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Barbiturates are drugs that depress the central nervous system. They are used for therapeutic applications for hypnotics, anticonvulsants and sedatives. This drug is taken orally as capsules or tablets.  The effects resemble those of alcohol intoxication. Repeated use of barbiturates can lead to tolerance and physical dependency. Once a popular drug of abuse, barbiturates use has declined in recent years, due to doctors not prescribing the drug as often.

Short acting Barbiturates taken at 400mg/day for 2-3 months produces 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 urine.

 

1 Panel Barbiturates Drug Test Dip
Description

The BAR One Step Barbiturates Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Barbiturates in human urine.  The One Step Drug Screen Test yields a positive result when the Barbiturates in urine exceeds 300ng/ml.


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Barbiturates are drugs that act as central nervous system depressants, and by virtue of this they produce a wide spectrum of effects, from mild sedation to anesthesia. They are also effective as anxiolytics, hypnotics and as anticonvulsants. They have addiction potential, both physical and psychological. Barbiturates have now largely been replaced by benzodiazepines mainly because benzodiazepines are significantly less dangerous in overdose. Barbiturates are derivatives of barbituric acid.

History

While barbituric acid itself does not have any effect on the central nervous system, to date, chemists have derived over 2,500 compounds that do possess pharmacologically active qualities. The broad class of barbiturates is broken down further and classified according to speed of onset and duration of action. Ultrashort-acting barbiturates are commonly used for anesthesia because their extremely short duration of action allows for greater control. These properties allow doctors to rapidly put a patient "under" in emergency surgery situations. Doctors can also bring a patient out of anesthesia just as quickly should complications arise during surgery. The middle two classes of barbiturates are often combined under the title "short/intermediate-acting." These barbiturates are also employed for anesthetic purposes, and are also sometimes prescribed for anxiety or insomnia. This is not a common practice anymore, however, owing to the dangers of long term use of barbiturates; they have been replaced by the benzodiazepines for these purposes. The final class of barbiturates are known as long-acting barbiturates (most notably phenobarbital, which has a half-life of roughly 92 hours). This class of barbiturates is used almost exclusively as anticonvulsants, although on rare occasions they are prescribed for daytime sedation. Barbiturates in this class are not used for insomnia, because owing to their extremely long half-life, patients would awake with a residual "hang-over" effect and feel groggy. No substance of medical value was discovered, however, until 1903 when two German chemists working at Bayer, Emil Fischer and Joseph von Mering, discovered that barbital was very effective in putting dogs to sleep. Barbital was then marketed by Bayer under the trade name Veronal. It is said that Von Mering proposed this name because the most peaceful place he knew was the Italian city of Verona.

Barbiturates can in most cases be used as either the free acid or as salts of sodium, calcium, potassium, magnesium, lithium, etc. Codeine- and Dionine-based salts of barbituric acid have been developed. In 1912, Bayer introduced another barbituric acid derivative, phenobarbital, under the trade name Luminal, as a sedative-hypnotic.

Buy Barbiturates Drug Test

Therapeutic uses

Barbiturates like pentobarbital and phenobarbital were long used as anxiolytics and hypnotics. Today benzodiazepines have largely supplanted them for these purposes, because benzodiazepines have less potential for lethal overdoses.

Barbiturates are classified as ultrashort-, short-, intermediate-, and long-acting, depending on how quickly they act and how long their effects last.  Barbiturates are still widely used in surgical anesthesia, especially to induce anesthesia, though their use during induction of anesthesia has largely been supplanted by Propofol. Ultrashort barbiturates such as thiopental (Pentothal) produce unconsciousness within about a minute of intravenous (IV) injection. These drugs are used to prepare patients for surgery; other general anesthetics like nitrous oxide are then used to keep the patient from waking up before the surgery is complete. Because Pentothal and other ultrashort-acting barbiturates are typically used in hospital settings, they are not very likely to be abused, noted the DEA.

Phenobarbital is used as an anticonvulsant for people suffering from seizure disorders such as febrile seizures, tonic-clonic seizures, status epilepticus, and eclampsia.

Long-acting barbiturates such as phenobarbital (Luminal) and mephobarbital (Mebaral) are prescribed for two main reasons. When taken at bedtime, they help treat insomnia. When taken during the day, they have sedative effects that can aid in the treatment of tension and anxiety. These same effects have been found helpful in the treatment of convulsive conditions like epilepsy. Phenobarbital has also been used in the treatment of delirium tremens during alcohol detoxification, although benzodiazepines have a more favorable safety profile and are more often used.  Long-acting barbiturates take effect within one to two hours and last 12 hours or longer.

