Drug Screening Test CupPackage Insert for testing of any combination of the following drugs:

AMP/BAR/BZO/BUP/COC/THC/MTD/MET/MDMA/OPI300/OPI/OXY/PCP/PPX/TCAAvailable with Specimen Validity Tests (S.V.T.) for:

Oxidants/PCC, Specific Gravity, pH, Nitrite, Glutaraldehyde and CreatinineOne step, rapid screening tests for the qualitative detection ofdrug(s) and drug metabolite (s) inhuman urine.For forensic use only.For in vitro diagnostic use only.INTENDED USEDrug Screening Test Cup is a lateral flow chromatographic immimoassay designed toqualitatively detect the presence of drugs and drug metabolites in human urine at thefollowing cut-off concentrations:

Amphetamine/AMP 1000 D-Amphetamine

Propoxvphene/PPX Propoxyphene 300 ng/mL

Drug Screening Test Cup provides only a preliminary analytical test result. The test isnot intended to be used in monitoring the drug levels. A more specific alternate methodmust be used in order to confirm the test result. Gas Chromatography/Mass Spectrometry(GC/MS) is the preferred confirmatory method. Clinical consideration and professionaljudgment should be applied to any drug of abuse test results, particularly whenpreliminary positive results are obtained.SUMMARY AND EXPLANATION OF THE TESTDrug Screening Test Cup is an easy, fast, qualitative, visually read competitive bindingimmunoassay method for screening specific drugs and their metabolites without the needof instrumentation. The method employs a unique mixture of antibodies to selectivelydetect the elevated levels of specific drugs and their metabolites in urine. Drug ScreeningTest Cup optionally includes an adulteration strip for testing pH, Specific Gravity andOxidants/ PCC.AMPHETAMINE / AMP 1000Amphetamines are central nervous system stimulants that produce alertness, wakefulness,increased energy, reduced hunger, and overall feeling of well-being. They are chemicallyrelated to the human body's natural catecholamines: epinephrine and norepinephrine.Large doses and extended usage can result in higher tolerance levels and physiologicaldependency leading to substance abuse. The effect of Amphetamines generally last 2-4hours following use, and the drug has a half-life of 4-24 hours in the body. About 30% ofAmphetamines are excreted in the urine in unchanged form, with the remainder ashydroxylated and deaminated derivatives. Drug Screening Test Cup yield a positiveresult when Amphetamines in urine exceed 1000 ng/mL, which is the suggested screeningcut-off for positive specimens by the Substance Abuse and Mental Health ServicesAdministration (SAMHSA, USA).AMPHETAMINE / AMP 300Drug Screening Test Cup yields a positive result when Amphetamines in urine exceed300 ng/mL. See AMPHETAMINE / AMP 1000 for summary.BARBITURATES / BARBarbiturates are central nervous system depressants. They are usually administered orallybut are sometimes injected intramuscularly and intravenously. Barbiturates range fromshort-acting (approximately 15 minutes, such as secobarbital) to long-acting (24 hours orlonger, such as Phenobarbital). Short-acting barbiturates are extensively metabolized inthe body, while the long-acting ones are secreted primarily unchanged. Barbituratesproduce alertness, wakefulness, increased energy, reduced hunger, and an overall feelingof well being. Large doses of Barbiturate could develop tolerance and physiologicaldependency and lead to its abuse. Drug Screening Test Cup yields a positive result whensecobarbital in urine exceeds 300ng/mL.

