One Step Drug Screen Test Card

Package Insert for Single and Multi Drug Screen Test Cards

This instruction Sheet is for testing of any combination of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine and Tricyclic Antidepressants.

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

For healthcare professionals including professionals at point of care sites. For in vitro diagnostic use only.

INTENDED USE 

The One Step Drug Screen 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:

Drugs and Cutoff Levels: Amphetamine (AMP) 1000 ng/mL

Barbiturates (BAR) 300 ng/mL Benzodiazepine (BDZ) 300 ng/mL

Cocaine (COC) 300 ng/mL

Marijuana (THC) 50 ng/mL

Methadone (MTD) 300 ng/mL

Methamphetamine (mAMP) 1,000 ng/mL

Methylenedioxymethamphetamine (MDMA) 500 ng/mL

Morphine (MOP 300) 300 ng/mL

Opiates (OPI) 2000 ng/mL

Phencyclidine (PCP) 25 ng/mL

Tricyclic Antidepressants (TCA) 1,000 ng/mL

Configurations of the One Step Multi-Drug Scrren Test Card can consist of any combination of the above listed drug analytes. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

SUMMARY

The one step Drug Screen Test Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of the specific drugs in urine.

 AMPHETAMINE (AMP)

Amphetamine is a Schedule II controlled substance available by prescription (Dexedrine) and is also available on the illicit market. Amphetamines are a class of potent sympathomimetic agents with therapeutic applications. They are chemically related to the human body's natural catecholamine: 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 One Step Drug Screen Test Card 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).

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 One Step Drug Screen Test Card 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 neuro chemical called gamma amino butyric 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, and 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. Valium and Versed are examples of benzodiazepines. The One Step Drug Screen Test Card 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. 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 24-40 hours after cocaine exposure. 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). MARIJUANA (THC) THC (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 One Step Drug Screen Test Card 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).

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, and 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. The MTD One Step Methadone Test Card yields a positive result when the Methadone in urine exceeds 300 ng/mL.

METHAMPHETAMINE (mAMP)

Methamphetamine is an addictive stimulant drug that strongly activates certain systems in the brain. Methamphetamine is closely related chemically to amphetamine, but the central nervous system effects of Methamphetamine are greater. Methamphetamine is made in illegal laboratories and has a high potential for abuse and dependence. The drug can be taken orally, injected, or inhaled. Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power. Cardiovascular responses to Methamphetamine include increased blood pressure and cardiac arrhythmias. More acute responses produce anxiety, paranoia, hallucinations, psychotic behavior, and eventually, depression and exhaustion. The effects of Methamphetamine generally last 2 4 hours and the drug has a half-life of 9-24 hours in the body. Methamphetamine is excreted in the urine as amphetamine and oxidized and deaminated derivatives. However, 10-20% of Methamphetamine is excreted unchanged. Thus, the presence of the parent compound in the urine indicates Methamphetamine use. Methamphetamine is generally detectable in the urine for 3-5 days, depending on urine pH level. The One Step Drug Screen Test Card yields a positive result when the Methamphetamine in urine exceeds 1,000 ng/mL.

METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

Methylenedioxymethamphetamine (ecstasy) is a designer drug first synthesized in 1914 by a German drug company for the treatment of obesity. 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 One Step Methylenedioxymethamphetamine Drug Screen Test Card yields a positive result when the Methylenedioxymethamphetamine in urine exceeds 500 ng/mL.

OPIATE (MOP 300)

Opiate refers to any drug that is derived from the opium poppy, including the natural products, morphine and codeine, and the semi-synthetic drugs such as heroin. Opioid is more general, referring to any drug that acts on the opioid receptor. Opioid analgesics comprise a large group of substances which control pain by depressing the central nervous system. Large doses of morphine can produce higher tolerance levels, physiological dependency in users, and may lead to substance abuse. Morphine is excreted unmetabolized, and is also the major metabolic product of codeine and heroin. Morphine is detectable in the urine for several days after an opiate dose. The One Step Drug Screen Test Card yields a positive result when the concentration of opiate exceeds the 300 ng/mL cut-off level. OPIATE (2000) The One Step Drug Screen Test Card 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). See opiate (MOP 300) for summary.

PHENCYCLIDINE (PCP)

Phencyclidine, also known as PCP or Angel Dust, is a hallucinogen that was first marketed as a surgical anesthetic in the 1950's. It was removed from the market because patients receiving it became delirious and experienced hallucinations. Phencyclidine is used in powder, capsule, and tablet form. The powder is either snorted or smoked after mixing it with marijuana or vegetable matter. Phencyclidine is most commonly administered by inhalation but can be used intravenously, intra-nasally, and orally. After low doses, the user thinks and acts swiftly and experiences mood swings from euphoria to depression. Self-injurious behavior is one of the devastating effects of Phencyclidine. PCP can be found in urine within 4 to 6 hours after use and will remain in urine for 7 to 14 days, depending on factors such as metabolic rate, user's age, weight, activity, and dieL5 Phencyclidine is excreted in the urine as an unchanged drug (4% to 19%) and conjugated metabolites (25% to 30%). The One Step Drug Screen Test Card yields a positive result when the phencyclidine level in urine exceeds 25 ng1mL. 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 One Step Drug Screen Test Card yields a positive result when the concentration of Tricyclic Antidepressants in urine exceeds 1,000 ng/mL.

PRINCIPLE

The One Step Drug Screen Test Card is an immunoassay based on the principle of completitive binding. Drugs which may be present in the urine specimen complete against their respective drug conjugate for binding sites on their specific antibody.

Drug 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 collodidal gold particles coated with mouse monoclonal antibody specific to Amphetamine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, THC, Phencyclidine, Benzodiazepine, Methadone, Barbiturate or Tricyclic Antidepressants.

PRECAUTIONS

. For healthcare professional including professional at point of care sites.                                                                  

. For invitro diagnostic use only. Do not use after the expiration date.

. The test panel should remain in the sealed pouch until use.

. All specimens should be considered potentially hazardous and handled in the same ammer as an infectious agent.

. The used test card should be discarded according to federal, state and local regulations.

STORAGE AND STABILITY

 Store as pachaged in the sealed pouch at 2-30 degrees C. The test is stable through the expiration date printed on the sealed pouch. The test devices must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

SPECIMEN COLLECTION AND PREPARATION 

Urine Assay

The urine specimen must be collected in a clean drug container. Urine collected at any time of the day may be used. Urine specimens exhibiting visble precipitates should be centrifuged, filtered, or allowed to settle to obtain a cler specimen for testing.

Urine specimens may be stored at 2-8 C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20c. Frozen specimens should be thawed and mixed well before testing.

MATERIALS

Materials Provided

. Test Cards

. Package insert

Materials Required But Not Provided

. Specimen collection container

. Timer

. External controls

For additional instruction please refer to the instruction page. A full insert can be requested at Testkit@msn.com