Other non-therapeutic uses

Barbiturates in high doses are used for physician-assisted suicide (PAS), and in combination with a muscle relaxant for euthanasia and for capital punishment by lethal injection.  Thiopental, an ultra-short acting barbiturate that is marketed under the name Sodium Pentothal, is sometimes used as a "truth serum". When dissolved in water, it can be swallowed or administered by intravenous injection. The drug does not itself force people to tell the truth, but is thought to decrease inhibitions, making subjects more likely to be caught off guard when questioned.

Mechanism of action

The principal mechanism of action of barbiturates is believed to be their affinity for the GABAA receptor (Acts on GABA : BDZ receptor Cl- channel complex). GABA is the principal inhibitory neurotransmitter in the mammalian central nervous system (CNS). Barbiturates bind to the GABAA receptor at the alpha subunit, which are binding sites distinct from GABA itself and also distinct from the benzodiazepine binding site. Like benzodiazepines, barbiturates potentiate the effect of GABA at this receptor. In addition to this GABA-ergic effect, barbiturates also block the AMPA receptor, a subtype of glutamate receptor. Glutamate is the principal excitatory neurotransmitter in the mammalian CNS. Taken together, the findings that barbiturates potentiate inhibitory GABAA receptors and inhibit excitatory AMPA receptors can explain the CNS-depressant effects of these agents. At higher concentration they inhibit the Ca2+ dependent release of neurotransmitters.  Barbiturates produce their pharmacological effects by increasing the duration of chloride ion channel opening at the GABAA receptor (pharmacokinetics: this increases the efficacy of GABA) whereas benzodiazepines increase the frequency of the chloride ion channel opening at the GABAA receptor (pharmacokinetics: this increases the potency of GABA). The direct gating or opening of the chloride ion channel is the reason for the increased toxicity of barbiturates compared to benzodiazepines in overdose.

Tolerance, dependence and overdose

Older adults and pregnant women should consider the risks associated with barbiturate use. When a person ages, the body becomes less able to rid itself of barbiturates. As a result, people over the age of sixty-five are at higher risk of experiencing the harmful effects of barbiturates, including drug dependence and accidental overdose.  When barbiturates are taken during pregnancy, the drug passes through the mother's bloodstream to her fetus. After the baby is born, it may experience withdrawal symptoms and have trouble breathing. In addition, nursing mothers who take barbiturates may transmit the drug to their babies through breast milk.

Tolerance and dependence

With regular use tolerance to the effects of barbiturates develops. This in turn may lead to a need for increasing doses of the drug to get the original desired pharmacological or therapeutic effect.  Barbiturate use can lead to both psychological and physical dependence and the drugs have a high abuse liability.  Psychological addiction to barbiturates can develop quickly. The GABAA receptor, one of barbiturates' main sites of action, is thought to play a pivotal role in the development of tolerance to and dependence on barbiturates, as well as the euphoric "high" that results from their abuse.  The mechanism by which barbiturate tolerance develops is believed to be different than that of ethanol or benzodiazepines, even though these drugs have been shown to exhibit cross-tolerance with each other.

Overdose

An overdose results when a person takes a larger-than-prescribed dose of a drug. Symptoms of an overdose typically include; sluggishness, incoordination, difficulty in thinking, slowness of speech, faulty judgment, drowsiness or coma, shallow breathing, staggering and in severe cases coma and death.  The lethal dosage of barbiturates varies greatly with tolerance and from one individual to another. Even in inpatient settings, however, the development of tolerance is still a problem, as dangerous and unpleasant withdrawal symptoms can result when the drug is stopped after dependence has developed.  Barbiturates in overdose with other CNS depressants for example, alcohol, opiates or benzodiazepines is even more dangerous due to additive CNS and respiratory depressant effects. In the case of benzodiazepines not only do they have additive effects, barbiturates also increase the binding affinity of the benzodiazepine binding site thus leading to an exagerated effect of benzodiazepines.

