Oral Detection Test for Cannabinoid Use

• US 20090159792A1
• Filed: 11/13/2008
• Published: 06/25/2009
• 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 7,816,143 B2
• Time in Patent Office: Days
• US Class Current: 250/282
• 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;

and

detecting the amount of 11-nor-Δ

⁹-THC carboxylic acid (“

THCA”

) in said test sample by ionizing THCA from the sample under conditions suitable to produce one or more ions detectable by mass spectrometry;

determining the amount of one or more ions by mass spectrometry; and

using the amount of said one or more ions to determine the amount of THCA in the sample.

2. The method of claim 1, wherein said THCA has been purified by high performance liquid chromatography (HPLC) prior to ionization.

3. The method of claim 1, wherein said THCA has been purified by solid phase extraction (SPE) prior to ionization.

4. The method of claim 3, wherein said SPE comprises high turbulence liquid chromatography (HTLC).

5. The method of claim 1, wherein the mass spectrometry is tandem mass spectrometry.

6. The method of claim 1, wherein the mass spectrometry is gas chromatography/mass spectrometry/mass spectrometry (GC/MS/MS).

7. The method of claim 5, wherein said THCA undergoes a negative chemical ionization.

8. The method of claim 7, wherein said THCA is fragmented into one or more THCA parent ions, wherein at least one of said THCA parent ions has a mass to charge ratio (m/z) of 620.5

9. The method of claim 8, wherein said at least one of said THCA parent ions is fragmented into one or more THCA products ions and at least one of said THCA product ions has a mass to charge ratio (m/z) of 492 or 383.

10. The method of claim 7, wherein an internal standard is added to said sample prior to mass spectrometry.

11. The method of claim 10, wherein said internal standard if THCA-d3.

12. The method of claim 11, wherein said THCA-d3 is fragmented into one or more THCA-d3 parent ions, wherein at least one of said THCA-d3 parent ions has a mass to charge ratio (m/z) of 623.5

13. The method of claim 12, wherein said at least one of said THCA-d3 parent ions is fragmented into one or more THCA-d3 products ions and at least one of said THCA-d3 product ions has a mass to charge ratio (m/z) of 495 or 386.

14. The method of claim 1, wherein the amount of THCA detected in said oral fluid is less than about 240 pg/ml.

15. 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.

16. The method of claim 14, wherein said pad is impregnated with one or more of a preservative, protein binding blocking agent, or detergent.

17. The method of claim 14, further comprising the step of storing the test sample in a preservative solution prior to said detecting step.

18. The method of claim 14, further comprising the step of extracting THCA and/or THCA-glucuronide from the absorbent pad using one or more organic reagents.

19. The method of claim 14, further comprising the step of extracting THCA and or THCA-glucuronide from the pad using an aqueous reagent mixture.

20. A method for quantifying the amount of 11-nor-Δ

⁹-THC carboxylic acid (“

THCA”

) in a sample comprising the steps of;

purifying THCA by solid phase extraction;

ionizing the purified THCA from the sample under conditions suitable to produce one or more parent ions detectable by mass spectrometry;

determining the amount of one or more parent ions by mass spectrometry; and

using the amount of said one or more parent ions to determine the amount of THCA in the sample.

22. The method of claim 20, wherein said solid phase extraction is high performance liquid chromatography (HPLC) or high turbulence liquid chromatography (HTLC).

23. The method of claim 20, wherein the mass spectrometry is tandem mass spectrometry.

24. The method of claim 20, wherein said mass spectrometry is tandem mass spectrometry (MS/MS).

25. The method of claim 24, wherein the mass spectrometry is gas chromatography/mass spectrometry/mass spectrometry (GC/MS/MS).

26. The method of claim 20, wherein at least one of said THCA parent ions has a mass to charge ratio (m/z) of 620.5

27. The method of claim 26, wherein said at least one of said THCA parent ions is fragmented into one or more THCA products ions and at least one of said THCA product ions has a mass to charge ratio (m/z) of 492 or 383.

28. The method of claim 20, wherein an internal standard is added to said sample prior to mass spectrometry.

29. The method of claim 28, wherein said internal standard if THCA-d3.

30. The method of claim 29, wherein said THCA-d3 is fragmented into one or more THCA-d3 parent ions, wherein at least one of said THCA-d3 parent ions has a mass to charge ratio (m/z) of 623.5

31. The method of claim 30, wherein said at least one of said THCA-d3 parent ions is fragmented into one or more THCA-d3 products ions and at least one of said THCA-d3 product ions has a mass to charge ratio (m/z) of 495 or 386.

21. The method of claim 21, wherein said sample comprises oral fluid.

32. A method for determining the amount of isotopically labeled 11-nor-Δ

⁹-THC carboxylic acid (“

THCA”

) in a sample, said method comprising;

ionizing said isotopically labeled THCA under conditions suitable to produce one or more parent ions detectable by mass spectrometry;

determining the amount of one or more parent ions by mass spectrometry; and

using the amount of said one or more parent ions to determine the amount of said isotopically labeled THCA in the sample.

33. The method of claim 32, wherein said isotopically labeled THCA is THCA-d3.

34. The method of claim 33, wherein said one or more parent ions are has a mass to charge ratio (m/z) of 623.5.

35. The method of claim 34, wherein said THCA-d3 is purified by solid phase extraction prior to ionization.

36. The method of claim 35, wherein said solid phase extraction is high performance liquid chromatography or high turbulence chromatography.

37. The method of claim 36, wherein said mass spectrometry comprises tandem mass spectrometry.

38. The method of claim 37, wherein at least one of said parent ions is fragmented into one or more product ions, wherein at least one of said product ions has a mass to charge (m/z) ratio of 495 or 386.