Oral detection test for cannabinoid use

• US 20060094123A1
• Filed: 11/03/2004
• Published: 05/04/2006
• Est. Priority Date: 11/03/2004
• Status: Active Grant

• Current Assignee: Labone Incorporated (Quest Diagnostics Incorporated)
• Original Assignee: Labone Incorporated (Quest Diagnostics Incorporated)
• Inventors: Day, David, Kuntz, David J., Feldman, Michael S.
• Granted Patent: US 7,465,586 B2
• Time in Patent Office: Days
• US Class Current: 436/93
• CPC Class Codes: G01N 33/948 Sedatives, e.g. cannabinoids, barbiturates opiates G01N33/9486
• CPC Class Codes: Y10S 436/901 Drugs of abuse, e.g. narcotics, amphetamine
• CPC Class Codes: Y10T 436/142222 Hetero-O [e.g., ascorbic acid, etc.]
• CPC Class Codes: Y10T 436/24 Nuclear magnetic resonance, electron spin resonance or other spin effects or mass spectrometry

Abstract

A method for confirming the active intake of marijuana and its active component Δ⁹-tetrahydrocannabinol (“Δ⁹-THC”) by detecting the amount of 11-nor-Δ⁹-THC carboxylic acid (“THCA”) in oral fluid at the picogram per milliliter (pg/ml) level using chromatography/mass spectrometry/mass spectrometry (“GC/MS/MS”).

Claims

1. a method for confirming the active intake of marijuana in a test subject comprising the steps of:

obtaining a test sample of oral fluid from said test subject;

detecting the presence or absence of an amount of 11-nor-Δ

⁹-THC carboxylic acid (“

THCA”

) THCA in said test sample;

wherein the presence of a predetermined amount of THCA present in the pg/ml range in said test sample confirms the active intake of marijuana by said test subject.

2. The method of claim 1 wherein said test sample is obtained from said test subject using a collection pad which is placed in the oral cavity of said test subject for about 30 seconds to about five minutes.

3. The method of claim 2 wherein said obtaining step is performed by placing an absorbent pad in the oral cavity of said test subject for up to about five minutes.

4. The method of claim 3 wherein said pad is impregnated with one or more of a preservative, protein binding blocking agent, or detergent.

5. The method of claim 3 further comprising the step of storing the test sample in a preservative solution prior to said detecting step.

6. The method of claim 3 further comprising the step of extracting THCA and/or THCA-glucuronide from the absorbed absorbent pad using one or more organic reagents.

7. The method of claim 6 wherein said organic reagents are selected from the group consisting of hexane, acetic acid, formic acid, trifluoroacetic acid, dichloromethane, chloroform, acetonitrile, methanol, and ethanol.

8. The method of claim 3 further comprising the step of extracting THCA and/or THCA-glucuronide from the pad using an aqueous reagent mixture.

9. The method of claim 8 wherein said aqueous reagent mixture comprises water plus one or more agents selected from the group consisting of zinc chloride, magnesium chloride, sodium sulfide, sodium deoxycholate, sodium hydroxide, and potassium hydroxide.

10. The method of claim 1 further comprising the step of liberating THCA from THCA-glucuronide in the oral fluid prior to said detecting step.

11. The method of claim 10 wherein said liberating step is performed by exposing said oral fluid to alkaline conditions.

12. The method of claim 1 further comprising the step of concentrating the amount of THCA in the test sample prior to said detecting step, wherein said concentrating step comprises passing said test sample through a solid phase extraction column.

13. The method of claim 1 wherein the step of detecting of the amount THCA in said test sample is performed using gas chromatography/mass spectrometry/mass spectrometry.

14. The method of claim 1 wherein the predetermined amount of THCA in the oral fluid from said test sample is at least about 10 pg/ml to indicate the active intake of marijuana.

15. The method of claim 1 wherein the predetermined amount of THCA in the oral fluid from said test sample is at least about 20 pg/ml to indicate the active intake of marijuana.

16. The method of claim 1 wherein the predetermined amount of THCA in the oral fluid from said test sample is between about 10 pg/mI and about 240 pg/ml to indicate the intake of marijuana.

17. The method of claim 1 further comprising the step of comparing the amount of THCA in said test sample with a control amount of THCA in a control sample of oral fluid from a control test subject who has not actively consumed marijuana, and wherein said predetermined amount of THCA in said test sample is higher than said control amount of THCA in said control sample by a predetermined differential to indicate the active intake of marijuana by said test subject.

18. The method of claim 17 wherein the predetermined differential is about 10 pg/ml or more.

19. The method of claim 17 wherein the predetermined differential is about 20 pg/ml or more.

20. A method for testing whether a test subject has falsely tested negative for the active intake of marijuana comprising the steps of:

obtaining a test sample of oral fluid from said test subject who has tested negative for active marijuana intake;

detecting the presence or absence of an amount of of 11-nor-Δ

⁹-THC carboxylic acid (“

THCA”

) THCA in said oral fluid in said test sample;

wherein the presence of a predetermined amount of THCA present in the pg/ml range in said test sample indicates the active intake of marijuana by said test subject.

21. The method of claim 20 further comprising the step of comparing the amount of THCA in said test sample with a control amount of THCA in a control sample of oral fluid from a control subject who has not actively consumed marijuana, and wherein said predetermined amount of THCA in said test sample is higher than said control amount of THCA in said control sample by a predetermined differential to indicate the active intake of marijuana by said test subject.

22. The method of claim 21 wherein the predetermined differential is about 10 pg/ml or more.

23. The method of claim 21 wherein the predetermined differential is about 20 pg/ml or more.

24. A method for converting conjugated THCA-glucuronide in the oral fluid of a test subject to free THCA comprising:

obtaining a test sample of oral fluid from said test subject; and

exposing said oral fluid to alkaline conditions.