Multi Drug test urine cup

One Step Multi-Drug Urine Cup offers any combination of 12 different drugs: Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Cocaine (COC), Cannabinoids (THC), Methadone (MTD), Methamphetamine (MET), Methylenedioxymethamphetamine (MDMA), Morphine (MOP), Opiate (OPI 2000), Phencyclidine (PCP), Tricyclic Antidepressants (TCA). 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 be relevant to your test. We refer to the labels on the packaging and the prints on the test strip to identify which drugs are included in your test.”

A rapid one step test for the qualitative detection of drug of abuse and their principal metabolites in human urine at specified cut off level.

For professional use only, For in vitro diagnostic use.

INTENDED USE

One Step Multi-Drug Urine 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 in human

urine at the following cut off concentrations:

Test	Calibrator	Cut off (ng/ml)
Amphetamine	Amphetamine	1,000
Barbiturates	Secobarbital	300
Benzodiazepines	Oxazepam	300
Cocaine	Benzoylecgonine	300
Marijuana	Marijuana	50
Methadone	Methadone	300
Methamphetamine	Methamphetamine	1,000
Methylenedioxymethamphetamine	3,4-Methylenedioxymethamphetamine HCl(MDMA)	500
Morphine	Morphine	300
Opiate	Morphine	2000
Phencyclidine	Phencyclidine	25
Tricyclic Antidepressants	Notriptyline	1,000

This assay provides only a preliminary test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass

spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are positive.

PRINCIPLE

One Step Multi-Drug Urine Cup is a competitive immunoassay that is used to screen for the presence of drugs of abuse in urine. It is chromatographic absorbent device in which drugs or

drug metabolites in a sample competitively combined to a limited number of antibody-dye conjugate binding sites.

When the absorbent end of the test device is immersed into the urine sample, the urine is absorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flows across the pre-coated membrane.

When sample drug levels are at or above the target cutoff, the drug in the sample binds to the antibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-protein pre-coated in the test region (T). This prevents the development of a distinct colored band in the test 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 has been 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 provided

· Cup with multi-drug card · Package insert

Material Required But Not Provided

·Timer · External controls

SPECIMEN COLLECTION AND PREPARATION

Collect a urine sample in the urine cup. Urine specimens may be refrigerated (2°C -8°C) and stored up to forty-eight hours. For longer storage, freeze the samples (-20°C or below).

Bring frozen or refrigerated samples to room temperature before testing. Use only clear aliquots for testing.

TEST PROCEDURE

Test Cup, urine specimen, and/or controls must be in room temperature (18ºC to 30ºC) prior to testing:

1. Open the sealed pouch by tearing along the notch.

Remove the cup from the pouch and use it as soon as

possible.

2. Donor provides specimen and secures the cap.

3. Technician check cap for tight seal.

Technician dates and initials the security seal

and attach the security over the cup cap.

4. On a flat surface, technician twists screw key to a fully position.

5. Read the result at 5 minutes. Do not read after 5 minutes.

INTERPRATATION OF RESULTS

Positive (+)

A rose-pink band is visible in each control region. No color band appears in the appropriate test region. 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 that the concentration of the corresponding drug of that specific test zone is below zero or the detection limit of the test.

Invalid

If a color band is not visible in each of the control region or a color band is only visible in each of the test region, the test is invalid. Another test should be run to re-evaluate the specimen. Please contact 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

Though there is an internal procedural control line in the test device of control region, the use of external controls is strongly recommended as good laboratory testing practice to confirm the test procedure and to verify proper test performance. Positive and negative control should give the expected results. When testing the positive and negative control, the same assay procedure should be adopted.

LIMITATIONS

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

2. Adulterated urine samples may produce erroneous results. Strong oxidizing agents such as bleach (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 quantitative concentration of drugs or the level of intoxication

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

5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when 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.

