Systems and methods for the detection of biomarkers

Abstract

Systems and methods for the detection of biomarkers. In at least one embodiment of a microarray system of the present disclosure, the microarray system comprises a microarray product comprising at least 100 diagnostic markers/cm 2 , a microarray identifier, and a stabilizing agent, a control microarray product comprising a first specific binding pair member that binds to a first detectable label, and a processor for providing information regarding the identification and concentration of markers on the microarray based on the identity of the array provided by the microarray identifier.

1 . A microarray system, comprising:
 a microarray product comprising at least 100 diagnostic markers/cm 2 , a microarray identifier, and a stabilizing agent;   a control microarray product comprising a first specific binding pair member that binds to a first detectable label; and   a processor for providing information regarding the identification and concentration of markers on the microarray based on the identity of the array provided by the microarray identifier.   
     
     
         2 . The microarray system of  claim 1 , wherein the microarray product is comprised of a compound selected from the group consisting of gel, nitrocellulose, nylon, quartz, glass, metal, silica based materials, silica, resins, polymers, or combinations thereof 
     
     
         3 . The microarray system of  claim 1 , wherein the diagnostic marker comprises a DNA fragment having a length of about 10 base pairs to about 50 base pairs of DNA. 
     
     
         4 . The microarray system of  claim 1 , wherein the diagnostic marker comprises an RNA fragment having a length of about 10 base pairs to about 50 base pairs of RNA. 
     
     
         5 . The microarray system of  claim 1 , wherein the diagnostic marker comprises a peptide fragment having a length of at least about 50 amino acids 
     
     
         6 . The microarray system of  claim 1 ,wherein the stabilizing agent is selected from the group consisting of a protease inhibitor, a DNase inhibitor, and a RNase inhibitor. 
     
     
         7 . The microarray system of  claim 1 , wherein the diagnostic marker is selected from the group consisting of a protein, a glycoprotein, a nucleic acid, an enzyme, an enzyme inhibitor, and a metabolite. 
     
     
         8 . The microarray system of  claim 1 , wherein the stabilizing agent is useful to completely or substantially inactivate an enzyme selected from the group consisting of an amylase, a lysozyme, a peroxidase, a glycosidase, an esterase, a protease, and a peptidase. 
     
     
         9 . The microarray system of  claim 1 , wherein the microarray system is capable of analyzing a body fluid is selected from the group consisting of saliva, a mucous secretion, tears, sweat, semen, urine, a vaginal secretion, exhalate, blood, serum, and an anal secretion. 
     
     
         10 . The microarray system of  claim 1 , wherein the stabilizing agent is selected from the group consisting of Fixanal® Buffer 6.0 (Sigma-Aldrich Co.), acetic acid, aluminum hydroxide bentonite, aluminum sulfate hydrate, aluminum potassium sulfate dodecahydrate, benzoic acid, caffeine, and 3-tert-butyl-hydroxyanisole, or a combination thereof 
     
     
         11 . The microarray system of  claim 1 , wherein the stabilizing agent comprises a plurality of stabilizing agents each present in approximately the same concentration. 
     
     
         12 . The microarray system of  claim 1 , wherein the stabilizing agent is capable of inhibiting degradation of the diagnostic marker to an inhibitory degree, wherein the inhibitory degree is selected from the group consisting of at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, and at least about 99%. 
     
     
         13 . The microarray system of  claim 1 , wherein the stabilizing agent has a concentration selected from the group consisting of about 200 parts per million (ppm) to about 2000 ppm, about 400 ppm to about 1600 ppm, about 600 ppm to about 1400 ppm, about 800 ppm to about 1200 ppm, and about 400 ppm to about 600 ppm. 
     
     
         14 . The microarray system of  claim 1 , wherein the stabilizing agent is able to inhibit the degradation or inactivation of the diagnostic marker for an inhibitory period selected from the group consisting of at least one minute, at least about five minutes, at least about ten minutes, at least about fifteen minutes, at least about thirty minutes, at least about one hour, at least about two hours, at least about four hours, and at least about eight hours. 
     
     
         15 . A microarray system, comprising:
 a microarray product comprising at least 100 diagnostic markers/cm 2 , a microarray identifier, and a stabilizing agent selected from the group consisting of Fixanal® Buffer 6.0 (Sigma-Aldrich Co.), acetic acid, aluminum hydroxide bentonite, aluminum sulfate hydrate, aluminum potassium sulfate dodecahydrate, benzoic acid, caffeine, and 3-tert-butyl-hydroxyanisole, or a combination thereof;   a control microarray product comprising a first specific binding pair member that binds to a first detectable label;   a processor for providing information regarding an identification and concentration of markers on the microarray based on the identity of the array provided by the microarray identifier; and   a database in communication with the processor, the database containing at least one correlation between the diagnostic marker and a disease state.