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One Step Multi-Drug Screen Test Card
common with amphetamine drugs, a capacity to increase blood pressure and heart rate. MDMA does
Benzodiazepines are medications that are frequently prescribed for the symptomatic treatment of anxiety
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
with Integrated E-Z Split Key™ Cup
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
serotonin. MDMA may also release dopamine, although the general opinion is that this is a secondary
replaced barbiturates in the treatment of both anxiety and insomnia. Benzodiazepines are also used as
effect of the drug (Nichols and Oberlender, 1990). The most pervasive effect of MDMA, occurring in
Instruction Sheet for testing of any combination of the following drugs:
sedatives before some surgical and medical procedures, and for the treatment of seizure disorders and
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
Risk of physical dependence increases if Benzodiazepines are taken regularly (e.g., daily) for more than
A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and
a few months, especially at higher than normal doses. Stopping abruptly can bring on such symptoms as
drug metabolites in human urine.
trouble sleeping, gastrointestinal upset, feeling unwell, loss of appetite, sweating, trembling, weakness,
OPIATE (MOP 300)
Opiate refers to any drug that is derived from the opium poppy, including the natural products, morphine
For healthcare professionals including professionals at point of care sites.
Only trace amounts (less than 1%) of most Benzodiazepines are excreted unaltered in the urine; most of
and codeine, and the semi-synthetic drugs such as heroin. Opioid is more general, referring to any drug
the concentration in urine is conjugated drug. The detection period for the Benzodiazepines in the urine
For in vitro diagnostic use only.
Opioid analgesics comprise a large group of substances which control pain by depressing the central
The One Step Drug Screen Test Card yields a positive result when the Benzodiazepines in urine exceed
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
The One Step Multi-Drug Screen Test Card with the integrated cup is a lateral flow chromatographic
metabolic product of codeine and heroin. Morphine is detectable in the urine for several days after an
immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the following
Cocaine is a potent central nervous system (CNS) stimulant and a local anesthetic. Initially, it brings
The One Step Drug Screen Test Card yields a positive result when the concentration of opiate exceeds the 300 ng/mL cut-off level.
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
The One Step Drug Screen Test Card yields a positive result when the morphine in urine exceeds 2,000
metabolite of cocaine, has a longer biological half-life (5-8 hours) than cocaine (0.5-1.5 hours), and can
ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and
generally be detected for 24-48 hours after cocaine exposure.3
Mental Health Services Administration (SAMHSA, USA). 4 See opiate (MOP 300) for a summary.
The One Step Drug Screen Test Card 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
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
THC (∆9--tetrahydrocannabinol) is the primary active ingredient in cannabis (marijuana). When smoked or
Phencyclidine is used in powder, capsule, and tablet form. The powder is either snorted or smoked after
Morphine (MOP 300)
orally administered, THC produces euphoric effects. Users have impaired short term memory and slowed
mixing it with marijuana or vegetable matter. Phencyclidine is most commonly administered by inhalation
Opiates (OPI 2000)
learning. They may also experience transient episodes of confusion and anxiety. Long-term, relatively
but can be used intravenously, intra-nasally, and orally. After low doses, the user thinks and acts swiftly
heavy use may be associated with behavioral disorders. The peak effect of marijuana administered by
and experiences mood swings from euphoria to depression. Self-injurious behavior is one of the
Tricyclic Antidepressants (TCA)
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
PCP can be found in urine within 4 to 6 hours after use and will remain in urine for 7 to 14 days,
Configurations of the One Step Multi-Drug Screen Test Card with Integrated Cup come with any
smoking. The main metabolite excreted in the urine is 11-nor-∆9-tetrahydrocannabinol-9-carboxylic acid
depending on factors such as metabolic rate, user’s age, weight, activity, and diet.5 Phencyclidine is
combination of the above listed drug analytes. This assay provides only a preliminary analytical
excreted in the urine as an unchanged drug (4% to 19%) and conjugated metabolites (25% to 30%).6
test result. A more specific alternate chemical method must be used in order to obtain a
The One Step Drug Screen Test Card yields a positive result when the concentration of THC-COOH in
The One Step Drug Screen Test Card yields a positive result when the phencyclidine level in urine
confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred
urine exceeds 50 ng/mL. This is the suggested screening cut-off for positive specimens set by the
exceeds 25 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance
confirmatory method. Clinical consideration and professional judgment should be applied to any
Substance Abuse and Mental Health Services Administration (SAMHSA, USA). 4
Abuse and Mental Health Services Administration (SAMHSA, USA).
drug of abuse test result, particularly when preliminary positive results are indicated.
