T-Cup Urine Drug Screen Testing Cup

One Step Multi-Drug Urine T-Cup offers any combination from 2 to 16 drugs of abuse tests for 16 different drugs: Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO),Cocaine (COC), Marijuana (THC), Methadone (MTD), Methamphetamine (MET),Methylenedioxymethamphetamine (MDMA), Morphine (MOP), Opiate (OPI 2000), Phencyclidine(PCP), Tricyclic Antidepressants (TCA), ), Buprenorphine (BUP), Oxycodone (OXY), Ketamine(KET), Propoxyphene (PPX). This drug test kit cup also provides adulteration testing forOxidant/Bleach, Specific, Gravity, pH, Nitrite, Creatinine and Pyridinium Chlorochromate.

This package insert applies to all combinations of multi-drug tests panel with integrated cup.Therefore, some information on the performance characteristics of the product may not berelevant to your test. We refer to the labels on the packaging and the prints on the test strip toidentify which drugs are included in your test.”

A rapid one step test for the qualitative detection of drug of abuse and their principal metabolites inhuman urine at specified cut off level.For healthcare professional use only. For in vitro diagnostic use.

INTENDED USE

One Step Multi-Drug Urine T-Cup is rapid urine screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites inhuman urine at the following cut off concentrations:

rotarbilaCtseT Cut off(ng/ml)

000,1enimatehpmAenimatehpmA003latibraboceSsetarutibraB003mapezaxOsenipezaidozneB003eninogcelyozneBeniacoC

05anaujiraManaujiraM003enodahteMenodahteM

000,1enimatehpmahteMenimatehpmahteMMethylenedioxymethamphetamine 3,4-Methylenedioxymethamphetamine

HCl(MDMA)500

003enihproMenihproM0002enihproMetaipO

52enidilcycnehPenidilcycnehP000,1enilytpirtoNstnasserpeditnAcilcycirT

01enihpronerpuBenihpronerpuB001enodocyxOenodocyxO

000,1enimateKenimateK003enehpyxoporPenehpyxoporP

This assay provides only a preliminary test result. A more specific alternative chemical methodmust be used in order to obtain a confirmed analytical result. Gas chromatography/massspectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration andprofessional judgment should be applied to any drug of abuse test result, particularly whenpreliminary results are positive.

PRINCIPLE

One Step Multi-Drug Urine T-Cup is a competitive immunoassay that is used to screen for thepresence of drugs of abuse in urine. It is chromatographic absorbent device in which drugs or drugmetabolites in a sample competitively combined to a limited number of antibody-dye conjugatebinding sites.When the absorbent end of the test device is immersed into the urine sample, the urine isabsorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flowsacross the pre-coated membrane.When sample drug levels are at or above the target cutoff, the drug in the sample binds to theantibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-proteinpre-coated in the test region (T). This prevents the development of a distinct colored band in thetest region indicating a potentially positive result.When sample drug levels are zero or below the target cutoff (the detection sensitivity of the test),antibody-dye conjugate binds to the drug-protein pre-coated in the test region (T) of the device.This produces a colored test line that, regardless of its intensity, indicates a negative result.To serve as a procedure control, a colored line will appear on the control region (C), if the test hasbeen performed properly.

WARNINGS AND PRECAUTIONS

This kit is for external use only. Do not swallow.Discard after first use. The test cannot be used more than once.Do not use test kit beyond expiration date.Do not use the kit if the pouch is punctured or not well sealed.Keep out of the reach of children.

STORAGE AND STABILITY

Store at 4 ºC ~ 30 ºC up to the expiration date.Keep away from sunlight, moisture and heat.DO NOT FREEZE.

MATERIAL

Material providedOne pouch containing a test T-cup and a desiccant.Package insertColor comparator chart for the adulteration testing labeled on the foil pouch.

Material Required But Not ProvidedTimer

SPECIMEN COLLECTION AND PREPARATION

Wash your hands with soap and warm water. Open the sealed pouch and remove the urine testT-cup.

