All You Would Ever Want to Know about Urine Toxicology Screening

1. All You Would Ever Want to Know about Urine Toxicology Screening Mohammad Al-Ghoul, PhD Chief Technical Officer Diane A. Tennies, PhD Lead TEAP Health Specialist, Humanitas

2. CDD Team Marian Tully, Sr. Account Manager Barbara Castro, Account Manager Veronica Rodriguez, Account Manager Keren Herrera, M.Sc, MT (ASCP) Toxicology Supervisor

3. Learning Objectives • Recognize the factors which enhance the reliability and validity of the urine toxicology screening process. • Identify the factors which constitute barriers to successful completion of the intervention process. • Describe the biochemical testing options available from the CDD.

4. Reliability and Validity of Urine Toxicology Specimen More than 70% of lab errors are due to pre-analytical issues

5. Pre-Analytical Variables • Specimen collection • Adulterated • Diluted • Substituted (Temp) • Volume (QNS) • Accessioning - Labeling - Proper labeling - Mismatch labeling Incorrectly labeled tube CDD WILL NOT SWITCH LABELS FOR TOX TESTING

6. Analytical (Testing Process) • Screening and confirmation • Controls • Monitor positivity rate • Monitor screened positives that confirm negative • Proficiency testing • Monitor percentage of samples resulted as unsuitable for testing

7. Post Analytical (After Testing) • Review of controls for each run • Review of all screening results • Review of each positive sample before releasing a result • An electronic system is in place to prevent reporting mismatched results • Investigation conducted as warranted

8. Urine Drug Testing Limitation • Urine drug testing only indicates prior use • Not useful for determining: • Time since last use • Extent/frequency of use • Additional use since last positive test • Current impairment

9. Test Menu Job Corps Toxicology Panel • AMP/Meth-AMP Panel   • Cannabinoids • Cocaine • Opiate • PCP

10. Testing Methods • Screening: Enzyme Immunoassay (EIA) • Confirmation: Gas Chromatography/Mass Spectrometry (GC/MS) • “Gold-Standard” for Drug Testing • NO BIOLOGICAL FALSE POSITIVES

11. Drugs of Abuse (DAU) Testing Methods and Cutoffs Regulated by SAMHSA (Substance Abuse and Mental Health Services Administration)

12. Factors That May Affect Test Results • Drug concentration in urine vary greatly based on: • Individual metabolism • Body composition • Time/Frequency of use • Potency of Drug • Current Hydration Status • Dehydrated = higher relative level • Over-hydrated = dilution effect

13. Cannabinoids • THC is lipophillic – Fat-soluble • Drug levels typically reduced by half in 24 – 48 hours (half-life) • Increased time to clear from system relative to other drugs creates challenges • Heavy users should clear THC in 30 days • Most subsequent positives due to additional use

14. THC Detection Time www.mayoclinicproceedings.com

15. Cannabinoids • Highly unlikely for an individual to test positive (50 ng/mL) for THC by urine immunoassay through passive exposure • Addition of Visine eye drops to urine samples has been shown to cause false-negative results for THC.

16. Drugs of Abuse (DAU) Kaplan and Pesce, Clinical Chemistry, Fourth edition, P1008.

17. Summary of Agents Contributing to Positive Results by Screening www.mayoclinicproceedings.com

18. Conclusion • Screening: presumptive only • Confirmatory test (GC-MS) is required • limitations of urine drug screens • time since last ingestion • overall duration of abuse • state of intoxication • Accurate interpretation of results

19. Questions from the Field Does CDD do any research into drug trends and make recommendations to their clients about what drugs they should be testing for? Answer: Yes and the best example is synthetic cannabinoids (Spice)

20. Questions from the Field Regarding synthetic cannabinoids: Since the CDD made this test available, how often are centers requesting this additional testing? Answer: About 20 - 30 tests/week What percentage of the tests are positive? Answer: Positivity rate of 4-5 %

21. Questions from the Field Which synthetic cannabinoids are tested for? Answer: Spice only (three metabolites two for JWH-18 and JWH-073) Would the test detect those Synthetic cannabinoids currently marketed as “JWH-free”? Answer: No the test would not detect metabolites other than JWH.

22. Other Tests Available • Spice Screen (Synthetic Cannabinoids) • Patient results report

23. Questions from the Field What is meant by “cut-off levels”? Answer: Cut-off levels are the minimum levels of drug detected in the sample. This is established by SAMHSA and determines when a test is considered “a positive.”

24. Questions from the Field I keep getting an “insufficient amount to test” notification. What does that mean, especially when the vial is filled up fully with urine?  Answer: This is most likely related to opiate testing. Opiate confirmation testing is performed at our reference laboratory, and in certain situations, they may need more sample for more testing. 

25. Questions from the Field Is there a way centers can access the cumulative data regarding their drug screening (such as the percentage testing positive on entrance and at 45 days) before the Annual Health and Wellness report is published? Answer: No, neither CDD nor Humanitas can make this data available to centers.

26. Questions from the Field Are creatinine-adjusted levels utilized for more concentrated urine samples to better monitor drug usage? Answer: Not on every sample, only on samples believed to be diluted.

27. Questions from the Field Why does it take longer for some drugs to go through the confirmation process?  Answer: Some tests take longer to process for confirmation testing than others. Other tests are send to a reference laboratory for testing, thus taking longer for the results to be reported back to centers.

28. Questions from the Field Is there anyway we can know if a student is over 800.00 ng? Answer: No because our technical and instrument capabilities are limited to 800ng/ml.  Any amount above this is reported as >800ng/ml. 

29. Questions from the Field Given the low incidence of PCP in this population, why do we continue to test for this drug? Answer: This is not CDD’s decision, these are the recommendation of SAMHSA, they are the only entity who would have to decide whether we should stop testing for it or not.

30. Questions from the Field Why don’t we test for opioids such as oxycodone? Is there a plan to offer a test for synthetic opiates? Answer: CDD does offer the option to order opioids (synthetic opiates), however the testing is performed at our reference laboratory.*

31. Questions from the Field Does CDD have a test for other synthetic drugs, such as “Bath Salts”? Answer: Not at the present time but we are evaluating the need to make this test available. If this test become available then a mass e-mail will be sent to centers.

32. Questions from the Field Are Adderall and Concerta (and their derivatives) detected in the tox screen? Answer: Adderall is an amphetamine-based drug, so yes, it would be detected.  Concerta is not an amphetamine-based drug and does not cross react with the amp/meth panel.  

33. Conclusions More Questions and Comments? Final Thoughts from the CDD