Rapid Exams, Inc. Multi-Drug Test Card
Package Insert for Single Test Strip and Multi-Drug Screening Dip card
This Instruction Sheet is for testing of any combination of Amphetamine,
Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine,
Methylenedioxymethamphetamine, Morphine (Opiates), Oxycodone, Phencyclidine,
Propoxyphene, Tricyclic Antidepressants, and Buprenorphine.
A rapid, multi-drug screening test for the simultaneous, qualitative detection of multiple drugs
and drug Metabolites in human urine. For Professional and In Vitro Diagnostic Use Only.
INTENDED USE
The Rapid Exams Multi-Drug Test is a lateral flow
chromatographic immunoassay for the qualitative detection of multiple drugs and drug
metabolites in urine at the following cut-off concentrations:
Test Calibrator Cut-off
Amphetamine (AMP) D-Amphetamine 1,000 ng/mL
Barbiturates (BAR) Secobarbital 300 ng/mL
Benzodiazepines (BZD) Oxazepam 300 ng/mL
Cocaine (COC) Benzoylecgonine 300 ng/mL
Marijuana (THC) 11-nor-
Ä9-THC-9 COOH 50 ng/mL
Methadone (MTD) Methadone 300 ng/mL
Methamphetamine(MET) D-Methamphetamine 1,000 ng/mL
Methylenedioxymethamphetamine
(MDMA)
D,L Methylenedioxymethamphetamine
500 ng/mL
Opiates (OPI 300) Morphine 300 ng/mL
Opiates (OPI 2000) Morphine 2,000 ng/mL
Oxycodone (OXY) Oxycodone 100 ng/mL
Phencyclidine (PCP) Phencyclidine 25 ng/mL
Propoxyphene (PPX) Propoxyphene 300 ng/mL
Tricyclic Antidepressants (TCA) Nortriptyline 1,000 ng/mL
Buprenorphine Buprenorphine 10 ng/mL
Configurations of the Rapid Exams Multi-Drug Test can consist of any combination of
the above listed drug analytes. This assay provides only a preliminary qualitative test
result. Use a more specific alternate quantitative analytical method to obtain a confirmed
analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred
confirmatory method.1 Apply clinical and professional judgment to any Multi-Drug test
result, particularly when preliminary positive results are obtained.
SUMMARY AND EXPLANATION OF THE TEST
The Rapid Exams™ Multi-Drug Test is a competitive immunoassay utilizing highly specific
reactions between antibodies and antigens for the detection of multiple drugs and
drug metabolites in human urine. The Rapid Exams Multi-Drug Test is a rapid urine
screening test that utilizes monoclonal antibodies to selectively detect elevated levels of
specific drugs in urine without the use of an instrument.
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 doses lead to enhanced stimulation of the central nervous
system and induce euphoria, alertness, reduced appetite, and a sense of increased
energy and power. Cardiovascular responses to Amphetamines include increased blood
pressure and cardiac arrhythmias. More acute responses produce anxiety, paranoia,
hallucinations, and psychotic behavior. The effects of Amphetamines generally last 2-4
hours following use, and the drug has a half-life of 4-24 hours in the body. About 30%
of Amphetamines are excreted in the urine in unchanged form, with the remainder as
hydroxylated and deaminated derivatives.
The Rapid Exams Multi-Drug Test yields a positive result when Amphetamines
in urine exceed 1,000 ng/mL. This is the suggested screening cut-off for positive
specimens set by the Substance Abuse and Mental Health Services Administration
(SAMHSA, USA). 2
BARBITURATES (BAR)
Barbiturates produce a wide spectrum of central
nervous system depression, from mild sedation to coma, and have been used as sedatives,
hypnotics, anesthetics, and anticonvulsants. Barbiturates are classified as ultrashort,
short, intermediate, and long-acting. These drugs are primarily used for insomnia and
preoperative sedation daytime sedation and the treatment of seizure disorders. Veterinarians
use pentobarbital, a long-acting barbiturate, for anesthesia and euthanasia.
Barbiturates are common drugs of abuse taken orally or intravenously. They
produce symptoms similar to intoxication. Chronic use will develop tolerance, physical
dependence and psychological dependence on barbiturates. Overdoses can cause
profound shock, coma, or death.
Shorter acting barbiturates (Allobarbital, Alphenal, Amobarbital, Aprobarbital,
Butabarbital, Butalbital, Butethal, Pentobarbital, Secobarbital) can be detected for only 1 to
4 days, while long-acting barbiturates (Barbital, Phenobarbital) can be detected for 2 to 3
weeks. Normally the suggested detection period for the Barbiturates in urine is 4 to 7 days.
The Rapid Exams Multi-Drug Test yields a positive result when the Barbiturates
(Secobarbital) in urine exceed 300 ng/mL.
