Drug Testing in 2005 and Beyond

David J. Kuntz, PhD, DABFT, DFTCB

LabOne – Salt Lake City

West Valley City, UT 84120

Phone: 801-293-2300

email:david.kuntz@nwtox.com

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

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

• SOP’s and other laboratory documents are stored indefinitely for discovery in arbitration/litigation

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)

• Dates missing or inconsistent• Collector signature/shipment method missing• Federal collection on non-federal form• Donor’s 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

Examples of Chain of Custody Discrepancies and Cancellations

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

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

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

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”

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

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

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

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

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 Schiff’s test and full-scan GC/MS• The use appears to be non-existent - but testing for this

adulterant continues

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

Results for 2002

Result Q1 Q2 Q3 Q4 TotalPercent

Substituted 47 55 52 38 192 0.03Invalid 110 85 35 18 248 0.04Nitrites 13 21 30 24 88 0.01Chromium 39 28 23 12 102 0.02Bleach 14 8 3 5 30 0.01Soap 1 0 2 0 3 0.00pH 21 15 21 15 72 0.01Glutaraldehyde 0 0 0 0 0 0.00Iodine 0 0 10 20 30 0.01

Total 245 212 176 132 765 0.13

Results for 2003Result 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

Results for 2004Result 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

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

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.

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

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.

POCT’sPoint 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

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

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

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”

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????????