TRICYCLIC ANTIDEPRESSANTS (TCA)
Methadone is a narcotic analgesic prescribed for the management of moderate to severe pain and for the
TCA (Tricyclic Antidepressants) are commonly used for the treatment of depressive disorders. TCA
The One Step Drug Screen Test Card is a rapid urine screening test that can be performed without the
treatment of opiate dependence (heroin, Vicodin, Percocet, Morphine). The pharmacology of oral
overdoses can result in profound central nervous system depression, cardiotoxicity and anticholinergic
use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of
Methadone is very different from IV Methadone. Oral Methadone is partially stored in the liver for later
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
use. IV Methadone acts more like heroin. In most states you must go to a pain clinic or a Methadone
excreted in urine mostly in the form of metabolites for up to ten days.
maintenance clinic to be prescribed Methadone.
The One Step Drug Screen Test Card yields a positive result when the concentration Tricyclic
Amphetamine is a Schedule II controlled substance available by prescription (Dexedrine®) and is also
Methadone is a long acting pain reliever producing effects that last from twelve to forty-eight hours.
Antidepressants in urine exceeds 1,000 ng/mL.
available on the illicit market. Amphetamines are a class of potent sympathomimetic agents with
Ideally, Methadone frees the client from the pressures of obtaining illegal heroin, from the dangers of
therapeutic applications. They are chemically related to the human body’s natural catecholamines:
injection, and from the emotional roller coaster that most opiates produce. Methadone, if taken for long
epinephrine and norepinephrine. Acute higher doses lead to enhanced stimulation of the central nervous
periods and at large doses, can lead to a very long withdrawal period. The withdrawals from Methadone
The One Step Multi-Drug Screen Test Card with the integrated cup
is an immunoassay based on the
system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power.
are more prolonged and troublesome than those provoked by heroin cessation, yet the substitution and
principle of competitive binding. Drugs which may be present in the urine specimen compete against
Cardiovascular responses to Amphetamines include increased blood pressure and cardiac arrhythmias.
phased removal of methadone is an acceptable method of detoxification for patients and therapists.1
their respective drug conjugate for binding sites on their specific antibody.
More acute responses produce anxiety, paranoia, hallucinations, and psychotic behavior. The effects of
The MTD One Step Methadone Test Card yields a positive result when the Methadone in urine exceeds
Amphetamines generally last 2-4 hours following use and the drug has a half-life of 4-24 hours in the
During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine
body. About 30% of Amphetamines are excreted in the urine in unchanged form, with the remainder as
specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The
hydroxylated and deaminated derivatives.
antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test
The One Step Drug Screen Test Card yields a positive result when Amphetamines in urine exceed 1,000
Methamphetamine is an addictive stimulant drug that strongly activates certain systems in the brain.
line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all
ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and
Methamphetamine is closely related chemically to amphetamine, but the central nervous system effects
the binding sites of the antibody. Therefore, the colored line will not form in the test line region.
Mental Health Services Administration (SAMHSA, USA). 4
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
A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip
doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness,
because of drug competition, while a drug-negative urine specimen will generate a line in the test line
Barbiturates are central nervous system depressants. They are used therapeutically as sedatives,
reduced appetite, and a sense of increased energy and power. Cardiovascular responses to
region because of the absence of drug competition.
hypnotics, and anticonvulsants. Barbiturates are almost always taken orally as capsules or tablets. The
Methamphetamine include increased blood pressure and cardiac arrhythmias. More acute responses
effects resemble those of intoxication with alcohol. Chronic use of barbiturates leads to tolerance and
produce anxiety, paranoia, hallucinations, psychotic behavior, and eventually, depression and exhaustion.
To serve as a procedural control, a colored line will always appear at the control line region, indicating
The effects of Methamphetamine generally last 2-4 hours and the drug has a half-life of 9-24 hours in the
that proper volume of specimen has been added and membrane wicking has occurred.
Short acting Barbiturates taken at 400 mg/day for 2-3 months can produce a clinically significant degree
body. Methamphetamine is excreted in the urine as amphetamine and oxidized and deaminated
of physical dependence. Withdrawal symptoms experienced during periods of drug abstinence can be
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
The test contains a membrane strip coated with drug-protein conjugates (purified bovine albumin) on the
Only a small amount (less than 5%) of most Barbiturates are excreted unaltered in the urine.
detectable in the urine for 3-5 days, depending on urine pH level.
test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad
The approximate detection time limits for Barbiturates are:
The One Step Drug Screen Test Card yields a positive result when the Methamphetamine in urine
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.
The One Step Drug Screen Test Card yields a positive result when the Barbiturates in urine exceed 300
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,
• For healthcare professionals including professionals at point of care sites.
such as increased muscle tension and sweating. MDMA is not clearly a stimulant, although it has, in
diagnostic use only. Do not use after the expiration date.
• The test panel should remain in the sealed pouch until use.
%Agreement with GC/MS
• All specimens should be considered potentially hazardous and handled in the same manner as an
A procedural control is included in the test. A red line appearing in the control region (C) is considered an
internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and
The used test card should be discarded according to federal, state and local regulations.
