IN THE UNITED STATES AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`In the matter of Registration No. 2,825,088
`Issued March 23, 2004
`For the Mark SVT®
`
`TTAB
`
`%i'=7?’//‘}i6/W//
`
`Dade Behring, Inc.
`
`Sciteck, Inc.
`
`Petitioner
`
`Registrant
`
`'-_o-v-../-...a-.J--..t--_/~._/-../-../'~&
`
`Date Received: 08121104
`
`Cancellation No. : 92043566
`
`Reg. No.2 2825088
`
`Date: September 15, 2004
`
`I hereby certify that this correspondence is being deposited with the
`United States Postal Service as Express Mail #EU757B50423US
`addressed to: Box adema rial .i- peal Board.
`
`Commissioner for de it/'
`Virginia 22202-3514
`
`
`
`Signature:
`;l///_"[////l/
`ep ember15,2004.
`
`Name:
`
`
`
`Virginia 22202-3514
`
`Sir:
`
`Sciteck,
`
`Inc. a corporation doing business in North Carolina, with its
`
`principal place of business at 317 Rutledge Road, Fletcher, NC 28732
`
`(hereinafter referred to as "Registrant"), states that it
`
`is not damaging Dade
`
`Behring (hereinafter
`
`referred to as "Dade") by a registration mark SVT®
`
`(Registration No. 2,825,088) owned by Sciteck. Sciteck's sole stockholder is Jack
`
`V. Smith (hereinafter referred to as “Smith") and is being damaged by Dade's
`
`IIllIII||||||||||IIIIIIIIIIIIIII|Il|||||||||IIIlII
`
`09-15-2004
`u.s. nun: Ii TMO‘?¢i'TM VIIJI nwtbt '22
`
`

`
`
`
`petition,
`
`including being damages from the following but not limited to Dade’s
`
`attempt to harm and damage the business (e.g. Sciteck) of Jack V. Smith also to
`
`include Dade’s own tortious interference with a business contract (attached)
`
`signed between Dade and Smith wherein Dade would not
`
`interfere with the
`
`business of Smith which includes adulteration testing. This is not limited to the
`
`fact that prior to signing this agreement in May of 2002 Dade conspired to
`
`commit fraud when Dade issued 80,000 stock options of Dade Behring stock to
`
`Smith while claiming bankruptcy less than 2 months later without notice to Smith
`
`that the stocks they gave to Smith were fraudulently represented and did not
`
`actually exist. In addition, Dade contracted from Smith the rights to manufacture
`
`adulteration testing reagents, which Smith taught Dade. Smith is
`
`the first
`
`individual to receive a patent for the use of adulteration reagents and in fact was
`
`the first person to sell and market such products and in fact coined the term
`
`"specimen validity testing".
`
`Adulteration Testing:
`
`“Adulteration Testing" is the main term used currently and has been for the last
`
`15 years. "Adu|teration Testing" stands for the testing of urine specimens
`
`submitted for drugs-of-abuse testing as to whether any foreign substances are
`
`present which may adversely affect the drugs—of-abuse testing results.
`
`It
`
`is
`
`patentably untrue that SVT® is in common use in the industry with regards to
`
`Adulteration Testing. This is not completely surprising with regards to Dade’s
`
`limited knowledge of Adulteration Testing. I only introduced them to this industry
`
`

`
`
`
`in 1999. in an effort to educate Dade and counsel the following should suffice. in
`
`the following explanation try to replace “Adulteration" with "Specimen Validity
`
`Testing" or "SVT".
`
`It doesn’t work and to suggest that "Specimen Validity
`
`Testing" is now the “Xerox" statement for “AduIteration Testing" is beyond
`
`ridiculous.
`
`To further explain Adulteration Testing:
`
`As the use of
`
`illicit drugs in this country has increased, public concern over
`
`the problems associated with its effects has grown into a major concern. This
`
`concern has led to workplace drug testing in order to identify, treat, and remove
`
`active drug users from the workforce. This trend started in the military, and
`
`spread rapidly to law enforcement and any "safety—sensitive" private sector jobs
`
`such as airline pilots,
`
`truck drivers, and active crew members of public
`
`transportation. These initial strides into drug testing in the workplace revealed the
`
`obtrusive incursion of drug use and abuse in the daily lives of a significant portion
`
`of Americans. Further research indicated the staggering costs to public and
`
`private industry in terms of lost productivity,
`
`increased health care costs, and
`
`human suffering and death due to this scourge of drug abuse. As a result, drug
`
`testing has rapidly spread to all areas of the public and private sector. The vast
`
`majority of workplace drug testing has taken the form of urine testing, because of
`
`ease of collection,
`
`low cost, and effective indication of recent drug use. Other
`
`forms of testing include analysis of blood, saliva, sweat, and hair.
`
`Because the effects of a positive test on the individual can be significant,
`
`and traumatic,
`
`the analysis procedures must guarantee accuracy with the
`
`

