Method and device for monitoring medication usage

• US 20050048666A1
• Filed: 08/23/2004
• Published: 03/03/2005
• Est. Priority Date: 08/28/2003
• Status: Active Grant

• Current Assignee: Marshfield Clinic
• Original Assignee: Marshfield Medical Research & Education Foundation
• Inventors: Richards, Thomas M., Larson, Michael E.M.
• Granted Patent: US 7,585,680 B2
• Time in Patent Office: Days
• US Class Current: 436/169
• CPC Class Codes: G01N 33/70 involving creatine or creatinine
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: G01N 33/946 CNS-stimulants, e.g. cocaine, amphetamines
• CPC Class Codes: G01N 33/9486 Analgesics, e.g. opiates, aspirine
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/901 Drugs of abuse, e.g. narcotics, amphetamine
• CPC Class Codes: Y10T 436/141111 Diverse hetero atoms in same or different rings [e.g., alkaloids, opiates, etc.]
• CPC Class Codes: Y10T 436/145555 Hetero-N
• CPC Class Codes: Y10T 436/147777 Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]
• CPC Class Codes: Y10T 436/173845 Amine and quaternary ammonium

Abstract

The present invention provides methods for detecting and quantifying metabolites in a biological sample by measuring the concentration of a test metabolite in the sample and comparing that concentration against the concentration of the reference metabolite; enabling accurate metabolite concentration measurements to determine aberrant drug usage patterns. Also disclosed is an analytical testing device and related computer-assisted products for detecting and quantifying metabolites in a biological sample efficiently and accurately.

Claims

1. A method for detecting and quantifying at least one metabolite in a biological sample comprising the steps of:

(a) contacting the biological sample comprising a test metabolite with an analytical device capable of distinguishing between the test metabolite and a reference metabolite;

(b) detecting the presence of at least one test metabolite in a biological sample with the device; and

(c) quantifying the concentration of at least one test metabolite in a biological sample by comparing a ratio between a set of unknown data from the test metabolite versus a set of known normative data specific to the reference metabolite.

2. The method of claim 1, further comprising using the ratio between the test metabolite and reference metabolite to identify nonadherence to a prescribed medication regimen.

3. The method of claim 1, wherein the device is a test strip.

4. The method of claim 1, wherein the biological sample is selected from the group consisting of urine, blood, saliva, sweat, spinal and brain fluids.

5. The method of claim 1, wherein the metabolite to be quantified is selected from the group consisting of oxycodone, morphine, codeine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidone (EDDP), fentanyl, propoxyphene, hydrocodone, amphetamine, diazepam/temazepam, alphahydroxyalprazolam, and lorazepam.

6. An analytical device for quantifying the concentration of at least one test metabolite in a biological sample using the method of claim 1.

7. The device of claim 6, wherein the device is a test strip.

8. A method of monitoring nonadherence to a prescribed medication regimen comprising the steps of:

(a) contacting a biological sample comprising a test metabolite with an analytical device capable of distinguishing between the test metabolite and a reference metabolite;

(b) detecting the presence of at least one test metabolite in a biological sample with the device; and

(c) quantifying the concentration of at least one test metabolite in a biological sample by comparing a ratio between a set of unknown data from the test metabolite versus a set of known normative data specific to the reference metabolite.

9. The method of claim 8, wherein the device is a test strip.