UA
Testing - UA Drug Tests - Urine
Drug Testing
_____________________
A drug test is a device that can detect the
presence of a drug or a number of drugs or their metabolized traces within human
tissue or fluids. T here are many
different kinds of drug tests. With
the increase of drug usage and abuse in America over the years,
drug testing has increased as well, leading to a need for more
drug testing information. Many people think that you
have to go to a doctor’s office or clinic to test for drugs.
However, practically every drug test can be purchased in the
form of a
home drug test kit, allowing you to
buy drug
test kits and perform a simple drug test from the
comfort and convenience of your home. The most popular
forms of drug tests are UA Tests and Alcohol UA (UA is short for
"urine analysis". UA
Testing is the most popular and proven way to detect drugs in
human urine. When it comes to UA Tests, you will not find
better tests or a better selection of drug tests than those
offered by Transmetron!
|
What Is Drug Testing? How Do Drug
Tests Work? |
Best Selling Drug Tests: |
|
Drug Testing is the
examination of human tissue or fluid samples to
determine the presence or absence of specified
drugs or their metabolized traces.
See also,
How To Use A Drug Test. |
5 Panel Drug Test
This is a dip strip drug test that
detects 5 different drugs at one time, a 5 panel drug
test (5 drug assay). We also offer a wide range of
multi panel drug tests that will test
from 2 to 12 drugs. |
|
Why
Is Drug Testing Performed? |
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Drug
testing is performed for a number of reasons. The main
reason is to ensure
safety in the workplace.
Drug tests used at homes and in
schools help to protect our kids. Drug testing is just another way to combat drug
usage and happens to be quite effective. If a drug dealer is
on probation and fails a drug test, he or she can be put
back in jail so that there will be one less drug dealer
on the streets. |
THC - Marijuana Drug Test
This is a dip strip drug test that
detects one drug at a time, a single panel drug test (1
drug assay). Here, we show a cannabis drug test to
test for marijuana (Marijuana Drug Test (THC Test)ing). |
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What Are The
Common Types of Drug Tests? |
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There are 5 different common
types of drug tests. They are as follows:
Urine Test Kits: Detect the presence
or absence of drugs and their metabolites in urine samples. These tests are often referred to as a UA
test.
Saliva Drug Test: Detects the presence
or absence of drugs and their metabolites in saliva samples.
Alcohol Drug Test: Detects the
presence or absence of alcohol and its metabolite in
urine, saliva or blood samples. These tests are
sometimes called an alcohol UA and breath alcohol test.
Hair Drug Test: Detects the presence
or absence of drugs incased in a shaft of human hair or
follicle.
Sweat Drug Test: Detects the presence
of drugs through a sweat sample, most often using what
is called a sweat patch. |
OrAlert - Oral Saliva Drug Test
Above is a mouth swab drug test,
sometimes referred to as the "Spit Drug Test".
The OrAlert drug test detects 6 different drugs at one
time (6 drug assay). |
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What Are The Pros and Cons of Drug Testing Methods? |
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There are pros and cons to
each drug testing methods:
Urine Drug Testing
(UA Testing):
PRO - very reliable
CON - viewed as being invasive
Saliva Drug Testing:
PRO - non invasive
CON - brief detection window
Hair Drug Testing:
PRO - very long window of
detection
CON - need a lab in order to
obtain the results
Sweat Drug Testing:
PRO - very easy to collect
CON - open to contamination
Detailed information
about the
Pros and Cons of Various Drug Testing Methods
|
E-Z Split Key Integrated Drug Test Cup
This is an integrated drug cup.
Here, the drug test is integrated or built into the cup.
This is an Easy To Use - Easy To Read drug test!
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Drug abuse
is a major problem not only in the United States, but around the
world and has indeed become a world wide epidemic! Now, to the
rescue, comes the
instant drug test kit!
Whatever may be the
type of drug test,
they help with the detection of drugs, which in turn forms the
basis for a person returning to leading a drug free life. These
tests can be done in total privacy and give extremely accurate
results. Drug tests are a realistic and affordable possibility
these days with the availability of discount drug testing kits.
