Drug Testing in 2005 and Beyond

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Drug Testing in 2005 and Beyond

• David J. Kuntz, PhD, DABFT, DFTCB
• LabOne Salt Lake City
• West Valley City, UT 84120
• Phone [phone]
• emaildavid.kuntz_at_nwtox.com

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Quality Assurance/Quality Control for Laboratory
Testing

• Certified by the SAMHSA/DHHS for urine testing
• Certified by the College of American Pathologists
  (CAP) and available state programs for urine and
  blood.
• Certified by Florida for hair and participate in
  a world-wide PT programs for hair and oral
  fluids. Federal hair and oral fluid PT programs
  are in development.
• More than twelve inspections per year by outside
  agencies
• Proficiency samples from private clients
• Active Quality Assurance Program
• Open and Blinded specimens in screening and
  confirmation assays
• Internal double blind program
• Multiple levels of review for negative and
  positive results

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Records and Sample Retention Policies

• All analytical records for non-negative (e.g.,
  positives, adulterated, substituted samples) are
  maintained for seven years
• Sample bottles in litigation are isolated in the
  long term freezer and are extended from 1 year
  storage to indefinite
• Negative samples are stored for a week before
  destruction
• Litigation packages are prepared on request and
  normally shipped within ten days
• SOPs and other laboratory documents are stored
  indefinitely for discovery in arbitration/litigati
  on

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Drug and Integrity Tests

• Drugs
• Amphetamines
• Cocaine
• Opiates
• Marijuana
• PCP
• Standard Integrity Tests
• Creatinine
• pH (acidity)
• Oxidants
• Generic test for multiple adulterants
• Specific Gravity

• Confirmation Tests for Adulterants
• Iodine
• Iodate
• Fluoride
• Chromium VI
• Nitrite
• Bleach
• Soap
• Glutaraldehyde
• Pyridine
• pH (addition of acids)

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Examples of Chain of Custody Discrepancies and
Cancellations

• Dates missing or inconsistent
• Collector signature/shipment method missing
• Federal collection on non-federal form
• Donors initials missing
• No donor employer ID or SSN
• Bottle and form ID numbers do not match
• No form with bottle
• Insufficient volume - bottle seal is
  broken/missing

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Initial Screening

• Often called the initial or immunoassay test
• All specimens are subjected to this test. It
  provides a rapid cost effective system to
  identify presumptive positive specimens
• This process requires 1 mL of urine to complete
  and will provide results for up to ten tests
  within 30 seconds
• Adulterants often target this process to change a
  positive screen to a negative test

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Confirmation Testing

• The first step is to separate the drug from other
  components of the urine (2-4 hours)
• Completed by a technique known as gas
  chromatography/mass spectrometry (GC/MS)
• The Gas Chromatograph further separates the
  remaining urine components
• The Mass Spectrometer identifies each drug
  through a chemical fingerprint which is unique -
  the identification is conclusive

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Lab Intervention in Adulteration

• For each sample, the lab conducts three chemical
  tests (pH, oxidants, creatinine), specific
  gravity (if the creatinine is less than 20 mg/dL)
  in addition to appearance, smell, and color
• The laboratory identifies approximately 2-3
  samples per thousand which are adulterated or are
  invalid
• Approximately 90 of adulterated specimens have
  drug identified in the urine sample
• If the adulterant can not be identified, it is
  reported as unsuitable

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Creatinine, Specific Gravity, pH and General
Oxidants

• Creatinine is a byproduct of protein metabolism
  and is related to muscle mass, exercise, and
  hydration
• Specific Gravity is only performed when
  creatinine is in the dilute or substituted
  categories
• pH is a measure of acidity and samples are
  typically acidic is the presence of adulterants
• The general oxidant test is generic test for
  oxidizing adulterants identification of the
  adulterant is the responsibility of the
  confirmation test. If the adulterant cannot be
  identified, the result is Invalid