`
`
`
`emphasis on zero false positive results. On the other hand, all efforts must be
`
`made to detect all drug users in order to insure the success of this policy. These
`
`two requirements dictate a policy of close and vigorous scrutiny of the collection,
`
`testing, and reporting procedures. Juxtaposed to these closely monitored
`
`procedures is the deep and abiding desire of illicit drug users to avoid detection
`
`in order to keep their use secret, and to keep theirjobs. Thus driven by these key
`
`desires, the ingenuity of a few in the drug abuse subculture has led to a plethora
`
`of ways to defeat the workplace drug testing procedures. These "adu|teration "
`
`methods all conspire to produce the same desired effect: a false negative result,
`
`which will protect the drug user's secret.
`
`Adulteration techniques can be divided into two distinct types. The first
`
`utilizes an “in vivo" technique in which the user consumes the adulterant. The
`
`second technique utilizes an "in vitro" method in which the abuser adds the
`
`adulterant directly to the urine specimen submitted for testing.
`
`The drug testing procedure involves two distinct parts. The initial segment
`
`is a panel of screening tests for the individual drugs.
`
`If a positive result
`
`is
`
`obtained in any of these initial tests, then a confirmation assay is performed for
`
`each drug that screened positive. Most adulteration techniques are aimed at the
`
`screening process, because of the inherent fragile nature of these inexpensive
`
`assays, which adapt well to rapid, automated analysis techniques. All screening
`
`tests utilize antibodylantigen reactions quantified via an enzyme indicator. On the
`
`other hand, confirmation assays are labor and time intensive, highly accurate,
`
`expensive, and more difficult to adulterate. In addition, the positive screen has
`
`already raised a red flag,
`
`thereby drawing attention to the sample. The
`
`confirmation analysis utilizes GC—MS (gas chromatography mass spectrometry)
`
`testing which is considered the "gold standard" for drug assays scientifically and
`
`legally.
`
`

`
`
`
`The "in vivo" methods function in one of three ways. These include dilution
`
`of the analyte of interest to a level below that required for a positive result,
`
`decreasing the time required to eliminate the consumed drug, or consuming a
`
`compound that will interfere with the screening method. Dilution is effected by
`
`consuming a large volume of liquid together with a diuretic to speed elimination
`
`of urine, and a B vitamin to add yellow color to the urine sample. Some
`
`commercial
`
`in vivo dilution products or "flushes" are sold under the following
`
`names: Carbo Clean, Test Pure, Kleen Test, Quick Flush, Naturally Klean, Test
`
`Free, UA Flush, Zydot's Special Blend, Daily Pure, Vale's Quick Clean, Test'n,
`
`and UR'n Kleen. Decreasing the elimination time will often enable the weekend
`
`drug user to avoid testing positive on a Monday morning drug test. This is
`
`accomplished by consuming acidic liquids (e.g. acidic fruit juices or ammonium
`
`chloride) to speed up elimination of basic drugs, or consuming basic liquids to
`
`speed up elimination of acidic drugs. Examples of an internally ingested
`
`substance which will disrupt the screening test procedure include aspirin and
`
`mefenamic acid, a prescription analgesic pain killer.
`
`In vitro methods utilize literally hundreds of products and compounds that
`
`will adversely affect either the screening or confirmation process. Products
`
`affecting the screening process include many household products (i.e. all types
`
`of cleaners including hand, clothes and dishwashing detergents and soaps, table
`
`salt, hydrogen peroxide (oxidant), oxidants (such as sodium nitrite, sodium
`
`bromate, potassium bromate, bromine, enzymes (such as contained in meat
`
`tenderizer, digestive enzymes, etc.), bleach (sodium hypochlorite (Cl), an
`
`oxidant),
`
`fingernail polish remover, vinegar, Drano,
`
`liquid plumber, sodium
`
`bicarbonate, Visine, fingernail polish, swimming pool cleaning chemicals and
`
`acid), or specialty products sold commercially as adulterants (i.e. Urine Luck
`
`(contains the oxidizer pyridinium chlorochromate), Purafyzit, Urine Sured, and
`
`

