null 8592126

3,4-methylenedioxymethamphetamine (MDMA) is classified as both a stimulant and
a hallucinogen, and is commonly known as Ecstasy. Like methamphetamine, adverse
effects of 3,4-methylenedioxymethamphetamine use include jaw clenching, teeth
grinding, dilated pupils, perspiring, anxiety, blurred vision, vomiting, and increased
blood pressure and heart rate. Overdose of 3,4-methylenedioxymethamphetamine may
cause heart failure or extreme heat stroke. 3,4-methylenedioxymethamphetamine is
taken orally in tablets or capsules and excreted in urine as parent compound, as well as
metabolites.
Rapid Drug Test Cup
FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE
CLIA CATEGORIZATION: WAIVED
Methadone is a synthetic analgesic drug originally used for the treatment of narcotic
addiction. The psychological effects induced by using methadone are analgesia,
sedation, and respiratory depression. Overdose of methadone may cause coma or even
death. Methadone is taken orally or intravenously and is metabolized in the liver and
has a biological half-life of 15-60 hours.
INTENDED USE
The CLIAwaived™ Inc. “RDTC” Cup is a one-step immunoassay for the qualitative
detection of multiple drugs and drug metabolites in human urine at the following cutoff
concentrations:
Test
AMP
BAR
BZO
COC
MDMA
MET
MTD
OPI
OXY
PCP
THC
TCA
Calibrator
d-Amphetamine
Secobarbital
Oxazepam
Benzoylecgonine
3,4-methylenedioxymethamphetamine
d-Methamphetamine
dl-Methadone
Morphine
Oxycodone
Phencyclidine
11-nor-∆9-THC-9-COOH
Nortriptyline
Cut-off (ng/ml)
1000
300
300
300
500
1000
300
2000
100
25
50
1000
Opiates, such as heroin, morphine, and codeine, are central nervous system (CNS)
depressants. Opiates are prescribed primarily as analgesics. The use of opiates at high
doses produces euphoria and release from anxiety. Physical dependence is apparent in
users and leads to depressed coordination, disrupted decision making, decreased
respiration, hypothermia and coma. Heroin is quickly metabolized to 6-acetylmorphine
(6-AM), morphine, and morphine glucuronide. Thus, the presence of morphine (or the
metabolite, morphine glucuronide) in the urine can indicate heroin, morphine, and/or
codeine use.
Oxycodone is a semi-synthetic opioid with a structural similarity to codeine. It
produces potent euphoria, analgesic and sedative effects, and has a dependence
liability similar to morphine. Oxycodone is most often administered orally and is
metabolized by demethylation to noroxycodone and oxymorphone followed by
glucuronidation. The window of detection for oxycodone in urine is expected to be
similar to that of other opioids such as morphine.
The configurations of the CLIAwaived™ Inc. RDTC Cup consist of any combination
of the drugs listed above with or without specimen validity test. The specimen validity
test provides information regarding the integrity of urine sample in the drugs of abuse
test by the semi-quantitative determination of creatinine, nitrite, pH, bleach/oxidant,
and specific gravity in human urine. The CLIAwaived™ Inc. RDTC Cup is used to
obtain a visual, qualitative result and is intended for professional use only. A certificate
of waiver is needed for your laboratory in order to run this test. Laboratories with a
certificate of waiver must follow the manufacturer’s instructions for performing the
test or the test is considered high complexity and is no longer CLIA waived.
Phencyclidine, commonly known as “angel dust” and “crystal cyclone", is an
arylcyclohexylamine that was originally used as an anesthetic agent and a veterinary
tranquilizer. The drug is abused by oral or nasal ingestion, smoking, or intravenous
injection. It produces hallucinations, lethargy, disorientation, loss of coordination,
trance-like ecstatic states, a sense of euphoria and visual distortions. It is well absorbed
following all routes of administration. Unchanged PCP is excreted in urine in moderate
amounts (10% of the dose).
