Device, Array, And Methods For Disease Detection And Analysis

Abstract

A device and array coupled to capture molecules are provided. Specifically, the device and array can be used for detecting the presence and concentration of biomarkers in a sample from a subject. The device and array can also allow the use of a method for scoring a sample for, e.g., the purpose of diagnosing a disease. The method can also be advantageous to applications where there is a need to accurately determine the disease stage of a subject for the purpose of making therapeutic decisions.

1 . A detection device, comprising:
 a solid support comprising a plurality of distinct capture molecule groups, each distinct capture molecule group comprising a plurality of capture molecules specific for a biomarker, wherein the plurality of distinct capture molecule groups is specific for a plurality of biomarkers;   a cover plate, wherein the cover plate forms an upper surface positioned above the solid support;   a vertical support, wherein the vertical support forms a connection between the solid support and the cover plate, the connection forming at least one channel around the capture molecule groups, and wherein the channel comprises a first end and a second end and wherein the first end of the channel comprises an opening; and   an absorbent material connected to the second end.   
     
     
         2 . The device of  claim 1 , wherein the solid support comprises glass. 
     
     
         3 . The device of  claim 1 , wherein the solid support comprises a glass slide. 
     
     
         4 . The device of  claim 1 , wherein the capture molecules comprise antibodies. 
     
     
         5 . The device of  claim 1 , wherein the capture molecules are specific for biomarkers selected from the group consisting of: Her-2, MMP-2, CA 15-3, VEGF, and OPN. 
     
     
         6 . The device of  claim 1 , wherein the capture molecules are specific for biomarkers selected from the group consisting of: Her-2, MMP-2, CA 15-3, VEGF, OPN, p53, CA 125, and SER. 
     
     
         7 . The device of  claim 1 , wherein the capture molecules are specific for Her-2, MMP-2, CA 15-3, and OPN. 
     
     
         8 . The device of  claim 1 , wherein the capture molecules are Clone 191924, Clone 36006.211, Clone M8071022, and Clone 190312. 
     
     
         9 . The device of  claim 1 , wherein the capture molecules are blocked by a blocking agent. 
     
     
         10 . The device of  claim 1 , wherein the plurality of distinct capture molecule groups of capture molecules is arranged in an array format. 
     
     
         11 . The device of  claim 1 , wherein the solid support comprises at least two capture molecule groups, the at least two capture molecule groups comprising identical capture molecules, and each of the at least two capture molecule groups comprising a different number of capture molecules. 
     
     
         12 . The device of  claim 1 , wherein the cover plate comprises glass. 
     
     
         13 . The device of  claim 1 , wherein the cover plate comprises a glass cover slip. 
     
     
         14 . The device of  claim 1 , wherein the vertical support comprises adhesive silicone. 
     
     
         15 . The device of  claim 1 , wherein the absorbent material comprises a Hi-Flow Plus Nitrocellulose Membrane HF240. 
     
     
         16 . The device of  claim 1 , comprising
 a glass slide comprising an array of a plurality of distinct groups of antibodies cross-linked to the slide, each distinct group specific for a biomarker selected from the group consisting of Her-2, MMP-2, CA 15-3, and OPN;   a glass cover slip positioned above the solid support; and   a silicone adhesive connection between the glass slide and the glass cover slip forming at least one channel around the antibody groups, and wherein the channel comprises a first open end and a second end connected to a Hi-Flow Plus Nitrocellulose Membrane HF240.   
     
     
         17 . The device of  claim 1 , further comprising a component for detecting biomarkers bound to the solid support. 
     
     
         18 . The device of  claim 17 , wherein said component comprises an optical reader and a screen for displaying output from the optical reader. 
     
     
         19 . A method for determining the presence or absence of a plurality of biomarkers in a sample, comprising:
 acquiring a liquid mixture, wherein the mixture comprises the sample;   applying the mixture to the open first end of the at least one channel of the device of  claim 1 ;   allowing the mixture to flow through the at least one channel over the solid support;   absorbing the mixture with the absorbent material connected to the second end; and   detecting the presence of biomarkers on the solid support, wherein presence of the biomarkers on the solid support indicates the presence of the biomarkers in the sample.   
     
     
         20 . The method of  claim 19 , wherein the device of  claim 1  comprises capture molecules comprising antibodies and the liquid mixture comprises the sample, at least one detector antibody, and at least one fluorescent reporter, and further comprising the steps of
 analyzing the sample with an optical reader to determine the presence or absence of the plurality of biomarkers in the sample; and   outputting the data, wherein the data comprise the presence or absence of the plurality of biomarkers in the sample.   
     
     
         21 . The method of  claim 19 , wherein the device of  claim 1  comprises capture molecules specific for a plurality of biomarkers selected from the group consisting of CA 15-3, OPN, Her-2, and MMP-2. 
     
     
         22 . The method of  claim 19 , wherein the sample comprises human blood serum.