Drugs of Abuse Integrated Cup(Urine)

Short Description:

INTENDED USE

The Drugs of Abuse Integrated Cup(Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of any combination of drugs and Adulteration of abuse in human urine specimens at the cut-off concentrations listed below:


Product Detail

Product Tags

Intended Use

The Drugs of Abuse Integrated Cup(Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of any combination of drugs and Adulteration of abuse in human urine specimens at the cut-off concentrations listed below:

Test

Calibrator

Cut-off (ng/mL)

AMP

Amphetamine

1,000

BZO

Oxazepam

300

COC

Cocaine/Benzoylecgonine

300

MET

Methamphetamine

1,000

OPI

Morphine

2,000

THC

11-nor- Δ9-THC-9-carboxylic acid

50

Adulteration

SG/PH/Oxidants/CRE/NIT/GLUT

Principle

The Drugs of Abuse Integrated Cup(Urine) is an immunoassay based on the principle of competitive binding. Drugs that may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody.
During testing, a portion of the urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will appear in the test line region of the corresponding drug strip. The presence of drug above the cut-off concentration in the urine specimen will saturate all the binding sites of the antibody. Therefore, no colored line will form in the test line region.
A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Adulteration is the tampering of a urine specimen with the intention of altering the test results. The use of adulterants can cause false negative results in drug tests by either interfering 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.

Materials

Materials Provided

Individually packed test cups with integrated drug of abuse test panels
Caps Keys
Package insert Color Card

Materials Required But Not Provided

Timer Centrifuge
Positive and negative controls

Reagents

Each test contains reagent strips mounted in a plastic housing. The amount of each antigen and/or antibody coated on the strip is less than 0.001 mg for antigen conjugates and goat anti-rabbit IgG antibodies, and less than 0.0015 mg for antibody components.
The control zone of each test contains Goat anti-rabbit IgG antibody. The test zone and conjugate pad of each test contain the following antigen and antibody components:

Test

Test Zone

Conjugate Pad

AMP

Amphetamine bovine protein antigen conjugate Monoclonal anti-amphetamine and rabbit antibody-colored particle complex

BZO

Oxazepam bovine protein antigen conjugate Monoclonal anti-oxazepam and rabbit antibody-colored particle complex

COC

Benzoylecgonine bovine protein antigen conjugate Monoclonal anti-benzoylecgonine and rabbit antibody-colored particle complex

MET

Methamphetamine bovine protein antigen conjugate Monoclonal anti-methamphetamine and rabbit antibody-colored particle complex

OPI

Monoclonal anti-morphine antibody Morphine bovine protein antigen conjugate and rabbit antibody-colored particle complex

THC

THC bovine protein antigen conjugate Monoclonal anti-THC and rabbit antibody-colored particle complex

For the adulteration

Adulteration Pad Reactive Indicator Buffer and Non-reactive Ingredient
pH 0.06% 99.94%
Specific Gravity (SG) 0.25% 99.75%
Oxidants/PCC OXI/PCC) 0.36% 99.64%
Creatinine (CRE) 0.04% 99.96%
Nitrite (NIT) 0.07% 99.93%
Glutaraldehyde (GLUT) 0.02% 99.98%

Precautions

★ For professional in vitro diagnostic use only.
★ Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
★ This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
★ Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
★ Read the entire procedure carefully prior to testing.
★ Do not eat, drink or smoke in the area where specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
★ Humidity and temperature can adversely affect results.
★ Used testing materials should be discarded in accordance with local regulations.

Storage and Stability

✽ The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
✽ The test must remain in the sealed pouch until use.
✽ Do not freeze.
✽ Kits should be kept out of direct sunlight.
✽ Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

Specimen Collection and Storage

✔ The Drugs of Abuse Integrated Cup(Urine) is intended for use with human urine specimens only.
✔ Urine collected at any time of the day may be used.
✔ Urine specimens must be collected in clean, dry containers.
✔ Turbid specimens should be centrifuged, filtered, or allowed to settle and only the clear supernatant should be used for testing.
✔ Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Urine specimens may be stored at 2-8°C for up to 2 days. For long term storage, specimens should be kept below -20°C.
✔ Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
✔ If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

Procedure

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1.Remove the cup with its key from sealed pouch and use it as soon as possible.
2.Donor provides a urine specimen in the cup and screws cap on to it.
3.Donor dates and initials body label.
4.Donor screws key deasil for 180°, and start timer immediately.
5.Operator checks the cap for tightness.
6.Remove the peel-off label.
7.Check the temperature strip label at 2-4 minutes after specimen collection. A green color will appear to indicate the temperature of the urine specimen. The proper range for an unadulterated specimen is 90-100°F (32-38°C).
8.Drug test results are indicated by the presence or absence of colored band(s) in the result area. The result should be read at 5 minutes. Do not interpret the result after 8 minutes.
9.For the adulteration,compared with the color card, and the results should be read at 2 minutes.
10.Positive test results must be confirmed by another test method. Send the cup and urine specimen intact to a toxicology laboratory for confirmation.

product

Interpretation of Results

(See previous illustration)
POSITIVE: Only one colored band appears, in the control region (C). No colored band appears in the test region (T) for the drug in question. A positive result indicates that the drug concentration exceeds the detectable level.
NEGATIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T) for the drug in question. A negative result indicates that
the drug concentration is below the detectable level.
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
For the adulteration:
Results are obtained by visually comparing the reacted color blocks on the test strip to the printed color blocks on the canister.

