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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: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.
Individually packed test cups with integrated drug of abuse test panels
Caps
Keys
Package insert
Color Card
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:(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.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:
Timer
Centrifuge
Positive and negative controls
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.
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
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%
★ 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.★ 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.
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
✽ 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.✔ 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.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.
(-)
(+)
Multiple Drugs Test Cup
GC/MS negative
Near cut-off negative (75% to cut off)
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 cut off)
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 cut off)
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 cut off)
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 cut off)
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% 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
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.
