Devices and Formulations for Detecting, Screening and Monitoring Levels of Certain Constituents in Bodily Fluids and Method

• US 20120100563A1
• Filed: 10/21/2011
• Published: 04/26/2012
• Est. Priority Date: 10/23/2010
• Status: Active Grant

• Current Assignee: Pop Test LLC
• Original Assignee: Pop Test LLC
• Inventors: Altschul, Randice Lisa, Rapkin, Myron, O'Brien, Rebecca
• Granted Patent: US 8,263,328 B2
• Time in Patent Office: Days
• US Class Current: 435/10
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: C12Q 1/60 involving cholesterol
• CPC Class Codes: C12Q 1/62 involving uric acid
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/98 involving alcohol, e.g. ethanol in breath

Abstract

A device is disclosed for conducting a non-invasive analysis of a bodily fluid to determine the presence and level of a certain constituent carried by the bodily fluid. An indicator formulation of the device changes color in response to exposure to the constituent to provide a visible indication of the presence and level of the constituent carried by the bodily fluid. A carrier substrate of the device is constructed of a material having voids providing a high void volume within the substrate.

The device is made by applying a chromagen to the carrier substrate to create a chromagen-laden carrier member. Then, a selected reagent having a particular constituent-specific formulation is applied to the chromagen-laden member. The selected reagent then combines with the chromagen, thereby establishing the indicator formulation within the carrier substrate in place for reception of a sample of the bodily fluid.

Claims

1. A method of making a device for conducting a non-invasive analysis of a bodily fluid to determine the presence and the level of a certain constituent carried by the bodily fluid, the device including an indicator formulation capable of changing color in response to exposure to the certain constituent to provide a visible indication of the presence and the level of the certain constituent carried by the bodily fluid, the method comprising:

providing a carrier substrate of a material having voids establishing a high void volume within the carrier substrate;

applying a chromagen formulation to the carrier substrate to create a chromagen-laden carrier member; and

subsequently applying to the chromagen-laden carrier member a selected reagent having a particular constituent-specific formulation to combine the selected reagent with the chromagen formulation applied to the carrier substrate, thereby establishing the indicator formulation within the carrier substrate in place for reception of a sample of the bodily fluid later placed upon the carrier substrate.

2. The method of claim 1 including storing the chromagen-laden carrier member prior to subsequently applying the selected reagent.

3. The method of claim 1 wherein the material of the carrier substrate comprises a non-woven material.

4. The method of claim 3 wherein the carrier substrate has a total volume and the high void volume is within a range of about ten to twelve percent of the total volume.

5. The method of claim 1 wherein the material of the carrier substrate comprises a non-woven synthetic polymeric material.

6. The method of claim 5 wherein the synthetic polymeric material is a polyester.

7. The method of claim 6 wherein the carrier substrate has a total volume and the high void volume is within a range of about eight to twelve percent of the total volume.

8. The method of claim 1 wherein the material of the carrier substrate comprises glass-fiber.

9. The method of claim 8 wherein the carrier substrate has a total volume and the high void volume is within a range of about eight to twelve percent of the total volume.

10. The method of claim 1 wherein the chromagen formulation remains the same, while the selected reagent having a constituent-specific formulation is selected from reagents having formulations responsive to levels of any one of a plurality of different certain constituents.

11. The method of claim 10 wherein the different certain constituents are glucose, cholesterol, ethanol, uric acid, and galactose.

12. The method of claim 1 wherein the chromagen formulation consists essentially of approximately equal parts of 0.05 to 0.5 M MBTH and 0.05 to 0.5 M DMAB.

13. The method of claim 12 wherein the certain constituent is glucose and the constituent-specific formulation consists essentially of approximately equal amounts of the enzymes glucose oxidase with an activity of approximately 200 U/mg, and peroxidase with an activity of approximately 200 U/mg in the presence of approximately equal amounts of 0.05 to 0.5 M HEPES, a blend of surface active agents within the range of about 0.1% to 10% each, and a stabilizer.

14. The method of claim 12 wherein the certain constituent is cholesterol and the particular constituent-specific formulation consists essentially of a selected amount of the enzyme cholesterol esterase with an activity of approximately 180 U/mg, the same selected amount of peroxidase with an activity of approximately 200 U/mg, and twice the selected amount of cholesterol oxidase with an activity of approximately 47 U/mg in the presence of approximately equal amounts of 0.05 to 0.5 M HEPES, a blend of surface active agents within the range of about 0.1% to 10% each, and a stabilizer.

