E Z Cup - EZ
Split Drug Test Cup
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EZ Drug Test Cups
There are 2 basic types of urine drug test
cups. They are described below:
Millennium Drug Test Cups
Millennium Drug Test Cups have a screw lid.
Simply take the sample. Screw the lid shut. Uncap the test
compartment. Insert the Drug Test Card. Press the key.
Wait one minute and read the test. For more detailed information on
Millennium Drug Test Cups, click one of the links below.
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2 Panel Millennium Drug Test Cups |
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Description
MIL-201 - Cocaine & Marijuana
MIL-202 - Methamphetamines &
Marijuana
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3 Panel Millennium Drug Test Cups |
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Description
MIL-301 - Cocaine,
Methamphetamines & Marijuana
MIL-303 - Cocaine, Marijuana &
Opiates
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4 Panel Millennium Drug Test Cups |
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Description
MIL-401 - Cocaine,
Methamphetamines, Marijuana & Opiates
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5 Panel Millennium Drug Test Cup |
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Description
MIL-501 - Cocaine, Amphetamines,
Methamphetamines, Marijuana & Opiates
MIL-502 - Cocaine,
Methamphetamines, Marijuana, Opiates & Phencyclidine
MIL-503 - Cocaine, Amphetamine,
Marijuana, Opiates & Phencyclidine
MIL-506 - Cocaine,
Methamphetamines, Marijuana, Ecstasy & Opiates
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5 Panel Millennium Drug Test Cup with "Built In" Adulteration |
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Description
MIL-555 - Cocaine, Amphetamines,
Methamphetamines, Marijuana & Opiates
With "Built In"
Adulteration Test Strips
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6 Panel Millennium Drug Test Cups |
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Description
MIL-601 - Cocaine, Amphetamine,
Methamphetamines, Marijuana, Opiates & Phencyclidine
MIL-602 - Cocaine, Amphetamine,
Methamphetamines, Marijuana, Ecstasy & Opiates
MIL-603 - Cocaine,
Methamphetamines, Marijuana, Ecstasy, Opiates & Phencyclidine
MIL-604 - Cocaine, Amphetamines,
Methamphetamines, Marijuana, Opiates & Benzodiazepines
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8 Panel Millennium Drug Test Cups |
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Description
MIL-801 - Cocaine, Amphetamine,
Methamphetamines, Marijuana, Methadone, Opiates, Phencyclidine,
Barbiturates & Benzodiazepines
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9 Panel Millennium Drug Test Cups |
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Description
MIL-902 - Cocaine, Amphetamine,
Methamphetamines, Marijuana, Methadone, Opiates, Phencyclidine,
Barbiturates & Benzodiazepines
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10 Panel Millennium Drug Test Cups |
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Description
MIL-1001
- Cocaine, Amphetamine, Methamphetamines, Marijuana, Methadone,
Opiates, Phencyclidine, Barbiturates, Benzodiazepines & Tricyclic
Anti-Depressants
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10 Panel Millennium Drug Test Cups with "Built In" Adulteration |
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Description
MIL-1055
- Cocaine, Amphetamine, Methamphetamines, Marijuana, Methadone,
Opiates, Phencyclidine, Barbiturates, Benzodiazepines & Tricyclic
Anti-Depressants.
With "Built In"
Adulteration Tests Strips
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12 Panel Millennium Drug Test Cups |
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Description
MIL-1201
- Cocaine, Amphetamine, Methamphetamines, Marijuana, Methadone,
MDMA, Opiates, Oxycodone, Propoxyphene, Phencyclidine, Barbiturates
& Benzodiazepines
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E-Z Split Integrated Key Cups
The E-Z Split Key Cup comes with the drug
test "built in" to the drug test cup. Simply take the sample.
Snap the lid shut. Wait one minute and read the test. For more
detailed information on the E-Z Split Key Cup, click one of the links below.
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5 Panel Integrated Cup |
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Description
INT-501
- Cocaine, Amphetamine, Methamphetamines, Marijuana & Opiates
(SUPER SPECIAL --> INT-501 - NOW ONLY $9.95 click
here to order!)
NOW
CLIA Waived!
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5 Panel Integrated Cup with Adulteration Strip |
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Description
INT-555
- Cocaine, Amphetamine, Methamphetamine, Marijuana, & Opiates.
With "Built In"
Adulteration Test Strips
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6 Panel Integrated Cup |
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Description
INT-608
- Cocaine, Amphetamine, Methamphetamines, Marijuana, Opiates &
Oxycodone
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10 Panel Integrated Cups |
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Description
INT-1002
- Cocaine, Amphetamine, Methamphetamines, Marijuana, Methadone,
Opiates, Phencyclidine, Barbiturates, Benzodiazepines & Ecstasy
(SUPER SPECIAL -->INT-1002 - NOW ONLY $13.95 click
here to order!)
