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5 Panel Split Specimen Cup
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$9.99
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NM-1257
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Features
Technical Specs
Instruction Sheet for testing of any combination of the following drugs:
AMP/BAR/BZO/COC/THC/MTD/mAMP/MDMA/MOP/OPI/PCP/TCA
Some cup configurations are available with adulteration strips that may include tests for
Oxidants/Pyridinium Chlorochromate, pH and Specific Gravity, Nitrite, Glutaraldehyde and Creatinine
A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug
metabolites in human urine.
For healthcare professionals including professionals at point of care sites.
Immunoassay for in vitro diagnostic use only.
INTENDED USE
The Split-Specimen CupTM is a lateral flow chromatographic immunoassay for the qualitative detection of multiple
drugs and drug metabolites in urine at the following cut-off concentrations:
Test Calibrator Cut-off
Amphetamine (AMP) D-Amphetamine 1,000 ng/mL
Barbiturates (BAR) Secobarbital 300 ng/mL
Benzodiazepines (BZO) Oxazepam 300 ng/mL
Cocaine (COC) Benzoylecgonine 300 ng/mL
Marijuana (THC) 11-nor-Δ9-THC-9 COOH 50 ng/mL
Methadone (MTD) Methadone 300 ng/mL
Methamphetamine (mAMP) D-Methamphetamine 1,000 ng/mL
Methylenedioxymethamphetamine
(MDMA) D,L-Methylenedioxymethamphetamine 500 ng/mL
Morphine (MOP 300) Morphine 300 ng/mL
Opiates (OPI 2000) Morphine 2,000 ng/mL
Phencyclidine (PCP) Phencyclidine 25 ng/mL
Tricyclic Antidepressants (TCA) Nortriptyline 1,000 ng/mL
Configurations of the Split-Specimen CupTM 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.
SUMMARY
The Split-Specimen CupTM is a rapid urine screening test that can be performed without the use of an instrument.
The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine.
AMPHETAMINE (AMP)
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 doses 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 half-life 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.
The Split-Specimen CupTM yields a positive result when Amphetamines in urine exceed 1,000 ng/mL. This is the
suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services
Administration (SAMHSA, USA). 4
BARBITURATES (BAR)
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 400 mg/day for 2-3 months can produce a clinically significant degree of
physical dependence. Withdrawal symptoms experienced during periods of drug abstinence can be severe
enough to cause death.
Only a small amount (less than 5%) of most Barbiturates are excreted unaltered in the urine.
The approximate detection time limits for Barbiturates are:
Short acting (e.g. Secobarbital) 100 mg PO (oral) 4.5 days
Long acting (e.g. Phenobarbital) 400 mg PO (oral) 7 days1
The Split Specimen CupTM yields a positive result when the Barbiturates in urine exceed 300 ng/mL.
BENZODIAZEPINES (BZO)
Benzodiazepines are medications that are frequently prescribed for the 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 as trouble
sleeping, gastrointestinal upset, feeling unwell, loss of appetite, sweating, trembling, weakness, anxiety and
changes in perception.
Only trace amounts (less than 1%) of most Benzodiazepines are excreted unaltered in the urine; most of the
concentration in urine is conjugated drug. The detection period for the Benzodiazepines in the urine is 3-7 days.
The Split-Specimen CupTM yields a positive result when the Benzodiazepines in urine exceed 300 ng/mL.
COCAINE (COC)
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, 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 Benzoylecgonine 2,3. 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 exposure.3
The Split-Specimen CupTM 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). 4
MARIJUANA (THC)
THC (Δ9--tetrahydrocannabinol) is the primary active ingredient in cannabis (marijuana). When smoked or orally
administered, THC 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 marijuana administered by smoking 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-Δ9-tetrahydrocannabinol-9-carboxylic acid (Δ9-THC-COOH).
The Split-Specimen CupTM yields a positive result when the concentration of THC-COOH 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). 4
METHADONE (MTD)
Methadone is a narcotic analgesic prescribed for the management of moderate to severe pain and for the
treatment of opiate dependence (heroin, Vicodin, Percocet, Morphine). The pharmacology of oral Methadone is
very different from IV Methadone. Oral Methadone is partially stored in the liver for later 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 forty-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 Split-Specimen CupTM yields a positive result when the Methadone in urine exceeds 300 ng/mL.
METHAMPHETAMINE (mAMP)
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 doses 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 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 Split-Specimen CupTM 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 Split-Specimen CupTM yields a positive result when
the Methylenedioxymethamphetamine in urine exceeds 500 ng/mL.
MORPHINE (MOP 300)
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 doses 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. 1
The Split-Specimen CupTM yields a positive result when the concentration of opiate exceeds the 300 ng/mL cutoff
level.
OPIATE (2000)
The Split-Specimen CupTM 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). 4 See Morphine (MOP 300) for a summary.
PHENCYCLIDINE (PCP)
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 Split-Specimen CupTM yields a positive result when the phencyclidine level 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).
TRICYCLIC ANTIDEPRESSANTS (TCA)
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 Split-Specimen CupTM yields a positive result when the concentration Tricyclic Antidepressants in urine
exceeds 1,000 ng/mL.
PRINCIPLE
The Split-Specimen CupTM 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.
REAGENTS
The test contains a membrane strip coated with drug-protein conjugates (purified bovine albumin) on the test
line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains
colloidal gold particles coated with mouse monoclonal antibody specific to Amphetamine, Cocaine,
Methamphetamine, Methylenedioxymethamphetamine, Morphine, THC, Phencyclidine, Benzodiazepine,
Methadone, Barbiturate or Tricyclic Antidepressants.
PRECAUTIONS
• For healthcare professionals including professionals at point of care sites.
• Immunoassay 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 card should be discarded according to federal, state and local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at 2-30°C. The test is stable through the expiration date printed on the
sealed pouch. The test devices must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond
the expiration date.
SPECIMEN COLLECTION AND 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 specimen for testing.
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.
MATERIALS
Materials Provided
• The Split-Specimen Cup™
• The Split-Specimen™ Cup has a Fahrenheit temperature strip affixed to aid in the determination of specimen
validity. Please use this temperature strip in conjunction with your Drug Free Policy (if applicable).
• Key
• Adulterant color chart (if applicable)
• Security seal
• Package insert
Materials Required But Not Provided
• Timer
• External controls
Features
Drugs Tested:
Cocaine
Methamphetamines
Marijuana
Opiates
Amphetamines
Test Features:
Split Specimen Cup
4 Panel Drug Cup Employee Drug Test
Workplace Drug Test
Key Triggered System
E-Z Split Cup
On-site Drug Testing
Mobile Drug Testing
Split Specimen
CLIA Waived Drug Testing
Rapid Drug Test Cup
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