Tetrahydrocannabinol (THC) is generally accepted to be the principle active
component in marijuana. When ingested or smoked, it produces euphoric effects.
Abusers exhibit central nervous system effects, altered mood and sensory perceptions,
loss of coordination, impaired short term memory, anxiety, paranoia, depression,
confusion, hallucinations and increased heart rate. When marijuana is ingested, the
drug is metabolized by the liver; the primary metabolite of marijuana excreted in the
urine is 11-nor-∆-9-tetrahydrocannabinol-9-carboxylic acid. Therefore, the presences
of detected cannabinoids, including the primary carboxyl metabolite, in the urine
indicate marijuana/cannabis use.
This assay provides only a preliminary result. Clinical consideration and
professional judgment must be applied to any drug of abuse test result, particularly
in evaluating a preliminary positive result. In order to obtain a confirmed analytical
result, a more specific alternate chemical method is needed. Gas
Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass
Spectrometry (LC/MS) are the preferred confirmation methods.
SUMMARY AND EXPLANATION
Tricyclic antidepressants (TCAs) have been prescribed for depression and
compulsive disorders. Because of the possibility of causing serious cardiac
complications, TCAs can be lethal if misused at high doses. TCAs are taken orally or
sometimes by injection. TCAs are metabolized in the liver. TCAs and their metabolites
are excreted in urine mostly in the form of metabolites for up to ten days.
Amphetamine/Methamphetamine and metabolites are potent central nervous system
stimulants. Acute higher doses induce euphoria, alertness, and sense of increased
energy and power. More acute responses produce anxiety, paranoia, psychotic
behavior, and cardiac dysrhythmias. Methamphetamine is excreted in urine as
amphetamine and oxidized as deaminated and hydroxylated derivatives. However,
methamphetamine is also excreted to some extent unchanged. Thus the presence of the
parent compound and metabolite in the urine indicates the use of methamphetamine.
For all drugs, the length of time following drug use of which a positive result may
occur is dependent upon several factors, including the frequency, amount of drug,
metabolic rate, excretion rate, drug half-life, and the drug user’s age, weight, activity
and diet.
Barbiturates are classified as central nervous system depressants. These products
produce a state of intoxication that is similar to alcohol intoxication. Symptoms
include slurred speech, loss of motor coordination and impaired judgment. Depending
on the dose, frequency, and duration of use, tolerance, physical dependence and
psychological dependence on barbiturates can occur. Barbiturates are taken orally, or
by intravenous and intramuscular injections. They are excreted in urine as parent
compound, as well as metabolites.
TEST PRINCIPLE
The CLIAwaived™ Inc. RDTC Cup is based on the principle of competitive
immunochemical reaction between a chemically labeled drug (drug-protein conjugate)
and the drug or drug metabolites which may be present in the urine sample for the limited
antibody binding sites. The test contains a nitrocellulose membrane strip pre-coated with
drug-protein conjugate in the test region and a pad containing colored antibody-colloidal
gold conjugate. During the test, the urine sample migrates upward and rehydrates the
antibody-colloidal gold conjugate. The mixture then migrates along the membrane
chromatographically by the capillary action to the immobilized drug-protein band on the
test region. When drug is absent in the urine, the colored antibody-colloidal gold
conjugate and immobilized drug-protein bind specifically to form a visible line in the test
region as the antibody complexes with the drug-protein. When drug is present in the urine,
it will compete with drug-protein for the limited antibody sites.
Benzodiazepines are central nervous system (CNS) depressants commonly prescribed for
the short-term treatment of anxiety and insomnia. In general, benzodiazepines act as
hypnotics in high doses, as anxiolytics in moderate doses and as sedatives in low doses.
The use of benzodiazepines can result in drowsiness and confusion. Psychological and
physical dependence on benzodiazepines can develop if high doses of the drug are given
over a prolonged period. Benzodiazepines are taken orally or by intramuscular or
intravenous injection, and are extensively oxidized in the liver to metabolites. Most
benzodiazepines are excreted in the urine as conjugates and metabolites.