BENZODIAZEPINES / BZOBenzodiazepines are a class of drugs that are often therapeutically used as anxiolytics,anti-convulsants and sedative hypnotics. Benzodiazepines manifest their presence byanalgesia, drowsiness, confusion, diminished reflexes, lowering of body temperature,respiratory depression, blockade of adrenocortical response, and a decrease in peripheralresistance without an impact on the cardiac index. The major pathways of elimination arethe kidneys (urine) and the liver where it is conjugated to glucuronic acid. Large doses ofBenzodiazepines could develop tolerances and physiological dependency and lead to itsabuse. Only trace amounts (less than 1%) of Benzodiazepines are excreted unaltered in theurine, most of Benzodiazepines in urine is conjugated drug. Oxazepam, a commonmetabolite of many benzodiazepines, remains detectable in urine for up to one week,which makes Oxazepam a useful marker of Benzodiazepines abuse. Drug Screening TestCup yields a positive result when oxazepam in urine exceeds 300ng/mL.BUPRENORPHINE / BUPBuprenorphine is a potent analgesic often used in the treatment of opioid addiction. Thedrug is sold under the trade names Subutex™, Buprenex™, Temgesic™ and Suboxone™,which contain Buprenorphine HC1 alone or in combination with Naloxone HC1.Therapeutically, Buprenorphine is used as a substitution treatment for opioid addicts.Substitution treatment is a form of medical care offered to opiate addicts (primarily heroinaddicts) based on a similar or identical substance to the drug normally used. In substitutiontherapy, Buprenorphine is as effective as Methadone but demonstrates a lower level ofphysical dependence. Concentrations of free Buprenorphine and Norbuprenorphine inurine may be less than 1 ng/ml after therapeutic administration, but can range up to20ng/ml in abuse situations. The plasma half life of Buprenorphine is 2-4 hours. Whilecomplete elimination of a single dose of the drug can take as long as 6 days, the windowof detection for the parent drug in urine is thought to be approximately 3 days. DrugScreening Test Cup yields a positive result when Buprenorphine in urine exceedsI Ong/mL.COCAINE / COC 300Cocaine is an alkaloid present in Coca leaves (Erythyroxine coca). Its pharmacologicalproperties, such as stimulating and euphoric effects, have been known for centuries.Cocaine produces alertness, wakefulness, increased energy, reduced hunger, and anoverall feeling of well being. In large dose, Cocaine causes fever, unresponsiveness,difficulty in breathing and unconsciousness. Cocaine is often self-administered by nasalinhalation, intravenous injection and free-base smoking. Cocaine is excreted in the urineprimarily as Benzoylecgonine, which can generally be detected for 24 - 48 hours aftercocaine exposure. Drug Screening Test Cup yields a positive result when the Cocainemetabolite in urine exceeds 300ng/mL, which is the suggested screening cut-off forpositive specimens set by the Substance Abuse and Mental Health Service Administration(SAMHSA, USA).COCAINE/COC 150Drug Screening Test Cup yields a positive result when the Cocaine metabolite in urineexceeds 150ng/mL. See COCAFNE / COC 300 for summary.MARIJUANA / THCTHC (A9 - tetrahydrocannabinol) is the primary active ingredient in cannabis (marijuana).THC is central nervous stimulant that alters mood and sensory perceptions, produces lossof coordination, impairs short-term memory, produces symptoms of anxiety, paranoia,depression, confusion, hallucination, and increases heart rate. Large doses of marijuanacould develop tolerances and physiological dependency and lead its abuse. The mainmetabolite excreted in the urine is 11-nor- A — tetrahydrocannabinol-9-carboxylic acid(A9-THC-COOH), which is found in the urine within hours of exposure and remainsdetectable for 3-10 days after smoking. Drue Screening Test Cup yields a positive resultwhen the concentration of THC-COOH in urine exceeds 50ng/mL, which is the suggestedscreening cut-off for positive specimens set by the Substance Abuse and Mental HealthService Administration (SAMHSA,USA).METHADONE / MTDMethadone is a narcotic analgesic prescribed for the management of moderate to severepain and for the treatment of opiate dependence (Heroin, Vicodin, Percocet, Morphine). Itis administered either orally, or by intravenous or intra-muscular injection. The duration ofeffect of methadone is 12 - 24 hours. Its major urinary excretion products are methadone,EDDP (2-ethylidene-l,5-dimethyl-3,3-diphenylprryolidine), and EMDP (2- ethyl-5-methy-3, 3-diphenylpyrrolidine). Drug Screening Test Cup yields a positive result when theconcentration of Methadone in urine exceeds 300ng/mL.METHAMPHETAMINES / MET 1000Methamphetamine is an addictive stimulant drug that strongly activates certain systems inthe brain. Methamphetamine is closely related chemically to amphetamine, but the centralnervous system effects of methamphetamine are greater. Methamphetamine can be takenorally, injected, or inhale. Acute higher doses lead to enhanced stimulation of the centralnervous system and induce euphoria, alertness, reduced appetite, and a sense of increasedenergy and power. Methamphetamine is excreted in the urine as amphetamine andoxidized and deaminated derivatives. However, 10 to 20 % of Methamphetamine is