`
`
`
`THC Free are acid—based products with some including other ingredients such as
`
`chromates and nitrites (oxidants), UrinAid and Clear Choice are glutaraldehyde
`
`containing products, Amber-13 contains sulfides, Mary Jane Super Clean 13 is a
`
`soap, Stealth, and Toxiclean). Commercial products aimed at interfering with the
`
`confirmation process include nitrite (oxidant) containing products Klear and
`
`Whizzies and bromine molecule containing product known as Stealth.
`
`Substitution, or using a clean urine sample supplied by a third party, can
`
`be either in vivo or in vitro adulteration. In its simplest form, participants hide a
`
`clean urine in their clothing and put it into the specimen collection container (in
`
`vitro).
`
`Individuals
`
`requiring more stealth including those giving observed
`
`collections (military and corrections primarily) may substitute via the in vivo
`
`technique which requires putting the clean urine into the subject's bladder using a
`
`catheter.
`
`Illicit drug users have learned to falsify urine screening tests by in vitro
`
`adulteration of urine samples by the addition of several readily available agents,
`
`including household products (soap, bleach, etc...), hydrogen peroxide, and
`
`commercially available adulteration products, such as "UrinAid and Clear
`
`Choice" (glutaraldehyde containing adulterants) or “Urine Luck" (a chromate
`containing adulterant).
`.
`
`The vast majority of urine collections are not observed due to privacy
`
`issues. Collection facilities try to prevent in vitro adulteration or substitution by
`
`recording the temperature of the sample as soon as it is collected.
`
`it must fall
`
`inside the very narrow range of 90.5 to 99.8 degrees Fahrenheit. They also may
`
`require subjects to leave excessive clothing out of the collection room, and
`
`provide no hot water which prevents dilution of the sample with water. Obviously,
`
`however,
`
`it
`
`is very easy to secret small quantities of adulterating substances
`
`into the collection room. ‘As
`
`little as a pinch of salt or a drop or two of
`
`

`
`
`
`glutaraldehyde, pyridinium chlorochromate or acid will affect most test screens.
`
`Because the effective amounts of most adulterants are very small, even
`
`observed collection as required by the military and criminal justice system can be
`
`defeated using the in vitro technique.
`
`In Response to Dade's grounds for petition:
`
`Page 2
`Rep. to No. 1:
`Dade Behring has only started selling and manufacturing adulteration reagents in
`late 1999 (as Chimera Research) my former company and did not actually start
`to make the reagents for adultertion testing for a couple of years. Dade is trying
`to make it look like they have been in this business for many years? But, truth
`that they are only in the business because of my knowledge of industry.
`
`Rep. to No. 2:
`Acknowledged
`
`Rep. to No. 3:
`If Dade has an interest in using Sciteck’s SVT® mark it should seek to license it
`from Sciteck in the usual above board manner instead of violating contractual
`agreement(s) and seeking a cancellation of a mark that was developed and
`created by the owner.
`
`Rep. to No. 4:
`False
`
`SVT is not generic and is not commonly or even widely used in the adulteration
`industry.
`
`The following are for examp|e(s) of the NON—USE of Specimen Validity Testing.
`But, there is so much public work on Adulteration Testing the actual term used
`in the industry that to bring it all fonzvard would be to cumbersome.
`
`from the 2004 Joint SOFT (Society of Forensic
`a) Program guide
`Toxicologist),
`FBI
`(Federal Bureau
`of
`investigation)
`and TIAFT
`(International Society of Forensic Toxicologist) meeting in August of 2004.
`The program at the top of pages 95 and 97 states the area of science that
`this program represents it states FUDT & Adulteration not SVT® or
`Specimen Validity Testing. FUDT stand for Forensic Urine Drug Testing.
`This is the top conference for scientist all over the world that perform
`drugs—of—abuse and adulteration testing and they not seem fit to use the
`term “Specimen Validity Testing".
`
`