Barbiturates Home Drug Test

Recreational use

Like ethanol, barbiturates are intoxicating and produce similar effects during intoxication. The symptoms of barbiturate intoxication include respiratory depression, lowered blood pressure, fatigue, fever, unusual excitement, irritability, dizziness, poor concentration, sedation, confusion, impaired coordination, impaired judgment, addiction, and respiratory arrest which may lead to death.

Recreational users report that a barbiturate high gives them feelings of relaxed contentment and euphoria. The main risk of acute barbiturate abuse is respiratory depression. Physical and psychological dependence may also develop with repeated use.  Other effects of barbiturate intoxication include drowsiness, lateral and vertical nystagmus, slurred speech and ataxia, decreased anxiety, a loss of inhibitions. Barbiturates are also misused to alleviate the adverse or withdrawal effects of illicit drug misuse.

Drug users tend to prefer short-acting and intermediate-acting barbiturates.  The most commonly abused are amobarbital (Amytal), pentobarbital (Nembutal), and secobarbital (Seconal). A combination of amobarbital and secobarbital (called Tuinal) is also highly abused. Short-acting and intermediate-acting barbiturates are usually prescribed as sedatives and sleeping pills. These pills begin acting fifteen to forty minutes after they are swallowed, and their effects last from five to six hours. Veterinarians use pentobarbital to anesthetise animals before surgery; in large doses, it can be used to euthanise animals.

Slang terms for barbiturates include; barbs, bluebirds, blues, downers, goofballs, tooties and yellow jackets.

Legal status

In the 1950s and 1960s, increasing reports began to be published about barbiturate overdoses and dependence problems which eventually led to the scheduling of barbiturates as controlled drugs.

In 1970 several barbiturates were designated in the United States as controlled substances with the passage of the American Controlled Substances Act of 1970. Pentobarbital, secobarbital and amobarbital were designated schedule II drugs, butabarbital schedule III, and barbital and phenobarbital schedule IV.

In 1971 the Convention on Psychotropic Substances was signed in Vienna. Designed to regulate amphetamines, barbiturates, and other synthetics, the treaty today regulates secobarbital, amobarbital, butalbital, cyclobarbital, and pentobarbital as schedule III, and allobarbital, methylphenobarbital, phenobarbital, and vinylbital as schedule IV scheduled substances.


Transmetron offers only the highest quality, instant drug test kits and supplies. Our tests are the same tests used by hospitals and clinics. Each test is FDA approved, easy to use and easy to read. We offer instant drug test dips, cassettes ( devices ), saliva drug tests, integrated drug test cups, breath alcohol and saliva alcohol tests. Our urine drug screen test kits can test for the following drugs: amphetamine ( AMP ), barbiturates, benzodiazepines ( BZO ), cocaine ( COC ), marijuana ( THC ), methadone ( MTD ), methamphetamine ( mAMP ) - meth, methylenedioxymethamphetamine ( MDMA ), morphine, opiate, opiates, phencyclidine ( PCP ), and tricyclic antidepressants ( TCA ). When you need to know, TRANSMETRON is the way to go!


One Step Single/Multi-Drug Screen Test Panel
Package Insert for 1 to 10 Drug Screen Panel “Dip”
Instruction Sheet for testing of any combination of the following drugs:
AMP, BAR, BZO, COC,THC, MTD , mAMP, OPI, PCP AND TCA

Amphetamine (AMP)
Barbiturates (BAR)
Benzodiazepines (BZO)
Cocaine (COC)
Marijuana (THC)
Methadone (MTD)
Methamphetamine (mAMP)
Opiate (300 ng/ml) (OPI 300 or MOP 300)
Opiate (OPI) (2000 ng/ml)
Phencyclidine
Tricyclic Antidepressant (TCA)
Non Cross-Reacting Compounds

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine. For healthcare professionals and professionals at point of care sites. For professional in vitro diagnostic use.
INTENDED USE
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The One Step Multi-Drug Screen Test Panel is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the following cut-off concentrations: 300 ng/mL Benzoylecgonine (Cocaine metabolite), 1,000 ng/mL Amphetamine, 1,000 ng/mL Methamphetamine, 50 ng/mL 11-nor-.9 -THC-9- COOH (THC), 2,000 ng/mL Opiate, 25 ng/mL Phencyclidine, in urine.

