Oral Fluid as a Chemical Test for the DRE Program


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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?
  • Oral Fluid as a Chemical Test for the DRE Program

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