excreted unchanged. Thus, the presence of the parent compound in the urine indicatesMethamphetamine use. Drug Screening Test Cup yields a positive remit when theconcentration of Methamphetamine in urine exceeds lOOOng/mL.METHAMPHETAMINES / MET 500Drug Screening Test Cup yields a positive result when the corcentration ofMethamphetamine in urine exceeds 500ng/mL. See METHAMPHETAMINE / MET 1000for summary.METHYLENEDIOXYMETHAMPHETAMINE / MDMAMDMA belongs to a family of man-made drugs. Its relatives irelude MDA(methylenedioxyamphetamine), and MDEA (methylenedioxyethylamphetanine). They allshare the amphetamine-like effects. MDMA is a stimulant with hallucinogeiic tendenciesdescribed as an empathogen as it releases mood-altering chemicals, such as cartooning andL-dopa, and may generate feelings of love and friendliness. The adverse effects of MDMAuse include elevated blood pressure, hyperthermia, anxiety, paranoia aid insomnia.MDMA is administered either by oral ingestion or intravenous injection, "he effects ofMDMA begin 30 minutes after intake, peak in an hour and last for 2 - 3 hours. DrugScreening TeslCup yields a positive result when the concentration of MDMA in urineexceeds 500ng/mL.OPIATES 300 / OPI 300Opiates refer to any drug that is derived from the opium poppy, includirg the naturalproducts, morphine and codeine, and the semi-synthetic drugs such as heroin. Opiatesexert their effects on the central nervous system and organs containing smooth muscle.Opiates manifest their presence by analgesia, drowsiness, euphoria, lowering of bodytemperature, respiratory depression, blockade of adrenocortical response. The majorpathways of elimination are kidneys (urine) and the liver where it is conjugated toglucuronic acid. Opiates and their metabolites can be detected in urine as result of heroin,morphine, codeine or poppy seed intake. Drug Screening Test Cup yields a positiveresult when the concentration of Opiates in urine exceeds 300ng/mL.OPIATES 2000 / OPIDrug Screening Test Cup yields a positive result when the concentration af Opiates inurine exceeds 2000ng/mL, which is the suggested screening cut-off for positive specimensset by the Substance Abuse and Mental Health Service Administration (SAVHSA, USA).See OPIATES 300 / OPI300 for summary.OXYCODONE/OXYOxycodone is an analgesic, which works by depressing the central ner/ous system.Oxycodone is abused for its opiate-like effects. In addition to its equal potency tomorphine in analgesic effects, it is also equipotent to morphine in relievirg abstinencesymptoms from chronic opiate (heroin, morphine) use. For this reason, it is aften used toalleviate or prevent the onset of opiate withdrawal by street users of heroin ard methadone.The drug is most often administered orally. Like other opiates, Oxycodone can alsodepress the respiratory system resulting in suffocation and death whei overdosed.Oxycodone is very addictive, both physically and psychologically. Sane physicalindications of Oxycodone abuse include extreme loss of appetite and weght, cramps,nausea, vomiting, excessive scratching and complaint of itching, excessive sweating,constipation, pin-point pupils and watery eyes, reduced vision, drowsiness, euphoria,trance-like states, excessive thirst, tremors, twitching, irritability, hallucinations andlethargy. Drug Screening Test Cup yields a positive result when the concentration ofOxycodone in urine exceeds lOOng/mL.PHENCYCLIDINE / PCPPhencyclidine, commonly known as PCP or "angel dust" is used primarily as recreationaldrug due to its hallucinogenic effects. It is generally self-administered b> intravenousinjection or by inhalation and concentrates fastest in fatty tissues and the brail. The effectsof PCP are very much dose related. Small amounts of Phencyclidines (PCI) are centralnervous system stimulants that produce alertness, wakefulness, increased energy,increased heat rate, and decreased sense of pain and touch, and an overall fesling of wellbeing. Large doses of Phencyclidine (PCP) can result in death due to convulsions, heartand lung failure and coma. Large repeated doses of Phencyclidine (PCP) could developtolerances and physiological dependency and lead to its abuse. PCP can be found in urinewithin 4 to 6 hours after use and will remain in urine for 7 to 14 days. Phencyclidine isexcreted in the urine as an unchanged drug (4% to 19%) and conjugated met&olites (25%to 30%). Drug Screening Test Cup yields a positive result when the con;entration ofPhencyclidine in urine exceeds 25ng/mL, which is the suggested screening cut-off forpositive specimens set by the Substance Abuse and Mental Health Service Administration(SAMHSA, USA).PROPOXYPHENE / PPXPropoxyphene is a prescription drug for the relief of pain. Overdose of propoxyphene canhave the symptoms including analgesia, stupor, respiratory depression and coma. Thehalf-life of propoxyphene is 8 to 24 hours. Propoxyphene reaches its peak in 1 to 2 hoursafter oral administration. Drug Screenine Test Cup yields a positive result when theconcentration of propoxyphene level in urine exceeds 300ng/mL.TRICYCLIC ANTIDEPRESSANTS /TCATricyclic Antidepressants are a group of antidepressant drugs that are commonly used for