`
`
`
`b) Page 253 from the Abstract from the 2004 joint conference with published
`peer review research on adulteration. Not one mention in these articles
`about SVT or specimen validity testing. For a term (SVT) that Dade claims
`is in as common use as "XEROX" for photocopying it is not illustrated by
`the Scientist in the industry or by the leading conference for this type of
`testing.
`c) SOFT 1999 Cover page and published article on adulterants. Again, the
`missing use of the SVT term is still not present.
`it is quite apparent that
`Dade has miss represented itself which is not uncommon. And, in fact only
`wants to use the term for its own marketing scheme to harm Sciteck and
`myself.
`-
`d) Copy of a Google search looking for the use of Unknown to Sciteck
`but the most common use of the term seems to be related to automobiles.
`
`Hardly the “XEROX" use for SVT as described by Dade.
`e) Scientific Program Guide for the 2004 Conference Wednesday September
`15‘ and the use of "FUDT and Adu|teration" is used. However, the accused
`use of SVT everywhere by Dade is missing. For such a common term is
`lack of use by the industry and scientist is puzzling.
`
`to present all of the research and published that has been done on
`Again,
`"Adulteration Testing" would take literally a 100 hours of photocopying to
`perform. However, it would should that the use of SVT and I or specimen testing
`is very limited and hardly an industry "|CON".
`
`Rep. to No. 5:
`False.
`
`The SVT mark is used to sell “Adulteration Testing" reagents which is the
`common terminology used industry not the use of SVT. Therefore the use of SVT
`is not in-fact wholly descriptive and is not used for its generic or descriptive
`meaning. It is true that the owner developed the industry and the terminology but
`it is hardly commonly used industry wide. 15 USC 1052 (e)(1).
`
`Rep. to No. 6:
`False, as illustrated above.
`
`Rep. to No. 7:
`False
`
`This is patentabiy untrue and is a blatant lie by Dade and their representative.
`The only party to this issue that has committed fraud is Dade as illustrated above
`when it gave 80,000 stock options to Smith and knew that they did not exist.
`Dade in fact knows that it is in violation of the agreements signed in 1999 and
`2002 and yet is still trying to do harm to an individual. Dade is a billion dollar
`corporation. Again, the representative developed and patented the product for
`the industry, used and coined the SVT terminology.
`
`

`
`
`
`Rep. to No. 8:
`False
`
`The use of SVT is just for our Adulteration testing line of products and in itself is
`of no use. it is used to sell our adulteration reagent. Dade only sells adulteration
`reagents because Smith allows it to do so. Dade currently pays Smith royalties
`on all of the adulteration reagents that it sells. The use of the mark is not hurting
`Smith, Smith receives royalties from Dades sell of adulteration reagents.
`
`Rep. to No. 9:
`False
`
`The only harm will come if the registrant “Sciteck" not allowed to use the its mark
`with its adulteration testing products. SVT is for selling "Adulteration Testing
`Reagents". NOT “specimen validity testing" reagents. lf we only used the term
`SVT or specimen validity testing we would be out of business.
`
`WHEREFORE, Sciteck prays for dismissal of this petition and this response is
`filed in triplicate.
`
`Respectfully Submitted,
`
`Sciteck. Inc
`
`Dated: 09/21/2004
`
`
`
`
`
`Fax: 828—650- " 735
`
`
`
`

`
`Wfle
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`
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`
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`
`flugust 3|] - September 3, 2004
`
`.
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`
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`‘
`“..-'.--‘e‘''
`
`.‘
`
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`
`

