Systems and methods for hemoglobin analysis

Abstract

Systems and methods for hemoglobin analysis. At least one embodiment of a stabilizing system comprises a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a glycosylated hemoglobin (HbA1c) in a body fluid and a detection agent capable of detecting the HbA1c.

1 . A stabilizing system, comprising:
 a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a glycosylated hemoglobin (HbA1c) in a body fluid; and   a detection agent capable of detecting the HbA1c.   
     
     
         2 . The stabilizing 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. 
     
     
         3 . The stabilizing 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. 
     
     
         4 . The stabilizing system of  claim 1 , wherein the 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. 
     
     
         5 . The stabilizing 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. 
     
     
         6 . The stabilizing system of  claim 1 , wherein the stabilizing agent comprises a plurality of stabilizing agents each present in approximately the same concentration. 
     
     
         7 . The stabilizing system of  claim 1 , wherein the stabilizing agent is capable of inhibiting degradation of the HbA1c 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%. 
     
     
         8 . The stabilizing 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. 
     
     
         9 . The stabilizing system of  claim 1 , wherein the stabilizing agent is able to inhibit the degradation or inactivation of the HbA1c 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. 
     
     
         10 . A stabilizing system, comprising:
 a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a glycosylated hemoglobin (HbA1c) in a body fluid comprising the diagnostic marker; and   a detection agent capable of detecting HbA1c;   wherein the stabilizing agent is selected from the group consisting of aluminum sulfate hydrate, aluminum potassium sulfate dodecahydrate, and benzoic acid; and   wherein the body fluid is saliva.   
     
     
         11 . A method of stabilizing a glycosylated hemoglobin (HbA1c), the method comprising the step of:
 mixing a body fluid comprising a HbA1c with an effective amount of a stabilizing agent;   wherein the stabilizing agent completely or substantially prevents the cleavage, degradation, or inactivation of the HbA1c.   
     
     
         12 . The method of  claim 11  wherein the step of mixing a body fluid with a stabilizing agent comprises introducing the stabilizing agent into a mouth/oral cavity of a patient so that the stabilizing agent mixes with saliva. 
     
     
         13 . The method of  claim 11 , 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. 
     
     
         14 . The method of  claim 11 , wherein the 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. 
     
     
         15 . The method of  claim 11 , 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. 
     
     
         16 . The method of  claim 11 , 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%. 
     
     
         17 . The method of  claim 11 , 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. 
     
     
         18 . The method of  claim 11 , wherein the stabilizing agent is able to inhibit the degradation or inactivation of the HbA1c 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.