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Oral Fluid as a Chemical Test for the DRE Program

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History, the Future, and Practical Considerations. …

History, the Future, and Practical Considerations.

Presented by Barry K Logan PhD, DABFT,
National Director of Forensic Services, NMS Labs, Willow Grove, PA at the 2011 IACP-DRE Conference in Montreal, Canada.

Published in: Health & Medicine

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  • Lipophilicity of drug Non-polar analytes (THC) partition into oral fluid more readily than polar metabolites (11-nor-9-carboxy-THC) Usually more parent drug than metabolites pKa of drug Non-ionized basic drugs in blood partition into more acidic oral fluid, become ionized & accumulate, “ion trapping of basic drugs” Molecular size of drug
  • Median and interquartile ranges presented on log axis. Dasehed lines indicate LOQ (2.5ug/L), SAMHSA (8ug/L) and DRUID (10ug/L) oral fluid cutoffs.
  • Time To Last Positive Methamphetamine oral fluid positive at 50 ng/mL requires 2.5 ng/mL amphetamine presence Methamphetamine urine positive at 500 ng/mL requires 200 ng/mL amphetamine presence After how many doses? After the last?
  • Transcript

    • 1. ORAL FLUID AS A CHEMICAL TEST FOR THE DRE PROGRAM : HISTORY, THE FUTURE, AND PRACTICAL CONSIDERATIONS Barry K Logan PhD, DABFT National Director of Forensic Services, NMS Labs Willow Grove PA
    • 2. Disclaimer
      • NMS Labs and Dräger Safety Diagnostics have created a partnership to develop and market oral fluid tests for the DRE marketplace.
    • 3. Current Options in Drug Testing
    • 4. Drug Testing: Current Approaches
      • Urine
        • Less Invasive sample collection.
        • Some on-site testing capability.
        • Broad detection time window.
        • Targeting metabolites for detection.
        • No relationship to brain concentrations.
        • No relationship between urine concentration and effect.
        • Time delay for collection.
    • 5. Drug Testing: Current Approaches
      • Blood
        • Closest relationship to brain concentrations.
        • Targeting parent drug for detection.
        • Large literature for comparative interpretation.
        • Somewhat invasive collection.
        • Limited detection window.
        • Time delay for collection.
        • Lack of strict quantitative/qualitative effect relationship.
        • No on-site testing capability.
    • 6. Drug Testing: Current Approaches
      • Oral Fluid
        • Least invasive collection.
        • No time delay for collection.
        • Targeting parent drug for detection.
        • Potential for on-site testing capability.
        • Limited relationship to blood concentrations.
        • No relationship between OF concentration and effect.
        • Limited detection window.
        • Limited specimen volume.
        • Workplace considerations
    • 7. Drugs in Oral Fluid
    • 8. Oral Fluid
      • Oral Fluid
      • Saliva is a mixture of fluids excreted from the Parotid, Sublingual, and Submandibular glands.
      • It is a plasma ultra-filtrate
      • Drugs partition from blood to oral fluid by diffusion and extraction.
    • 9. Cocaine in Oral Fluid 150 mg/70 kg sc cocaine, (N=14 oral fluid) (N=13 plasma) Courtesy, Marilyn Huestis, NIDA
    • 10. THC in Oral Fluid Courtesy, Marilyn Huestis, NIDA Hours 0.01 0.1 1 10 100 1000 10000 0 1 10 100 Oral Fluid Plasma 3.55%THC GC-MS ng/mL or ng/mg
    • 11. Methamphetamine in Oral Fluid 0 20 40 60 80 Low Dose High Dose Hours Oral fluid (cutoffs 50 Meth/2.5 Amp) Urine (cutoffs 500Meth/200 Amp) Courtesy, Marilyn Huestis, NIDA
    • 12. History of OF Drug Testing
    • 13.
      • 2002 ROSITA II contract signed (www.rosita.org).
      • 2004 Australian states begin random roadside oral fluid testing.
      • 2005 ROSITA II report issued.
        • Not ready for forensic implementation
        • Limited sensitivity
        • Operator dependent
        • Poor QC in manufacturing
      History of OF Drug Testing