`
`
`
`FUDT & Adulteration
`Poster Presentation
`Session A
`
`Wednesday, September 1st
`Russell/Hart/Cannon
`
`_
`_
`Presenters must be at their
`Posters from 9:00 __ 10:30 a_m_ Moderators: Davin’ Kuntz, PhD and/lnya PISFCE’, PhD
`
`8:00 a.m. —
`12:00 p.m.
`
`Automated Approach to Non-Negative Specimen List (NNSL)
`Production and Application for 5AMHSA~Certified
`*
`Laboratories
`W.N. Bennett and .4. Wu*
`
`F14
`
`Method Validation for the Analysis of Amphetamine,
`8:00 a.m. —
`12:00 p.m.
`Methamphetamine, MDA and MDMA in Urine
`
`M.Pa-rlg 5. Chat; E. Kim, M. l_im*, M. Pyo, and/-l. Chung
`
`F15
`
`Urinary Excretion of Morphine and Codeine Following the
`8:00 a.m. -
`12:00 p.m.
`Administration of Single and Multiple-Dose of Brown Mixture
`
`0. Lin, H. Llu*, H. H0, CZ lll_’ang, arid RH. Uu
`
`F16
`
`8:00 a.m. —
`12:00 p.m.
`
`A Modified Method for the Liquid-Liquid Extraction and
`GC/MS Analysis of Methadone from Human Urine in a CAP-
`FUDT Certified Drug Testing Laboratory
`J. Le ve//e, B. Brunellr; E. A Zary*, and J. Keller
`
`F17
`
`F18
`
`8:00 a.m. -
`. 12:00 p.m.
`
`A Rapid LC/MS Method for the Determination of
`Methamphetamine/Dimethyiamphetamine and Their
`Metabolites in Urine - A Study of the Current Situation in
`Hong Kong
`l/l/CC. Cheng", and WC Mok
`
`8:00 a.m. -
`12:00 p.m.
`
`F19
`
`‘Confirmation Rates of Initial Drug Assays in a Group of HHS-'
`Certified Laboratories: January 01 Through December 31,
`2003 — I: Federally Regulated Specimens
`D.M. Bush *, MR. Baylor, J. Irving, J.M. Mitchell, and CIA. Suthefmer
`
`F20
`
`.8:00 a.m. —
`12:00 p.m.
`
`Confirmation Rates of Initial Drug Assays in a Group of HHS-
`Certified Laboratories on On-Regulated Specimens: January
`01 Through December 31, 2003 — II: Non-Regulated
`Specimens
`
`CA. Sut/7elmer*, M.R. Baylor, .7. Irving, J.M. Mitchell and D.M. Bush
`
`F21
`
`8:00 a.m. —
`12:00 p.m.
`
`Determination of Benzodiazepines in Human Urine Using
`Solid-Phase Extraction and High Performance Liquid
`Chromatography Electrospray Ionisation Tandem Mass
`Spectrometry
`
`5. Hegstao”, E.l.. Olesraafi U. Johansen, and A5. Cfinstophersen
`
`
`
`
`
`8:00 a.m. —
`12:00 p.m.
`
`Use of Compounds Altering Vigilance Performance:
`Preliminary Results of Prevalence in Haulage Drivers in the
`Nord-Pas-De-Calais Region (France)
`L. Label: 5. Dehon, M. l.hermltfe*
`
`F22
`
`
`
`Page 97
`
`

`
`
`
`”"' 8:00 a.m. _-'
`.12:oo p.m.
`
`'
`
`' "
`
`'
`
`8:00 a.m. —
`12:00 pm.
`
`8:00 a.m. —
`12:00 pm.
`
`8:00 a.rn. --
`12:00 p.m.
`
`8:00 a.rn. —
`12:00 p.m.
`
`F23
`'
`
`F24
`
`F25
`
`F26
`
`F27
`
`. Screening of Buprenorphine in Urine of Suspected Abusers
`by ELISA
`A. Hamza/7*, P.C. Peh, CM. Um, and CP. Lul ’
`
`.
`
`A Comparison of Microgenics DRI° Opiate and Microgenics
`DR!‘ Oxycodone Immunoassays with Gas
`Chromatography] Mass Spectrometry for the Detection of
`Opiates and Oxycodone in Urine
`J.R. Manforte‘; R. Backer, ana'A. Pokfis
`
`The Identification of a Chlorinated 3,4-Methylenedioxy-
`methamphetamine in Illicit Drug Abuser Urine
`V. Maresovai J. I-lamp; Z. Chundela, F. Zrcek, M. Po/asek, and.1.
`Chad:
`.
`
`Testing Medical Professionals for an Expanded Menu of
`Drugs - A Preliminary Summary of Positive Findings
`M. McMuIlfn *andA. Costantino
`
`Linear Relationships of A’-Tetrahydrocannabinol Metabolites
`in Urine
`.5 Larson‘ andJ.D. Hutchison, Jr.
`
`Page 98 ,
`
`