NOTE:
1.The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region (T) should be considered negative. Please note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2.Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

Quality Control

★ Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
★ External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

Limitations of the Test

A. Accuracy
The accuracy of the Drugs of Abuse Integrated Cup(Urine) was established by running urine samples against GC/MS.
Amphetamine (GC/MS values calibrated to amphetamine): In this study, one hundred three (103) negative and positive urine samples (0 to 46,922 ng/mL) were tested and compared with GC/MS. The concentrations of two discrepant specimens were confirmed with GC/MS to be close to the cut-off value (1,064 and 1,117 ng/mL). The results are summarized below:

(-) (+)
Multiple Drugs Test Cup GC/MS negative Near cut-off negative
(75% to cutoff)
Near cut-off positive
(cut-off to 125%)
GC/MS positive (>125%)
(+) 0 0 5 41
(-) 48 7 2 0
Total 48 7 7 41

Positive Agreement: 95.8% Negative Agreement: 100% Total Agreement: 98.1%

Benzodiazepines (GC/MS values calibrated to oxazepam, nordiazepam, or alprazolam): In this study, ninety-nine (99) negative and positive urine samples (0 to >10,000 ng/mL) were tested and compared with GC/MS. The six discrepant specimens were confirmed with GC/MS to have concentrations of oxazepam - 292 and 319 ng/mL, and alprazolam – 315, 317, 367 and 488 ng/mL. The results are summarized below:

(-) (+)
Multiple Drugs Test Cup GC/MS negative Near cut-off negative
(75% to cutoff)
Near cut-off positive
(cut-off to 125%)
GC/MS positive (>125%)
(+) 3 1 5 36
(-) 47 5 2 0
Total 50 6 7 36

Positive Agreement: 95.3% Negative Agreement: 92.9% Total Agreement: 93.9%

Cocaine (GC/MS values calibrated to benzoylecgonine): In this study, one hundred ten (110) negative and positive urine samples (0 to 245,682 ng/mL) were tested and compared with GC/MS. The concentrations of two discrepant specimens were confirmed with GC/MS to be close to the cut-off value (284 and 328 ng/mL). The results are summarized below:

(-) (+)
Multiple Drugs Test Cup GC/MS negative Near cut-off negative
(75% to cutoff)
Near cut-off positive
(cut-off to 125%)
GC/MS positive (>125%)
(+) 0 1 4 51
(-) 47 6 1 0
Total 47 7 5 51

Positive Agreement: 98.2% Negative Agreement: 98.1% Total Agreement: 98.2%

Methamphetamine (GC/MS values calibrated to methamphetamine): In this study, one hundred fifteen (115) negative and positive urine samples (0 to 82,106 ng/mL), were tested and compared with GC/MS. The concentrations of two discrepant specimens were confirmed with GC/MS to be close to the cut-off value (1,007 and 1,040 ng/mL). The results are summarized below:

(-) (+)
Multiple Drugs Test Cup GC/MS negative Near cut-off negative
(75% to cutoff)
Near cut-off positive
(cut-off to 125%)
GC/MS positive (>125%)
(+) 0 0 4 57
(-) 44 8 2 0
Total 44 8 6 57

Positive Agreement: 96.8% Negative Agreement: 100% Total Agreement: 98.3%

OPI (GC/MS specifications are the value of morphine or codeine): In this study, one hundred and five (105) negative and positive urine samples (0 to 50236 ng/ml) were tested and compared with GC/MS. The concentrations of two discrepant specimens were confirmed with GC/MS to be close to the cutoff value (1836 and 2041.5 ng/ml). The results are summarized below:

(-) (+)  
Drug Screen GC/MS Negative

(0 ng/ml to 75%)

Near cutoff negative (75%- cutoff) Near cutoff positive (cutoff to 125%) GC/MS Positive (>125%) % Agreement with GC/MS
(+) 0 1 7 33 97.6 %
(-) 56 7 1 0 98.4 %
Total 56 8 8 33 98.1 %

Positive Agreement: 97.6% and Negative Agreement: 98.4%

THC (GC/MS values calibrated to 11-nor-9-THC-9-COOH): In this study, one hundred twenty-two (122) negative and positive urine samples (0 to >2,000 ng/mL) were tested and compared with GC/MS. The concentrations of three discrepant specimens were confirmed with GC/MS to be close to the cut-off value (48, 50 and 54 ng/mL). The results are summarized below:

(-) (+)
Multiple Drugs Test Cup GC/MS negative Near cut-off negative
(75% to cutoff)
Near cut-off positive
(cut-off to 125%)
GC/MS positive (>125%)
(+) 0 1 7 53
(-) 45 14 2 0
Total 45 15 9 53