One Step Multi-Drug Urine T-CupThe donors collect their urine samples. Open the cap of the cup and urinate directly into the testcup. The sample volume should be higher than the minimum urine level. Re-cap the cup.

TEST PROCEDURE

1. After the urine has been collected, re-cap the cup and place the test T-cup on a flat surface.2. Peel the label from right to left.3. Read adulteration testing results at the times specified, compare the colors on the adulterationstrip to the color chart labeled on the foil pouch. Proper read time is critical for optimal results. Ifthe results indicate adulteration, do not read the drug test results.4. If results do not indicate adulteration, read drug test results within 5 minutes. Do not readresults after 10 minutes.

INTERPRATATION OF RESULTS

Positive (+)A rose-pink band is visible in each control region. No color band appears in the appropriate testregion. It indicates a positive result for the corresponding drug of that specific test zone.

Negative (-)A rose-pink band is visible in each control region and the appropriate test region. It indicates thatthe concentration of the corresponding drug of that specific test zone is zero or below thedetection limit of the test.

InvalidIf a color band is not visible in each of the control region or a color band is only visible in each ofthe test region, the test is invalid. Another test should be run to re-evaluate the specimen. Pleasecontact the distributor or the store, where you bought the product, with the lot number.

Note: There is no meaning attributed to line color intensity or width.

QUALITY CONTROL

Users should follow the appropriate federal state, and local guidelines concerning the frequency ofassaying external quality control materials.Though there is an internal procedural control line in the test device of Control region, the use ofexternal controls is strongly recommended as good laboratory testing practice to confirm the testprocedure and to verify proper test performance. Positive and negative control should give theexpected results. When testing the positive and negative control, the same assay procedureshould be adopted.

LIMITATIONS

1. This test has been developed for testing urine samples only. The performance of this test usingother specimens has not been substantiated.

2. Adulterated urine samples may produce erroneous results. Strong oxidizing agents such asbleach (hypochlorite) can oxidize drug analyses. If a sample is suspected of being adulterated,obtain a new sample.

3. This test is a qualitative screening assay. It is not designed to determine the quantitativeconcentration of drugs or the level of intoxication

4. It is possible that technical or procedural errors, as well as other interfering substances in theurine specimen may cause erroneous results.

5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtainedwhen drug is present but below the cut-off level of the test.

6. The test result does not distinguish between drugs of abuse and certain medicines.7. A positive result might be obtained from certain foods or food supplements.8. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results

regardless of the analytical method used. If adulteration is suspected, the test should berepeated with another urine specimen.

9. The adulteration assays are for screening purposes only; all abnormal results should beconfirmed by an alternative methodology,

PERFORMANCE CHARACTERISTICS

Accuracy

1080 (eighty of each drug) clinical urine specimens were analyzed by GC-MS and by eachcorresponding One Step Drug of Abuse Test. Each Wondfo test was read by three viewers.Samples were divided by concentration into four categories: less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows:

AMPViewer A:

Result

Less thanhalf the cutoffconcentration

by GC/MSanalysis

Near CutoffNegative (Between

50% below the cutoffand the cutoffconcentration)

Near Cutoff Positive(Between the cutoffand 50% above the

cutoffconcentration)

High Positive(greater than50% abovethe cutoff

concentration)Positive 0 4 11 29

00882evitageN% agreement among positives is 100%% agreement among negatives is 90.0%

Minimum Urine Level

Remove This LabelTo View Results

T-CUP T-CUP T-CUPID_____DATE____

Jeremy [email protected]

Viewer B:

ResultLess than

half the cutoffconcentration

by GC/MSanalysis



Near CutoffPositive (Betweenthe cutoff and 50%

above the cutoffconcentration)


concentration)Positive 0 1 11 29Negative 28 11 0 0

% agreement among positives is100%% agreement among negatives is 97.5%

Viewer C:

ResultLess than


by GC/MSanalysis


50% below thecutoff and the cutoff

concentration)