treatment of depressive disorders. TCAs can be taken orally or by intramuscularlyinjection (IM). The symptoms of TCAs overdoses include agitation, confusion,hallucinations, hypertonicity, seizures, and EKG changes. The half-life of TCA variesfrom a few hours to several days. The commonly used TCAs are excreted with a very lowpercentage of unchanged drugs in the urine. Therefore, detection of the metabolites ofTCAs in human urine has been used for screening the abuse of TCAs. Drug ScreeningTest Cup yields a positive result when the concentration of Nortriptyline in urine exceedsl,OOOng/mL.S.V.T. SUMMARYThe strips contain chemically treated reagent pads. Three to five minutes following theactivation of the reagent pads by the urine sample, the colors that appear on the pads canbe compared with the printed color chart card. The color comparison provides asemi-quantitative screen for any combination of oxidants/pyridinium chlorochromate(PCC), specific gravity, pH, nitrite, glutaraldehyde and creatinine in human urine whichcan help to assess the integrity of the urine sample.WHAT IS ADULTERATION?Adulteration is the tampering of a urine specimen with the intention of altering the testresults. The use of adulterants can cause false negative results in drug tests by eitherinterfering with the screening test and/or destroying the drugs present in the urine.Dilution may also be employed in an attempt to produce false negative drug test results.One of the best ways to test for adulteration or dilution is to determine certain urinarycharacteristics such as pH, specific gravity and creatinine and to detect the presence ofoxidants/PCC, nitrites or glutaraldehyde in urine.. Oxidants/PCC (Pyridinium chlorochromate) tests for the presence of oxidizingagents such as bleach and hydrogen peroxide. Pyridinium chlorochromate (sold under thebrand name UrineLuck) is a commonly used adulterant.6 Normal human urine should notcontain oxidants of PCC.• Specific gravity tests for sample dilution. The normal range is from 1.003 to 1.030.Values outside this range may be the result of specimen dilution or adulteration.• pH tests for the presence of acidic or alkaline adulterants in urine. Normal pH levelishould be in the range of 4.0 to 9.0. Values outside of this range may indicate the samplhas been altered.• Nitrite tests for commonly used commercial adulterants such as Klear and Whizzies.They work by oxidizing the major cannabinoid metabolite THC-COOH.9 Normal urineshould contain no trace of nitrite. Positive results generally indicate the presence of aiiadulterant.. Glutaraldehyde tests for the presence of an aldehyde. Adulterants such as UrinAidand Clear Choice contain glutaraldehyde which may cause false negative results bydisrupting the enzyme used in some immunoassay tests.7 Glutaraldehyde is not normallyfound in urine; therefore, detection of glutaraldehyde in a urine specimen is generally anindicator of adulteration.. Creatinine is a waste product of creatine; an amino-acid contained in muscle tissueand found in urine. A person may attempt to foil a test by drinking excessive amounts ofwater or diuretics such as herbal teas to "flush" the system. Creatinine and specific gravityare two ways to check for dilution and flushing, which are the most common mechanismsused in an attempt to circumvent drug testing. Low Creatinine and specific gravity levelsmay indicate dilute urine. The absence of Creatinine (<5 mg/dl) is indicative of aspecimen not consistent with human urine.PRINCIPLE OF TESTDrug Screening Test Cup is a competitive binding immunoassay in which drugs anddrug metabolites in a urine sample compete with immobilized drug conjugate for limitedlabeled antibody binding sites. When a sufficient amount of urine specimen is applied tothe sample pad of the test device, the urine specimen migrates through the test device bycapillary action. If the drug or drug metabolite concentration in the specimen is below thecut-off level, the anti-drug antibodies in colloidal gold particles will bind to the drugantigens coated in the test line of the nitrocellulose membrane to form a T line, whichindicates a negative result. If the concentration of drug in the urine specimen is above thecut-off level, it will bind with antibodies conjugated with colloidal gold particles, so thatno T line will be developed in the test region, which indicates a positive result.REAGENTSDrug Screening Test Cup contains membrane strips coated with drug-protein conjugates(purified bovine albumin) on the T zone, goat polyclonal antibody against gold-proteinconjugate at the C zone, and a dye pad which contains colloidal gold particles coated withmouse monoclonal antibodies specific against to Amphetamine, Barbiturates,Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine,Methyfenedioxymethamphetamine, Morphine, Oxycodone, Phencyclidine, Propoxypheneand Tricyclic Antidepressants.

S.V.T. REAGENTSAdulteration PadCreatinineNitriteGlutaraldehydepHSpecific GravityOxidants / PCC

Reactive indicator0.04%0.07%0.02%0.06%0.25%0.36%

Buffers and non-reactive ingredients99.96%99.93%99.98%99.94%99.75%99.64%

MATERIALS PROVIDED• Drug Test Cup • Product insert • Security Seal• Procedure Card • .Adulteration color card (Optional)

MATERIALS REQUIRED BUT NOT PROVIDED• Clock or timer * External positive and negative controls

PRECAUTIONS1. For forensic use only.2. For in vitro diagnostic use only.3. Do not use after the expiration date.4. The test cup should remain in the sealed pouch until use.5. All specimens should be considered potentially hazardous and handle in the same wayas an infectious material.6. All used cup should be discarded according to federal, state and local regulation.STORAGE AND STABILITYStore Drug Screening Test Cup in the sealed pouch at 2°Cto 30°C. The cup is stablethrough the expiration date printed on the sealed pouch. The cup must remain in the sealedpouch until use. If store at 2°C to 8°C, allow the cup to reach room temperature (15°C to30°C) before performing the test. Dot not freeze, do not use beyond the expiration date.SPECIMEN COLLECTION AND STORAGEFresh urine specimens should be collected directly into a clean and dry container. Urinecollected at any time of the day may be used for testing. Urine specimen exhibiting visibleprecipitates should be centrifuged, filtered or allowed the precipitates to settle to obtain aclear specimen for testing.For best results, test a fresh specimen immediately following collection. Storage ofspecimens should not exceed 2 hours at room temperature or 4 hours refrigerated (2-8°C)prior to using.TEST PROCEDUREAllow the cup, urine specimen, and/or controls to reach room temperature (15-30°C)before testing.1. Remove the cup from the sealed pouch and use il as soon as possible.2. Collect specimen in the cup and secure the cap tightly.3. Read urine temperature between 2-4 minutes after voiding to verify the temperatureranges between 90-1 DOT.4. Place the cup on a flat surface.5. Date and initial the security seal, and place the security seal on the cap.6. Peel off the label on the cup to view the results.7. If adulteration test is included on the test cup, read the adulteration test results between2 to 5 minutes. See the color chart for interpretation. If the specimen indicates adulteration,we recommend not to interpret the drug test results and either retest the urine or collectanother specimen.8. Read the test results at 5 minutes. See the illustration below. For detailed operationinstructions, please refer to the Procedure Card.