    • 14.
      • 2006 DRUID Project begins
      • 2009 “ESTHER” report issued.
        • Evaluation of oral fluid Screening devices by TISPOL to Harmonise European police Requirements.
        • 16 Devices evaluated
        • Technology has improved and devices are being evaluated in roadside surveys through DRUID project.
      History of OF Drug Testing
    • 15. DUID Oral Fluid Use Belgium: saliva screening, blood/saliva confirmation Australia: saliva screening (2x), saliva confirmation Germany: saliva/urine testing, blood confirmation UK: FST, blood sampling; no device being used France: saliva screening, blood confirmation Switzerland: Approved for use
    • 16.
      • Australia (THC, Meth, MDMA)
      • Almost 90,000 drivers tested in Victoria
        • small vehicles: Positive rate 1:65 (all 3 drugs)
        • large vehicles: Positive rate 1:47 (mainly meth.)
      • The rate has come down from 1:40 in the first 2 years.
      • This compares to alcohol positive rate of 1:100 for same driver cohort
      • False positive rate: 1% - very low since two screening devices are used
      • Aimed at deterrence, not impairment
      Drug Testing Around the World
    • 17.
      • Belgium (THC, Amps, MDMA, Benzos, cocaine, opiates)
      • Since October 2010:
      • Drivers stopped by the police (not randomly selected)
      • Indication of recent drug use: oral fluid on-site screening test
      • Screen Positive: blood sampling, later oral fluid sampling for confirmation analysis
      • Faster procedure (no test battery, no doctor needed)
      • Judicial authority: less false positives; therefore more cost effective
      • OF sampling more user-friendly
      Drug Testing Around the World
    • 18. DUID Oral Fluid Use United States: OF Specifically Approved in: Alabama Arizona Colorado Indiana Kansas Louisiana Missouri New York North Carolina North Dakota Ohio Oregon South Dakota Utah Canada: OF Approved in Federal Legislation
    • 19. Cut-Offs - Amphetamines
      • Belgian legislation
        • Screen 50 ng/mL
        • Confirm 25 ng/mL (AMP, MDMA)
      • French legislation
        • Confirm 50 ng/mL (AMP, MAMP, MDMA)
      • Australian legislation
        • Screen must be positive by 2 POCT devices
        • Confirm MAMP, MDMA & THC on any amphetamines or cannabinoids positive screen
    • 20. OF Workplace Testing in the US
      • SAMHSA Proposes Oral Fluid Workplace Testing.
      • Federal Register Volume 76, Number 112
        • (Friday, June 10, 2011)
        • • What analytes should be measured in oral fluid for the initial and confirmatory tests?
        • What initial and confirmation cutoffs should be used for the oral fluid drug tests?
        • Should the oral fluid drug testing panel be expanded to include schedule II prescription medications?
        • • Specimen Validity, Collection, Collection Devices, Technologies
    • 21. US National Roadside Survey 2007
    • 22. 2007 US National Roadside Survey
        • Conducted in Fall 2007
        • 7000 drivers at 63 sites
        • 6000 Oral Fluid Samples
        • 3000 Blood samples
        • Tested for therapeutic and abused drugs
        • Preliminary results July 2009
    • 23. Sample Collection
      • Blood: Gray-topped tube
        • Approximately 3,276 samples (all night-time)
      • Oral fluid: Quantisal TM collection device:
        • 1 mL of oral fluid collected (+-10%)
        • 3 mL stabilization buffer
        • Day-time: 1,850
        • Night-time: 5,869
    • 24. 2007 US NRS Scope
      • Cocaine
      • Marijuana
      • Opiates
        • Codeine, morphine, hydrocodone, hydromorphone, 6-AM, 6-AC
      • Amphetamines
        • AMP, METH, MDMA, MDA, MDEA, phentermine, pseudoephedrine,
        • phenylpropanolamine
      • Benzodiazepines
        • oxazepam, nordiazepam,
        • lorazepam, bromazepam,
        • temazepam, diazepam,
        • alprazolam, triazolam,
        • chlordiazepoxide, nitrazepam,
        • nordiazepam, clonazepam,
        • flurazepam, flunitrazepam
      • Tramadol
      • Methadone
