Q3 Innovations DrugHAWK ECO Cup User Manual
One Step Drug Test
Package Insert for Multi Drug Screen Test cup
This Instruction Sheet is for testing of any combination of Amphetamine, Barbiturates, Benzodiazepines, Cocaine,
Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone,
Phencyclidine and Tricyclic Antidepressants.
Including Adulterant Tests (Specimen Validity Tests) for:
Oxidants (OX), Specific Gravity (S.G) and pH.
A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites
For Professional and In Vitro Diagnostic Use Only.
The ECO CUP™ One Step Drug Test 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
Amphetamine(AMP)
Barbiturates(BAR)
Benzodiazepines(BZO)
Cocaine(COC)
Marijuana(THC)
Methadone(MTD)
Methamphetamine(mAMP)
MDMA (Ecstasy)
Opiate 300 (OPI 300,MOP,MOR)
Opiate 2000 (OPI 2000)
Oxycodone (OXY)
Phencyclidine (PCP)
Tricyclic Antidepressants (TCA)
Configurations of the
drug analytes. This assay provides only a preliminary qualitative test result. Use a more specific alternate
quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry
(GC/MS) is the preferred confirmatory method.1 Apply clinical and professional judgment to any drug of abuse
test result, particularly when preliminary positive results are obtained.
ECO CUP™ One Step Drug Test can consist of any combination of the above listed
SUMMARY AND EXPLANATION OF THE TEST
The ECO CUP™ One Step Drug Test is a competitive immunoassay utilizing highly specific reactions
between antibodies and antigens for the detection of multiple drugs and drug metabolites in human urine.
ECO CUP™ One Step Drug Test is a rapid urine screening test that utilizes monoclonal
The
antibodies to selectively detect elevated levels of specific drugs in urine without the use of an instrument.
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
stimulation of
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
PN: Y0311111901
Amphetamines are excreted in the urine in unchanged form, with the remainder as hydroxylated
and deaminated derivatives.
The ECO CUP™ One Step Drug Test 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).
the central nervous system and induce euphoria, alertness, reduced appetite, and a
in human urine.
INTENDED USE
Calibrator
D-Amphetamine
Secobarbital
Oxazepam
Benzoylecgonine
9
-THC-9 COOH
11-nor-∆
Methadone
D-Methamphetamine
D,L-Methylenedioxymethamphetamine
Morphine
Morphine
Oxycodone
Phencyclidine
Nortriptyline
1,000 ng/mL
300 ng/mL
300 ng/mL
300 ng/mL
50 ng/mL
300 ng/mL
1,000 ng/mL
500 ng/mL
300 ng/mL
2,000 ng/mL
100 ng/mL
25 ng/mL
1,000 ng/mL
lead to enhanced
3
Cut-off
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 days
The ECO CUP™ One Step Drug Test
yields a positive result when the Barbiturates in urine
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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 ECO CUP™ One Step Drug Test 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
and spasms.
In large amounts, cocaine causes fever, unresponsiveness, difficulty in breathing and
resulting in tremors, over-sensitivity
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.
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.
2
The ECO CUP™ One Step Drug Test 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).
MARIJUANA (THC)
9
THC (∆
-tetrahydrocannabinol) is the primary active ingredient in cannabis (marijuana). When
3
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
urine is 11-nor-∆
9
-tetrahydrocannabinol-9-carboxylic acid ( ∆9-THC-COOH).
3-10 days after smoking. The main metabolite excreted in the
The ECO CUP™ One Step Drug Test yields a positive result when the concentration of THCCOOH 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).
3
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.
4
The ECO CUP™ One Step Drug Test 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
Methamphetamine is
excreted unchanged. Thus, the presence of the parent compound in the
and delaminated derivatives. However, 10-20% of
urine indicates Methamphetamine use. Methamphetamine is generally detectable in the urine for
3-5 days, depending on urine pH level.
The ECO CUP™ One Step Drug Test yields a positive result when the Methamphetamine in
urine exceeds 1,000 ng/mL.
MDMA (Ecstasy)
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 ECO CUP™ One Step Drug T
est yields a positive result when the
Methylenedioxymethamphetamine in urine exceeds 500 ng/mL.
1.2
OPIATE (OPI 300,MOP
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,
,MOR)
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.
4
The ECO CUP™ One Step Drug Test yields a positive result when the concentration of opiate
exceeds the 300 ng/mL cut-off level.
OPIATE (OPI 2000)
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
detectable in the urine for several days after an opiate dose.
3
and heroin. Morphine is
The ECO CUP™ One Step Drug Test 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).
OXYCODONE (OXY)
Oxycodone, [4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-morphinan-6-one,
dihydrohydroxycodeinone] is a semi-synthetic opioid agonist derived from thebaine, a constituent
of opium. Oxycodone is a Schedule II narcotic analgesic and is widely used in clinical medicine.
The pharmacology of oxycodone is similar to that of morphine, in all respects, including its abuse
and dependence liabilities. Pharmacological effects include analgesia, euphoria, feelings of
relaxation, respiratory depression, constipation, papillary constriction, and cough suppression.
Oxycodone is prescribed for the relief of moderate to high pain under pharmaceutical trade names
as OxyContin® (controlled release), OxyIR®, OxyFast®(immediate release formulations), or
Percodan® (aspirin) and Percocet® (acetaminophen) that are in combination with
nonnarcotic analgesics.
release product, OxyContin®, has a longer duration of action (8-12 hours).
The ECO CUP™ One Step Drug Test yields a positive result when the Oxycodone in urine
exceeds 100 ng/mL.
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
6
30%).
