Devices and formulations for detecting, screening and monitoring levels of certain constituents in bodily fluids and method

• US 9,651,545 B1
• Filed: 12/22/2016
• Issued: 05/16/2017
• Est. Priority Date: 10/23/2010
• Status: Active Grant

• Current Assignee: Pop Test LLC
• Original Assignee: Pop Test LLC
• Inventors: Rapkin, Myron, O'Brien, Rebecca, Altschul, Randice Lisa, Theise, Neil David
• Primary Examiner(s): Shen, Bin
• Application Number:
  US15/388,697
• Publication Number:
  US 20170153227A1
• Time in Patent Office: 145 Days
• CPC Class Codes: C12Q 1/52 involving transaminase
• 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: C12Y 206/01001 Aspartate transaminase (2.6.1.1), i.e. aspartate-aminotransferase
• CPC Class Codes: C12Y 206/01002 Alanine transaminase (2.6.1.2), i.e. alanine-aminotransferase
• CPC Class Codes: G01N 2021/752 Devices comprising reaction zones
• CPC Class Codes: G01N 21/29 using visual detection G01N21/31 takes precedence
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 2333/91188 transferring nitrogenous groups (2.6)
• CPC Class Codes: G01N 2800/085 Liver diseases, e.g. portal hypertension, fibrosis, cirrhosis, bilirubin
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/57438 of liver, pancreas or kidney
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• 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 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 a range of about eight to twelve percent of the total volume of 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 either one of the certain constituents alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

2. The device of claim 1 wherein the chromagen formulation consists essentially of the following components, in the indicated proportions:

approximately 500 to 1,000 mg DAOS mixed with 100 ml ethanol.

3. The device of claim 1 wherein the certain constituent is alanine aminotransferase (ALT) and the constituent-specific formulation consists essentially of the following components, mixed together in the indicated proportions:

approximately 100 mg of L-alanine, about 2200 units of pyruvate oxidase, about 560 mg of 4-aminoantipyrine, about 10,000 units of peroxidase, about 12,000 units of ascorbate oxidase, about 400 mg of thiamine pyrophosphate, about 640 mg of magnesium chloride and about 100 uL of 10% ON870.

4. The device of claim 3 wherein the chromagen formulation consists essentially of the following components, in the indicated proportions:

approximately 500 to 1,000 mg DAOS mixed with 100 ml ethanol.

5. The device of claim 1 wherein the certain constituent is aspartate aminotransferase (AST) and the particular constituent-specific formulation consists essentially of the following components, mixed together in the indicated proportions:

approximately 200 mg of sodium-L-aspartate, approximately 16 mg of a-ketoglutaric acid, approximately 1060 mg of oxalacetic acid decarboxylase, approximately 2200 units of pyruvate oxidase, approximately 640 mg of 4-aminoantipyrine, approximately 10,000 units of peroxidase, approximately 12,000 units of ascorbate oxidase, approximately 3.8 mg of thiamine pyrophosphate, approximately 6.4 mg of magnesium chloride and approximately 100 uL of 10% ON870.

6. The device of claim 5 wherein the chromagen formulation consists essentially of the following components, in the indicated proportions:

approximately 500 to 1,000 mg DAOS mixed with 100 ml ethanol.

7. The device of claim 1 wherein the material of the carrier substrate comprises a non-woven material.

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

9. The device of claim 8 wherein the synthetic polymeric material is a polyester.

10. The device of claim 7 wherein the material of the carrier substrate comprises glass-fiber.