00782evitageN% agreement among positives is 100%% agreement among negatives is 87.5%

BARViewer A:

ResultLess than


by GC/MSanalysis







% agreement among positives is 87.5%% agreement among negatives is 90%

Viewer B:

ResultLess than


by GC/MSanalysis



concentration)





% agreement among positives is 95%% agreement among negatives is 95%

Viewer C:

ResultLess than


by GC/MSanalysis



concentration)





% agreement among positives is 95%% agreement among negatives is 92.5%

BZOViewer A:

ResultLess than


by GC/MSanalysis



concentration)






Viewer B:

ResultLess than


by GC/MSanalysis



concentration)






Viewer C:

ResultLess than


by GC/MSanalysis



concentration)






COCViewer A:

ResultLess than


by GC/MSanalysis

Near Cutoff Negative(Between 50%

below the cutoff andthe cutoff

concentration)






Viewer B:

ResultLess than


by GC/MSanalysis



concentration)






Viewer C:

ResultLess than


by GC/MSanalysis



concentration)






THCViewer A:

ResultLess than


by GC/MSanalysis



concentration)






Viewer B:

ResultLess than


by GC/MSanalysis






concentration)

Positive 0 0 17 22Negative 22 18 1 0


Viewer C:

ResultLess than


by GC/MSanalysis



concentration)






MTDViewer A:

ResultLess than


by GC/MSanalysis



concentration)






Viewer B:

ResultLess than


by GC/MSanalysis



concentration)






Viewer C:

ResultLess than


by GC/MSanalysis



concentration)






METViewer A:

ResultLess than


by GC/MSanalysis



Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration)



01962evitageN% agreement among positives is 97.5%% agreement among negatives is 87.5%)

Viewer B:

ResultLess than


by GC/MSanalysis



concentration)




concentration)


% agreement among positives is97.5%% agreement among negatives is 87.5%

Viewer C:

ResultLess than


by GC/MSanalysis








MDMAViewer A:

ResultLess than


by GC/MSanalysis



concentration)






Viewer B:

ResultLess than


by GC/MSanalysis



concentration)





% agreement among positives is 97.5%% agreement among negatives is 92.5%

Viewer C:

ResultLess than


by GC/MSanalysis



concentration)






MOPViewer A:

ResultLess than


by GC/MSanalysis








Viewer B:

ResultLess than


by GC/MSanalysis



concentration)






Viewer C:

ResultLess than


by GC/MSanalysis



concentration)




concentration)



OPIViewer A:

ResultLess than


by GC/MSanalysis



concentration)






Viewer B:

ResultLess than


by GC/MSanalysis



concentration)






Viewer C:

ResultLess than


by GC/MSanalysis







Negative 30 9 2 0% agreement among positives is 95%% agreement among negatives is 97.5%

PCPViewer A:

ResultLess than


by GC/MSanalysis






concentration)


% agreement among positives is 92.5%% agreement among negatives is100%

Viewer B:

ResultLess than


by GC/MSanalysis








Viewer C:

ResultLess than


by GC/MSanalysis



concentration)






TCAViewer A:

ResultLess than


by GC/MSanalysis








Viewer B:

ResultLess than


by GC/MSanalysis



concentration)





% agreement among positives is100%% agreement among negatives is 95%

Viewer C:

ResultLess than


by GC/MSanalysis








OXYViewer A:

ResultLess than


by GC/MSanalysis








Viewer B:

ResultLess than


by GC/MSanalysis



concentration)






Viewer C:

ResultLess than


by GC/MSanalysis



concentration)





BUPViewer A:

ResultLess than


by GC/MSanalysis



concentration)






Viewer B:

ResultLess than


by GC/MSanalysis



concentration)






Viewer C:

ResultLess than


by GC/MSanalysis



concentration)





PPXViewer A:

ResultLess than


by GC/MSanalysis



concentration)






Viewer B:

ResultLess than


by GC/MSanalysis








Viewer C:

ResultLess than


by GC/MSanalysis



concentration)






KETViewer A:

ResultLess than


by GC/MSanalysis



concentration)






Viewer B:

ResultLess than


by GC/MSanalysis



concentration)





% agreement among positives is100%% agreement among negatives is 95%

Viewer C:

ResultLess than


by GC/MSanalysis



concentration)






Precision and Sensitivity

To investigate the precision and sensitivity, each drug samples were analyzed at the followingconcentrations: cutoff - 50%, cutoff - 25%, cutoff, cutoff +25%, and the cutoff + 50%.All concentrations were confirmed with GC-MS. Each concentration was tested using threedifferent lots of the corresponding drug of abuse test. Thirty samples were analyzed at each concentration, and each result was read by three viewers, for a total of 90 results perconcentration per lot of the corresponding drug of abuse test.

AMPLot 1

Approximate concentration ofsample (ng/mL)

Number ofdeterminations

ResultsNegative/ Positive

0/090900521/870905785/2309000167/4109052109/0090051

Lot 2Approximate Concentration of

sample (ng/mL)Number of

determinationsResults

Negative/ Positive500 90 90/0

21/870905785/2309000167/41090521

09/0090051

Lot 3Approximate Concentration of

sample (ng/mL)Number of



21/87090571000 90 32/581250 90 14/761500 90 0/90

BARLot 1

Approximate concentrationof sample (ng/mL)



0/090905111/970952284/240900327/810957309/009054

Lot 2Approximate Concentration

of sample (ng/mL)Number of


Negative/ Positive150 90 90/0225 90 79/11300 90 42/48375 90 18/72450 90 0/90




Negative/ Positive0/090905111/970952284/240900327/810957309/009054

BZOLot 1




0/090905111/970952294/140900318/90957309/009054









COCLot 1




0/09090518/280952235/730900377/310957309/009054









THCLot 1




0/09095241/67098374/34090587/21093609/00957








Negative/ Positive0/09095241/67098374/34090587/210936

0957 0/90

MTDLot 1




0/090905151/570952294/140900338/70957309/009054









METLot 1




0/09090059/1809057

1000 90 34/561250 90 13/771500 90 0/90





9/180905765/4309000177/3109052109/0090051





09/0090051

MDMALot 1




0/090905241/680957305/030900518/90952609/009057








Negative/ Positive0/090905241/680957305/0309005

18/90952609/009057

MOPLot 1




0/090905131/770902226/820900328/80957309/009054








Negative/ Positive0/090905131/770902226/8209003

48/60957309/009054

OPILot 1




1000 90 90/01500 90 80/102000 90 44/462500 90 12/783000 90 0/90









09/0090003

PCPLot 1




0/0909317/38097134/74095267/41092309/00983









09/00983

TCALot 1




0/090900521/8709057

1000 90 41/491250 90 13/771500 90 0/90





21/870905794/1409000177/3109052109/0090051





09/0090051

OXYLot 1

Approximate Concentrationof sample (ng/mL)



0/5757521/36575756/015700127/35752157/057051








Negative/ Positive0/5757521/365757

66/95700137/25752157/057051

BUPLot 1




0/5757531/26575.766/9570117/4575.2157/05751




Negative/ Positive0/5757521/36575.776/8570127/3575.2157/05751




Negative/ Positive0/5757541/16575.7

66/9570137/2575.2157/05751

PPXLot 1




0/575705101/565752266/95700396/65757357/057054









KETLot 1




500 75 75/031/265705766/957000117/457052157/0570051





11/465705746/1157000117/457052157/0570051




Negative/ Positive0/575700521/3657057

66/957000137/257052157/0570051

Analytical Specificity

To test the specificity of the test, the test device was used to test various drugs, drug metabolitesand other components that are likely to be present in urine, All the components were added todrug-free normal human urine. These concentrations (ng/mL) below also represent the limits ofdetection for the specified drugs or metabolites.