The ECO CUP™ One Step Drug Test 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
TRICYCLIC ANTIDEPRESSANTS (TCA)
(Tricyclic Antidepressants) are commonly used for the treatment of depressive disorders.
TCA
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 ECO CUP™ One Step Drug Test yields a positive result when the concentration of Tricyclic
Antidepressants in urine exceeds 1,000 ng/mL.
Oxycodone's behavioral effects can last up to 5 hours. The controlled-
Administration (SAMHSA, USA).
other
ADULTERANT TESTS (SPECIMEN VALIDITY TESTS) SUMMARY
The Adulterant Test Strip contains chemically treated reagent pads. Observation of the color
change on the strip compared to the color chart provides a semi-quantitative screen for oxidants,
specific gravity and pH in human urine which can help to assess the integrity of the urine
specimen.
ADULTERATION
Adulteration is the tampering of a urine specimen with the intention of altering the test results. The
use of adulterants in the urine specimen can cause false negative results by either interfering with
the test and/or destroying the drugs present in the urine. Dilution may also be used to produce
false negative drug test results. To determine certain urinary characteristics such as specific
gravity and pH, and to detect the presence of oxidants in urine are considered to be the best ways
to test for adulteration or dilution.
•
Oxidants (OX): Tests for the presence of oxidizing agents such as bleach and peroxide in the
urine.
• Specific Gravity (S.G.): Tests for sample dilution. Normal levels for specific gravity will range
from 1.003 to 1.030. Specific gravity levels of less than 1.003 or higher than 1.030 may be an
indication of adulteration or specimen dilution.
• pH: tests for the presence of acidic or alkaline adulterants in urine. Normal pH levels should be
in the range of 4.0 to 9.0. Values below pH 4.0 or above pH 9.0 may indicate the sample has
been altered.
PRINCIPLE
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The ECO CUP™ One Step Drug Test
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
is an immunoassay based on the principle of competitive
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, Benzodiazepines, Methadone, Barbiturates, Tricyclic Antidepressants or
Oxycodone.
ADULTERANT TESTS (SPECIMEN VALIDITY TESTS) REAGENTS
Adulteration Pad
Oxidants (OX)
Specific Gravity (S.G.)
pH
Reactive Indicator
0.36%
0.25%
0.06%
Buffers and Non-reactive Ingredients
99.64%
99.75%
99.94%
PRECAUTIONS
• For Professional Use Only.
• For In Vitro Diagnostic Use Only.
• Do not use after the expiration date.
• The test panel should remain in the sealed pouch until use.
• The test is for single use.
• While urine is not classified by OSHA or the CDC as a biological hazard unless visibly
contaminated with blood8,9, the use
with the specimen.
The used test card and urine specimen should be discarded according to federal, state and local
•
regulations.
of gloves is recommended to avoid unnecessary contact
STORAGTE AND STABILITY
Store as packaged in the sealed pouch at 2-30°C (36-86°F). The test is stable through the
expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until
use. DO NOT FREEZE. Do not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARATION
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 allowed to settle to
obtain a clear specimen for testing.
Urine specimens may be stored at 2-8°C (36-46°F) 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.
Urine Assay
Specimen Storage
MATERIALS
Materials Provided
• Package insert • Procedure Card• Test cup • Disposable gloves
• Color Chart Card for Adulterant Interpretation (when applicable)
Materials Required But Not Provided
· Timer
• Security seal label
DIRECTIONS FOR USE
Allow the test cup to come to room temperature [15-30oC (59-86oF)] prior to testing.
1) Tear the foil bag open, remove test cup and disposable gloves provided for donor. Label the
device with donor information.(Fig. 1)
2) Wear disposable gloves to collect urine specimen. Open test cup lid. Urinate directly into the
test cup. Be sure to fill up the test cup with the urine specimen between minimum 30ml to
maximum 70ml (marked on the cup).(Fig. 2)
3) After urine specimen has been collected, close the lid securely and return cup to collection
official.(Fig. 3)
4) Collection official use glove provided. Peel off label to reveal test result. Read test result at 5
minutes. DO NOT INTERPRET RESULT AFTER 10 MINUTES.
(Fig. 1)
C
T
(Fig. 4)
NEGATIVE POSITIVE INVALID
(Fig. 4)
5
)3 .giF()2 .giF(
C
T
C
T
INTERPRETATION OF RESU
(Please refer to the previous illustration)
NEGATIVE: Two lines appear. * One color line should be in the control region (C), and another
apparent color line adjacent should be in the test region (T). This negative result indicates that the
drug concentration is below the detectable level.
*NOTE: The shade of color in the test line region (T) will vary, but it should be considered negative
whenever there is even a faint distinguishable color line.
POSITIVE: One color line appears in the control region (C). No line appears in the test region (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 device. If the problem persists, discontinue using the lot immediately and
contact your supplier.
ADULTERANT TESTS (SPECIMEN VALIDITY TESTS) INTEPRETATION
(Please refer to the color chart)
Semi-quantitative results are obtained by visually comparing the reacted color blocks on the strip
to the printed color indicator on the color chart. No instrumentation is required.
ADULTERANT TESTS (SPECIMEN VALIDITY TESTS) LIMITATIONS
1. The adulterant tests included with the product are meant to aid in the determination of abnormal
specimens, but may not cover all the possible adulterants.
2. Oxidants: Normal human urine should not contain oxidants. The presence of high level of
antioxidants in
oxidants pad..
3. Specific Gravity: Elevated levels of protein in urine may cause abnormally high specific gravity
values.
the specimen, such as ascorbic acid, may result in false negative results for the
QUALITY CONTROL
A procedural control is included in the test. A color line appearing in the control region (C) is
considered an internal procedural control. It confirms sufficient specimen volume, adequate
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