`
`
`
`ULTERATEQIM
`
`Scientiiio Program
`
`
`
`FUDT & Adulteration
`Platform Presentation
`Session #1
`.
`Tuesday, August 315‘
`Moderators: Michael Baylor, PhD andSusan Paterson, PhD
`Capitol Ballroom _ D/E
`
`1:30 - 1:45 p.m.
`F1
`The Description of a Multi-anaiyte Homogeneous Enzyme
`Immunoassay for Detection of DAU in Urine Samples
`M..l Coyer*
`
`
`
`1:45 - 2:00 p.m.
`F2
`Urine Adulteration Trends from 2001-2003
`DJ. Kun£z*, C. Jones, K Bate/ho, andM. Fe/omen
`
`
`2:00 - 2:15 p.m.
`F3
`Analysis of Urinary Sulfate Metabolites Using Ion»Paired
`Extraction
`A. Car/Iey*, R. Kazfauskas G. Trout, and A. George
`
`2:15 - 2:30 p.m.
`
`F4
`
`2:30 - 2:45 p.m.
`
`F5
`
`Iodine Containing Adulterant- Its Effect on Rapid Drug
`Screen and Detection by Intect 8
`B. Ci‘:ien‘5 J. 500k, and RC. Wong
`
`.
`Papain, a Novel Urine Adulterant
`0.1.. Burrows‘, A. Nicolaides, D.A. Johnson, M.M. Dufiourc, and ICE.
`Fers/ew
`*** SOFT Education Research A ward (ERA) Winner “*
`
`2:45 - 3:30 p.m.
`
`Break
`
`
`3:30 - 3:45 p.m.
`F6
`A Comparative Evaluation of the Instant-View 5 Panel Test
`Card with Ontrak Testcup Pro 5: Comparison to GC/MS and
`Instrument Screening with Online Reagents
`D.E. Moody‘: VI/.5’. Fang, D.M. Andrenyak, K5. Mono; and C. Jones
`
`3:45 - 4:00 p.m.
`
`F7
`
`-
`Direct Analysis of Opiates in Urine by Liquid
`Chromatography/Mass Spectrometry/Mass Spectrometry
`4.
`LE. Eo':nboro*, RC. Backer, and A. Pok/is
`
`
`
`Page 95
`
`

`
`
`
`.
`Lu av!
`_4:00 - 4:15 p.m."'i"-‘* f- F8.‘-F
`‘
`
`,..:
`
`»
`
`:
`~ Unusual Drug Test Results from Known Heroin Users
`N. Fortne-r*, D. Crook R. Turk, and A. Waszyn
`-_‘._
`
`-
`
`4:15 - 4:30 p.rn. '
`
`' F9
`
`‘Estimate of Detection Period in Urine for Markers of Street
`Heroin
`5. Paterson*, R. Cordero, and5. Bur/Fnson
`
`‘
`
`4:30 - 4:45 pm.
`
`Effectiveness of Free and Total Morphine Concentration as
`Criteria for Selecting Urine Specimens for Testing 6-
`Acetylmorphine
`5. Wang, J.W. $oper*, D. Canfie/oi and /?.H. Liu
`
`F10
`
`4:45 - 5:00 p.m.
`
`‘ Analysis of a Mu|ti—Drug Positive USAF Member
`V.M. Papa‘: $.—0,zment, 72 Cox, 72 Farrell; and .4. Jacobs
`
`
`F11
`
`F12
`
`5:00 - 5:15 p.n1.
`
`Amphetamine Concentrations in Urine After the Use of
`Dexedrine “Go-Pills": Comparison of single and Double
`Doses of D-Amphetamine
`_ P.l.. Mob/ey*, 5.H. Constable, RD. I/anderbeek, TIA. Frazier, C5.
`Ramsey, and D. Wheeler
`
`5:15 - 5:30 p.m.
`
`Workplace Urine Opiate Testing: A Case of Scientific
`F13 "‘
`Injustice in the U.K.
`‘
`'
`M/. We-5tenbn'nk*
`
`'
`
`Page 96 '
`
`

`
`
`
`Scientific Session
`
`Abstracts:
`
`Forensic Urine
`Drug Testing 8;
`Adulteration
`
`—.
`
`W”
`
`
`
`Page 253
`
`

