公开(公告)号：US11493498B2

公开(公告)日：2022-11-08

申请号：US17570413

申请日：2022-01-07

Applicant: VISION DIAGNOSTICS, INC.

Inventor： Jerry W. Denney

IPC: G01N33/487 ,  G01N33/493 ,  G01N33/52 ,  G01N33/537 ,  G01N33/539

Abstract: Assays and methods for verifying the validity of a urine sample submitted for Drugs of Abuse (DOA) testing. Embodiments include a SUD Diagnostic Panel that includes six assays: specific gravity index assay, long-duration counterfeit urine assay, short-duration counterfeit urine assay, oxidant history assay, pH assay, and creatinine assay. The SUD Diagnostic Panel detects twelve principle classes of adulteration. Detection of adulteration of one or more urine samples from a patient indicates an attempt to subvert test results and provides an objective indication in one instance and an object diagnosis in another instance of SUD.

公开(公告)号：US20190025284A1

公开(公告)日：2019-01-24

申请号：US16139802

申请日：2018-09-24

Applicant: Vision Diagnostics, Inc.

Inventor： Jerry W. Denney

IPC: G01N33/493 ,  G01N21/31 ,  G01N21/78

CPC classification number: G01N33/493 ,  G01N21/3103 ,  G01N21/78 ,  Y10T436/148888 ,  Y10T436/16

Abstract: The problem of confirming the presence of an adulterant in a urine sample is solved by the use of a reagent capable of reacting with uric acid and non-urate markers in a urine sample. In one embodiment, a phosphotungtate reagent is used to react with the urine sample to create a blue coloration in the presence of uric acid or uric acid equivalents. A reduction or elimination of the blue coloration, resulting in a reduction in the light absorbance, of the urine sample can be used as an indicator of the historical presence of an adulterant. An Oxidant History test can also be generated using the phosphostungtate reagent, wherein the light absorbance resulting from the blue coloration is measured over time, with a measured reduction in the absorbance being an indication that an adulterant is or has been present in the urine sample and is oxidizing the uric acid and non-urate markers over time.

公开(公告)号：US11214821B2

公开(公告)日：2022-01-04

申请号：US15651334

申请日：2017-07-17

Applicant: Vision Diagnostics, Inc.

Inventor： Jerry W. Denney

IPC: C12Q1/34 ,  G01N33/94 ,  C12Q1/00

Abstract: Reagents and methods for using automated laboratory equipment to determine whether the specific gravity of a urine sample is out of normal range as an indication of adulteration. The sodium (Na+) and potassium (K+) normally found in a urine sample can be used as markers. A sodium-potassium dependent β-galactosidase can be utilized with o-nitrophenylgalactoside (o-NPG) which is cleaved into o-nitrophenol, which turns the sample yellow. The sample can be analyzed by spectrophotometry methods utilized in most clinical analyzers at a pre-determined primary wavelength to obtain a Specific gravity Index (SGI). Measurements of the SGI that are outside a known normal range can indicate that the sample integrity has been compromised.

公开(公告)号：US10082495B2

公开(公告)日：2018-09-25

申请号：US15462157

申请日：2017-03-17

Applicant: Vision Diagnostics, Inc.

Inventor： Jerry W. Denney

IPC: G01N21/31 ,  G01N21/78 ,  G01N33/493

CPC classification number: G01N33/493 ,  G01N21/3103 ,  G01N21/78 ,  Y10T436/148888 ,  Y10T436/16

Abstract: The problem of confirming the presence of an adulterant in a urine sample is solved by the use of a reagent capable of reacting with uric acid and non-urate markers in a urine sample. In one embodiment, a phosphotungtate reagent is used to react with the urine sample to create a blue coloration in the presence of uric acid or uric acid equivalents. A reduction or elimination of the blue coloration, resulting in a reduction in the light absorbance, of the urine sample can be used as an indicator of the historical presence of an adulterant. An Oxidant History test can also be generated using the phosphostungtate reagent, wherein the light absorbance resulting from the blue coloration is measured over time, with a measured reduction in the absorbance being an indication that an adulterant is or has been present in the urine sample and is oxidizing the uric acid and non-urate markers over time.

公开(公告)号：US11460409B1

公开(公告)日：2022-10-04

申请号：US15961003

申请日：2018-04-24

Applicant: Vision Diagnostics, Inc.

Inventor： Jerry W. Denney

IPC: G01N21/78 ,  G01N33/493 ,  C12Q1/42 ,  G01N21/77 ,  G01N33/487 ,  G01N21/75

Abstract: The problem of detecting whether a urine sample is true human urine or a counterfeit urine product is solved by the use of reagent systems that detect two markers normally present in human urine. The markers acid phosphatase and alkaline phosphatase catalyze the substrates thymolphthalein monophosphate and p-nitrophenol phosphate, respectively. These substrates are formulated as spot tests on a dip stick or as reagents for use in automated chemical analyzers. The presence of the markers can be qualitatively detected by color-changes in the sample, formed by the pH-specific chromogens that result from catalysis of the substrates with the markers. The control reagent can further indicate whether a counterfeit urine product contains one or both of the chromogens.

