MEDICAL REVIEW OFFICER

2. MEDICAL REVIEW OFFICER Greg Elam, M.D.,CMRO Medical Director National Toxicology Specialists 866-534-1888 gelam@drugtestinfo.com With contributions from Dr. Howard Taylor, Dr. Greg Skipper, Joe Jones, MS , Dr. Paul Cary, Dr. Dave Kuntz, Dr. Kevin McCauley , Dr. Martin Javors, et al.

3. Reasons to Test Diagnosis Treatment Monitoring Legal purposes- (required)

4. Length of monitoring predicts abstinence rates • Recovery rates with routine treatment and no monitoring= 40-50% • Recovery rates with treatment and long term monitoring= >80% • JW Boyd and JR Knight , Journal of Addiction Medicine, 2012

6. Goals of Forensic Drug Testing Laboratory To discriminate reliably between those specimens which contain drug or its metabolite at or above the cut off and those which do not To do this in a legally defensible manner

8. Cutoff Levels LOD Limit of Detection (Quantitation not Accurate, Able to Detect drug vs Noise) Determined Experimentally LOQ Limit of Quantitation (Lowest value to Lab can Accurately Quantitate) Determined Experimentally Cutoff Laboratory Sets (Subject to Regulation) Determined Arbitrarily ULOL Upper limit of Linearity (Highest Value the Lab can Accurately Quantitate) Determined Experimentally

9. Testing Methods Immunoassay Screening Methods Incorporates antibodies engineered to recognize specific drugs or metabolites Each immunoassay method uses specific detection method, e.g., EIA (Enzyme immunoassay) aka EMIT RIA (Radioimmunoassay) FPIA (Fluorescence polarization immunoassay) Bound molecules cause measurable reaction

10. Methamphetamine Look Alikes

11. Confirmatory Test Positive screen results confirmed Only HHS acceptable method is GC/MS or LC/MS GC = Gas chromatography LC=Liquid Chromatography MS = Mass spectrometry These two methods are linked together Significant preparation time is required to “extract” drug/metabolite for analysis

12. Gas Chromatography Serves as a separation technique Specimen injected into a long column at high temperature (275 degrees F) Material converted into gas and separated with a unique “retention” time Once separated, substance enters MS portion of instrument combination

13. Mass Spectrometry Materials are bombarded with stream of electrons and fragmented at their weak bond sites in a predictable way Pattern of fragmentation is characteristic of a specific material, e.g. fingerprint Each pattern compared to computer library for a definitive match Quantitation determined

14. Urine Pros Cons Easy to adulterate Levels variable with urine concentration and time from use, so Levels cannot determine time of use or degree of impairment Levels cannot determine pattern of use without sequential testing • Easy to collect • Easy to run • Cheap • Many drugs tested • Withstood legal challenges

15. “All we ever talk about anymore is plagues.”

16. Blood/Breath Alcohol

18. Area under the curve

19. Sensitivity is the proportion of participants meeting the specific alcohol use criterion who had a positive EtG test. Specificity is the proportion of participants not meeting the alcohol use criterion who had a negative EtG test.

20. Urine ETG cutoff evaluation Ethyl Glucuronide: A Sensitive Marker for Alcohol Consumption By Ntei Abudu, PhD.

23. Adulteration

24. EtG in Hair Once produced, EtG is trapped and accumulates in the keratin fibers of hair EtG incorporation into hair is the same for scalp hair, chest hair, arm and leg hair, less for axillary hair and increased for pubic hair EtG can be detected in hair after 1-2 weeks up to 3 months 24

25. EtG in Hair • Society of Hair Testing Suggestions http://www.soht.org/index.php/consensus

26. Hair versus Urine Steelcase Corporation(Sample size = 774) % Positive Urine Hair • Cocaine • Marijuana • other drugs • Overall positives 0.5% 3.5% 1.7% 6.1% 2.7% 18.0% 0.5% 8.4%

28. EtG in Nails EtG also incorporates into nail keratin, often capturing more of the biomarker than in hair due to the increased thickness of nails. 28

29. EtG in Nail • Berger et al (2014)

30. Sensitivity and Specificity of Hair and Nails for ETG at 20 pg/mg

31. ETG in Nails: Cons

32. Blood Test! PEth incorporation into rbc’s PEth can form in red blood cells as a component of the cellular membrane, only when ethanol is present. 32

33. The corresponding values for PEth 0.006 µmol/l (4.2 ng/ml) were sensitivity 100% and specificity 78%. Only at the level 0.04 µmol/l (28 ng/ml) did the specificity reach 100% (at the expense of sensitivity 28%) meaning that at this level there are no false positives. Alcohol and Alcoholism, 2015, Vol. 50, No. 4

34. PEth 16:0/18:1 vs. hEtG to differentiate abstinence from moderate alcohol consumption (AUROC 0.85, P value <0.0001).

35. ROC analysis for PEth vs. hEtG. a PEth 16:0/18:1 vs. hEtG to differentiate excessive from moderate alcohol consumption (AUROC 0.899, P value <0.0001).

36. Abstinence Monitoring (Sensitivity/Specificity) 37% / 100% 14% / 100% 2 Weeks 67% / 90% 95% / 98% 36

37. Cellular Photo Digital Breathalyzer • Soberlink • Immediate reporting of positives • Random selection times • Picture ID every time tested • No collection site issues • No sample issues

38. Sensitivity • 16 healthcare professionals monitored with Soberlink - drinking discovered using data from the device and/or additional peth testing for two years =37.5% • Peth positive overall at USDTL = 25% • Selected peth in addition to urine etgs in my hands =15%

39. Swedish Train Operator( SJ) uses 100% IR Alcohol Sreening • • Fast -360 tests per hour • • Contactless- no mouthpiece required • • Web-based interface- for administration/management analysis and reporting • Programmable- real-time alerts text/email, detailed pdf test reports

40. Summary • Drug testing is only one measure of one treatment goal and it should not be the only method of detecting substance use or monitoring treatment outcomes; results should be interpreted in the context of collateral and self-report and other indicators.

41. Questions? Dr. Elam is available for questions anytime and may be reached at 353-1888 or gelam@drugtestinfo.com “And then clean out the gutters.”