`
`
`
`F5
`
`PAPAIN, A NOVEL URINE ADULTERANT
`
`David L. Burrows", M.S.; Andrea Nicolaides‘,B.S.; David A. Johnson’, Ph.D.; Michelle M. Duffourc’,
`Ph.D.; Kenneth E. Ferslew', Ph.D., Section of Toxicology‘, Dept. of Pharrnacology”; Dept. of
`Biochemistry and Molecular Biology’, James H. Quillen College of Medicine, East Tennessee State
`University, Johnson City, TN. 37614
`
`illicit drugs is
`The estimated number of employees in the United States screened annually for
`approximately 20 million, with marijuana being the most frequently abused drug. Urine adulterants
`provide an opportunity for illicit drug users to obtain a false negative result on commonly used primary
`drug screening methods such as the Fluorescence Polarized immunoassay (FPIA) technique. Typical
`chemical adulterants such as nitrites are easily detected or render the urine specimen invalid as defined in
`the proposed SAM}-lSA guidelines for specimen validity testing based on creatinine, specific gravity and
`‘-5..:-
`pH.
`
`Papain is a cysteine protease with intrinsic ester hydrolysis capability and several residues that serve as
`hydrophilic and hydrophobic binding sites that can act as a potential urine adulterant. These mechanisms
`would exists in a novel class of urine adulterartts and urine adulteration with hydrolytic enzymes can be
`attained with a relatively smaller quantity as compared to their typical chemical counterparu. The primary
`metabolite of the psychoactive chemical
`in marijuana,
`I1-norcarboxy-delta-9-tetrahydrocannibinol
`(1 INC), was assayed by FPIA in concentrations ranging from 25 to 500 ng/rnL, at pH values ranging from
`4.5 to 8, over the course of 3 days with papain concentrations ranging from 0 to 10 mg/mL. FPIA analysis
`of other frequently abused drugs: amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and
`phencyclidine, along with gas chromatography I mass spectrometry (GCIMS) of 1lNC and high
`performance liquid chromatography I ultraviolet (HPLCIUV) of nordiazepam was performed in order to
`determine if the mechanism of urine adulteration by papain was analyte specific. Control and adulterated
`urine specimens (n=30) were assayed for creatinine, specific gravity, osmolarity and pH to determine if
`papain rendered the specimens invalid based on the proposed SAMHSA guidelines. There was a direct
`pH, temperature, and time dependent correlate between the increase in papain concentration and the
`decrease in 1lNC concentration from the untreated control groups (p<0.0l). The average 72-hour IINC
`concentration decrease at pH 6.2 with a papain concentration of lo mglml. was 50%. GC/MS of l INC
`revealed a 67% decrease in concentration with a 24-hour incubation at room temperature (22 °C) and a
`papain concentration of 10 mg!ml.. Papain did not significantly decrease the concentration of the other
`drugs analyzed with the exception of nordiazepam. None of the specimens were rendered invalid by the
`parameters of specimen validity testing with the addition of a maximum concentration of 10 mgJml..
`papain. Twice recrysatllized papain (lmgJmL) that was deactivated by E-64 yielded a 33% decrease in the
`reported value of 1 INC by FPlA analysis. The mechanism of interference with FPIA analysis is analyte
`specific for l1NC and nordiazeparn and does not require active enzyme, which does not allow detection of
`papain by a rapid enzyme activity assay.
`lmmediate I-‘PIA analysis andfor refrigeration is suggested to
`minimize the interfering effects of papain with regards to IINC analysis.
`
`Key words: 1i-nor-delta—9-carboxy-tetrahydrocannabinol, immunoassay, protease
`
`Page 258
`
`