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 used.
SUMMARY
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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 does 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 halflife 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 AMP One Step Amphetamine Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Amphetamine in urine. The AMP One Step Amphetamine Test Strip yields a positive result when Amphetamines in urine exceed 1,000 ng/mL.
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 400mg/day for 2-3 months produces 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 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 days1
The One Step Drug Screen Test yields a positive result when the Barbiturates in urine exceeds 300ng/ml.
BENZODIAZEPINES (BZO)
Benzodiazepines are medications that are frequently prescribed for 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 trouble sleeping, gastrointestinal upset, feeling unwell, loss of appetite, sweating and trembling, weakness, anxiety and changes in perception.
Only trace amounts (less than 1%) of most Benzodiazepines are excreted unaltered in urine; most of the concentration in urine is conjugated drug. The detection period for the Benzodiazepines in urine is 3 – 7 days.
The One Step Drug screen Test Card yields a positive result when the Benzodiazepines in urine exceeds 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, and 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 Benzoylecgonine1,2. 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 exposure2.
The COC One Step Cocaine Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of cocaine metabolite in urine. The COC One Step Cocaine Test Strip 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 (.9--tetrahydrocannabinol) is the primary active ingredient in cannabinoids (marijuana). When smoked or orally administered, it 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 smoking marijuana 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 THC One Step Marijuana Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of marijuana in urine. The THC One Step Marijuana Test Strip yields a positive result when the concentration of marijuana 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 pain reliever for medium to severe pain. It is also used in the treatment of heroin (opiate dependence: Vicodin, Percocet, Morphine, etc.) addiction. Oral Methadone is very different than IV Methadone. Oral Methadone is partially stored in the liver for late 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 forth-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.1
The MTD One step Methadone test yields a positive result when 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 does 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 primarily 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 mAMP One Step Methamphetamine Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Methamphetamine in urine. The mAMP One Step Methamphetamine Test Strip yields a positive result when the Methamphetamine in urine exceeds 1,000 ng/mL.
OPIATE (300 ng/ml) (OPI 300 or 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 dose 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 OPI One Step Opiate Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of morphine in urine. The OPI One Step Opiate Test Strip yields a positive result when the morphine in urine exceeds 300 ng/mL.
OPIATE (OPI) (2000 ng/ml)
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 dose 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 OPI One Step Opiate Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of morphine in urine. The OPI One Step Opiate Test Strip 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).
PHENCYCLIDINE
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 PCP One Step Phencyclidine Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of phencyclidine metabolite in urine. The PCP One Step Phencyclidine Test Strip yields a positive result when the phencyclidine metabolite 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 ANTIDEPRESSANT (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 Tests yields a positive result when the Tricyclic Antidepressant in urine exceeds 1,000 ng/ml.
PRINCIPLE
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The One Step Multi-Drug Screen Test Panel 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
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The test panel contains specific mouse monoclonal antibody, goat polyclonal antibody and drug protein conjugates.
PRECAUTIONS
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• For healthcare professionals and professionals at point of care sites.
• For in vitro 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 manner as an infectious agent.
• The used test panel should be discarded according to federal, state and local regulations

STORAGE AND STABILITY
Kit can be stored at room temperature or refrigerated at 2-30°C. The test panel is stable through the expiration date printed on the sealed pouch. The test panel must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
MATERIALS PROVIDED
• Test panels
• Package insert
MATERIALS REQUIRED BUT NOT PROVIDED
• Specimen collection container
• External controls
• Timer
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 centrifuged, filtered, or allowed to settle to obtain a clear supernatant for testing.
SPECIMEN STORAGE
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 -20°C. Frozen specimens should be thawed and mixed well before testing.
QUALITY CONTROL
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A procedural control is included in the test. A colored 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.
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 performance.
LIMITATIONS
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1. The One Step Multi-Drug Screen Test Panel provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography and mass spectrometry (GC/MS) is the preferred confirmatory method. 3,4,7
2. There is a possibility that technical or procedural errors, as well as other interfering substances 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.
4. A Positive result does not indicate level or intoxication, administration route or concentration in urine.
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.
PERFORMANCE CHARACTERISTICS - ACCURACY
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A side-by-side comparison was conducted using The One Step Single Drug Test and commercially available drug rapid tests. Testing was performed on approximately 300 specimens previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were 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.
TEST Compounds Contributed to the Totals of GC/MS