Various types of tests
such as
urine drug test,
saliva drug test and
hair
follicle drug test are administered in order to
detect drug abuse. Among the most
commonly used tests is the urine test and you can find many
urine drug testing kits available at a wide
range of pharmacies these days. The drawbacks of purchasing from a pharmacy is
twofold. First, their test kits are extremely expensive (a single panel Marijuana Drug Test (THC Test)
will cost $13 or more each! Whereas,
we
only charge $2.95 for a single Marijuana Drug Test (THC Test)). And, we have the
Guaranteed Lowest Prices on the internet! Second, pharmacies have a very limited
selection of tests. Typically a local drugstore will only carry about
3 or 4
different types of drug tests. Whereas, we carry perhaps the largest selection
of drug test kits on the internet today. With this large selection of drug tests, you can find out
the presence or absence of nearly any specific drug. One of the major advantages
with the urine drug testing kits is that up to
12 different drugs can be detected using a single drug
test kit. With this all inclusive drug test kit, you
can rest positive knowing if they are clean and drug free.
In many instances
saliva drug test kits are used as a non-invasive way to drug
test employees, family members and even self drug testing.
This drug test for saliva works by detecting
traces of certain drugs found in a
person’s mouth, specifically in the saliva, sometimes call spit. This test is
often referred to as the spit test or mouth swab drug test. The results of
saliva tests are almost always reliable with no
known adulterants and it is therefore a
method that is used extensively for drug tests. A saliva drug test is also easy to
conduct and allows for the detection of six different types of drugs. These now
come in two different configurations, one testing for cocaine, amphetamines,
methamphetamines, opiates, marijuana and phencyclidine. The
new OrAlert
test replaces the PCP with benzodiazepines. The oral saliva
drug test can be done almost anywhere and in total privacy, making it among the
preferred methods of drug testing.
Similarly you can find
many
hair follicle drug testing kits that
can help with
detection of certain drugs. Hair
follicles are known to store traces of drugs for a fairly long period of time
(much longer than urine or saliva tests). Using this method one can find out a
lot of details about a particular person’s drug abuse history.
These days you can also
find spray drug testing kits being sold at online stores. These drug tests are
perhaps the easiest to conduct as far as self drug tests go. Another reason for
the popularity of spray drug tests is that the results are very accurate and are
difficult to manipulate.
Most of the drug testing
kits that are available these days are easy to use. The list of drugs that can
be detected using them include
opiates,
cocaine,
marijuana,
methamphetamines,
amphetamines and benzodiazepines to mention only a few. There are
also a wide range of testing kits that can be used for
detecting smoke and alcohol. We offer the
smoker’s nicotine test and
two types of alcohol tests:
breath alcohol and
saliva alcohol tests. These tests
are a great resource for and especially in the case of minors. Many a times an
anxious parent wants to know whether their child is under the influence of
drugs, administering these easy to use drug tests on their child is the best way
they can find out about his or her drug habit. We provide an extensive list of
drug test resources for parents.
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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 |
| 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. |
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| 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 |
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| 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.
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| 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. |
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| 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). |
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| 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). |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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 |
|
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| 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 |
| ń-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 |
|
|
|
? ? ?
Questions
? ? ?
Give Us A Call:
(801) 596-2709
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Professionals
ready to
answer your call! |
Super Special Deals On Drug Tests
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 |
|
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 |
|
Back To Top |