BENZODIAZEPINES (BZD)
Benzodiazepines are medications that are
frequently prescribed for the symptomatic treatment of anxiety and sleep disorders.
They produce their effects via specific receptors involving a 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 as trouble sleeping, gastrointestinal
upset, feeling unwell, loss of appetite, sweating, trembling, weakness, anxiety and
changes in perception.
Only trace amounts (less than 1%) of most Benzodiazepines are excreted
unaltered in the urine; most of the concentration in urine is conjugated drug. The
detection period for the Benzodiazepines in the urine is 3-7 days.
The Rapid Exams Multi-Drug Test yields a positive result when the
Benzodiazepines in urine exceed 300 ng/mL.
COCAINE (COC)
Cocaine is a potent central nervous system (CNS) stimulant and
a local anesthetic. Initially, it brings about extreme energy and restlessness while gradually
resulting in tremors, over-sensitivity and spasms. In large amounts, cocaine causes
fever, unresponsiveness, difficulty in breathing and unconsciousness.
Cocaine is often self-administered by nasal inhalation, intravenous injection
and free-base smoking. It is excreted in the urine in a short time primarily as
Benzoylecgonine.2.4 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 exposure.4
The Rapid Exams Multi-Drug Test 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). 2
MARIJUANA (THC)
THC (Ä9-tetrahydrocannabinol) is the primary active ingredient
in cannabis (marijuana). When smoked or orally administered, THC produces
euphoric effects. Users have impaired short term memory and slowed learning. They
may also experience transient episodes of confusion and anxiety. Long-term, relatively
heavy use may be associated with behavioral disorders. The peak effect of marijuana
administered by smoking occurs in 20-30 minutes and the duration is 90-120
minutes after one cigarette. Elevated levels of urinary metabolites are found within
hours of exposure and remain detectable for 3-10 days after smoking. The main
metabolite excreted in the urine is 11-nor-
Ä9-tetrahydrocannabinol-9-carboxylic acid (Ä9-THC-COOH).
The Rapid Exams Multi-Drug Test yields a positive result when the concentration
of THC-COOH in urine exceeds 50 ng/mL. This is the suggested screening cut-off
for positive specimens set by the Substance Abuse and Mental Health Services
Administration (SAMHSA, USA). 2
METHADONE (MTD)
Methadone is a narcotic analgesic prescribed for the
management of moderate to severe pain and for the treatment of opiate dependence
(heroin, Vicodin, Percocet, Morphine). The pharmacology of Oral Methadone is very
different from IV Methadone. Oral Methadone is partially stored in the liver for later use.
IV Methadone acts more like heroin. In most states you must go to a pain clinic or
a Methadone maintenance clinic to be prescribed Methadone. Methadone is a long
acting pain reliever producing effects that last from twelve to forty-eight hours. Ideally,
Methadone frees the client from the pressures of obtaining illegal heroin, from the
dangers of injection, and from the emotional roller coaster that most opiates produce.
Methadone, if taken for long periods and at large doses, can lead to a very long withdrawal
period. The withdrawals from Methadone are more prolonged and troublesome
than those provoked by heroin cessation, yet the substitution and phased removal of
methadone is an acceptable method of detoxification for patients and therapists.13
The Rapid Exams™ Multi-Drug Test yields a positive result when the Methadone in
urine exceeds 300 ng/mL.
METHAMPHETAMINE (MET)
Methamphetamine is an addictive stimulant
drug that strongly activates certain systems in the brain. Methamphetamine is
closely related chemically to amphetamine, but the central nervous system effects of
Methamphetamine are greater. Methamphetamine is made in illegal laboratories and
has a high potential for abuse and dependence. The drug can be taken orally, injected,
or inhaled. Acute higher doses lead to enhanced stimulation of the central nervous
system and induce euphoria, alertness, reduced appetite, and a sense of increased
energy and power. Cardiovascular responses to Methamphetamine include increased
blood pressure and cardiac arrhythmias. More acute responses produce anxiety,
paranoia, hallucinations, psychotic behavior, and eventually, depression and exhaustion.
The effects of Methamphetamine generally last 2-4 hours and the drug has a half-life
of 9-24 hours in the body. Methamphetamine is excreted in the urine as amphetamine
and oxidized and delaminated 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 Rapid Exams Multi-Drug Test yields a positive result when the
Methamphetamine in urine exceeds 1,000 ng/mL.
METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
MDMA, ECSTASY; 3,4-METHYLENEDIOXY-N-METHYLAMPHETAMINE was first identified by a DEA
Lab in 1972. MDMA is a Schedule 1 synthetic, psychoactive drug possessing stimulant
and hallucinogenic properties. MDMA possesses chemical variations of the stimulant
amphetamine or methamphetamine and a hallucinogen, most often mescaline.