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Important Links:
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How To
Use - Complete instructions on how to use
various drug testing kits.
Instruction
Sheet for testing of any combination of the following drugs:
AMP/BAR/BZO/COC/THC/MTD/mAMP/MDMA/MOP/OPI/PCP/TCA |
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A rapid, one step screening test for the simultaneous, qualitative
detection of multiple drugs and drug metabolites in human urine. For
healthcare professionals and professionals at point of care sites. For
professional in vitro diagnostic use. |
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INTENDED USE |
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The One Step
Multi-Drug Screen Test Card with the integrated cup is a lateral flow
chromatographic immunoassay for the qualitative detection of multiple
drugs and drug metabolites in urine at the following cut-off
concentrations:
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Test
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Calibrator
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Cut-off
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Amphetamine (AMP)
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D-Amphetamine
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1,000 ng/mL
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Barbiturates (BAR)
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Secobarbital
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300 ng/mL
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Benzodiazepines (BZO)
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Oxazepam |
300 ng/mL
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Cocaine (COC)
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Benzoylecgonine
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300 ng/mL
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Marijuana (THC)
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11-nor-∆9-THC-9
COOH |
50 ng/mL
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Methadone (MTD)
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Methadone |
300 ng/mL
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Methamphetamine (mAMP)
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D-Methamphetamine
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1,000 ng/mL
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Methylenedioxymethamphetamine
(MDMA) |
D,L Methylenedioxymethamphetamine |
500 ng/mL
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Morphine (MOP 300)
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Morphine |
300 ng/mL
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Opiates (OPI 2000)
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Morphine |
2,000 ng/mL
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Phencyclidine (PCP)
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Phencyclidine
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25 ng/mL
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Tricyclic Antidepressants (TCA)
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Nortriptyline
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1,000 ng/mL
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Configurations of the One Step Multi-Drug Screen Test Card with
Integrated Cup come with any combination of the above listed drug
analytes. This assay provides only a preliminary analytical test result.
A more specific alternate 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 positive results are
indicated. |
| This assay
provides only a preliminary analytical test result. A more specific
alternate 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 positive results are used. |
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SUMMARY |
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AMPHETAMINE (AMP) |
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| Amphetamine is a
Schedule II controlled substance available by prescription (Dexedrine®)
and is also available on the illicit market. Amphetamines are a class of
potent sympathomimetic agents with therapeutic applications. They are
chemically related to the human body’s natural catecholamines:
epinephrine and norepinephrine. Acute higher does lead to enhanced
stimulation of the central nervous system and induce euphoria,
alertness, reduced appetite, and a sense of increased energy and power.
Cardiovascular responses to Amphetamines include increased blood
pressure and cardiac arrhythmias. More acute responses produce anxiety,
paranoia, hallucinations, and psychotic behavior. The effects of
Amphetamines generally last 2-4 hours following use, and the drug has a
halflife of 4-24 hours in the body. About 30% of Amphetamines are
excreted in the urine in unchanged form, with the remainder as
hydroxylated and deaminated derivatives. |
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| The AMP One Step
Amphetamine Test Strip is a rapid urine screening test that can be
performed without the use of an instrument. The test utilizes a
monoclonal antibody to selectively detect elevated levels of Amphetamine
in urine. The AMP One Step Amphetamine Test Strip yields a positive
result when Amphetamines in urine exceed 1,000 ng/mL. |
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BARBITURATES (BAR) |
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Barbiturates are
central nervous system depressants. They are used therapeutically as
sedatives, hypnotics, and anticonvulsants. Barbiturates are almost
always taken orally as capsules or tablets. The effects resemble those
of intoxication with alcohol. Chronic use of barbiturates leads to
tolerance and physical dependence.
Short acting Barbiturates taken at 400mg/day for 2-3 months produces a
clinically significant degree of physical dependence. Withdrawal
symptoms experienced during periods of drug abstinence can be severe
enough to cause death. |
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| Only a small
amount (less than 5%) of most Barbiturates are excreted unaltered in
urine. The approximate detection time limits for Barbiturates are: |
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Short Acting (e.g. Secobarbital) |
100 mg PO (oral) |
4 – 5 days |
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Long Acting (e.g. Phenobarbital |
400 mg PO (oral) |
7 days1 |
| The One Step
Drug Screen Test yields a positive result when the Barbiturates in urine
exceeds 300ng/ml. |
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BENZODIAZEPINES (BZO) |
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Benzodiazepines
are medications that are frequently prescribed for symptomatic treatment
of anxiety and sleep disorders. They produce their effects via specific
receptors involving a neurochemical called gamma aminobutyric acid
(GABA). Because they are safer and more effective, Benzodiazepines have
replaced barbiturates in the treatment of both anxiety and insomnia.
