled with length, diameter, thickness, shape, color or identification codes so as to be distinguished from each other. 
     
     
         25 . The method according to  claim 21 , further comprising providing 2 to 10 wash wells between the second well and the third well and sequentially immersing the magnetic particle-biological material-detection probe complexes in the wash wells to wash the complexes. 
     
     
         26 . The method according to  claim 25 , wherein the magnetic particle-biological material-detection probe complexes are immersed and transferred for washing using an external magnetic force. 
     
     
         27 . The method according to  claim 21 , wherein the method is designed for diagnosis within less than 30 minutes. 
     
     
         28 . The method according to  claim 21 , wherein the method is carried out through a POCT process.