15. The method of claim 12 wherein the certain constituent is ethanol and the particular constituent-specific formulation consists essentially of approximately equal selected amounts of about 1% to 20% PVP K30, about 0.5% to 5.0% ethoxylated surfactant and about 0.05 to 0.5 M phosphate buffer at pH 8.5, one-half the selected amount of alcohol oxidase with an activity of approximately 400 U/ml and one-quarter the selected amount of peroxidase with an activity of approximately 200 U/mg.

16. The method of claim 12 wherein the certain constituent is uric acid and the particular constituent-specific formulation consists essentially of approximately ten parts of uricase, about fifteen parts of ascorbate oxidase and about six parts of peroxidase with an activity of approximately 200 U/mg in 0.05 to 0.5 M phosphate buffered saline at pH 6.4.

17. The method of claim 12 wherein the certain constituent is galactose and the particular constituents-specific formulation consists essentially of approximately five parts of about 0.05 to 0.5 M phosphate buffer at pH 7.0, approximately five parts of peroxidase with an activity of approximately 200 U/mg, and approximately five parts of ethanol, in about twenty-five parts of 10% polyvinyl alcohol, and 4200 units of galactose oxidase.

18. A device for conducting a non-invasive analysis of a bodily fluid to determine the presence and the level of a certain constituent carried by the bodily fluid, the device including an indicator formulation capable of changing color in response to exposure to the certain constituent to provide a visible indication of the presence and the level of the certain constituent carried by the bodily fluid, the device comprising:

a carrier substrate of a material having voids establishing a high void volume within the carrier substrate; and

an indicator formulation carried by the carrier substrate, the indicator formulation consisting essentially of a chromagen formulation and a constituent-specific formulation selected from formulations responsive to levels of any one of a plurality of different certain constituents.

19. The device of claim 18 wherein the different certain constituents are glucose, cholesterol, ethanol, uric acid, and galactose.

20. The device of claim 19 wherein the chromagen formulation consists essentially of approximately equal parts of 0.05 to 0.5 M MBTH and 0.05 to 0.5 M DMAB.

21. The device of claim 20 wherein the certain constituent is glucose and the constituent-specific formulation consists essentially of approximately equal amounts of the enzymes glucose oxidase with an activity of approximately 200 U/mg, and peroxidase with an activity of approximately 200 U/mg in the presence of approximately equal amounts of 0.05 to 0.5 M HEPES, a blend of surface active agents within the range of about 0.1% to 10% each, and a stabilizer.

22. The device of claim 20 wherein the certain constituent is cholesterol and the particular constituent-specific formulation consists essentially of a selected amount of the enzyme cholesterol esterase with an activity of approximately 180 U/mg, the same selected amount of peroxidase with an activity of approximately 200 U/mg, and twice the selected amount of cholesterol oxidase with an activity of approximately 47 U/mg in the presence of approximately equal amounts of 0.05 to 0.5 M HEPES, a blend of surface active agents within the range of about 0.1% to 10% each, and a stabilizer.

23. The device of claim 20 wherein the certain constituent is ethanol and the particular constituent-specific formulation consists essentially of approximately equal selected amounts of about 1% to 20% PVP K30, about 0.5% to 5.0% ethoxylated surfactant and about 0.05 to 0.5 M phosphate buffer at pH 8.5, one-half the selected amount of alcohol oxidase with an activity of approximately 400 U/ml and one-quarter the selected amount of peroxidase with an activity of approximately 200 U/mg.

24. The device of claim 20 wherein the certain constituent is uric acid and the particular constituent-specific formulation consists essentially of approximately ten parts of uricase, about fifteen parts of ascorbate oxidase and about six parts of peroxidase in 0.05 to 0.5 M phosphate buffered saline at pH 6.4.

25. The device of claim 20 wherein the certain constituent is galactose and the particular constituents-specific formulation consists essentially of approximately five parts of about 0.05 to 0.5 M phosphate buffer at pH 7.0, approximately five parts of peroxidase with an activity of approximately 200 U/mg, and approximately five parts of ethanol, in about twenty-five parts of 10% polyvinyl alcohol, and 4200 units of galactose oxidase.

26. The device of claim 18 wherein the material of the carrier substrate comprises a non-woven material.

27. The device of claim 26 wherein the carrier substrate has a total volume and the high void volume is within a range of about eight to twelve percent of the total volume.

28. The device of claim 18 wherein the material of the carrier substrate comprises a non-woven synthetic polymeric material.

29. The device of claim 28 wherein the synthetic polymeric material is a polyester.

30. The device of claim 29 wherein the carrier substrate has a total volume and the high void volume is within a range of about eight to twelve percent of the total volume.

31. The device of claim 26 wherein the material of the carrier substrate comprises glass-fiber.

32. The device of claim 31 wherein the carrier substrate has a total volume and the high void volume is within a range of about eight to twelve percent of the total volume.