Cocaine is a potent central nervous system stimulant and a local anesthetic found in
the leaves of the coca plant. The psychological effects induced by using cocaine are
euphoria, confidence and sense of increased energy. These psychological effects are
accompanied by increased heart rate, dilation of the pupils, fever, tremors and
sweating. Cocaine is excreted in the urine primarily as benzoylecgonine in a short
period of time. Benzoylecgonine has a biological half-life of 5 to 8 hours, which is
much longer than that of cocaine (0.5 to 1.5 hours), and can be generally detected for
24 to 60 hours after cocaine use or exposure.
The line on the test region will become less intense with increasing drug concentration.
When a sufficient concentration of drug is present in the urine, it will fill the limited
antibody binding sites. This will prevent attachment of the colored antibody-colloidal
gold conjugate to the drug-protein on the test region. Therefore, the presence of the
line on the test region indicates a negative result for the drug and the absence of a line
on the test region indicates a positive result for the drug.
1
A visible line generated by a different antigen/antibody reaction is also present at the
control region of the test strip. This line should always appear, regardless of the
presence of drugs or metabolites in the urine sample. This means that negative urine
sample will produce both a test line and control line, and a positive urine sample will
generate only a control line. The presence of control lines serve as built-in control,
which demonstrates that the test was performed properly.
INTERPRETATION OF RESULTS
Negative (-): Colored lines appear in both the Control Region (C) and the Test
Region (T1, T2, for 2-drug strip and T for 1-drug strip). The line in the control
region is the control line, which is used to indicate proper performance of the device.
The line in the test region is the drug line. The test line may have varying intensity
either weaker or stronger in color than that of the control line. A negative result for a
drug indicates that the concentration for that drug in urine is below the cutoff level.
REAGENTS & MATERIALS SUPPLIED
•
•
•
•
25 individually wrapped test devices. Each device consists of different test strips in
a plastic test strip holder. The test strip contains a colloidal gold pad coated with
antibody and rabbit antibody. It also contains a membrane coated with drug- protein
conjugate in the test band and goat anti-rabbit antibody in the control band.
Positive (+): Colored line appears in the control region. No line appears at a
specific drug test region. The complete absence of a test line indicates a preliminary
positive result for that drug. A preliminary positive result for a drug indicates that the
concentration of that drug in the urine is at or above the cutoff level.
25 Cups for sample collection
One (1) Instruction Sheet
Invalid: No colored line appears in the control region. If the control line does not
form, the test result is invalid and should be repeated.
25 Security Seals (if applicable)
MATERIAL REQUIRED BUT NOT PROVIDED
•
•
Timer
C
T2
External positive and negative controls
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
C
C
C
C
C
T
T2
T
T2
T
T1
T1
For professional in vitro diagnostic use only.
T1
T1 (+)
Urine specimens and used devices may be potentially infectious. Proper handling
and disposal methods should be established.
NEGATIVE
(-)
Test device should remain sealed until ready for use.
T (+)
PRELIMINARY
POSITIVE
(+)
INVALID
Do not use the test kit after the expiration date.
Color blindness may affect interpretation of results.
QUALITY CONTROL
Do not store and/or expose reagent kits at temperature greater than 30°C. Do not
freeze.
A procedural control is included in the test device. A colored line appearing in the
Control (C) region is considered an internal procedural control. It confirms sufficient
specimen volume, adequate membrane wicking and correct procedural technique.
STORAGE
Note: Urine specimens and all materials coming in contact with them should be
handled and disposed as if capable of transmitting infection. Avoid contact with skin
by wearing gloves and proper laboratory attire.
To ensure proper kit performance, it is recommended that the CLIAwaived™ Inc.