Benzodiazepines are also used as sedatives before some surgical and
medical procedures, and for the treatment of seizure disorders and
alcohol withdrawal.
Risk of physical dependence increases if Benzodiazepines are taken
regularly (e.g., daily) for more than a few months, especially at higher
than normal doses. Stopping abruptly can bring on such symptoms trouble
sleeping, gastrointestinal upset, feeling unwell, loss of appetite,
sweating and trembling, weakness, anxiety and changes in perception.
Only trace amounts (less than 1%) of most Benzodiazepines are excreted
unaltered in urine; most of the concentration in urine is conjugated
drug. The detection period for the Benzodiazepines in urine is 3 – 7
days.
The One Step Drug screen Test Card yields a positive result when the
Benzodiazepines in urine exceeds 300 ng/ml. |
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COCAINE (COC) |
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Cocaine is a
potent central nervous system (CNS) stimulant and a local anesthetic.
Initially, it brings about extreme energy and restlessness while
gradually resulting in tremors, over-sensitivity and spasms. In large
amounts, cocaine causes fever, unresponsiveness, and difficulty in
breathing and unconsciousness.
Cocaine is often self-administered by nasal inhalation, intravenous
injection and free-base smoking. It is excreted in the urine in a short
time primarily as Benzoylecgonine1,2. Benzoylecgonine, a
major metabolite of cocaine, has a longer biological half-life (5-8
hours) than cocaine (0.5-1.5 hours), and can generally be detected for
24-48 hours after cocaine exposure2.
The COC One Step Cocaine Test Strip is a rapid urine screening test that
can be performed without the use of an instrument. The test utilizes a
monoclonal antibody to selectively detect elevated levels of cocaine
metabolite in urine. The COC One Step Cocaine Test Strip yields a
positive result when the cocaine metabolite in urine exceeds 300 ng/mL.
This is the suggested screening cut-off for positive specimens set by
the Substance Abuse and Mental Health Services Administration (SAMHSA,
USA). |
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MARIJUANA (THC) |
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THC
(.9--tetrahydrocannabinol) is the primary active ingredient in
cannabinoids (marijuana). When smoked or orally administered, it
produces euphoric effects. Users have impaired short term memory and
slowed learning. They may also experience transient episodes of
confusion and anxiety. Long term relatively heavy use may be associated
with behavioral disorders. The peak effect of smoking marijuana occurs
in 20-30 minutes and the duration is 90-120 minutes after one cigarette.
Elevated levels of urinary metabolites are found within hours of
exposure and remain detectable for 3-10 days after smoking. The main
metabolite excreted in the urine is
11-nor-.9-tetrahydrocannabinol-9-carboxylic acid (.9-THC-COOH).
The THC One Step Marijuana Test Strip is a rapid urine screening test
that can be performed without the use of an instrument. The test
utilizes a monoclonal antibody to selectively detect elevated levels of
marijuana in urine. The THC One Step Marijuana Test Strip yields a
positive result when the concentration of marijuana in urine exceeds 50
ng/mL. This is the suggested screening cut-off for positive specimens
set by the Substance Abuse and Mental Health Services Administration
(SAMHSA, USA).
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METHADONE (MTD) |
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Methadone is a
narcotic pain reliever for medium to severe pain. It is also used in the
treatment of heroin (opiate dependence: Vicodin, Percocet, Morphine,
etc.) addiction. Oral Methadone is very different than IV Methadone.
Oral Methadone is partially stored in the liver for late use. IV
Methadone acts more like heroin. In most states you must go to a pain
clinic or a Methadone maintenance clinic to be prescribed Methadone.
Methadone is a long acting pain reliever producing effects that last
from twelve to forth-eight hours. Ideally, Methadone frees the client
from the pressures of obtaining illegal heroin, from the dangers of
injection and from the emotional roller coaster that most opiates
produce. Methadone, if taken for long periods and at large doses, can
lead to a very long withdrawal period. The withdrawals from Methadone
are more prolonged and troublesome than those provoked by heroin
cessation, yet the substitution and phased removal of methadone is an
acceptable method of detoxification for patients and therapists.1
The MTD One step Methadone test yields a positive result when Methadone
in urine exceeds 300 ng/ml. |
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METHAMPHETAMINE (mAMP) |
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Methamphetamine is an addictive stimulant drug that strongly activates
certain systems in the brain. Methamphetamine is closely related
chemically to amphetamine, but the central nervous system effects of
Methamphetamine are greater. Methamphetamine is made in illegal
laboratories and has a high potential for abuse and dependence. The drug
can be taken orally, injected, or inhaled. Acute higher does lead to
enhanced stimulation of the central nervous system and induce euphoria,
alertness, reduced appetite, and a sense of increased energy and power.