PERFORMANCE CHARACTERISTICS

Accuracy

A comparison was conducted using each of the tests and commercially available drug rapid test (Acon One Step Multi-Line Screen Test with Integrated E-Z Split Key IM Cup (Urine)). 580 specimens were used in the test. Positive results were confirmed by GC/MS. The results were listed as follows:

% Agreement with commercial kit

Specimen	AMP	BAR	BZO	COC	THC	MTD	MET	MDMA	MOP 300	OPI 2000	PCP	TCA
Positive	>99%	97.5%	95%	100%	95%	90%	>99%	95%	97.5%	97.5%	97.5%	95%
Negative	>99%	99%	100%	99%	99%	99%	>99%	99%	99%	99%	99%	99%
Accuracy	>99%	98.6%	97.9%	>99%	97.9%	96.4%	>99%	97.9%	98.6%	98.6%	98.6%	97.9%

% Agreement with GC/MS

Specimen	AMP	BAR	BZO	COC	THC	MTD	MET	MDMA	MOP 300	OPI 2000	PCP	TCA
Positive	94%	92%	97%	96%	95%	95%	99%	97%	98%	99%	91%	95%
Negative	99%	98%	97%	99%	96%	99%	99%	99%	98%	99%	99%	99%
Accuracy	97%	95%	97%	98%	96%	97%	99%	98%	98%	99%	95%	97%

Analytical Sensitivity

Standard drugs were spiked into urine samples to the concentration of ± 50% cut off and ± 25% cut off. The results were summarized below.

Drug Concentration (Cut-off range)	n	AMP		BAR		BZO		COC		THC		MTD
Drug Concentration (Cut-off range)	n	-	+	-	+	-	+	-	+	-	+	-	+
0% Cut-off	30	30	0	30	0	30	0	30	0	30	0	30	0
-50% Cut-off	30	30	0	30	0	30	0	30	0	30	0	30	0
-25% Cut-off	30	25	5	26	4	26	4	25	5	25	5	23	7
Cut-off	30	12	18	10	20	14	16	12	18	15	15	14	16
+25% Cut-off	30	0	30	0	30	1	29	2	28	2	28	3	27
+50% Cut-off	30	0	30	0	30	0	30	0	30	0	30	0	30

Drug Concentration (Cut-off range)	n	MET		MDMA		MOP 300		OPI 2000		PCP		TCA
Drug Concentration (Cut-off range)	n	-	+	-	+	-	+	-	+	-	+	-	+
0% Cut-off	30	30	0	30	0	30	0	30	0	30	0	30	0
-50% Cut-off	30	30	0	30	0	30	0	30	0	30	0	30	0
-25% Cut-off	30	29	1	23	7	24	6	25	5	26	4	24	6
Cut-off	30	13	17	10	20	10	20	14	16	15	15	14	16
+25% Cut-off	30	5	25	4	26	3	27	5	25	7	23	6	24
+50% Cut-off	30	0	30	0	30	0	30	0	30	0	30	0	30

