the value of innovation © by doa_consulting 2000 chain of custody and adulteration

The Value of Innovation

© by DOA_Consulting 2000

Chain of Custody

and Adulteration



DefinitionDefinitionDefinitionDefinition

Reproduceability and Traceability of all Actions related to the Urine Specimen or the analytical Result

Security of Test Results



ProceduresProcedures

Sample CollectionStorage

TransportStorage

AnalysisInterpretationConfirmationReporting

Documentation: Who?, Where?, When?, What?, How?



Sample CollectionSample Collection Collection under sight if possible No jackets, bags, etc. allowed at collection site Patient should wash hands before donation Use special toilette for urine collection No soap at collection site No hot water at collection site Left hand in the neck Coloured rinse water Look for possible adulterants at the toilette Split B-specimen Immediate pH and temperature measurement Seal collection vessel; patient should sign vessel Store sample in locked fridge or freezer



Collection Form 1Collection Form 1



Collection Form 2Collection Form 2



Transportation & Storage

Transportation & Storage

Storage:Restricted AreaCooled or frozenPhotosensitivity

of some drugs

TransportationSealed shipping boxLogbook

ID of all SpecimenSignature of Collection siteSignature of TransportTransport (Batch) ID



Transportation Form

Transportation Form



CoC FormCoC FormPatient Name and/or IDCollection Information:

Name of responsible supervisor at collectionName of requesting personNames of all persons having access to the specimenComments regarding specimen

Laboratory InformationDate and time on arrival to the LabName of person who receives the specimen within the labRequested ParameterName of Person who does the analysis/validates the resultsResults: immunological or confirmation, ev. with Cut-off values



Results Form

Results Form



CoC Laboratory Procedures

CoC Laboratory Procedures

CoC Form: control for signatures and sealsSpecimens to be stored in secured areaFull documentation of specimen entryLog of calibration dataLog of control dataPatient ID should be coded not identified by Pat. NameEv. Confirmation analysis (as requested)In case of pos. result: store specimen over agreed timeframe



CoC Reporting Procedures

CoC Reporting Procedures

Declare reporting options with customerAvoid any transmission of results via phoneUpon transmission via fax, email or network printers:

check privacyDeliver hardcopies in anywaySend completed CoC form



Collection DevicesCollection Devices

Specimen Collection Kits with implemented temp or pH control

pH stripsElectron. Thermo probes / one way thermo-sticksSealsLabelsTransport boxes



Drug Testing Programm in your Company ? Yes ?Mary Jane Superclean 13 wipes off all dirty results from the Analyser !Dial: 1-800-TEST-CLEAN

Radio commercial, Feb.1994, Cal., USA



Adulteration - Why?

Purpose of adulterantsA negative result from a sample that

contains drugTo generate an invalid result Force a retest, time to “get clean”

Specimen sources Urine Hair (cleansing shampoos & conditioners)



Adulteration – Mode of Action

External adulterationCommercial products: Nitrites, GlutaraldehydeVinegar, soap, lemon juice, Visine, bleach

Internal adulterationCleansing drinks, teas, powders, herbal capsules,

diureticsVitamin B and Creatine

Substitution Drug-free urine (internal/external)



External Adulteration - Products

WaterApple, Lemon JuiceVinegarSaltVitamin C

BleachAftershaveKaolin - PectinGlutaraldehyde (UrinAid)Nitrites (KLEAR)



External AdulterationInterfere with screening test method

Produce false negativeRates lower than cutoff or negative

calibratorProduce invalid result

Increased Initial absorbance (A0)Absorbance flags / Invalid result flags

Interfere with GC/MS (Nitrites)



External Adulteration - Markers

pHPresence of Nitrites or GlutaraldehydeSmellFoaming, when swirledColor / appearance



Internal Adulteration Urine dilution Of greatest benefit in borderline positive samples Most of these products require drinking a lot of fluids

with the product Refrain from use of “toxins” for 24-72 hours prior to

testing Self over-hydration

Water loading Over-hydration

Carbohydrate-based “detoxification/purification” productsDiuretics - herbal productsAcidic beverages



Internal Adulteration - Markers

Urine markers for dilutionCreatinineSpecific GravityOsmolality

Most commercial adulterant products contain Creatine and Vitamin B complex

JJ J

J JJ

J

J J J

J

J

J

J J J J J

J

J

J J J

-60 -30 0 30 60 90 120 150 180 2100

1

2

3

4

5

6

7

8

9

10

Urineproduction

rate(mL/min)

Drink 1 L. water

Time (min)