Cardiovascular responses to Methamphetamine include increased blood
pressure and cardiac arrhythmias. More acute responses produce anxiety,
paranoia, hallucinations, psychotic behavior, and eventually, depression
and exhaustion.
The effects of Methamphetamine generally last 2-4 hours and the drug has
a half-life of 9-24 hours in the body. Methamphetamine is excreted in
the urine primarily as amphetamine and oxidized and deaminated
derivatives. However, 10-20% of Methamphetamine is excreted unchanged.
Thus, the presence of the parent compound in the urine indicates
Methamphetamine use. Methamphetamine is generally detectable in the
urine for 3-5 days, depending on urine pH level.
The mAMP One Step Methamphetamine Test Strip is a rapid urine screening
test that can be performed without the use of an instrument. The test
utilizes a monoclonal antibody to selectively detect elevated levels of
Methamphetamine in urine. The mAMP One Step Methamphetamine Test Strip
yields a positive result when the Methamphetamine in urine exceeds 1,000
ng/mL.
METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
Methylenedioxymethamphetamine (ecstasy)
is a designer drug first synthesized in 1914 by a German drug
company for the treatment of obesity.8
Those who take the drug frequently report adverse
effects, such as increased muscle tension and sweating. MDMA
is not clearly a stimulant, although it has, in common with
amphetamine drugs, a capacity to increase blood pressure and heart
rate. MDMA does produce some perceptual changes in the form of
increased sensitivity to light, difficulty in focusing, and blurred
vision in some users. Its mechanism of action is thought to be via
release of the neurotransmitter serotonin. MDMA may also release
dopamine, although the general opinion is that this is a secondary
effect of the drug (Nichols and Oberlender, 1990). The most
pervasive effect of MDMA, occurring in virtually all people who took
a reasonable dose of the drug, was to produce a clenching of the
jaws. The One Step Drug Screen Test Card yields a positive
result when the Methylenedioxymethamphetamine in urine exceeds 500
ng/mL.
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OPIATE (300 ng/ml) (OPI 300 or MOP 300) |
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Opiate refers to
any drug that is derived from the opium poppy, including the natural
products, morphine and codeine, and the semi-synthetic drugs such as
heroin. Opioid is more general, referring to any drug that acts on the
opioid receptor.
Opioid analgesics comprise a large group of substances which control
pain by depressing the central nervous system. Large dose of morphine
can produce higher tolerance levels, physiological dependency in users,
and may lead to substance abuse. Morphine is excreted unmetabolized, and
is also the major metabolic product of codeine and heroin. Morphine is
detectable in the urine for several days after an opiate dose.4
The OPI One Step Opiate Test Strip is a rapid urine screening test that
can be performed without the use of an instrument. The test utilizes a
monoclonal antibody to selectively detect elevated levels of morphine in
urine. The OPI One Step Opiate Test Strip yields a positive result when
the morphine in urine exceeds 300 ng/mL. |
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OPIATE (OPI) (2000 ng/ml) |
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Opiate refers to
any drug that is derived from the opium poppy, including the natural
products, morphine and codeine, and the semi-synthetic drugs such as
heroin. Opioid is more general, referring to any drug that acts on the
opioid receptor.
Opioid analgesics comprise a large group of substances which control
pain by depressing the central nervous system. Large dose of morphine
can produce higher tolerance levels, physiological dependency in users,
and may lead to substance abuse. Morphine is excreted unmetabolized, and
is also the major metabolic product of codeine and heroin. Morphine is
detectable in the urine for several days after an opiate dose.4
The OPI One Step Opiate Test Strip is a rapid urine screening test that
can be performed without the use of an instrument. The test utilizes a
monoclonal antibody to selectively detect elevated levels of morphine in
urine. The OPI One Step Opiate Test Strip yields a positive result when
the morphine in urine exceeds 2,000 ng/mL. This is the suggested
screening cut-off for positive specimens set by the Substance Abuse and
Mental Health Services Administration (SAMHSA, USA). |
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PHENCYCLIDINE |
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Phencyclidine,
also known as PCP or Angel Dust, is a hallucinogen that was first
marketed as a surgical anesthetic in the 1950’s. It was removed from the
market because patients receiving it became delirious and experienced
hallucinations.