公开(公告)号：US20220381698A1

公开(公告)日：2022-12-01

申请号：US17875473

申请日：2022-07-28

Applicant: Vision Diagnostics, Inc.

Inventor： Jerry W. Denney

IPC: G01N21/78 ,  G01N33/493 ,  G01N33/487 ,  C12Q1/42

Abstract: The problem of detecting whether a urine sample is true human urine or a counterfeit urine product is solved by the use of reagent systems that detect two markers normally present in human urine. The markers acid phosphatase and alkaline phosphatase catalyze the substrates thymolphthalein monophosphate and p-nitrophenol phosphate, respectively. These substrates are formulated as spot tests on a dip stick or as reagents for use in automated chemical analyzers. The presence of the markers can be qualitatively detected by color-changes in the sample, formed by the pH-specific chromogens that result from catalysis of the substrates with the markers. The control reagent can further indicate whether a counterfeit urine product contains one or both of the chromogens.

公开(公告)号：US11493497B1

公开(公告)日：2022-11-08

申请号：US16226768

申请日：2018-12-20

Applicant: Vision Diagnostics, Inc.

Inventor： Jerry W. Denney

IPC: G01N33/487 ,  G01N33/539 ,  G01N33/537 ,  G01N33/52 ,  G01N33/493

Abstract: Assays and methods for verifying the validity of a urine sample submitted for Drugs of Abuse (DOA) testing. Embodiments include a SUD Diagnostic Panel that includes six assays: specific gravity index assay, long-duration counterfeit urine assay, short-duration counterfeit urine assay, oxidant history assay, pH assay, and creatinine assay. The SUD Diagnostic Panel detects twelve principle classes of adulteration. Detection of adulteration of one or more urine samples from a patient indicates an attempt to subvert test results and provides an objective indication in one instance and an object diagnosis in another instance of SUD.

公开(公告)号：US10571457B2

公开(公告)日：2020-02-25

申请号：US16139802

申请日：2018-09-24

Applicant: Vision Diagnostics, Inc.

Inventor： Jerry W. Denney

IPC: G01N33/493 ,  G01N21/78 ,  G01N21/31

Abstract: The problem of confirming the presence of an adulterant in a urine sample is solved by the use of a reagent capable of reacting with uric acid and non-urate markers in a urine sample. In one embodiment, a phosphotungtate reagent is used to react with the urine sample to create a blue coloration in the presence of uric acid or uric acid equivalents. A reduction or elimination of the blue coloration, resulting in a reduction in the light absorbance, of the urine sample can be used as an indicator of the historical presence of an adulterant. An Oxidant History test can also be generated using the phosphostungtate reagent, wherein the light absorbance resulting from the blue coloration is measured over time, with a measured reduction in the absorbance being an indication that an adulterant is or has been present in the urine sample and is oxidizing the uric acid and non-urate markers over time.

公开(公告)号：US20180127799A1

公开(公告)日：2018-05-10

申请号：US15651334

申请日：2017-07-17

Applicant: Vision Diagnostics, Inc.

Inventor： Jerry W. Denney

IPC: C12Q1/34

CPC classification number: C12Q1/34 ,  G01N33/94 ,  G01N2333/938

Abstract: Reagents and methods for using automated laboratory equipment to determine whether the specific gravity of a urine sample is out of normal range as an indication of adulteration. The sodium (Na+) and potassium (K+) normally found in a urine sample can be used as markers. A sodium-potassium dependent β-galactosidase can be utilized with o-nitrophenylgalactoside (o-NPG) which is cleaved into o-nitrophenol, which turns the sample yellow. The sample can be analyzed by spectrophotometry methods utilized in most clinical analyzers at a pre-determined primary wavelength to obtain a Specific gravity Index (SGI). Measurements of the SGI that are outside a known normal range can indicate that the sample integrity has been compromised.

公开(公告)号：US20170269058A1

公开(公告)日：2017-09-21

申请号：US15462157

申请日：2017-03-17

Applicant: Vision Diagnostics, Inc.

Inventor： Jerry W. Denney

IPC: G01N33/493 ,  G01N21/31 ,  G01N21/78

CPC classification number: G01N33/493 ,  G01N21/3103 ,  G01N21/78 ,  Y10T436/148888 ,  Y10T436/16

Abstract: The problem of confirming the presence of an adulterant in a urine sample is solved by the use of a reagent capable of reacting with uric acid and non-urate markers in a urine sample. In one embodiment, a phosphotungtate reagent is used to react with the urine sample to create a blue coloration in the presence of uric acid or uric acid equivalents. A reduction or elimination of the blue coloration, resulting in a reduction in the light absorbance, of the urine sample can be used as an indicator of the historical presence of an adulterant. An Oxidant History test can also be generated using the phosphostungtate reagent, wherein the light absorbance resulting from the blue coloration is measured over time, with a measured reduction in the absorbance being an indication that an adulterant is or has been present in the urine sample and is oxidizing the uric acid and non-urate markers over time.