Amphetamine Methamphetamined-Amphetamine 1,000 D(+)-Methamphetamine 1,000

000,05enimatehpmA-D000,3enimatehpmA-1.d000,05eniuqorolhC000,05enimatehpmA-1

(+/-)3,4-methylenedioxyamphetamine

000,05enirdehpE-)-/+(000,5

000,52enimatehpmahteM-)-(000,3enimretnehPBarbiturates (+/-)3,4-methylenedioxumethamphetamin

e(MDMA)2,000

000,05enimalyhtelynehP-b003latibraboceSA 000,01edimaznebohtemirT003latibrabomA 051lonehplA 002latibraborp Methylenedioxymethamphetamine(MDMA)

enimatehpmahtemyxoidenelyhteM-4,357latibrabatuBHCl(MDMA)

500

000,3lCHenimatehpmayxoidenelyhteM-4,3001lahtatuB003enimatehpmalyhteyxoidenelyhteM-4,3005,2latiblatuB

Cyclopentobarbital 600 Morphine003enihproM003latibrabotneP003eniedoC001latibrabonehP

Benzodiazepines 003enihproMlyhtE000,5enodocordyH003mapezaxO

A 000,5enohpromordyH002malozarpl-Hydroxyalprazolam 1,500 Morphinie-3- -d-glucuronide 1,000

Bromaz hT005,1mape 000,03eniabeChlordiazepoxide 1,500 Opiate 2000

000,2enihproM008lCHmapezanolC000,2eniedoC001mazabolC000,5enihpromlyhtE008mapezanolC

005,21enodocordyH002muissatopidetapezarolC000,5enihpromordyH005,1mapezaroleD

000,57lonahproveL004mapezarulflyklaseD002mapezaiD -Monoacetylmorphine 5,000

-3enihproM005,2malozatsE -D-glucuronide 2,000005,21eniedocroN004mapezartinulF000,05enohpromroN005,1mapezaroL-L,D000,52enodocyxO000,52enihpromyxO

005,21malozadiM

000,051eniacorP001mapezartiN

000,001eniabehT002edixopezaidrolhcroN004mapezaidroN

Phencyclidine52enidilcycnehP

Temazepam 001

005,21enidilcycnehpyxordyH-4005,2malozarT

stnasserpeditnAcilcycirTeniacoC

000,1enilytpirtoN003eninogcelyozneB

000,1enipexodroN057lCHeniacoC

005,21enelyhteacoC000,23eninogcE

Marijuana000,3eniimarpimirT

11-nor-D9-THC-9-COOH 50A 005,1enilytpirtim

005,1enizamorP03HOOC-9-CHT-8D-ron-11 002enimarpiseD

005,2lonibannacordyharteT-9D-yxordyh-11 004enimarpimI005,7lonibannacordyharteT-8D 005,21enimarpimolC

000,01lonibannacordyharteT-9D 000,2enipexoD000,01lonibannaC

000,001loidibannaC000,2enilitorpaM

Methadone000,52enizahtemorP

003enodahteM Buprenorphine51edinoruculG-D-3enihpronerpuB000,05enimalyxoD

Oxycodone 02enihpronerpubroNDihydrocodeine 20,000 Norbuprenorphine 3-D-Glucuronide 200

000,001eniedoC Ketamine000,05enodahteM000,001enohpromordyH005,21enidihteP000,001>enihproM

Acetylmorphine >100,000 Methylamphetamine 12,500Buprenorphine >100,000 Methoxyphenamine 12,500

000,52enizahtemorP000,001>enihpromlyhtEPropoxyphene 000,52enidilcycnehP

003enehpyxoporP-d003enehpyxoporproN-d

Cross-Reactivity

Considering the complexity of clinical urine specimens and the possibility that various urinespecimens contain potentially interfering substances, we simulated above situations by adding thepotentially interfering substances to a certain concentration as specimen. The followingcomponents show no cross-reactivity when tested with One Step Multi-Drug Urine Test T-Cup at aconcentration of 100 g/ml.