Phencyclidine is used in powder, capsule, and tablet form. The powder is
either snorted or smoked after mixing it with marijuana or vegetable
matter. Phencyclidine is most commonly administered by inhalation but
can be used intravenously, intra-nasally, and orally. After low doses,
the user thinks and acts swiftly and experiences mood swings from
euphoria to depression. Self-injurious behavior is one of the
devastating effects of Phencyclidine.
PCP can be found in urine within 4 to 6 hours after use and will remain
in urine for 7 to 14 days, depending on factors such as metabolic rate,
user’s age, weight, activity, and diet.5 Phencyclidine is excreted in
the urine as an unchanged drug (4% to 19%) and conjugated metabolites
(25% to 30%).6
The PCP One Step Phencyclidine Test Strip is a rapid urine screening
test that can be performed without the use of an instrument. The test
utilizes a monoclonal antibody to selectively detect elevated levels of
phencyclidine metabolite in urine. The PCP One Step Phencyclidine Test
Strip yields a positive result when the phencyclidine metabolite in
urine exceeds 25 ng/mL. This is the suggested screening cut-off for
positive specimens set by the Substance Abuse and Mental Health Services
Administration (SAMHSA, USA). |
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TRICYCLIC ANTIDEPRESSANT (TCA) |
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TCA (Tricyclic
Antidepressants) are commonly used for the treatment of depressive
disorders. TCA overdoses can result in profound central nervous system
depression, cardiotoxicity and anticholinergic effects. TCA overdose is
the most common cause of death from prescription drugs. TCAs are taken
orally or sometimes by injection. TCAs are metabolized in the liver.
Both TCAs and their metabolites are excreted in urine mostly in the form
of metabolites for up to ten days.
The One Step Drug Screen Tests yields a positive result when the
Tricyclic Antidepressant in urine exceeds 1,000 ng/ml. |
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PRINCIPLE |
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The One Step
Multi-Drug Screen Test Panel is an immunoassay based on the principle of
competitive binding. Drugs which may be present in the urine specimen
compete against their respective drug conjugate for binding sites on
their specific antibody.
During testing, a 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 show up in the test line region of the specific drug
strip. The presence of drug above the cut-off concentration will
saturate all the binding sites of the antibody. Therefore, the colored
line will not 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. |
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DIRECTIONS FOR USE |
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Allow
the test card, urine specimen, and/or controls to equilibrate to room
temperature (15-30°C)
prior to testing.
1. Bring
the pouch to room temperature before opening it. Remove the cup from the
sealed pouch and use it as soon as possible.
2. Donor
provides specimen and secures the cap by pressing down on all three
corners.
3. Technician
checks cap for tight seal. Technician dates and initials the security
seal and attaches the security seal over the cup cap.
4. On
a flat surface, technician pushes key to a fully closed position.
5. Peel
off the label on the multi-drug test card to view results. The test is
read in the reaction well.
6. Start the timer and
wait for the red lines to appear. The results should be read at 5
minutes. Results remain stable for up to sixty minutes. See the
illustration below. For detailed operation instructions, please refer to
the Procedure Card.
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INTERPRETATION OF RESULTS |
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(Please refer
to the illustration above)
NEGATIVE:*
Two lines appear. One red line
should be in the control region (C), and another apparent red or
pink line adjacent should be in the test region (Drug/T). This
negative result indicates that the drug concentration is below the
detectable level. *NOTE: The shade of red in the test line
region (Drug/T) will vary, but it should be considered negative
whenever there is even a faint pink line.
POSITIVE: One red line
appears in the control region (C). No line appears in the test region
(Drug/T). This positive result indicates that the drug concentration
is above the detectable level.
INVALID: Control line fails to appear. Insufficient specimen
volume or incorrect procedural techniques are the most likely reasons
for control line failure. Review the procedure and repeat the test using
a new test panel. If the problem persists, discontinue using the lot
immediately and contact your manufacturer. |
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REAGENTS |
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| The test panel
contains specific mouse monoclonal antibody, goat polyclonal antibody
and drug protein conjugates. |
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PRECAUTIONS |
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•
For healthcare professionals and professionals at point of care sites.
• For in vitro
diagnostic use only. Do not use after the expiration date.
• The test panel
should remain in the sealed pouch until use. |
• All specimens should be considered potentially hazardous and handled
in the same manner as an infectious agent.
• The used test
panel should be discarded according to federal, state and local
regulations |
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STORAGE AND STABILITY |
| Kit can be
stored at room temperature or refrigerated at 2-30°C. The test panel
is stable through the expiration date printed on the sealed pouch.
