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One Step Multi-Drug Screen Test Card
BENZODIAZEPINES (BZO)
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 AMP/BAR/BZO/COC/THC/MTD/mAMP/MDMA/MOP/OPI/PCP/TCA
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 INTENDED USE
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 (COC)
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. Test Calibrator
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. Amphetamine (AMP)
D-Amphetamine
1,000 ng/mL
Cocaine is often self-administered by nasal inhalation, intravenous injection and free-base smoking. It is OPIATE (2000)
Barbiturates (BAR)
Secobarbital
300 ng/mL
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 Benzodiazepines (BZO)
Oxazepam
300 ng/mL
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 Cocaine (COC)
Benzoylecgonine
300 ng/mL
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. Marijuana (THC)
11-nor-∆9-THC-9 COOH
The One Step Drug Screen Test Card yields a positive result when the cocaine metabolite in urine PHENCYCLIDINE (PCP)
Methadone (MTD)
Methadone
300 ng/mL
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 Methamphetamine (mAMP)
D-Methamphetamine
1,000 ng/mL
anesthetic in the 1950’s. It was removed from the market because patients receiving it became delirious Methylenedioxymethamphetamine
D,L Methylenedioxymethamphetamine
500 ng/mL
MARIJUANA (THC)
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)
Morphine
300 ng/mL
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)
Morphine
2,000 ng/mL
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 Phencyclidine (PCP)
Phencyclidine
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)
Nortriptyline
1,000 ng/mL
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 (MTD)
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. AMPHETAMINE (AMP)
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 PRINCIPLE
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. METHAMPHETAMINE (mAMP)
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 BARBITURATES (BAR)
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 REAGENTS
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. METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
PRECAUTIONS
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 in vitro diagnostic use only. Do not use after the expiration date. • The test panel should remain in the sealed pouch until use. QUALITY CONTROL
%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 LIMITATIONS
SPECIMEN COLLECTION AND PREPARATION
1. The One Step Multi Drug Screen Test Card with the integrated cup provides only a qualitative, Urine Assay
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. Specimen Storage
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 MATERIALS
drug is present but below the cut-off level of the test. Materials Provided
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. Precision
• The Integrated E-Z Split Key™ Cup has a Fahrenheit temperature strip affixed to aid in the PERFORMANCE CHARACTERISTICS
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 Accuracy
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 AMPHETAMINE (AMP)
Materials Required But Not Provided
confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total Amphetamine
amount of drugs found in presumptive positive urine samples tested. conc. (ng/mL)
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°C)
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 11-nor-∆9-tetrahydrocannabinol-9-carboxylic acid 2. Donor provides specimen and secures the cap by pressing down on all three corners. BARBITURATES (BAR)
3. Technician checks cap for tight seal. Technician dates and initials the security seal and attaches the Secobarbital
conc. (ng/mL)
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
BENZODIAZEPINES (BZO)
Oxazepam
conc. (ng/mL)
INTERPRETATION OF RESULTS
COCAINE (COC)
(Please refer to the illustration above) Benzoylecgonine
conc. (ng/mL)
NEGATIVE:* Two lines appear. One red line should be in the control region (C), and another apparent
red or pink line adjacent should be in the test region (Drug/T). This negative result indicates that the drug concentration is below the detectable level. *NOTE: The shade of red in the test line region (Drug/T) will vary, but it should be considered negative
whenever there is even a faint pink line. POSITIVE: One red line appears in the control region (C). No line appears in the test region
(Drug/T). This positive result indicates that the drug concentration is above the detectable level.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques
are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact your manufacturer. MARIJUANA (THC)
TRICYCLIC ANTIDEPRESSANTS (TCA)
BARBITURATES
11-nor-9 -THC-9-
Nortiptyline
COOH conc. (ng/mL)
conc. (ng/mL)
METHADONE (MTD)
Analytical Sensitivity
Methadone
A drug-free urine pool was spiked with drugs at concentrations listed. The results are summarized below. conc. (ng/mL)
Drug Concentration
BENZODIAZEPINES
Cut-off Range
0% Cut-off
-50% Cut-off
METHAMPHETAMINE (mAMP)
Methamphetamine
-25% Cut-off
conc. (ng/mL)
+25% Cut-off
+50% Cut-off
Drug Concentration
METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
Methylenedioxymeth-
Cut-off Range
amphetamine
conc. (ng/mL)
0% Cut-off
-50% Cut-off
-25% Cut-off
+25% Cut-off
OPIATE (OPI 2000)
Morphine
+50% Cut-off
conc. (ng/mL)
Drug Concentration
Cut-off Range
0% Cut-off
MARIJUANA (THC)
-50% Cut-off
OPIATES (OPI 300)
Morphine
-25% Cut-off
conc. (ng/mL)
+25% Cut-off
+50% Cut-off
METHADONE
Analytical Specificity
PHENCYCLIDINE (PCP)
The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by Phencyclidine
One Step Drug Screen Test Card at 5 minutes. conc. (ng/mL)
METHAMPHETAMINE
AMPHETAMINE
METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
Effect of the Urinary pH
BIBLIOGRAPHY
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 3,4-Methylenedioxyethyl-amphetamine (MDE) 3. Ambre J. J. Anal. Toxicol. 1985; 9:241. 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), Cross-Reactivity
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, 114. 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 OPIATES (2000)
Hydrochlorothiazide Hydrocortisone O-Hydroxyhippuric acid Isoxsuprine Ketamine Ketoprofen Labetalol Phenelzine Trans-2-phenylcyclo-propylamine 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.

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2003

Aggiornamento normativo del mese di febbraio 2009 Scadenze dichiarazioni redditi: Sono state emanate le scadenze definitive delle prossime dichiarazioni di redditi: ƒ 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;ƒ modello unico (socie

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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

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