SYSTEMS AND METHODS FOR DETECTING PREGNANCY
Systems and methods for detecting pregnancy. In at least one embodiment of a system of the present disclosure, the system comprises a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a diagnostic marker for pregnancy in a body fluid comprising the diagnostic marker, and a detection agent capable of detecting the diagnostic agent.
1 . A stabilizing system, comprising:
a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a diagnostic marker for pregnancy in a body fluid comprising the diagnostic marker; and
a detection agent capable of detecting the diagnostic marker.
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 diagnostic marker is selected from the group consisting of a protein, a glycoprotein, a nucleic acid, an enzyme, an enzyme inhibitor, and a metabolite.
4 . 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.
5 . 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.
6 . 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.
7 . The stabilizing system of claim 1 , wherein the stabilizing agent comprises a plurality of stabilizing agents each present in approximately the same concentration.
8 . The stabilizing 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%.
9 . 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.
10 . The stabilizing 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.
11 . The stabilizing system of claim 1 , wherein the diagnostic marker is selected from the group consisting of human chorionic gonadotropin (hCG) and early pregnancy factor (EPF).
12 . A stabilizing system, comprising:
a stabilizing agent useful to completely or substantially prevent degradation or inactivation of a diagnostic marker for pregnancy in a body fluid comprising the diagnostic marker; and
a detection agent capable of detecting the diagnostic marker;
wherein the diagnostic marker is selected from the group consisting of human chorionic gonadotropin (hCG) and early pregnancy factor (EPF); and
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.
13 . A method of stabilizing a diagnostic marker, the method comprising the step of:
mixing a body fluid comprising a diagnostic marker for pregnancy with an effective amount of a stabilizing agent;
wherein the stabilizing agent completely or substantially prevents the cleavage, degradation, or inactivation of the diagnostic marker.
14 . The method of claim 13 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.
15 . The method of claim 13 , 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.
16 . The method of claim 13 , 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.
17 . The method of claim 13 , 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.
18 . The method of claim 13 , 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%.
19 . The method of claim 13 , 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.
20 . The method of claim 13 , wherein the diagnostic marker is selected from the group consisting of human chorionic gonadotropin (hCG) and early pregnancy factor (EPF).