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Nitrites

• One of the most popular adulterants several years
  and prevented the confirmation testing of
  marijuana
• Every sample is screened at 200 mcg/ml and
  confirmed with a second aliquot at 500 mcg/ml
• Nitrite is a normal constituent of urine,
  especially in urinary tract infections, but is
  only in low concentration (less than 100 mcg/mL)
• Samples exceeding 500 mcg/ml are reported as
  adulterated

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Chromium

• There are two types
• Chromium (6) is extremely toxic and corrosive
• Chromium (3) is the dietary form as chromium
  picolinate in vitamin supplements and does not
  interfere with testing nor is it identified in
  the testing
• Primarily effective against marijuana - works
  within minutes to destroy the presence of
  marijuana in the sample

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Bleach

• One of the few adulterants that can be detected
  by the collector through its odor
• Typically identified through odor at the time
  samples are aliquoted for the screening test
• Disappears from the urine over time and makes the
  confirmation for Lab B difficult

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Soap

• As with bleach, it has been used for decades to
  interfere with screening and confirmation tests
• Usually identified through excessive, long
  lasting bubbles and a flowery smell upon
  opening of the bottle
• The type of soap is not identified. Normally
  about a 1/2 teaspoonful is added

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Glutaraldehyde

• Became popular in 1992 as the first commercial
  adulterant
• It is used as a chemical sterilant and tissue
  fixative
• The presence of glutaraldehyde is indicative of
  intentional adulteration
• Screening tests provided ultra-negative
  immunoassay results screening by Schiffs test
  and full-scan GC/MS
• The use appears to be non-existent - but testing
  for this adulterant continues

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Iodine and Iodate

• Dietary iodine is converted to iodide in the body
  and transported to the thyroid for converting
  into proteins
• Iodide is normally found in the urine - NOT
  iodine
• Iodine can be purchased in adulterants or as a
  water treatment product
• If urine leaks from the container, it will darken
  the label and a drop on paper will turn the paper
  purple
• Iodate is the combination of iodine and oxygen
  and works slowly to destroy the drugs more
  difficulty for the Bottle B laboratory as the
  drug is gone and is unable to confirm the
  adulterant
• Iodine and Iodate are confirmed by separate
  methods - Amounts are very large and ignores
  dietary iodine

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Results for 2002

• Result Q1 Q2 Q3 Q4 Total Percent
• Substituted 47 55 52 38 192 0.03
• Invalid 110 85 35 18 248 0.04
• Nitrites 13 21 30 24 88 0.01
• Chromium 39 28 23 12 102 0.02
• Bleach 14 8 3 5 30 0.01
• Soap 1 0 2 0 3 0.00
• pH 21 15 21 15 72 0.01
• Glutaraldehyde 0 0 0 0 0 0.00
• Iodine 0 0 10 20 30 0.01
• Total 245 212 176 132 765 0.13

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Results for 2003

• Result Q1 Q2 Q3 Q4 Total Percent
• Substituted 49 77 70 52 248 0.04
• Invalid 82 96 108 156 442 0.07
• Nitrites 23 24 18 12 77 0.01
• Chromium 15 17 15 11 58 0.01
• Bleach 6 1 9 4 20 0.00
• Soap 0 0 1 0 1 0.00
• pH 31 20 23 23 97 0.01
• Glutaraldehyde 1 0 0 0 1 0.00
• Iodine 14 22 31 18 85 0.01
• Fluoride 0 0 4 5 9 0.00
• Iodate 0 0 11 9 20 0.00
• Total 221 257 290 290 1058 0.16

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Results for 2004

• Result Q1 Q2 Q3 Q4 Total Percent
• Substituted 51 55 61 14 181 0.03
• Invalid 144 138 137 73 492 0.08
• Nitrites 19 19 24 14 76 0.01
• Chromium 15 9 15 5 44 0.01
• Bleach 8 5 8 10 31 0.01
• Soap 1 0 0 0 1 0.00
• pH 15 26 17 15 73 0.01
• Glutaraldehyde 0 0 0 0 0 0.00
• Iodine 12 14 11 17 54 0.01
• Fluoride 0 0 0 1 1 0.00
• Iodate 30 30 11 62 57 0.03
• Total 295 296 335 206 1132 0.19