STORAGE AND STABILITY
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
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
SPECIMEN COLLECTION AND PREPARATION
1. The One Step Multi Drug Screen Test Card with the integrated cup
provides only a qualitative,
preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result.
The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day
Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. 3,4,7
may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to
2. There is a possibility that technical or procedural errors, as well as other interfering substances in the
settle to obtain a clear specimen for testing.
urine specimen may cause erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage,
regardless of the analytical method used. If adulteration is suspected, the test should be repeated with
specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well
Forty (40) clinical samples for each drug were run using each of The One Step Single Drug Test Strip by
4. A Positive result does not indicate level or intoxication, administration route or concentration in urine.
an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained
5. A Negative result may not necessarily indicate drug-free urine. Negative results can be obtained when
statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained
drug is present but below the cut-off level of the test.
6. Test does not distinguish between drugs of abuse and certain medications.
• Integrated E-Z Split Key™ Cup with multi-drug card
7. A positive test result may be obtained from certain foods or food supplements.
• The Integrated E-Z Split Key™ Cup has a Fahrenheit temperature strip affixed to aid in the
A study was conducted at three physician offices by untrained operators using three different lots of
determination of specimen validity. Please use this temperature strip in conjunction with your Drug
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,
A side-by-side comparison was conducted using the One Step Single Drug Test Strip and commercially
blinded and tested at each site. The results are given below:
available drug rapid tests. Testing was performed on approximately 300 specimens per drug type
previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were
Materials Required But Not Provided
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.
Compounds Contributed to the Totals of GC/MS
DIRECTIONS FOR USE
Allow the test card, urine specimen, and/or controls to equilibrate to room temperature (15-30
Secobarbital, Butalbital, Phenobarbital, Pentobarbital
prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the cup from the sealed pouch and
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
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,
The following results are tabulated from these clinical studies:
%Agreement with Commercial Kit
INTERPRETATION OF RESULTS
(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.
: 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
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.
TRICYCLIC ANTIDEPRESSANTS (TCA)
COOH conc. (ng/mL)
A drug-free urine pool was spiked with drugs at concentrations listed. The results are summarized below.
OPIATE (OPI 2000)
OPIATES (OPI 300)
The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by
One Step Drug Screen Test Card at 5 minutes.
Effect of the Urinary pH
D,L-3,4-Methylenedioxymethamphetamine HCI (MDMA)
The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments
1. Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders Company. 1986; 1735.
and spiked with drugs at 50% below and 50% above cut-off levels. The spiked, pH-adjusted urine was
2. Stewart DJ, Inaba T, Lucassen M, Kalow W. Clin. Pharmacol. Ther.
April 1979; 25 ed: 464, 264-8.
tested with One Step Drug Screen Test Card. The results demonstrate that varying ranges of pH does
3. Ambre J. J. Anal. Toxicol.
not interfere with the performance of the test.
4. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse
. National Institute for Drug Abuse (NIDA),
OPIATE 300 (MOP)
A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free
5. FDA Guidance Document: Guidance for Premarket Submission for Kits for Screening Drugs of Abuse
urine or drug positive urine containing Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana,
Methadone, Methamphetamine, Methylenedioxymethamphetamine, Opiate, Phencyclidine or Tricyclic
6. Robert DeCresce. Drug Testing in the workplace,
antidepressants. The following compounds show no cross-reactivity when tested with One Step Drug
7. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man.
2nd Ed. Biomedical Publ., Davis, CA
Screen Test Card at a concentration of 100 µg/mL.
Non Cross-Reacting Compounds
8. Winger, Gail, A Handbook of Drug and Alcohol Abuse, Third Edition, Oxford Press, 1992, page 146.
Chlorothiazide D/L-Chloropheniramine Chlorpromazine Chloroquine
Hydrochlorothiazide Hydrocortisone O-Hydroxyhippuric acid
Isoxsuprine Ketamine Ketoprofen Labetalol
Tetrahydrocortisone 3 (β-D-glucuronide) Tetrahydrozoline
Effect of Urinary Specific Gravity
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 One Step Drug Screen Test Card
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.
Parent compound only; metabolizes into amphetamine and methamphetamine in the body.
Aggiornamento normativo del mese di febbraio 2009 Scadenze dichiarazioni redditi: Sono state emanate le scadenze definitive delle prossime dichiarazioni di redditi: modello 730 consegna documenti allo studio entro il 1 giugno 2009 (trasmissione all’agenzia delle entrate il 15 luglio 2009) influirà sulle ritenute di “competenza” del mese di luglio 2009; modello unico (socie
CURRICULUM VITAE SUMMARY PERFORMANCE • Medical Team Leader responsible for managing the activities of a team of 3 Medical Officers who evaluate the safety and efficacy of drugs for investigational use (IND) and for commercial marketing (NDA), O-6 billet • Team of Medical Officers completed 1 NDA review, 24 IND reviews, 44 End-of-Phase 2, Pre-NDA, and Pre-IND submissions, and 5 consu