Peel OffLabel ~

Authorized PersonnelOnly Peel Off Thislabel View Results

NKSMIW (-1 POSITIVE (+)

Urine CupRead results at 5 minutes

NEGATIVE POSITIVE INVALID

f\ .-''Security ~~~™ \ X] Security Seal[,''\ Seal Inltlala Date X\T"Ubel

NEGATIVE (-) POSITIVE (+}

-DrugTestName(s) -

- C Line in "C" Region -- T Line in T1 Region •

NEGATIVE (-) POSITIVE {+)

INTERPRETATION OF RESULTSPositive: One colored line appears in the Control zone (C). No line appears in theTest Zone (T). The absence of a line in the test region (T line) indicates a positive result.The positive result indicates that the drug level is above the detectable level.Note: The samples with positive results should be confirmed with more specific method.Negative: One colored line appears in the Control zone, and another colored lineappears in the Test zone. The negative result indicates the drug or its metabolite level isbelow the detectable level.Invalid: No line appears in the Control zone. If no C line or no C line and T linedevelop within 5 to 10 minutes, the test is invalid. The test should be repeated with a newtest device. Insufficient specimen volume or the incorrect procedural techniques are themost likely reasons for invalid result. Review the procedure and repeat the test using anew test strip or device. If the problem persists, discontinue using the current lot andcontact your suppliers.ADULTERATION INTERPRETATION(Please refer to the color chart, if applicable)Semi-quantitative results are obtained by visually comparing the reacted color blocks onthe strip to the printed color blocks on the color chart. No instrumentation is required.QUALITY CONTROL1. Built-in Control: the test contains a built-in control feature, the C line. The presence ofthe C line indicates that the test is performed properly. If a C line does not form, the test isconsidered invalid. In this case, the testing should be repeated with a new device.2. External Quality Control: Control materials are not supplied with this kit. However, it isrecommended that positive and negative controls should be tested as good laboratorypractice to confirm the test procedure and to verify proper test performance.3. Test each new lot and shipment by using external quality control materials (positive andnegative), with each new untrained operator, monthly for storage, and as otherwiserequired by your lab internal quality system procedures.S.V.T. ADULTERATIONS LIMITATIONS1. The adulteration tests included with the product are meant to aid in the determination ofabnormal specimens. While comprehensive, these tests are not mean: to be an''all-inclusive" representation of possible adulterants.2. Oxidants/PCC: Normal human urine should not contain oxidants or PCC. The presenceof high levels of antioxidants in the specimen, such as ascorbic acid, may result in falsenegative results for the oxidants/PCC pad.3. Specific Gravity: Elevated levels of protein in urine may cause abnormally high specificgravity values.4. Nitrite: Nitrite is not a normal component of human urine. However, nitrite found inurine may indicate urinary tract infections or bacterial infections. Nitrite levels of > 20mg/dL may produce false positive glutaraldehyde results.5. Glutaraldehyde: is not normally found in urine. However certain metabolicabnormalities such as ketoacidosis (fasting, uncontrolled diabetes or high protein diets)may interfere with the test results.6. Creatinine: Normal Creatinine levels are between 20 and 350 mg/dL. Under rareconditions, certain kidney diseases may show dilute urine.LIMITATIONS1. Drug Screening Test Cup provides only a qualitative, preliminary testing result. Amore specific testing method must be used in order to obtain a confirmed testing result.Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.2. There is a possibility that technical or procedural errors, as well as other interferingsubstances in the urine specimen may cause erroneous results.3. Adulterants such as bleach or other oxidizing agents may produce erroneous results. Ifsuspected, the test should be repeated with a fresh specimen and a new device.4. The urine specimens with bacterial contamination should not be used for testing, as

these contaminations may interfere with the test and cause false results.5. A positive result does not indicate the level of intoxication, the route of the drugadministration or the concentration of the drug in the urine.6. A negative result may not necessarily indicate drug-free urine. Negative results can beobtained when drug is present but below the cut-off level of test.7. Test does not distinguish between drugs of abuse and certain medications.8. Certain foods or food supplements may cause a false positive result.PERFORMANCE CHARACTERISTICS

The comparison studies were conducted using Drug Screening Test Cup andcommercially available rapid drugs of abuse tests. The studies were performed onapproximately 128 clinical specimens per drug type previous collected from the clinicalsettings. Presumptive positive results were confirmed by GC/MS. The following resultsare summarized from these comparison studies:

% Agreement with Commercial Kit

PositiveAgreementNegativeAgreementTotalAgreement

AMP 1 000

100%

98%

99%

PositiveAgreement

AgreementTotalAgreement

MET 1000

100%

98%

99%

AMP300

100%

100%

100%

BAR

98%

98%

98%

II /O

97%

97%

97%

i IP

100%

100%

100%

cue '.mi

100%

100%

100%

COC 150

97.5%

97.5%

97.5%

THC

1 00%

98%

99%

Mi'.'raio

100%

100%

100%

MDMA

97%

97%

97%

OP1300

!00%

100%

100%

OP]

100%

100%

100%

OXY

98%

98%

98%

PCP

100%

98%

99%

PPX

98%

98%

98%

MTD

98%

97%

97.5%

TCA

100%

98%

99%

% Agreement with GC/MS

PositiveAgreementNegativeAgreementTotal

AMP 1000

100%

98%

99%

AMP300

95%

100%

97.5%

BAR

98%

98%

98%

BZO

97%

97%

97%

BLIP"

95%

100%

97.5%

COC300

100%

100%

100%

PositiveAgreementNegative

Tola]Agreement

MET 1000

100%

98%

99%

MiiTSOO

100%

97.5%

99%

MDMA

97%

97V,

97%

OPDOO

100%

100%

100%

OP

100%

100%

100%

OXY

98%

98%

98%

COC 150

100%

97.5%

99%

THC

100%

98%

99%

PCP

100%

98%

99%

PPX

98%

98%

98%

MTD

98%

97%

97.5%

TCA*

100%

98%

99%

TCA*; TCA was based on HPLC data. BUP**: BUP was based on LC/MS data.