Analytical Specificity

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

Amphetamine		Methamphetamine
d-Amphetamine	1,000	D(+)-Methamphetamine	1,000
d.1-Amphetamine	3,000	D-Amphetamine	50,000
1-Amphetamine	50,000	Chloroquine	50,000
(+/-)3,4-methylenedioxyamphetamine	5,000	(+/-)-Ephedrine	50,000
Phentermine	3,000	(-)-Methamphetamine	25,000
Barbiturates		(+/-)3,4-methylenedioxumethamphetamine(MDMA)	2,000
Secobarbital	300	b-Phenylethylamine	50,000
Amobarbital	300	Trimethobenzamide	10,000
Alphenol	150
Aprobarbital	200	Methylenedioxymethamphetamine(MDMA)
Butabarbital	75	3,4-MethylenedioxymethamphetamineHCl(MDMA)	500
Butathal	100	3,4-MethylenedioxyamphetamineHCl	3,000
Butalbital	2,500	3,4-Methylenedioxyethylamphetamine	300
Cyclopentobarbital	600	Morphine
Pentobarbital	300	Morphine	300
Phenobarbital	100	Codeine	300
Benzodiazepines		EthylMorphine	300
Oxazepam	300	Hydrocodone	5,000
Alprazolam	200	Hydromorphone	5,000
a-Hydroxyalprazolam	1,500	Morphinie-3-b-d-glucuronide	1,000
Bromazepam	1,500	Thebaine	30,000
Chlordiazepoxide	1,500	Opiate2000
ClonazepamHCl	800	Morphine	2,000
Clobazam	100	Codeine	2,000
Clonazepam	800	Ethylmorphine	5,000
Clorazepatedipotassium	200	Hydrocodone	12,500
Delorazepam	1,500	Hydromorphine	5,000
Desalkylflurazepam	400	Levorphanol	75,000
Diazepam	200	s-Monoacetylmorphine	5,000
Estazolam	2,500	Morphine3-b-D-glucuronide	2,000
Flunitrazepam	400	Norcodeine	12,500
D,L-Lorazepam	1,500	Normorphone	50,000
Midazolam	12,500	Oxycodone	25,000
Nitrazepam	100	Oxymorphine	25,000
Norchlordiazepoxide	200	Procaine	150,000
Nordiazepam	400	Thebaine	100,000
Temazepam	100	Phencyclidine
Trazolam	2,500	Phencyclidine	25
		4-Hydroxyphencyclidine	12,500
Cocaine		TricyclicAntidepressants
Benzoylecgonine	300	Notriptyline	1,000
CocaineHCl	750	Nordoxepine	1,000
Cocaethylene	12,500
Ecgonine	32,000
Marijuana		Trimipramiine	3,000
11-nor-D9-THC-9-COOH	50	Amitriptyline	1,500
11-nor-D8-THC-9-COOH	30	Promazine	1,500
11-hydroxy-D9-Tetrahydrocannabinol	2,500	Desipramine	200
D8-Tetrahydrocannabinol	7,500	Imipramine	400
D9-Tetrahydrocannabinol	10,000	Clomipramine	12,500
Cannabinol	10,000	Doxepine	2,000
Cannabidiol	100,000	Maprotiline	2,000
Methadone		Promethazine	25,000
Methadone	300
Doxylamine	50,000

Cross-Reactivity

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

Non Crossing-Reacting Compounds

Acetophenetidin Creatinine Loperamide Quinidine

Nalidixic acid Deoxycorticosterone Meprobamate Quinine

Acetylsalicylic acid Dextromethorphan Methoxyphenamine Ranitidine

Aminopyrine Diclofenac Nalidixic acid Salicylic acid

Amoxicillin Diflunisal Naloxone Serotonin

Ampicillin Digoxin Naltrexone Sulfamethazine

L-Phenylephrine Diphenhydramine Naproxen Sulindac

Apomorphine L-y-Ephedrine Niacinamide Tetracycline

Aspartame Ecgonine methylester Nifedipine Tetrahydrocortisone,

Atropine Ethyl-p-aminobenzoate Norethindrone 3-Acetate

Benzilic acid b-Estradiol D-Norpropoxyphene Tetrahydrocortisone,

Benzoic acid Estrone-3-sulfate Noscapine (b-D-glucuronide)

Benzphetamine Erythromycin D,L-Octopamine Tetrahydrozoline

Bilirubin Fenoprofen Oxalic acid Thiamine

Deoxycorticosterone Furosemide Oxolinic acid Thioridazine

Caffeine Gentisic acid Oxymetazoline D,L-Tyrosine

Hemoglobin Papaverine Tolbutamide

Chloralhydrate Hydralazine Penicillin-G Triamterene

Chloramphenicol Hydrochlorothiazide Perphenazine Trifluoperazine

Chlorothiazide Hydrocortisone Phenelzine Trimethoprim

D,L-Chlolrpheniramine O-Hydroxyhippuric acid L-Phenylephrine Tyramine

Chlorpromazine 3-Hydroxytyramine b-Phenylethylamine D,L-Tryptophan

Chlorquine D,L-Isoproterenol Phenylpropanolamine Urine acid

Cholesterol Isoxsuprine Prednisone Verapamil

Clonidine Ketamine D,L-Propanolol Zomepirac

Cortisone Ketoprofen D-Propoxyphene

L-Cotinine Labetalol D-Pseudoephedrine

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

BIBLIGRAPHY OF SUGGESTED READING

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

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

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

Harvey, R.A., Champe, P.C. Lippincotts Illustrated Reviews. Pharmacology. 91-95, 1992.

Hawwks RL, CN Chiang. Urine Testing for drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monography 73, 1986

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.