Urine Production Rate After Water Loading

Baldes and Smirk, 1934


Drink 2 L. water

J

JJJ

JJJ

J

JJ

J

0

2

4

6

8

10

12

14

16

18

0 50 100 150 200 250 300

Urine Production Rate After Water Loading

Urineproduction

rate(mL/min)

Time (min)Macallum and Benson, 1909


JJ

JJ

J

J

1

1.005

1.01

1.015

1.02

1.025

1.03

-150 -100 -50 0 50 100 150 200 250

Specificgravity

Time (min)

Drink 1 L. water

Urine Specific Gravity After Water Loading

Gounden and Newall, 1983



Drink 1.0 L water (

G

GG

G

G

G

J

JJ

J

J

J

0 1 2 3 4 50

20

40

60

80

100

120

140

160

180

200

Creatinine(mg/dL)

Time (hr)

Drink 0.5 L water ( G)

J )

Effect of Water Consumption on Urinary Creatinine

LaFolie et al., 1991



Recommendations

Observed and controlled collections (EA) Minimize time limit for specimen collection - one hour or less (IA) Do not allow donor to drink more than one liter of liquid, and

preferably not all at once (IA) Check the temperature of the urine (Substitution) Include testing methods in screening procedure (IA / EA)

Creatinine Specific Gravity pH Nitrites Glutaraldehyde



Adulteration Products Substitute drug free urine is available, in concentrate form

Most of the adulterants purchased offered money back guarantees,

in some cases double your money, upon receipt of official

unsatisfactory results

All claim to work for all drugs, unless otherwise stated such as

Whizzies, which only works for THC

Adulteration products tend to change frequently, while the name

remains the same

All of these products are quite expensive, US$30-50 average



Clear Choice Instant Clean ADD-IT-ive

EXTRA STRENGTH

Appears to contain sodium nitrite Manufactured by HEALTH TECH

Instructions: “Add entire contents of vial into

sample then urinate.”

Not for human consumption.

“Not intended to be used for

lawfully administered urine tests.” is

printed on outer bottle.



Terminador Pure

Contains nitrites or glutaraldehyde Manufactured by ONE-STOP, Inc. Customer service 1-800-539-1926

Instructions: Just add contents of bottle into 4 oz. Of

liquid for Pure to work.

“Compare to URINE LUCK & WHIZZIES”



A SCIENTIFIC BREAKTHROUGH

KLEARTHE ULTIMATE PURIFIER IN 2 MICRO-TUBES

Clear crystals packaged in two small “micro-tubes”

Used to contain sodium nitrite, may be glutaraldehyde now Distributed by ITG, Inc.

For large samples of more than 4 oz, use two tubes

If kept away from moisture, remains potent for up to 2 yrs. Not sensitive to heat or cold

Instructions: Add contents of one tube of KLEAR

to each urine sample. KLEAR dissolves almost instantly. Swirl your urine for a complete mix.

For best results on urine tests, drink at least a quart of any liquid the day of the test. (Herbal teas are no better than water or coffee). If possible, take a 50mg B vitamin to turn your urine a nice golden color and impress the tester.



WHIZZIES

Indications for use: Keep on hand for surprise attacks by piss testers at work

Do not eat WHIZZIES or expose to open flame

“There is a drug war going on, and Smoke Screen Laboratories guarantees nothing.” is printed on insert

Contains sodium nitriteDistributed by ITG, Inc.Manufactured by Smoke

Screen Laboratories

Instructions:Add one vial to 45-60mLs of

urine. In case of split samples, add before specimen is divided



Tommy Chong’s URINE LUCK Vial of yellow liquid, looks like

Terminador Pure or Clear Choice

Manufactured/distributed by Spectrum Laboratories

Photo of Tommy Chong (of Cheech and Chong fame) with a dialogue bubble “It works for me, it will work for you!”

Contains sodium nitrite Do not store in sunlight

Instructions: Urinate 1-2 times before test. Add one vial to 3-5 oz (90-150mLs)

of urine. Use half vial for less than 3 oz (90mL) of urine.

Do not use with other detoxifying products, an do not drink more than 16oz of water on day of test. Mix slightly.

Special Note: Please call yearly to obtain the latest product formulation. Older formulations can be exchanged free of charge



ResourcesWebsitesNORML (National Organization for the Reform

of Marijuana Laws)Informational pamphlets/publications

UR-INE TroubleConquering the Urine TestsSteal This Urine TestHigh Times MagazineDrug Test Digest

Many of these distributors have their own newsletters



Websiteswww.peretto.comwww.urineluck.comwww.hightimes.comwww.testclean.comwww.testingfree.comwww.youreclean.comwww.testpure.comwww.cleartest.com

the value of innovation © by doa_consulting 2000 chain of custody and adulteration

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