AMP Amphetamine

BAR Secobarbital, Butalbital, Phenobarbital, Pentobarbital

BZO Oxazepam, Nordiazepam, a-OH-Alprazolam, Desalklflurazepam

COC Benzoylecgonine

THC 11-nor-.9-tetrahydrocannabinol-carboxylic acid

TEST Compounds Contributed to the Totals of GC/MS

MTD Methadone

mAMP Methamphetamine

OPI Morphine, Codeine

PCP Phencyclidine

TCA Nortriptyline

The following results are tabulated from these clinical studies:
Forty (40) clinical samples for each drug were run using each of the One Step Single Drug tests by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained Laboratory personnel.
*Note: TCA was based on HPLC data.
Precision
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A study was conducted at three physician offices by untrained operators using three different lots of 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 as a blind and tested at each site. The results are given below:









Analytical Sensitivity
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A drug-free urine pool was spiked with drugs to the concentrations at ± 50% cut-off and ± 25% cut-off. The results are summarized below.
Drug conc. (Cut-off range) n AMP BAR BZO COC THC MTD mAMP OPI PCP TCA
- + - + - + - + - + - + - + - + - + - +
0% Cut-off 30 30 0 30 0 30 0 30 0 30 0 30 1 30 0 30 0 30 0 30 0
-50% Cut-off 30 30 0 30 0 30 0 30 0 30 0 29 1 30 0 30 0 30 0 30 0
-25% Cut-off 30 30 0 27 3 26 4 30 0 12 1 24 6 30 0 30 0 19 11 22 8
Cut-off 30 18 12 22 8 12 18 4 26 1 29 21 9 18 12 30 17 16 14 12 18
+25% Cut-off 30 1 29 7 23 3 27 0 30 1 29 2 28 1 29 30 26 6 24 7 23
+50% Cut-off 30 0 30 2 28 0 30 0 30 0 30 0 30 0 30 0 30 0 30 0 30
Analytical Specificity
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The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by The One Step Multi-Drug Screen Test Panel at 5 minutes.
AMPHETAMINE
D-Amphetamine 1,000
D,L-Amphetamine sulfate 3,000
L-Amphetamine 50,000
(±)3,4-Methylenedioxyamphetamine 2,000
Phentermine 3,000
Secobarbital 300
Amobarbital 300
Alphenol 150
Aprobarbital 200
Butalbital 75
Butethal 2500
Cyclopentobarbital 100
Pentobarbital 600
Phenobarbital 300
Benzodiazepines
Oxazepam 300
Alprazolam 196
a-Hydroxyalprazolam 1262
Bromazepam 1562
Chlordiazepoxide 1562
Chlordiazepoxide HCI 781
Clobazam 98
Clonazepam 781
Clorazepate dipotassium 195
Delorazepam 1562
Desalkyflurazepam 390
Diazepam 195
Estazolam 2500
Flunitrazepam 390
( + ) Lorazepam 1562
RS-Lorazepam glucuronide 156
Midazolam 12500
Nitrazepam 98
Norchlordiazepoxide 195
Nordiazepam 390
Temazepam 98
Triazolam 2500
COCAINE ng/ml
Benzoylecgonine 300
Cocaine HCl 780
Cocaethylene 12,500
Ecgonine HCl 32,000
MARIJUANA (THC)
11-nor-.9 -THC-9 COOH 50
Cannabinol 20,000
11-nor-.8-THC-9 COOH 30
.8 -THC 15,000
.9 -THC 15,000
Methadone
Methadone 300
Doxylamine 50000
METHAMPHETAMINE
D-Methamphetamine 1,000
ñ-Hydroxymethamphetamine 30,000
L-Methamphetamine 8,000
(±)-3,4-Methylenedioxymethamphetamine 2,000
Mephentermine 50,000
OPIATES ng/ml
Morphine 2,000
Codeine 2,000
Ethylmorphine 5,000
Hydrocodone 12,500
Hydromorphone 5,000
Levophanol 75,000
6-Monoacetylmorphine 5,000
Morphine 3-â-D-glucuronide 2,000
Norcodeine 12,500
Normorphone 50,000
Oxycodone 25,000
Oxymorphone 25,000
Procaine 150,000
Thebaine 100,000
PCP
Phencyclidine 25
4-Hydroxyphencyclidine 12,500
TCA
Nortriptyline 1,000
Nordoxepine 1,000
Trimipramine 3,000
Amitriptyline 1,500
Promazine 1,500
Desipramine 200
Imipramine 400
Clomipramine 12,500
Doxepin 2,000
Maprotiline 2,000
Promethazine 25,000

 

 

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