RDTC Cup be tested using external controls with each new lot or shipment of product,
with each new operator (i.e. one who has not performed the test recently), when
problems (storage, operator, instrument, or other) are suspected or identified, and as
otherwise required by your laboratory’s internal quality system procedures. Depending
on storage conditions, operators may also test controls monthly as a check on
continued storage conditions. Control specimens should be performed the same as
patient specimens (refer to Directions for Use, Interpretation of Results). If unexpected
results are seen when running the external positive or negative controls, review the
Direction for Use, Interpretation of Results and Limitations sections and repeat the test
with another cup. If the problem persists, discontinue use of the test kit immediately
and call (1-888-882-7739). External controls are available from commercial sources.
Additional testing may be necessary to comply with the requirements accrediting
organizations and/or local, state, and/or federal regulators.
ASSAY PROCEDURE FOR DRUG TEST ONLY
LIMITATIONS OF PROCEDURE
The CLIAwaived™ Inc. RDTC Cup should be stored at 2-30°C (36-86°F) in the
original sealed pouch. Do not freeze. Do not store and/or expose reagent kits at
temperatures greater than 30°C.
SPECIMEN COLLECTION AND HANDLING
Fresh urine does not require any special handling or pretreatment. A fresh urine sample
should be collected in the container provided. Alternately, a clean, dry plastic or glass
container may be used for specimen collection. If the specimen will not be tested
immediately after collection, the specimen may be refrigerated at 2-8°C up to 2 days or
frozen at -20°C for a longer period of time. Specimens that have been refrigerated must
be equilibrated to room temperature prior to testing. Specimens previously frozen must
be thawed and mixed thoroughly prior to testing.
1.
Preparation
1.
If a specimen, or test devices have been stored at refrigerated temperatures,
allow them to warm to room temperature before testing.
2.
Do not open test device pouch until ready to perform the test.
2.
Testing
1.
Remove test device lid from the sealed pouch and write donor name or ID on
the cap in the section provided.
3.
2.
Secure test device lid to the filled specimen cup. IMPORTANT: Cup lid must
be secured tightly by twisting it a quarter turn AFTER lid is snug. Place cup on
its side to activate testing.
4.
3.
Read results of test in 5 minutes. Do not interpret result after 10 minutes.
5.
6.
7.
The CLIAwaived™ Inc. RDTC Cup without specimen validity test
2
The CLIAwaived™ Inc. RDTC Cup provides only a qualitative, preliminary
analytical result. A secondary analytical method must be used to obtain a
confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the
preferred confirmatory method.
There is a possibility that technical or procedural errors, as well as interfering
substances in the urine specimen may cause erroneous results.
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 be repeated with another urine specimen.
A positive result does not indicate level of intoxication, administration route or
concentration in urine.
A negative result may not necessarily indicate drug-free urine. Negative results
can be obtained when drug is present but below the cutoff level of the test.
This test does not distinguish between drugs of abuse and certain medication.
A positive test result may be obtained from certain foods or food supplements.