Non Crossing-Reacting Compounds

Acetophenetidin Creatinine Loperamide QuinidineNalidixic acid Deoxycorticosterone Meprobamate QuinineAcetylsalicylic acid Dextromethorphan Methoxyphenamine RanitidineAminopyrine Diclofenac Nalidixic acid Salicylic acidAmoxicillin Diflunisal Naloxone SerotoninAmpicillin Digoxin Naltrexone SulfamethazineL-Phenylephrine Diphenhydramine Naproxen SulindacApomorphine L- -Ephedrine Niacinamide TetracyclineAspartame Ecgonine methylester Nifedipine Tetrahydrocortisone,Atropine Ethyl-p-aminobenzoate Norethindrone 3-AcetateBenzilic acid -Estradiol D-Norpropoxyphene Tetrahydrocortisone,Benzoic acid Estrone-3-sulfate Noscapine ( -D-glucuronide)

Benzphetamine Erythromycin D,L-Octopamine TetrahydrozolineBilirubin Fenoprofen Oxalic acid ThiamineDeoxycorticosterone Furosemide Oxolinic acid ThioridazineCaffeine Gentisic acid Oxymetazoline D,L-Tyrosine

Hemoglobin Papaverine TolbutamideChloralhydrate Hydralazine Penicillin-G TriamtereneChloramphenicol Hydrochlorothiazide Perphenazine TrifluoperazineChlorothiazide Hydrocortisone Phenelzine TrimethoprimD,L-Chlolrpheniramine O-Hydroxyhippuric acid L-Phenylephrine TyramineChlorpromazine 3-Hydroxytyramine -Phenylethylamine D,L-TryptophanChlorquine D,L-Isoproterenol Phenylpropanolamine Urine acidCholesterol Isoxsuprine Prednisone VerapamilClonidine Ketoprofen D,L-Propanolol ZomepiracCortisone Labetalol L-Cotinine D-Pseudoephedrine

From the results above, it is clear that One Step Multi-Drug Urine Test T-Cup resists wellagainst interference from these substances.

Effect of Urinary Specific Gravity

5 urine samples with density ranges (1.000-1.035) are collected and spiked with each drug at 50%below and 50% above cutoff level. One Step Multi-Drug Urine Test was tested in duplicate. Theresults demonstrate that varying ranges of urinary specific gravity do not affect the test result.

Effect of Urinary PH

The pH of an aliquot negative urine pool is adjusted to a pH range of 4 to 9 in 1 pH unitincrements and spiked with morphine at 50% below and 50% above cutoff levels. One StepMulti-Drug Urine Test was tested in duplicate. The result demonstrate that varying ranged ofPH do not interfere with the performance of the test.

BIBLIGRAPHY OF SUGGESTED READING

1. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man. Biomedical Publications, Davis,CA, 1982.

2. Ellenhorn, M.J. and Barceloux, D. G Medical Toxicology. Elservier Science Publishing Company,Inc., New York, 1988

3. Gilman, A. G., and Goodman, L. S. The Pharmacological Fluids, in Martin WR(ed): DrugAddiction I, New York, Spring – Verlag, 1977.

4. Harvey, R.A., Champe, P.C. Lippincotts Illustrated Reviews. Pharmacology. 91-95, 1992.5. Hawwks RL, CN Chiang. Urine Testing for drugs of Abuse. National Institute for Drug Abuse

(NIDA), Research Monography 73, 19866. Hofmann F.E., A Handbook on Drug and Alcohol Abuse: The Biomedical Aspects, New York,

Oxford University Press, 1983.McBay, A. J. Clin. Chem. 33,33B-40B, 1987.

MEANING OF SYMBOLS ON PACKAGE

Version18/02/2011

Keep away from sunlight

Store between 4°C and 30°C

Keep dry

Do not re-use

Manufactured for: Confirm Biosciences, Inc. 800 908 5603 www.confirmbiosciences.com

800 908

Healthcare

T-Cup Urine Drug Screen Testing Cup