The test panel must remain in the sealed pouch until use. DO NOT
FREEZE. Do not use beyond the expiration date. |
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MATERIALS PROVIDED |
• Test
panels
• Package insert |
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MATERIALS REQUIRED BUT NOT PROVIDED |
• Specimen
collection container
• External controls
• Timer |
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PREPARATION URINE ASSAY |
| The urine
specimen must be collected in a clean and dry container. Urine
collected at any time of the day may be used. Urine specimens
exhibiting visible precipitates should be centrifuged, filtered, or
allowed to settle to obtain a clear supernatant for testing. |
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SPECIMEN STORAGE |
| Urine
specimens may be stored at 2-8°C for up to 48 hours prior to
testing. For prolonged storage, specimens may be frozen and stored
below -20°C. Frozen specimens should be thawed and mixed well before
testing. |
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QUALITY CONTROL |
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A procedural
control is included in the test. A colored line appearing in the control
region (C) is considered an internal procedural control. It confirms
sufficient specimen volume, adequate membrane wicking and correct
procedural technique.
Control standards are not supplied with this kit. However, it is
recommended that positive and negative controls be tested as good
laboratory practice to confirm the test procedure and to verify proper
test performance. |
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LIMITATIONS |
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1. The One Step
Multi-Drug Screen Test Panel provides only a qualitative, preliminary
analytical result. A secondary analytical method must be used to obtain
a confirmed result. Gas chromatography and mass spectrometry (GC/MS) is
the preferred confirmatory method. 3,4,7
2. There is a possibility that technical or procedural errors, as well
as other interfering substances in the urine specimen may cause
erroneous results.
3. 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.
4. A Positive result does not indicate level or intoxication,
administration route or concentration in urine.
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. Test does not distinguish between drugs of abuse and certain
medications. |
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PERFORMANCE CHARACTERISTICS - ACCURACY |
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| A side-by-side
comparison was conducted using The One Step Single Drug Test and
commercially available drug rapid tests. Testing was performed on
approximately 300 specimens previously collected from subjects
presenting for Drug Screen Testing. Presumptive positive results were
confirmed by GC/MS. The following compounds were quantified by GC/MS and
contributed to the total amount of drugs found in presumptive positive
urine samples tested. |
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TEST Compounds Contributed to the Totals of GC/MS
AMP Amphetamine
BAR Secobarbital,
Butalbital, Phenobarbital, Pentobarbital
BZO Oxazepam,
Nordiazepam, a-OH-Alprazolam, Desalklflurazepam
COC Benzoylecgonine
THC
11-nor-.9-tetrahydrocannabinol-carboxylic acid |
TEST Compounds Contributed to the Totals of GC/MS
MTD Methadone
mAMP Methamphetamine
OPI Morphine,
Codeine
PCP Phencyclidine
TCA Nortriptyline |
| The following
results are tabulated from these clinical studies: |
 |
 |
| Forty (40)
clinical samples for each drug were run using each of the One Step
Single Drug tests by an untrained operator at a Professional Point of
Care site. Based on GC/MS data, the operator obtained statistically
similar Positive Agreement, Negative Agreement and Overall Agreement
rates as trained Laboratory personnel. |
|
|
*Note: TCA was based on HPLC data. |
|
|
Precision |
|
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|