PERFORMANCE CHARACTERISTICS
Bromazepam
Chlordiazepoxide
Clobazam
Clonazepam
Clorazepate
Desalkylflurazepam
Diazepam
Estazolam
A. Accuracy
The accuracy of the CLIAwaived™ Inc. RDTC Cup was evaluated in comparison to
commercially available drug screen tests. Sixty (60) negative urine samples collected
™
from presumed non-user volunteers were tested using both CLIAwaived Inc. RDTC
Cups and commercially available drug screen tests. Of these negative urine samples
tested, all were found negative by both methods. In a separate study, positive urine
samples, obtained from clinical laboratories where the drug concentrations were
determined by GC/MS (TCA concentrations were determined by HPLC), were tested
by the CLIAwaived™ Inc. RDTC Cup and commercial drug screen tests. The results of
accuracy study are presented below:
Drug Test
AMP
GC/MS
GC/MS
(<-50% C/O) (–50% C/O to
C/O)
GC/MS
(C/O to +50%
C/O)
GC/MS
% Agreement
(>+50% C/O) with GC/MS
(+)
(-)
0
15
0
9
10
1
55
0
98.5
100
(+)
(-)
(+)
(-)
0
15
0
18
1
7
2
18
5
2
13
0
83
0
37
0
97.8
95.7
100
94.7
COC
(+)
(-)
0
15
0
8
8
1
71
0
98.8
100
MDMA
(+)
(-)
(+)
(-)
0
24
0
20
1
6
0
8
6
0
5
1
37
0
58
0
100
96.8
98.4
100
MTD
(+)
(-)
0
15
0
5
6
1
65
0
98.6
100
OPI
(+)
(-)
0
15
2
6
9
0
45
0
100
91.3
OXY
(+)
(-)
0
15
1
7
6
0
47
0
100
91.3
PCP
(+)
(-)
0
15
0
4
4
2
56
0
96.8
100
THC
(+)
(-)
0
15
1
12
24
0
32
0
100
96.4
TCA
(+)
(-)
0
23
1
11
12
0
9
0
100
97.1
BAR
BZO
MET
B.
C.
Compound
500
450
(+/-)3,4-MDA
PCP
Phencyclidine
1,000
2,500
1,250
d-Methamphetamine
(+/-)3,4-MDMA
Barbiturates
Secobarbital
Allobarbital
Alphenal
Amobarbital
Aprobarbital
Barbital
300
600
200
1500
300
1500
Butabarbital
Butalbital
Butethal
Pentobarbital
Phenobarbital
400
300
450
400
450
300
400
Flunitrazepam
Flurazepam
300
300
1000
50,000
>100,000
50,000
100,000
300
2,000
2,000
1,000
5,000
100
5,000
50,000
25
(+/-)3,4-MDMA
l-Methamphetamine
Ephedrine
Mephentermine
3,000
10,000
>100,000
75,000
Methadol
1,500
Hydrocodone
Hydromorphone
Morphine-3-glucuronide
Nalorphine
4,000
5,000
2,500
5,000
Morphine
Codeine
Nalorphine
>100,000
50,000
5,000
Tenocyclidine
THC
11-nor-∆9-THC-9-COOH
11-hydroxy-∆9-THC
∆8-tetrahydrocannabinol
50
1,000
5,000
∆9-tetrahydrocannabinol
Cannabinol
Cannabidiol
Tricyclic Antidepressant
Nortriptyline
Nordoxepin
Trimipramine
Amitriptyline
1,000
2,000
2,000
1,500
Promazine
Desipramine
Doxepin
Maprotiline
D.
4,000
2,000
5,000
10,000
>100,000
1,500
400
3,000
2,000
Interference
Two pools of drug-free urine were spiked with drug standards to 50% below and 50%
above cutoff concentrations. The drug concentrations were confirmed by GC/MS. The
following compounds were evaluated for potential positive and/or negative
interference using the CLIAwaived™ Inc. RDTC Cup. All compounds were dissolved
™
in the spiked sample solutions and tested with the CLIAwaived Inc. RDTC Cup. An
unaltered sample was used as a control.
No positive interference or negative interference was found for the following
compounds when tested at concentrations up to 100 µg/ml.
Acetaminophen
Acetone
Acetylsalicylic Acid
Albumin
Ampicillin
Ascorbic Acid
Aspartame
Aspirin
Atropine
Benzocaine
Bilirubin
Caffeine
Chloroquine
(+)-Chlorpheniramine
(+/-)-Chlorpheniramine
Creatine
Dexbrompheniramine
Dextromethorphan
Conc. (ng/ml)
Amphetamine
d-Amphetamine
dl-Amphetamine
(+/-)3,4-MDA
Benzodiazepines
Oxazepam
Alprazolam
MDMA
(+/-)3,4-MDMA
(+/-)3,4-MDEA
Oxycodone
Oxycodone
Hydrocodone
Hydromorphone
Specificity
Conc.