`
`
`
`F4
`
`IODINE CONTAINING ADULTERANT — rrs rzrracr on RAPID DRUG scaaarv AND"
`DETECTION av INTECT” s
`
`Beckie Chien*, Jan Sook, Raphael C. Wong, Branan Medical Corporation, Irvine, CA, USA
`
`Ar'ms:New generation of commercial adulterants have included iodine as the main ingredient at sample
`concentration of about 1 mg per ml. The objective of this study was to evaluate iodine‘s effect on a certain
`rapid drug screen and its detection by an onsite adulterant dipstick, lntect‘8.
`
`Method: The adulteration effect of iodine was studied by adding iodine to a urine sample containing three
`times the SAMHSA cut-off concentrations of five drugs including benzoyl ecgonine (COC), morphine
`(OPI), amphetamine (AMP), THC and PCP. The final concentration of iodine in the sample was I rnglrnl.
`The adulterated sample was then tested by an onsite rapid drug screen Monitect® PCII over one hour
`period. The same sample was also tested with the new Intect S onsite adulteration test strip mat contains 8
`test pads including creatinine (CR), nitrite (NI), glutaraldehye (GL), pyl, specific gravity (SG), bleach (BL),
`pyridinium chlorochromate (FCC) and iodine (I) to evaluate the adu|terant‘s detection ‘over time.
`
`Results.‘ Negative (-) result in the drug screen indicates adulterant was able to modify the positive drug test
`result to negative result whereas (+l-) indicates a possible adulteration effect for that specific drug; normal
`(N) result in the {meet 8 pad suggests no effect of iodine on the specific test pad while_ abnormal (A)
`indicates detection of the adulterant by the specific pad.
`
`-ii:
`Invalid results due to no control line
`—j_
`
`
`
`Urine spiked with PCC or BL did not cause an abnormal result with the lodine pad.
`
`Conci'u.r:'on: iodine containing adultcrant is shown to mask the presence of THC. It also has some effect on
`opiate. This adulterant is detectable by an onsitc adulteration test device lntect‘8 in a 30-minute window.
`
`Keywords: Adulteration, Intect, iodine
`
`'14
`
`
`
`
`
`Page 257
`
`

`
`SOFT 1999
`
`Society of Forensic Toxicologists
`
`Program and Abstracts
`
`

`
`
`
`
`
`48
`
`Development of a Nitrite-Detect“ Test for the Automated Chemistry Analyzers to Test
`'
`Urine Samples Adulterated with Nitrite Based Adulterants.
`
`Waiting Lua, Amaolya Peapall , and I_akshmiAnnc“‘. Diagrwstic Reagents, Inc, Sumgyvrzle, CA.
`
`
`Implementation
`Specimen tampering is a growing problem for the drug testing laboratories.
`of pre-employment drug testing by many industries contributed to an increase in adulteration
`of samples to escape drug detection. Adulteration of samples can be simple dilution,
`substitution or addition of a chemical agent. Currently, the most prevalent chemical agent
`added to urine is the product called K]ear®. The adulterant Klear can be purchased via
`Internet and is supplied as a package of two vials, each containing 500 mg white powder. The
`white powder in Kiear has previously been identified as Potassium Nitrite. l/Vhizzies is another
`nitrite-based adulterant that contains Sodium Nitrite. Users of Klear are instructed to add the
`contents of one vial to 54 ounces of urine. The addition of nitrite does not cause a change in
`color, pH or specific gravity of the urine but it interferes with the detection of most drugs with
`THC being the most affected. The samples that are detected as positives by immunoassay fail
`to be confirmed by GC/MS because of the destruction of the internal standard by the nitrite in
`
`We have developed a method for the automated chemistry analyzers to test for nitrite levels
`in urine samples adulterated with nitrite based adulterants. The method is based on the Griess
`reaction in which the nitrite in the sample forms a diazonium compound that produces pink
`color by cornplexing with the indicator dye N-(1-napthy1)ethylenediamine. The absorbance at
`540nm is directly proportional to the nitrite concentration in urine. The method employs one
`reagent system and consists of a ready-to-use liquid reagent and calibrators. Both the within-
`run and between-run precision (%CV) for low and high controls is < 5%. No significant
`interference was observed with the endogenous substances. The method is linear over the
`concentration range 16-1000ug/mL with a correlation coefficient of 0.999. The limit of
`detection of the test is 6 ug/mlz. The accuracy of the method was determined by testing the
`recovery of spiked samples and correlation of 110 samples with a commercially available
`method. Recovery of the spiked samples at 150-2500ug/mi. ranged from 94-107% and a
`sample correlation of 0.999 was obtained.
`is applicable to several automated chemistry
`In conclusion,
`the Nitrite-Detectl” Test
`analyzers. It is a convenient, reliable, precise and economical method to detect nitrite in urine
`samples adulterated with Klear.
`
`
`
`Key Words: l<]ear®, Nitrite, N-(1-napthyl)ethylenediarnine.
`
`H
`
`

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