| A study was
conducted at three physician offices by untrained operators using three
different lots of product to demonstrate the within run, between run and
between operator precision. An identical panel of coded specimens,
containing drugs at the concentration of ± 50% and ± 25% cut-off level,
was labeled as a blind and tested at each site. The results are given
below: |
|
|
Analytical Sensitivity |
|
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|
| A drug-free
urine pool was spiked with drugs to the concentrations at ± 50% cut-off
and ± 25% cut-off. The results are summarized below. |
|
|
Drug conc. (Cut-off range) |
n |
AMP |
BAR |
BZO |
COC |
THC |
MTD |
mAMP |
OPI |
PCP |
TCA |
|
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
|
0% Cut-off |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
1 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-50% Cut-off |
30 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
29 |
1 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
|
-25% Cut-off |
30 |
30 |
0 |
27 |
3 |
26 |
4 |
30 |
0 |
12 |
1 |
24 |
6 |
30 |
0 |
30 |
0 |
19 |
11 |
22 |
8 |
|
Cut-off |
30 |
18 |
12 |
22 |
8 |
12 |
18 |
4 |
26 |
1 |
29 |
21 |
9 |
18 |
12 |
30 |
17 |
16 |
14 |
12 |
18 |
|
+25% Cut-off |
30 |
1 |
29 |
7 |
23 |
3 |
27 |
0 |
30 |
1 |
29 |
2 |
28 |
1 |
29 |
30 |
26 |
6 |
24 |
7 |
23 |
|
+50% Cut-off |
30 |
0 |
30 |
2 |
28 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
0 |
30 |
|
|
|
Analytical Specificity |
|
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|
| The following
table lists the concentration of compounds (ng/mL) that are detected
positive in urine by The One Step Multi-Drug Screen Test Panel at 5
minutes. |
|
|
AMPHETAMINE |
|
D-Amphetamine |
1,000 |
|
D,L-Amphetamine sulfate |
3,000 |
|
L-Amphetamine |
50,000 |
|
(±)3,4-Methylenedioxyamphetamine |
2,000 |
| Phentermine |
3,000 |
| Secobarbital |
300 |
| Amobarbital |
300 |
| Alphenol |
150 |
| Aprobarbital |
200 |
| Butalbital |
75 |
| Butethal |
2500 |
|
Cyclopentobarbital |
100 |
|
Pentobarbital |
600 |
|
Phenobarbital |
300 |
|
Benzodiazepines |
| Oxazepam |
300 |
| Alprazolam |
196 |
|
a-Hydroxyalprazolam |
1262 |
| Bromazepam |
1562 |
|
Chlordiazepoxide |
1562 |
|
Chlordiazepoxide HCI |
781 |
| Clobazam |
98 |
| Clonazepam |
781 |
| Clorazepate
dipotassium |
195 |
| Delorazepam |
1562 |
|
Desalkyflurazepam |
390 |
| Diazepam |
195 |
| Estazolam |
2500 |
|
Flunitrazepam |
390 |
| ( + )
Lorazepam |
1562 |
| RS-Lorazepam
glucuronide |
156 |
| Midazolam |
12500 |
| Nitrazepam |
98 |
|
Norchlordiazepoxide |
195 |
| Nordiazepam |
390 |
| Temazepam |
98 |
| Triazolam |
2500 |
| COCAINE |
ng/ml |
|
Benzoylecgonine |
300 |
| Cocaine HCl |
780 |
| Cocaethylene |
12,500 |
| Ecgonine HCl |
32,000 |
|
MARIJUANA (THC) |
| 11-nor-.9
-THC-9 COOH |
50 |
| Cannabinol |
20,000 |
| 11-nor-.8-THC-9
COOH |
30 |
| .8
-THC |
15,000 |
| .9
-THC |
15,000 |
|
|
Methadone |
| Methadone |
300 |
| Doxylamine |
50000 |
|
METHAMPHETAMINE |
|
D-Methamphetamine |
1,000 |
|
ñ-Hydroxymethamphetamine |
30,000 |
|
L-Methamphetamine |
8,000 |
|
(±)-3,4-Methylenedioxymethamphetamine |
2,000 |
|
Mephentermine |
50,000 |
| OPIATES |
ng/ml |
| Morphine |
2,000 |
| Codeine |
2,000 |
|
Ethylmorphine |
5,000 |
| Hydrocodone |
12,500 |
|
Hydromorphone |
5,000 |
| Levophanol |
75,000 |
|
6-Monoacetylmorphine |
5,000 |
| Morphine
3-â-D-glucuronide |
2,000 |
| Norcodeine |
12,500 |
| Normorphone |
50,000 |
| Oxycodone |
25,000 |
| Oxymorphone |
25,000 |
| Procaine |
150,000 |
| Thebaine |
100,000 |
|
PCP |
|
Phencyclidine |
25 |
|
4-Hydroxyphencyclidine |
12,500 |
|
TCA |
|
Nortriptyline |
1,000 |
| Nordoxepine |
1,000 |
| Trimipramine |
3,000 |
|
Amitriptyline |
1,500 |
| Promazine |
1,500 |
| Desipramine |
200 |
| Imipramine |
400 |
| Clomipramine |
12,500 |
| Doxepin |
2,000 |
| Maprotiline |
2,000 |
| Promethazine |
25,000 |
|
|
|
|
Effect of Urinary Specific Gravity |
|
Back To Top |
|
|
Fifteen (15) urine samples of normal, high, and low specific gravity