Positive Agreement: 96.8% Negative Agreement: 98.3% Total Agreement: 97.5%

B. Sensitivity

The sensitivity of The QuikCup Drugs of Abuse Integrated Cup(Urine) was determined by testing GC/MS confirmed controls at negative, -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off and 3 times cut-off concentrations. The results are summarized below:

Drug Conc.(Cut-off Range) n AMP BZO COC
- + - + - +
Negative 50 50 50 50
50% Cut-off 50 50 50 50
75% Cut-off 50 50 50 50
Cut-off 50 16 34 17 33 11 39
125% Cut-off 50 50 50 50
150% Cut-off 50 50 50 50
3X Cut-off 50 50 50 50
Drug Conc.(Cut-off Range) n MET OPI THC
- + - + - +
Negative 50 50 50 50
50% Cut-off 50 50 50 50
75% Cut-off 50 50 50 50
Cut-off 50 23 27 13 37 17 33
125% Cut-off 50 50 50 50
150% Cut-off 50 50 50 50
3X Cut-off 50 50 50 50

B. Specificity

The following tables list the concentrations of compounds (ng/mL) above which the QuikCup Drugs of Abuse Integrated Cup(Urine) identified positive results at 5 minutes.

Amphetamine-Related Compounds Concentration (ng/mL)
d-Amphetamine 1,000
l-Amphetamine 100,000
3,4-Methylenedioxyamphetamine (MDA) 1,250
Paramethoxyamphetamine (PMA) 625
Phentermine 1,250
Tyramine 100,000
Benzodiazepine-Related Compounds Concentration (ng/mL)
Alprazolam 125
Bromazepam 625
Chlordiazepoxide 2,500
Clobazam 63
Clonazepam 2,500
Clorazepate dipotassium 3,330
Delorazepam 2,500
Desalkylflurazepam 250
Diazepam 250
Estazolam 5,000
Flunitrazepam 375
(±) Lorazepam 1,250
RS-Lorazepam glucuronide 1,250
Midazolam 100,000
Nitrazepam 25,000
Norchlordiazepoxide 250
Nordiazepam 500
Oxazepam 300
Sulindac 100,000
Temazepam 63
Triazolam 5,000
Cocaine-Related Compounds Concentration (ng/mL)
Benzoylecgonine 300
Cocaine 1,000
Ecgonine 100,000
Marijuana-Related Compounds

Concentration (ng/mL)

11-nor-∆9-THC-9-COOH

50

11-nor-∆8-THC-9-COOH

50

∆9-tetrahydrocannabinol

15,000

∆8-tetrahydrocannabinol

15,000

Cannabinol

>20,000

Methamphetamine-Related Compounds

Concentration (ng/mL)

Chloroquine

25,000

Fenfluramine

12,500

MDEA

50,000

MDMA

313

Mephentermine hemisulfate salt

31,250

l-Methamphetamine

10,000

d-Methamphetamine

1,000

PMMA

625

OPI -Related Compounds

Concentration (ng/mL)

Morphine

2,000

Acetylcodeine

1,563

Buprenorphine

25,000

Codeine

500

Diacetyl Morphin (Heroin)

1,250

Dihydrocodeine

1,563

Ethylmorphine

800

Hydrocodone

50,000

Hydromorphone

25,000

6-Monoacetylmorphine

1,250

Morphine-3-β-d-glucuronid

12,500

Nalorphine

100,000

Thebaine

50,000

A study was conducted to determine the cross-reactivity of the test with compounds spiked into drug-free PBS stock. The following compounds demonstrated no false positive results on the QuikCup Drugs of Abuse Integrated Cup(Urine) when tested at concentrations up to 100 µg/mL.

Acetaminophen Ethanol
Acetone Furosemide
Albumin Guaiacol glyceryl ether
Ampicillin Hemoglobin
Aspartame Ibuprofen
Aspirin (±)-Isoproterenol
Atropine Lidocaine
Benzocaine N-Methyl-ephedrine
Bilirubin (+)-Naproxen
Caffeine Oxalic acid
Chlorpheniramine Penicillin-G
Creatine Pheniramine
Dextrorphan tartrate Phenothiazine
4-Dimethylaminoantipyrine L-Phenylephrine
Dopamine β-Phenylethylamine
(±)-Ephedrine Quinidine
Erythromycin Ranitidine

Literature References

1.Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd ed. Davis: Biomedical Publications; 1982.
2.Hawks RL, Chiang CN, eds. Urine Testing for Drugs of Abuse. Rockville: Department of Health and Human Services, National Institute on Drug Abuse; 1986.
3.Substance Abuse and Mental Health Services Administration. Mandatory Guidelines for Federal Workplace Drug Testing Programs. 53 Federal Register; 1988.
4.McBay AJ. Drug-analysis technology--pitfalls and problems of drug testing. Clin Chem. 1987 Oct; 33 (11 Suppl): 33B-40B.
5.Gilman AG, Goodman LS, Gilman A, eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan; 1980.


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