      • Fluoxetine
      • Sertraline
      • Phencyclidine
      • Barbiturates
      • TCA’s
        • Amitriptyline, nortriptyline imipramine, desipramine
      • Zolpidem
      • Carisoprodol
      • Methylphenidate
      • Oxycodone /Oxymorphone
      • Meperidine
      • Propoxyphene
      • Dextromethorphan
      • Ketamine
    • 25. 2007 National Roadside Survey
        • 2.2% of randomly tested drivers positive for alcohol >0.08g/100mL
        • 16.3% positive for drugs other than alcohol.
        • #1 Marijuana – 6.8%
        • #2 Cocaine – 3.9%
        • #3 OTC Drugs 3.9%
        • #4 Methamphetamine 1.3%
    • 26. 2007 National Roadside Survey
        • Nightime Positivity – Blood and Oral Fluid
        • 2.2% of randomly tested drivers positive for alcohol >0.08g/100mL
        • 16.3% positive for drugs other than alcohol.
      Drug Positivity THC 8.65% Cocaine 3.92% Hydrocodone 0.68% Oxycodone 0.82% Alprazolam 0.64% Methamphetamine 0.84% Sertraline 0.50% Propoxyphene 0.52% Tramadol 0.46% Diazepam 0.38% Amphetamine 0.45% Fluoxetine 0.37% Phentermine 0.26% Dextromethorphan 0.22% Methadone 0.19%
    • 27. 2007 NRS - OF Positivity
    • 28. 2007 NRS - Paired Specimens
      • Agreement between paired samples:
        • Overall, 5,869 oral fluid samples (OF) and 3,276 blood samples were collected from night-time drivers.
        • Of the paired specimens, 559 pairs showed at least one matrix as drug positive; 326 pairs were positive in both matrices.
        • In 129 cases, OF was negative with a corresponding positive blood
        • In 104 cases, the blood was negative with a corresponding positive OF.
        • A breakdown shows blood to be superior to OF for sertraline, phentermine and benzodiazepine analysis;
        • OF was superior for cocaine as well as several pain medications.
        • THC was found in oral fluid but not blood in 72 cases (although 43 of the bloods had THC-COOH present).
    • 29. 2007 NRS - Paired Specimens
      • Agreement between paired positives:
      • 3,276 paired oral fluid/blood samples
      • 326 pairs positive in both matrices:
        • 247 (75.7%) were an exact drug match across all classes
        • 70 (21.4%) had at least one drug class match
        • 97.1% correlation rate for paired specimens
        • 9 (2.7%) were a complete mis-match
    • 30. Most common exact matches
    • 31. Implementing OF Testing
    • 32. Making OF Testing work for DRE
      • Reliable Roadside/Portable Test
        • Targeted to DRE priority drugs
        • Sensitive
        • Non-subjective
        • Documentable
      • Laboratory Confirmation
        • Integrated with screen wrt scope and sensitivity
        • Validated for collection devices
        • Works well with limited sample volume
    • 33. Making OF Testing work for DRE
      • Reliable Roadside/Portable Test
        • Targeted to DRE priority drugs
        • Robust
        • Rapid training curve
        • Sensitive
        • Non-subjective
        • Documentable
    • 34. Making OF Testing work for DRE
      • Sample Collection Storage and Shipping
        • QC of manufactured devices
        • Consistent volume
        • Capacity indicator
        • Stimulated vs non-stimulated
        • Differential blood to plasma ratios
        • Variability of Oral Fluid
        • Should be ambient temp. stable
    • 35. Making OF Testing work for DRE
      • Forensic Laboratory Confirmation
        • Integrated with screen wrt scope and sensitivity
        • Validated for collection devices
          • Recovery
          • Stability
          • Interference
          • Matrix matching
        • Works well with limited sample volume
        • Forensic chain of custody
    • 36. Summary
      • Oral Fluid testing for Law Enforcement purposes is a proven strategy.
      • Advantages center around ease of collection.
      • Oral Fluid ≠Blood.
      • Screen, collection and confirmation phases must be carefully planned and validated.
      • Adoption requires management support and buy in from prosecutors.