ranges (1.000-1.037) were spiked with drugs at 50% below and 50% above
cut-off levels respectively. The Multi-Drug Screen Test was tested in
duplicate using fifteen drug-free urine and spiked urine samples. The
results demonstrate that varying ranges of urinary specific gravity does
not affect the test results. |
|
|
Effect of the Urinary pH |
|
Back To Top |
|
| The
pH of an aliquoted negative urine pool was adjusted to a pH range of 5
to 9 in 1 pH unit increments and spiked with drugs at 50% below and 50%
above cut-off levels. The spiked, pH-adjusted urine was tested with The
One Step Multi-Drug Screen Test Panel. The results demonstrate that
varying ranges of pH does not interfere with the performance of the
test. |
|
|
Cross-Reactivity |
|
Back To Top |
|
| A
study was conducted to determine the cross-reactivity of the test with
compounds in either drug-free urine or Cocaine, Amphetamine,
Methamphetamine, Marijuana, Opiate or Phencyclidine positive urine. The
following compounds show no cross-reactivity when tested with the One
Step Multi-Drug Screen Test Panel at a concentration of 100 µg/mL. |
|
|
Non Cross-Reacting Compounds |
|
Back To Top |
|
| Acetaminophen |
Deoxycorticosterone |
Loperamide |
Promazine |
| Acetophenetidin |
Dextromethorphan |
Maprotiline |
Promethazine |
|
N-Acetylprocainamide |
Diazepam |
MDE |
DL-Propranolol |
| Acetylsalicylic
acid |
Diclofenac |
Meperidine |
D-Propoxyphene |
| Aminopyrine |
Diflunisal |
Meprobamate |
D-Pseudoephedrine |
| Amitryptyline |
Digoxin |
Methadone |
Quinacrine |
| Amoxicillin |
Diphenhydramine |
Methoxyphenamine |
Quinidine |
| Ampicillin |
Doxylamine |
Nalidixic acid |
Quinine |
| L-Ascorbic acid |
(-) -Ø-Ephedrine |
Naloxone |
Ranitidine |
| DL-Amphetamine
sulfate |
â-Estradiol |
Naltrexone |
Salicylic acid |
| Apomorphine |
Estrone-3-sulfate |
Naproxen |
Serotonin |
| Aspartame |
Ethyl-p-aminobenzoate |
Niacinamide |
Sulfamethazine |
| Atropine |
[1R,2S] (-)
Ephedrine |
Nifedipine |
Sulindac |
| Benzilic acid |
(L) –
Epinephrine |
Norethindrone |
Temazepam |
| Benzoic acid |
Erythromycin |
D-Norpropoxyphene |
Tetracycline |
| Benzphetamine |
Fenoprofen |
Noscapine |
Tetrahydrocortisone, 3-acetate |
| Bilirubin |
Furosemide |
DL-Octopamine |
Tetrahydrocortisone 3- |
| (±) –
Brompheniramine |
Gentisic acid |
Oxalic acid |
(â-D-glucuronide) |
| Caffeine |
Hemoglobin |
Oxazepam |
Tetrahydrozoline |
| Cannabidiol |
Hydralazine |
Oxolinic acid |
Thiamine |
| Chloralhydrate |
Hydrochlorothiazide |
Oxymetazoline |
Thioridazine |
| Chloramphenicol |
Hydrocortisone |
Papaverine |
DL-Tyrosine |
| Chlorothiazide |
O-Hydroxyhippuric acid |
Penicillin-G |
Tolbutamide |
| (±) –
Chlorpheniramine |
p-Hydroxyamphetamine |
Pentazocine
hydrochloride |
Triamterene |
| Chlorpromazine |
3-Hydroxytyramine |
Perphenazine |
Trifluoperazine |
| Chlorquine |
Ibuprofen |
Phenelzine |
Trimethoprim |
| Cholesterol |
Imipramine |
Trans-2-phenylcyclo-propylamine |
Trimipramine |
| Clomipramine |
Iproniazid |
hydrochloride |
Tryptamine |
| Clonidine |
(±) –
Isoproterenol |
L-Phenylephrine |
DL-Tryptophan |
| Cortisone |
Isoxsuprine |
â-Phenylethylamine |
Tyramine |
| (-) Cotinine |
Ketamine |
Phenylpropanolamine |
Uric acid |
| Creatinine |
Ketoprofen |
Prednisolone |
Verapamil |
| |
Labetalol |
Prednisone |
Zomepirac |
1. Stewart DJ,
Inaba T, Lucassen M, Kalow W. Clin Pharmacol. Ther, April 1979; 25 ed:
464, 264-8
2. Ambre J. J. Anal. Toxicol. 1985; 9:241
3. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National
Institute for Drug Abuse (NIDA), Research Monograph 73, 01986; 1735.
4. Tietz NA. Textbook of Clinical Chemistry. W.B. Saunders Company.
1986; 1735.
5. FDA Guidance Document: Guidance for Premarket Submission for Kits for
Screening Drugs of Abuse to be used by the Consumer, 199.
6. Robert DeCresce. Drug Testing in the workplace, 114.
7. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd
ED. Biomedical Publ., Davis, CA 1982; 487.
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