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

• US 10,160,994 B2
• Filed: 03/20/2018
• Issued: 12/25/2018
• Est. Priority Date: 10/23/2010
• Status: Expired due to Fees

• Current Assignee: Pop Test LLC
• Original Assignee: Pop Test LLC
• Inventors: Altschul, Randice Lisa, Theise, Neil, Rapkin, Myron, O'Brien, Rebecca
• Primary Examiner(s): Shen, Bin
• Application Number:
  US15/925,929
• Publication Number:
  US 20180208965A1
• Time in Patent Office: 280 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 selected one of the low density and high density lipoid fractions of cholesterol carried by the bodily fluid, the device including an indicator formulation capable of changing color in response to exposure to cholesterol to provide a visible indication of the presence and the level of cholesterol carried by the bodily fluid, the device comprising:

at least first and second test pads, each test pad being comprised of a carrier substrate of a material having voids establishing a high void volume within the carrier substrate, 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;

an indicator formulation carried by the carrier substrate of each test pad, the indicator formulation consisting essentially of a chromagen formulation and a cholesterol-specific formulation responsive to the presence and level of cholesterol;

a treatment pad juxtaposed with the second test pad; and

a lipoid precipitation agent carried by the treatment pad, the lipoid precipitation agent being specific to the precipitation of a lipoid fraction selected from the group consisting of a low density lipoid fraction and a high density lipoid fraction of cholesterol, such that upon applying a sample of the bodily fluid to the first test pad a visible indication will be provided of the presence and level of cholesterol carried by the bodily fluid, and upon applying a further sample of the bodily fluid to the treatment pad, the further sample will pass through the treatment pad wherein the lipoid fraction removed is selected from the group consisting of a low density and a high density lipoid fraction will be removed prior to the further sample entering the second test pad to provide a visible indication of the presence and level of the other of the low density and high density lipoid fractions of cholesterol in the bodily fluid, thereby enabling a determination of the presence and level of the selected one of the low density and high density lipoid fractions present in the bodily fluid.

2. The device of claim 1 wherein the lipoid precipitation agent is specific to the precipitation of low density lipoid fractions, thereby providing a visible indication of the presence and level of high density lipoid fractions of cholesterol in the bodily fluid and enabling a calculation to determine the presence and level of low density lipoid fractions present in the bodily fluid.

3. The device of claim 2 including:

a target area for the reception of a single sample of the bodily fluid, the treatment pad being juxtaposed with the target area and interposed between the target area and the second test pad;

the target area being juxtaposed with the first test pad in direct communication with the first test pad, and being juxtaposed with the treatment pad in direct communication with the treatment pad, such that upon applying the single sample to the target area, a first portion of the single sample will enter the first test pad to provide the visible indication of the presence and level of cholesterol carried by the bodily fluid, while a second portion of the single sample will pass through the treatment pad wherein the low density lipoid fractions will be removed prior to the second portion of the single sample entering the second test pad to provide the visible indication of the presence and level of high density lipoid fractions of cholesterol in the bodily fluid, thereby enabling the calculation to determine the presence and level of low density lipoid fractions present in the bodily fluid.

4. The device of claim 3 including a filter member interposed between the treatment pad and the second test pad for precluding the passage of lipoid precipitation agent from the treatment pad to the second test pad.