Five Panel ECO Cup

The 5 Panel ECO Cup is a one step screening test for the simultaneous, qualitative detection of multiple detection of multiple drug Metabolites in human urine. The current configuration tests for THC/COC/AMP/OPI/PCP.

Drugs of detection:

Five Panel ECO Cup II

The Eco-Cup II is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine.

The multi-drug configurations test for any of the following analytes: Methamphetamine, Amphetamine, Barbiturates, Benzodiazepines, Cocaine Metabolites, Marijuana (THC), Methadone, Opiates (300 ng/mL cut-off), Phencyclidine, and Tricyclic Antidepressants (TCA).

The Eco-Cup II drug screen device is FDA 510(k) cleared to market and is ideal for pre-employment, corrections, clinical and hospital use.

• Available tests include: *AMP, M-AMP, BAR, BZO, COC, MTD, OPI, PCP, TCA and THC.
• Self contained cup minimizes collector exposure to urine
• Performance comparable to laboratory screening methods
• Results in 5 minutes
• Flexible 4-6, and 10 drug test combinations
• FDA 510(k) cleared to market
• NIDA 5 cut-off levels meet SAMHSA guidelines (Opiates 300 ng/mL)

Eco II Cup^™ is a convenient, single-step drug screening kit that selectively detects elevated levels of specific drugs and their metabolites in human urine within 5 minutes from the collection of specimen.

This drug test kit is FDA 510k approved. As a privacy feature, the test panel remains concealed from view until the security strip is peeled-off by the testing officer. It comes equipped with a temperature strip to guard against specimen substitution. Specimen collection is also made easier and less messy with a wider cup opening.

The Eco II CUP™ 12-Panel Test Cup tests for the following illegal drugs and/or prescription drugs and their metabolites.

Advantages of Using the ECO II Cup 12

• Privacy - K2 spice or synthetic marijuana has dangerously grown in popularity among teenagers and concerned parents and school administrators are constantly looking for ways to test for drug use as discreetly as they can manage it. This one-step test kit conveniently allows them to do just that.

• Safety and Security Features - This 12-panel test cup comes with sterile handling gloves, a temperature strip to guard against specimen substitution and a security seal to keep the results concealed from other people before a testing officer is ready to read them.

• Value for money - this drug test kit enables employers to test for 12 substances at once and get accurate results within minutes. It saves them the additional cost of screening for other drugs and/or waiting for the lab to get back with results.

Six Panel ECO Cup III

Product Features

Instructions for ECO CUP, ECO II CUP & ECO III CUP

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 in human urine.

For Professional and In Vitro Diagnostic Use Only.

INTENDED USE

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:

Configurations of the ECO CUP^™ One Step Drug Test can consist of any combination of the above listed 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.

SUMMARY AND EXPLANATION OF THE TEST

Configurations of the ECO CUP^™ One Step Drug Test can consist of any combination of the above listed 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.

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 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). 3

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 4
The ECO CUP™ One Step Drug Test 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 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 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. 1.2
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 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). 3

MARIJUANA (THC)

THC (∆⁹-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-∆⁹-tetrahydrocannabinol-9-carboxylic acid ( ∆⁹-THC-COOH).
The ECO CUP™ One Step Drug Test 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). 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 and delaminated 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 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 Test yields a positive result when the
Methylenedioxymethamphetamine in urine exceeds 500 ng/mL.

OPIATE (OPI 300,MOP,MOR)

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. 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 and heroin. Morphine is detectable in the urine for several days after an opiate dose. 3
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 other nonnarcotic analgesics. Oxycodone's behavioral effects can last up to 5 hours. The controlledrelease 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
30%). 6
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 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 ECO CUP^™ One Step Drug Test yields a positive result when the concentration of Tricyclic Antidepressants in urine exceeds 1,000 ng/mL.

ADULTERANT TESTS (SPECIMEN VALIDITY TESTS) REAGENTS

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

The ECO CUP^™ One Step Drug Test 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, Benzodiazepines, Methadone, Barbiturates, Tricyclic Antidepressants or Oxycodone.

ADULTERANT TESTS (SPECIMEN VALIDITY TESTS) REAGENTS

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 of gloves is recommended to avoid unnecessary contact with the specimen.
• The used test card and urine specimen should be discarded according to federal, state and local regulations.

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

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 allowed to settle to obtain a clear specimen for testing.

Specimen Storage

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.

MATERIALS

Materials Provided

• Test cup
• Disposable gloves
• Package insert
• Procedure Card
• Security seal label
• Color Chart Card for Adulterant Interpretation (when applicable)

Materials Required But Not Provided

• Timer

INTERPRETATION OF RESULTS

(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
3. Specific Gravity: Elevated levels of protein in urine may cause abnormally high specific gravity values.

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 membrane wicking and correct procedural technique.

LIMITATIONS

1. The ECO CUP^™ One Step Drug Test 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.
2. There is a possibility that technical or procedural errors, as well as other interfering substances %Agreement with GC/MS Marijuana(THC) 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 and a new test device.
4. A Positive result does not indicate intoxication of the donor, the concentration of drug in the urine, or the route of drug administration.
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.
7. A positive test result may be obtained from certain foods or food supplements.