Sensitivity:Sensitivity of Drug Screening Test Cup was characterized by validating the testperformance around the claimed cut-off concentration of each test. The cut-off of each testwas determined by the lowest concentration of drug which produces at least 50% positivetesting results in total numbers of determinations. The results were summarized as thefollowing:

Cut-off Range

0% Cut-off-50% Cut-off-25% Cut-off+25% Cut-off+50% Cut-off

Drug concentrationCut -off Range

0% Cut-off-50% Cut-off-25% Cut-off+25% Cut-off+50% Cut-off

Drug concentrationCut-off Range

0% Cut-off-50% Cut-off-25% Cut-off+25% Cut-off+50% Cut-off

n

2020202020

n

2(120

202020

n

20202020

20

AMP 1000

2020201

0

-

000192(}

BUP

2020

2000

+

000

2020

AMP 300

20201300

+

007

2020

BAR

20202000

+

0002020

RZQ

20202000

COC 300

20

20207

0

+

0001320

MTD

202020

1

0

+

000

1920

MET 1000

20202000

+

000

2020

Drug concentrationCut-off Range

0% Cut-off-50% Cut-off-25% Cut-off+25% Cut-off+50% Cut-off

"

2020202020

OPI 300

2020

2000

000

20

20

OPI-

20201300

+

007

2020

COC 150

20

202000

+

000

2020

+{)

0

02020

THC

20202020

+

0

001820

M1-T500

20202000

+

{)(]0

2020

OXY

20202030

+

0(101720

MDMA

202020(1

0

+

0002020

PCP

20

202050

0001520

-25% Cut-off 2+25% Cut-off 2+50% Cut-off 2

0 200 40 0

01620

2040

Based on above data, sensitivity of the assay to the 1 8 analytesAmphetamine 1000: 1000 ng/mLAmphetamine 300:Barbiturates:B enzodiazepines :Buprenorphine:Cocaine 300:Cocaine 150:Marijuana:Methadone:

300 ng/mL300 ng/mL300 ng/mL10 ng/mL300 ng/ mL150 ng/mL50 ng/mL300 ng/mL

01620

is as follows:Methamphetamine 1000: 1000 ng/mLMethamphetamine 500: 500 ng/mLMDMA:Opiates 300:Opiates 2000:Oxycodone:Phencyclidine:Propoxyphene:

500 ng/mL300 ng/mL2000 ng/mL100 ng/mL25 ng/mL300 ng/mL

Tricyclic Antidepressants: 1 000 ng/mLPrecision / Reproducibility:Reproducibility was determined by replicating tests on uve

+ „«•different concentrations

each drug in urine specimens: negative, 50% below cut-off, 25% below cut-off, 25%above cut-off and 50% above cut- off. Each drug test was tested four times daily for fiveconsecutive days with a total 20 assays at each concentration. The data are summarizedbelow:Amphetamine 1000 Precision /Reproducibility Study;Amphetamine I I M 1 0Concentration (ng/mL)

(I50075012501500

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/0

1 / 1 90/20

Precision (%)

100%100%100%95_%100%

Amphetamine 300 Precision /Repntducibility Study:

Barbiturates Precision/Reprodncihilityjjliidy:

s Prccision/Rcproducibility Study:

Buprenorphine Precision/Reproducibility Study:

Cocaine 300 Precision/Rep roducibility Study:

Amphetamine 30(1Concentration (ng/mL)

0150225375450

Total numbers ofDeterminations

202(1202020

Results#!Neg/#Pos

20/020/018/20/200/20

Precision (%)

100%100%90%100%100%

BarbituratesConcentration (ng/mL)

(I150225375450

Total numbers ofDeterminations

2020202020

Results#Ncg/#Pos

20/020/020/00/200/20

Precision (%)

100%100%1 00'",,

100%100%

Ben/odia/epincsConcentralion (ng/mL)

01 5 0225375450

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/00/200/20

Precision (%)

1 00%1 00%100%1 00%100%

BuprenorphineConcentration (ng/mL)

05

7.512.5

15

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/02 U I )1 / 1 90/20

Precision (%)

100%100%100%95%100%

Cocaine 300Concentration (ng/mL)

015022537545_0

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/07/130/20

Precision (%)

100%100%1 00%65%

1 00%

Cocaine 150 Precision /Reproducibility StudyCocaine 150Concentration (ng/mL)

0150225375450

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/1120/0IS/20/200/20

Precision (%)

100%100%90%100%100%

Marijuana Precision/Rcproducibility Study:

MeiMamphetamines 500 Precision /Rcproilucibility Study:

MDMA Precis!on/Reproducibility Study:

Opiates 2000 Precision/Rep rod ucibility Study:

Phencyclidinc Precis! on/Rep roducibility Study:

MarijuanaConcentration (ny/mL)

025

37.562.575

Methadone Precision/ReMethadoneConcentration (ng/mL)

0150225375450

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/02/180/20

Precision (%)

100%100%100%90%100%

Deducibility Study:Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/01/190/20

Precision (%)

100%100%100%95%100%

Meth amphetamines lOOOPrecision/Reproducibility Study:Methamphetamines 1(10(1Concentration (ng/mL)

0500750

12501500

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/00/200/20

Precision (%)

100%100%100%100%100%

Methampnetamines 500Concentration (ng/mL)

0250375625750

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/00/200/20

Precision (%)

100%100%100%100%100%

MDMAConcentration (ng/mL)

0250375625750

Total numbers ofDeterminations

2020202020

Results#Nea/#Pos

20/020/020/00/200/20

Precision (%)

100%100%100%100%100%

Opiates 300 Precision/Reproducibility Study:Opiates 300Concentration (ng/mL)

0150225375450

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/00/200/20

Praision (%)

100%100%100%100%100%

Opiates 2000Concentration (ng/mL)

01000150025003000

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/013/70/200/20

Precision (%)

100%100%65%100%100%

Oxycodone Precision/Reprodiicibility Study:OxycndoneConcentration (ng/mL)

05075125150

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/03/170/20

Precision <%)

100%100%100%85%100%

PhencyclidineConcentration (ng/mL)

012.5

18.7531.2537.5

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/05 /150/20

Precision <%)

100%100%100%75%100%

Propoxvphene Precision /Reprodiicibility Study:PropoxypheneConcentration (ng/mL)

0150225375450

Determinations2020202020

Results#Me(>/#Pos

20/020/020/04/160/20

Precision (%)

100%100%100%80%100%

Tricyclic Antideprossanls Prccision/Reprodiicibilily Study:Tricyclic AntidepressantsConcentration (ng/mL)

050075012501500

Total numbers ofDeterminations

2020202020

Results#Neg/#Pos

20/020/020/04/160/20

Precision (%)

100%100%100%80%100%

The data presented here demonstrates excellent precision/ reproducibility of Dm;Screening Test Cup across multiple concentrations of human urine.

Analytical Specificity:Cross-reactivity was established by spiking various concentrations of similarly structured

drug compounds into drug-free urine /a negative control. Analyzing various concentration

of each compound by using Drug Screening Test Cup, the concentration of the drug that

produced a response approximately equivalent to the cut-off concentration of the assay

was determined. Results of those studies appear in the table(s) below:CompoundAMPHETAMINE 1000 (AMP)D-AmphetamineD,L AmphetamineL- Amphetamine(±)3,4-Methylcnedioxyamphetaminc(MDA)Ejihedrme3,4-Methylenedioxythylamphetamine(MDEA)AMPHETAMINE 300 (AMP)D-AmphetamineD,L-AmphetammeL- AmphetamineD-MethamphetamineL-Methamphctamine(±) 3,4-Methylethyenedioxyamphetamine fMDA)Ephedrine3,4-Melhylenedinxvetln amphetamine (MDEA)BARBITURATES (BAR)SecobarbitalPhcnobarbilalUu la lb i t a jPentobarbitalAmobarbitalCyclopentobarbitalHutothalBarbitalButabarbitalBKN/.OD1 A/EPINES (BZO)OxazepamAlprazolama-HydroxyalprazolamBromazepam•ClobazamCkina/epamClorazepateDelorazepamDiazepamEstazolamFlunitra/epamLora/epamMidazolamNitrazepamNordiazepjunTemazepamTriazolamBUPRENORPIIINE(BUP)BuprenorphineNorbuprenorphineBuprcnovphine-3-D-glucuronideNorbuprenorphi ne-3 -D-glucuronideMorphine-3-D-glucuronideMorphineOxymorphoneHydromorphoneCOCAINE 300 (COC)CocaineBenzoylecgontneEcgonine HCICOCAINE 150 (COC)CocaineBenzovlecogonineEcgonine HCI