Ecstasy is said to produce empathy, decreased anxiety, relaxation and heightened
senses. MDMA also suppresses appetite, thirst and the need to sleep. Because of this
in combination with dancing and increased activity can cause severe dehydration and
exhaustion. Adverse effects may include nausea, cold sweats, chills, hallucinations,
increased body temperature, tremors, teeth clenching, tremors, double vision and
muscle cramps. Long term after-effects of MDMA include anxiety, paranoia and
depression. This is most likely attributed to the decreased serotonin levels found in the
brain for up to three weeks after their last dose. The National Institute of Mental Health
conducted a study in 1998 to support this. It was found that the use of MDMA severely
damaged the neurons in the brain that transmit serotonin. Serotonin is the chemical that
is used in learning, sleep, and integration of emotion. The study concluded that even
recreational users of the drug might be at risk of developing permanent damage that
can manifest depression, anxiety, memory loss, and neuropsychotic disorders.
In addition to these troubling facts, recent research is pointing to the real cause
of the long term effects of MDMA. The drug acts primarily on the serotonin receptor
sites in the brain, enabling them to take in large quantities of serotonin. It also enables
them to take in other chemicals in the brain. Namely, it takes in dopamine and as the
serotonin receptor sites attempt to break the dopamine down, it produces hydrogen
peroxide. Which many researches believe is the cause of long term damage to serotonin receptors.
The Rapid Exams™ Multi-Drug Test yields a positive result when the Methylenedioxymethamphetamine in urine exceeds 500 ng/mL.
OPIATES (OPI 300)
Opiates refers to any drug that is derived from the opium
poppy, including the natural products, morphine and codeine, and the semi-synthetic
drugs such as heroin. Opioid is more general, referring to any drug that acts on the
opioid receptor.
Opioid analgesics comprise a large group of substances which control pain by
depressing the central nervous system. Large doses of morphine can produce higher
tolerance levels, physiological dependency in users, and may lead to substance abuse.
Morphine is excreted unmetabolized, and is also the major metabolic product of codeine
and heroin. Morphine is detectable in the urine for several days after an opiate dose.
The Rapid Exams Multi-Drug Test yields a positive result when the concentration
of opiate exceeds the 300 ng/mL cut-off level.
OPIATES (2000)
Opiates refers to any drug that is derived from the opium poppy,
including the natural products, morphine and codeine, and the semi-synthetic drugs such
as heroin. Opioid is more general, referring to any drug that acts on the opioid receptor.
Opioid analgesics comprise a large group of substances which control pain by
depressing the central nervous system. Large doses of morphine can produce higher
tolerance levels, physiological dependency in users, and may lead to substance abuse.
Morphine is excreted unmetabolized, and is also the major metabolic product of codeine
and heroin. Morphine is detectable in the urine for several days after an opiate dose.4
The Rapid Exams Multi-Drug Test 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).
OXYCONTIN (OXY)
Oxycodone, [4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-morphinan-6-one, dihydrohydroxycodeinone] is a semi-synthetic opioid agonist
derived from thebaine, a constituent of opium. Oxycodone is a Schedule II narcotic
analgesic and is widely used in clinical medicine. The pharmacology of oxycodone is
similar to that of morphine, in all respects, including its abuse and dependence liabilities.
Pharmacological effects include analgesia, euphoria, feelings of relaxation, respiratory
depression, constipation, papillary constriction, and cough suppression.
Oxycodone is prescribed for the relief of moderate to high pain under pharmaceutical
trade names as OxyContin® (controlled release), OxyIR®, OxyFast®(immediate release
formulations), or Percodan® (aspirin) and Percocet® (acetaminophen) that are in
combination with other nonnarcotic analgesics. Oxycodone’s behavioral effects can
last up to 5 hours. The controlled-release product, OxyContin®, has a longer duration of action (8-12 hours).
The Rapid Exams Multi-Drug Test yields a positive result when the Oxycodone in
urine exceeds 100 ng/mL.
PHENCYCLIDINE (PCP)
Phencyclidine, also known as PCP or Angel Dust, is a hallucinogen that was first marketed as a surgical anesthetic in the 1950’s. It
was removed from the market because patients receiving it became delirious and experienced hallucinations.
Phencyclidine is used in powder, capsule, and tablet form. The powder is either
snorted or smoked after mixing it with marijuana or vegetable matter. Phencyclidine is
most commonly administered by inhalation but can be used intravenously, intra-nasally,
and orally. After low doses, the user thinks and acts swiftly and experiences mood
swings from euphoria to depression. Self-injurious behavior is one of the devastating
effects of Phencyclidine.
PCP can be found in urine within 4 to 6 hours after use and will remain in urine
for 7 to 14 days, depending on factors such as metabolic rate, user’s age, weight,
activity, and diet.5 Phencyclidine is excreted in the urine as an unchanged drug (4% to
19%) and conjugated metabolites (25% to 30%).6
The Rapid Exams Multi-Drug Test yields a positive result when the phencyclidine
level 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).