(ng/ml)
300
Cocaine
Opiates
Morphine
Codeine
Ethylmorphine
Heroin(diacetylmorphine)
The specificity for the CLIAwaived™ Inc. RDTC Cup was determined by testing
various drugs, drug metabolites, and other compounds that are likely to be present in
urine. All compounds were prepared in drug-free normal human urine.
The following compounds produce positive results when tested at levels greater than
the concentrations listed below.
Compound
500
300
250
150
500
200
450
300
Methadone
(+/-) Methadone
A study was conducted at three physician offices and Ameditech in an effort to
determine the precision of the CLIAwaived™ Inc. RDTC Cup across three (3)
consecutive days. Testing was conducted on the methylenedioxymethamphetamine,
amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methamphetamine,
methadone, opiates, oxycodone, phencyclidine, and tricyclic antidepressants assays
using three different lots of product to demonstrate the within-run, between-run and
between-operator precision. An identical panel of coded samples, containing drugs at
specific concentrations around each assay cutoff was blinded and tested at each site.
The correlation with expected results for the solutions targeted to +/- 50% of the cutoff
was >99% across all lots, all sites and all operators.
Lorazepam
Medazepam
Nitrazepam
Nordiazepam
Prazepam
Temazepam
Triazolam
Cocaine
Benzoylecgonine
Methamphetamine
d-Methamphetamine
d-Amphetamine
l-Amphetamine
(+/-)3,4-MDEA
(+/-)3,4-MDA
Precision
250
300
1000
500
150
200
450
300
50,000
50,000
3
Diphenhydramine
Dopamine
(+/-)-Epinephrine
Erythromycin
Ethanol
Furosemide
Glucose
Guaiacol Glyceryl Ether
Hemoglobin
Ibuprofen
(+/-)-Isoproterenol
Ketamine
Levorphanol
Lidocaine
Myoglobin
(+)-Naproxen
Niacinamide
Nicotine
(+/-)-Norephedrine
Oxalic Acid
Penicillin-G
Pheniramine
Phenothiazine
l-Phenylephrine
β-Phenylethylamine
Procaine
Pseudoephedrine
Quinidine
Ranitidine
Riboflavin
Sodium Chloride
Sulindac
Theophylline
Tyramine
4-Dimethylaminoantipyrine
(1R,2S)-(-)-N-MethylEphedrine
E.
Effect of Specimen pH
Drug sample solutions with 50% below and 50% above cutoff concentrations were
adjusted to pH 4-9 and tested using the CLIAwaived™ Inc. RDTC Cup. An unaltered
sample was used as a control. The results demonstrate that varying ranges of specimen
pH do not interfere with the performance of the test.
F.
Effect of Specimen Specific Gravity
Drug sample solutions with 50% below and 50% above cutoff concentrations were
adjusted to specific gravity 1.003-1.04 and tested using the CLIAwaived™ Inc. RDTC
Cup. An unaltered sample was used as a control. The results demonstrate that varying
ranges of specimen specific gravity do not interfere with the performance of the test.
BIBLIOGRAPHY OF SUGGESTED READING
1. Baselt, R. C., Disposition of Toxic Drugs and Chemicals in Man, Biomedical
Publications, Davis, CA, 1982.
2. Urine testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA),
Research Monograph 73, 1986.
3. Fed. Register, Department of Health and Human Services, Mandatory Guidelines
for Federal Workplace Drug Testing Programs, 53, 69, 11970-11979, 1988.
4. Liu, Ray H. and Goldberger, Bruce A., Handbook of Workplace Drug Testing,
AACC Press (1995).
5. Gilman, A. G. and Goodman, L. S., The Pharmacological Basis of Therapeutics,
eds. MacMillan Publishing, New York, NY, 1980.
Distributed by:
San Diego, CA 92121
Protected by patent US 7,300,626; other rights granted and pending.
42141-CW-WP
Revision 1
4