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Legal Issues and Arbitration

• Many cases involve adulteration and substitution
  and are more difficult to prosecute than drugs
• The laboratory staff provides testimony in about
  75-100 cases per year
• November 1, 2004 the latest SVT regulations took
  place to adjust substitution numbers and set more
  guidance for adulteration testing and reporting
• Fewer issues regarding substitution with the
  lowering of the creatinine cutoff to 2 mg/dL

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Are You Ready for the Future?

• SAMHSA is in the process of finalizing new
  regulations that were in a NPRM last summer for
  release this summer
• Time-frame for implementation has not been
  established and still subject to additional
  scientific and legal review
• These regulations affect urine testing, alternate
  matrices, POCT, and screening-only laboratories
• These regulations are the biggest change since
  the initiation federal urine drug testing in 1988.

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Changes in Laboratory Testing

• Changing amphetamine screening and confirmation
  levels from 1000/500 to 500/250 ng/mL and will
  include MDMA and MDA
• Increased testing requirements for heroin
• Lowering cocaine screening and confirmation
  levels from 300/150 to 150/100 ng/mL
• Results will increase positive rates and increase
  testing costs in the laboratory to incorporate
  new tests and increased confirmation rates

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Initial Immunoassay Testing Facilities (IITF)

• Regulations will provide for screening only
  laboratories that will be federally certified
• All screen positives will be forwarded to a
  SAMHSA certified laboratory
• Quality control procedures will be identical to
  the full-service laboratories
• Would potentially generate satellite labs and
  possibly more hospital-labs since the complexity
  of GC/MS would not be required.

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POCTsPoint of Collection Tests

• Regulations would allow for federal agencies to
  use these devices for limited circumstances
• Quality control measures would have to improve to
  be used (identify /- 25 of cutoff pos and neg
  controls)
• Management of this program will be difficult as
  the devices vary in quality and the ability to
  read the results
• Federal agencies would be required to have a
  hands-on management function for POCT
• Presumptive positive results would still need to
  be confirmed

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Sweat Testing

• Requires a patch to be applied to the donor and
  the patch would remain for several days before
  removal and shipped to a laboratory
• Logistics only allow limited purposes
• May have a much larger application in the
  criminal justice market than in the federal
  workforce
• Patch may provide information regarding drug
  usage for up to a week

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Oral Fluid Testing

• Several laboratories currently provide testing
• Oral fluid collections are easier than urine
  collection split collections are possible
• Current concept is to use adsorbent pad
  collectors to transfer the oral fluid to a
  shipment container
• Broad applications in the federal testing program
  and could potentially replace urine collections
• Minimal potential for adulteration
• Must use alternate screening methods to identify
  drug use and increased technical requirements for
  confirmation
• Positive testing rates are similar to urine

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Hair Testing

• Federal testing will require up to 100 mg of hair
  that is 1 ½ inches long (split collections are
  required)
• Approximately 90-day detection window
• Cannot be used to determine a single use single
  use is best identified through urine testing
• Controversy is surrounds hair color and will need
  to be resolved before widespread implementation
  in the federal drug testing program
• Positive rates are higher than urine and the use
  of hair testing can eliminate dilution issues and
  adulteration since the collection is not private

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Where Do We Go From Here?

• For the next 12-24 months there will probably be
  legal challenges to the new regulations and the
  labs will improve technically with alternative
  specimens
• Proficiency programs and lab certification will
  need to be completed
• DOT will develop their policy based on the
  experience of HHS
• Which agency will be first to use the alternate
  technologies and defend their result and decision
  to use alternate specimens????????

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