NOTE:
Effexor Tablets (venlafaxine hydrochloride) a treatment for depressive, anxiety
and social disorder have shown to cause false positive urine results for Phencyclidine
(PCP). Positive urine screening should always be confirmed by GCMS.
PROPOXYPHENE (PPX)
Propoxyphene (PPX) is a mild narcotic analgesic found
in various pharmaceutical preparations, usually as the hydrochloride or napsylate salt.
These preparations typically also contain large amounts of acetaminophen, aspirin, or
caffeine. Peak plasma concentrations of propoxyphene are achieved from 1 to 2 hours
post dose. In the case of overdose, propoxyphene blood concentrations can reach
significantly higher levels. In human, propoxyphene is metabolized by N-demethylation to
yield norpropoxyphene. Norpropoxyphene has a longer half-life (30 to 36 hours) than
parent propoxyphene (6 to 12 hours). The accumulation of norpropoxyphene seen with
repeated doses may be largely responsible for resultant toxicity.
The Rapid Exams Multi-Drug Test yields a positive result when the concentration
of Propoxyphene or Norpropoxyphene in urine exceeds 300 ng/mL.
TRICYCLIC ANTIDEPRESSANTS (TCA)
TCA (Tricyclic Antidepressants) are
commonly used for the treatment of depressive disorders. TCA overdoses can result in
profound central nervous system depression, cardiotoxicity and anticholinergic effects.
TCA overdose is the most common cause of death from prescription drugs. TCAs are
taken orally or sometimes by injection. TCAs are metabolized in the liver. Both TCAs and
their metabolites are excreted in urine mostly in the form of metabolites for up to ten days.
The Rapid Exams Multi-Drug Test yields a positive result when the concentration
of Tricyclic Antidepressants in urine exceeds 1,000 ng/mL.
BUPRENORPHINE (BUP)
Buprenorphine is a semi-synthetic opioid analgesic
derived from thebain, a component of opium. It has a longer duration of action than
morphine when indicated for the treatment of moderate to severe pain, peri-operative
analgesia, and opioid dependence. Low doses buprenorphine produces sufficient
agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids
without experiencing withdrawal symptoms. Buprenorphine carries a lower risk of
abuse, addiction, and side effects compared to full opioid agonists because of the
“ceiling effect”, which means no longer continue to increase with further increases in
dose when reaching a plateau at moderate doses. However, it has also been shown
that Buprenorphine has abuse potential and may itself cause dependency. Subutex®,
and a Buprenorphine/Naloxone combination product, Suboxone®, are the only two
forms of Buprenorphine that have been approved by FDA in 2002 for use in opioid
addiction treatment. Buprenorphine was rescheduled from Schedule V to Schedule III
drug just before FDA approval of Suboxone and Subutex.
The Rapid Exams Multi-Drug Test yields a positive result when the concentration
of Buprenorphine in urine exceeds 10 ng/mL.
PRINCIPLE
The Rapid Exams Multi-Drug Test 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
The test contains a membrane strip coated with drug-protein
conjugates (purified bovine albumin) on the test line, a goat polyclonal antibody against
gold-protein conjugate at the control line, and a dye pad which contains colloidal gold
particles coated with mouse monoclonal antibody specific to Amphetamine, Cocaine,
Methamphetamine, Methylenedioxymethamphetamine, Morphine, THC, Phencyclidine,
Benzodiazepines, Methadone, Barbiturates, Propoxyphene, Oxycodone, Tricyclic
Antidepressants, or Buprenorphine.
PRECAUTIONS
· For Professional Use Only. · For In Vitro Diagnostic Use Only.
· Do not use after the expiration date. · The test panel should remain in the sealed
pouch until use. · While urine is not classified by OSHA or the CDC as a biological
hazard unless visibly contaminated with blood, the use of gloves is recommended
to avoid unnecessary contact with the specimen. · The used test card and urine
specimen should be discarded according to federal, state and local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at
2-30°C (36-86°F). The test is stable through the expiration date printed on the sealed
pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do
not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
The urine specimen must be collected in a clean and dry container.
Urine collected at any time of the day may be used. Urine specimens exhibiting visible
precipitates should be allowed to settle to obtain a clear specimen for testing.
Specimen Storage
Urine specimens may be stored at 2-8°C (36-46°F) 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.
MATERIALS PROVIDED
· Test devices · Desiccant · Package insert / Instructions · Color Procedure Card (for tests with Adulterations strips)
Materials Required But Not Provided
· Specimen collection container (free w/min. 25) · Disposable gloves · Timing device (i.e. timer, clock, watch, etc.)
|