| 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 |
|
Back To Top |
|
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 |
|
Back To Top |
|
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 |
|
Back To Top |
|
| The test panel
contains specific mouse monoclonal antibody, goat polyclonal antibody
and drug protein conjugates. |
|
|
PRECAUTIONS |
|
Back To Top |
|
•
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 |
|
Back To Top |
|
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 |
|
Back To Top |
|
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 |
|
Back To Top |
| 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 |
|
|
|
|
| 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 |
|
Back To Top |
|
| 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 Sensitivityty |
|
Back To Top |
|
| 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 |
|
Back To Top |
|
| 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 |
|
ń-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 |
|
|
|
|
Effect of Urinary Specific Gravity |
|
Back To Top |
|
|
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 Multi-Drug Screen Test 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. |
|
|
Effect of the Urinary pH |
|
Back To Top |
|
| The
pH of an aliquoted negative urine pool was adjusted to a pH range of 5
to 9 in 1 pH unit increments and spiked with drugs at 50% below and 50%
above cut-off levels. The spiked, pH-adjusted urine was tested with The
One Step Multi-Drug Screen Test Panel. The results demonstrate that
varying ranges of pH does not interfere with the performance of the
test. |
|
|
Cross-Reactivity |
|
Back To Top |
|
| A
study was conducted to determine the cross-reactivity of the test with
compounds in either drug-free urine or Cocaine, Amphetamine,
Methamphetamine, Marijuana, Opiate or Phencyclidine positive urine. The
following compounds show no cross-reactivity when tested with the One
Step Multi-Drug Screen Test Panel at a concentration of 100 µg/mL. |
|
|
Non Cross-Reacting Compounds |
|
Back To Top |
|
| Acetaminophen |
Deoxycorticosterone |
Loperamide |
Promazine |
| Acetophenetidin |
Dextromethorphan |
Maprotiline |
Promethazine |
| N-Acetylprocainamide |
Diazepam |
MDE |
DL-Propranolol |
| Acetylsalicylic
acid |
Diclofenac |
Meperidine |
D-Propoxyphene |
| Aminopyrine |
Diflunisal |
Meprobamate |
D-Pseudoephedrine |
| Amitryptyline |
Digoxin |
Methadone |
Quinacrine |
| Amoxicillin |
Diphenhydramine |
Methoxyphenamine |
Quinidine |
| Ampicillin |
Doxylamine |
Nalidixic acid |
Quinine |
| L-Ascorbic acid |
(-) -Ř-Ephedrine |
Naloxone |
Ranitidine |
| DL-Amphetamine
sulfate |
â-Estradiol |
Naltrexone |
Salicylic acid |
| Apomorphine |
Estrone-3-sulfate |
Naproxen |
Serotonin |
| Aspartame |
Ethyl-p-aminobenzoate |
Niacinamide |
Sulfamethazine |
| Atropine |
[1R,2S] (-)
Ephedrine |
Nifedipine |
Sulindac |
| Benzilic acid |
(L) –
Epinephrine |
Norethindrone |
Temazepam |
| Benzoic acid |
Erythromycin |
D-Norpropoxyphene |
Tetracycline |
| Benzphetamine |
Fenoprofen |
Noscapine |
Tetrahydrocortisone, 3-acetate |
| Bilirubin |
Furosemide |
DL-Octopamine |
Tetrahydrocortisone 3- |
| (±) –
Brompheniramine |
Gentisic acid |
Oxalic acid |
(â-D-glucuronide) |
| Caffeine |
Hemoglobin |
Oxazepam |
Tetrahydrozoline |
| Cannabidiol |
Hydralazine |
Oxolinic acid |
Thiamine |
| Chloralhydrate |
Hydrochlorothiazide |
Oxymetazoline |
Thioridazine |
| Chloramphenicol |
Hydrocortisone |
Papaverine |
DL-Tyrosine |
| Chlorothiazide |
O-Hydroxyhippuric
acid |
Penicillin-G |
Tolbutamide |
| (±) –
Chlorpheniramine |
p-Hydroxyamphetamine |
Pentazocine
hydrochloride |
Triamterene |
| Chlorpromazine |
3-Hydroxytyramine |
Perphenazine |
Trifluoperazine |
| Chlorquine |
Ibuprofen |
Phenelzine |
Trimethoprim |
| Cholesterol |
Imipramine |
Trans-2-phenylcyclo-propylamine |
Trimipramine |
| Clomipramine |
Iproniazid |
hydrochloride |
Tryptamine |
| Clonidine |
(±) –
Isoproterenol |
L-Phenylephrine |
DL-Tryptophan |
| Cortisone |
Isoxsuprine |
â-Phenylethylamine |
Tyramine |
| (-) Cotinine |
Ketamine |
Phenylpropanolamine |
Uric acid |
| Creatinine |
Ketoprofen |
Prednisolone |
Verapamil |
| |
Labetalol |
Prednisone |
Zomepirac |
1. Stewart DJ,
Inaba T, Lucassen M, Kalow W. Clin Pharmacol. Ther, April 1979; 25 ed:
464, 264-8
2. Ambre J. J. Anal. Toxicol. 1985; 9:241
3. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National
Institute for Drug Abuse (NIDA), Research Monograph 73, 01986; 1735.
4. Tietz NA. Textbook of Clinical Chemistry. W.B. Saunders Company.
1986; 1735.
5. FDA Guidance Document: Guidance for Premarket Submission for Kits for
Screening Drugs of Abuse to be used by the Consumer, 199.
6. Robert DeCresce. Drug Testing in the workplace, 114.
7. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd
ED. Biomedical Publ., Davis, CA 1982; 487.
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