Response equivalent to cutoff in n&/mL

10002500

500003000

> 100000Mixjoon

300850

17500100000

> 100000650

>moowi> 100000

3002500500

1 50025005008003001500

3002001000250

25001008502501600200200Wl100015001004(10150500

1015

12.5175

100000> 100000> 100000-hioono

> 1 00000300

35000

> 100000150

17000

Drug CompoundMARIJUANA (THC)ll-nor-A*-THC-9-COOHll-nor-A'-THC-9-COOHAs-TelrahydraeannabinolA^-TelrahydroeannabinolCannabinolCannabidiolMETHADONE (MTD)Methadone(±)2-Ethyl-l,5-dimethyl-3,3-dipheny]pyrroliniumDoxylamineM I : I H \ i \ i p in< : iAi \ i iM 'S nmo<Mi ' .n+/-M ethamp hetamine+ M cthamphetami ne3,4-Methy!enedioxyclhyUimphctamine(MnKA)(4V-)3,4-Methylenedioxyniethaniphetamine(MDMA)Ranitidine(Zantac)( . - lAl^wlei icdioxvui-nphelLimiiK-IMDA)D- Amphetamine[.-Amphetaminel.phedrineMETH AMPHETAMINES 500 (MET)(1) Mcthamphclamine(•) MclhamprnMiiminc(1) \4-Mcthvlenedioxyrnethamphelamine ( M D M A )Ranidinu3,4-MethvlenedioxymnphtUini ine(MI>A>D-AmphetamineL-Amp_hetamineEphcdrincMETHYLENEDIOXYMETHAMPHETAMINK (\IDMA)< + /-)3.4-MeUiylenedio\ymelhamphelamine(Mr)MA)l)-AmphctamineL-Mcthamphetamine3,4-MethylencdioxyclhylatnphetammL-(MDIIA)3,4-McthylencdioxyamphetaminefMDA)OPIATE 3(10 (OPI 300)MorphineCodeineHydrocodoneHydro morphoneMorphine 3-fl-D-glucuronide6-MonoacelylmoiphineNormorphoneOxy^odoneO\\iin-rphciii i . 'ThebaineOPIATE 2000 (OPI)MorphineCodeineHydrocodoncIlydromorphoneMorphine 3-fl-D-glueuromde; i - M u t i ( i , H . k . V . l M H > i r . | H n C

NormorphoneO\y_codoneOxymorphoneThebaineOXYCODONE (OXY):, ; \ , i . i u l o i ] eMorphineCodeineMorphine 3-p-D-glucuronideHydrocodoneHydromorphoneNormorphoneOxvmorphonePHENCVCUDINK(PCP)Pheneyelidinc4-1 IvdroxvpliencvelidinePKOPOXYPIIK!NE(PPX)PropoxypheneNorpropoxypheneMethadoneI R K Y< 1.IC A IN Tll)KPRESSA.VrS(TCA)

NotriptilineTrimipramine\mjlr ip_t ; I N K -

PromazineDesipramineImipramineClomipramineHoxcpjiiMaprot i lnic

Response equivalent to cutoff in ng/mL

5050

800(11 00001 0000

1 00000

3005000050000

20001000

350002000

1 OOOOl)> 100000

- 1 00000[00000

> 100000

] 0005001000

0> 100000> 100000> 100000

- 10(1000

500> 100000I 00000

2002000

300300

200035IK)300600

10000010000500007000

20002000

1 0000700020005000

1000002000010(100070000

1005000025000500001600

15000100000

1 500

2515000

3007500

> 100000

100045001000UIOO100010007500300050000

Interfering Compounds:The following compounds in both drug-free urine and drug positive urines with

Amphetamine, Cocaine, Barbiturate, Benzodiazepine, Buprenorphire, Marijuana,

Methadone, Mehtylenedioxymethamphetamine, Methamphetamine, Opiates, Oxycodone,

Phencyclidine, Propoxyphene, Tricyclic Antidepressants show no cross-reactivity when

tested with Drug Screening Test Cup at a concentration of 100ug/mL.

Common Substances:AcetaminophenAcetoneAlbuminA m p i u i l l mAscorbic AcidAsparlameAspirinAtropinetienzocaineBilirubinCaffeineChloroquine(-i-)-Chlorpheniraminc(+/-)-Chlorpheni ramineCreaiineDexbromphemrammeDexiromeihorphan

DiphenhydnimineDopamine{+<'-)- Fpi nephriticErythromycinEthanolFurosemideGlucoseGuaiacol Glyceryl EtherHemoglobinIbuprofen(+/-)-IsoproterenolKetamineLevorphanolLidocame( I )-NaproxcnNiaeinamiik-Nicotine

(+/-)-NorephediineOxalie AeidPenieillin-CiPhcniraminePhenothiazine1-Phenylephrintli-l ' l icnvlethylainincProcaineQuinidineRanitidineRiboflavinSodium ChlorideSulindacTheophyllineTyramine4-Dimethylamiiioantipyrine(|R,2S)-(-)-N-Methyl-Ephedrine

Biological Materials:Albumin

Bilirubin

CreatineHemoglobin

Glucose

Vitamin(L-Ascorbic Acid)

Uric Acid

Urine pH 4.5-9.0

Urine Specific Gravity 1.002-1.035g/mL

(There is a possibility that other substances and/or factors not listed above may interfere

with the test and cause false results.)

Bibliography:1. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, ̂ Ed, Biomedical Publ, Davis, CA.,1995.2. Department of Health and Human Service, Mandatory Guidelines for Federal Workplace Drug TestingProgram, Fed Register. 53(69): 11970-11979, 1988.3. Oilman, A. G, and Goodman, L.S., The pharmacological basis of therapeutics Ed. MacMillanPublishing, New York, NY, 1980.4. Urine Testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA): Research Monograph, 73,1986.5. Wilson, John, Abused Drugs II, a laboratory Pocket Guide. AACC Press. Washington, DC; 1994.6. Cody, J.T., "Specimen Adulteration in drug urinalysis. Forsenic Sci. Rev., 1990, 2:63.7. Tsai, S.C. et.al., J. Anal. Toxicol. 1998; 22 (6): 474.8. TietzNW. Textbook of Clinical Chemistry. W.B.Saunders Company. 1986;! 735.

Revised: March, 2010