# US 2016/0257989 A1 · Devices and Formulations for Detecting, Screening and Monitoring Levels of Certain Constituents in Bodily Fluids and Method

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- Number: US 2016/0257989 A1
- Document ID: US20160257989A1
- Status: Published application
- Kind: A1
- Application number: 15/155,803
- Filed: 2016-05-16
- Published: 2016-09-08
- Earliest claimed: 2013-03-15
- Assignees: Pop Test LLC
- Applicants: Pop Test LLC
- Inventors: Randice Lisa Altschul; Neil David Theise; Myron Rapkin; Rebecca O'Brien
- Web page: https://patentgrep.com/patent/US20160257989A1

## CPC

- C12Q 1/62: involving uric acid
- C12Q 1/52: involving transaminase
- C12Q 1/54: involving glucose or galactose
- C12Q 1/60: involving cholesterol
- G01N 21/29: using visual detection (G01N21/31 takes precedence)
- G01N 21/78: producing a change of colour
- 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)}
- G01N 33/523: {the element being adapted for a specific analyte}
- G01N 33/54388: {based on lateral flow}
- G01N 33/57525: of the liver or pancreas
- G01N 33/66: involving blood sugars, e.g. galactose
- G01N 33/92: involving lipids, e.g. cholesterol {, lipoproteins, or their receptors (steroid hormones G01N33/743)}
- G01N 33/98: involving alcohol, e.g. ethanol in breath
- C12Y 206/01001: Aspartate transaminase (2.6.1.1), i.e. aspartate-aminotransferase
- C12Y 206/01002: Alanine transaminase (2.6.1.2), i.e. alanine-aminotransferase
- G01N 2021/752: {Devices comprising reaction zones}
- G01N 2333/91188: transferring nitrogenous groups (2.6)
- G01N 2800/085: Liver diseases, e.g. portal hypertension, fibrosis, cirrhosis, bilirubin
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- C12Y: ENZYMES

## 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-ladencarrier 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

### Claim 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;
wherein the different certain constituents are alanine aminotransferase (ALT) and aspartame aminotransferase (AST).

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 3)

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.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 5)

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

### Claim 7 (depends on 6)

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.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 8)

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.

### Claim 10

The method of claim I 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 alanine aminotransferase (ALT) and aspartame aminotransferase (AST).

### Claim 11 (depends on 1)

The method 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.

### Claim 12 (depends on 11)

The method of claim 11 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, approximately 2200 units of pyruvate oxidase, approximately 560 mg of 4-aminoantipyrine, approximately 10,000 units of peroxidase, approximately 12,000 units of ascorbate oxidase, approximately 400 mg of thiamine pyrophosphate, approximately mg of magnesium chloride and approximately 100 uL of 10% ON870.

### Claim 13 (depends on 11)

The method of claim 11 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.