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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.)

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PERFORMANCE CHARACTERISTICS

Accuracy

A side-by-side comparison was conducted using The Rapid Exams

Multi-Drug Test and other commercially available rapid drug tests. Testing was performed

on 120 specimens per drug type previously collected from subjects presenting

for drug screen testing. All the presumptive positive and negative 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

BZD Oxazepam, Nordiazepam, _ -OH-Alprazolam, Desalkylflurazepam

COC Benzoylecgonine

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

MTD Methadone

MET Methamphetamine

MDMA D,L Methylenedioxymethamphetamine, Methylenedioxyamphetamine

OPI, OPI300

Morphine, Codeine

OXY Oxycodone

PCP Phencyclidine

PPX Propoxyphene

TCA Nortriptyline

BUP Buprenorphine

The following results are tabulated from these clinical studies:

%Agreement with Commercial Kit

AMP BAR BZD

Positive Agreement

98% 100% 100%

Negative

Agreement

100% 100% 98%

Total Results 99% 100% 99%

COC THC MTD

Positive Agreement

98% 98% 100%

Negative

Agreement

100% 100% 100%

Total Results 99% 99% 100%

MET MDMA OPI 300

Positive Agreement

98% 100% 98%

Negative

Agreement

100% 100% 100%

Total Results 99% 100% 99%

%Agreement with Commercial Kit

OPI OXY PCP

Positive Agreement

98% 100% 98%

Negative

Agreement

100% 100% 100%

Total Results 99% 100% 99%

%Agreement with Commercial Kit

PPX TCA BUP

Positive Agreement

98% 98.5% 95%

Negative

Agreement

100% 100% >99%

Total Results 99% 99% 97.5%

%Agreement with GC/MS

AMP BAR BZD

Positive Agreement

95% 98.5% 95.7%

Negative

Agreement

100% 98% 98%

Total Results 97.5% 98.2% 96.8%

COC THC MTD

Positive Agreement

95% 95% 98.5%

Negative

Agreement

100% 100% 96%

Total Results 97.5% 97.5% 97%

MET MDMA OPI 300

Positive Agreement

95% 97.1% 95%

Negative

Agreement

100% 98% 100%

Total Results 97.5% 97.5% 97.5%

OPI PCP TCA

Positive Agreement

95% 95% 95.7%

Negative

Agreement

100% 100% 98%

Total Results 97.5% 97.5% 96.8%

Forty (40) clinical samples for each drug were run using each strip contained within

The Rapid Exams Multi-Drug Test by an untrained operator at a Professional Point of

Care site. Based on GC/MS data, the untrained operator obtained statistically similar

Positive Agreement, Negative Agreement and Overall Agreement rates as trained

laboratory personnel. *Note: TCA was based on HPLC data.

AMP BAR BZD

Positive Agreement

95% 97.4% 95.7%

Negative

Agreement

100% 97.6% 100%

Total Results 97.5% 97.5% 97.5%

COC THC MTD

Positive Agreement

96% 96% 93.7%

Negative

Agreement

100% 100% 97.9%

Total Results 98% 98% 96.2%

MET MDMA OPI 300

Positive Agreement

96% 92.5% 96%

Negative

Agreement

100% 100% 100%

Total Results 98% 96.2% 98%

OPI OXY PCP

Positive Agreement

100% 95% 95%

Negative

Agreement

96% 100% 100%

Total Results 98% 97.5% 97.5%

PPX TCA

Positive Agreement

95% 97.5%

Negative

Agreement

100% 100%

Total Results 97.5% 98.7%

Reproducibility

Reproducibility studies were carried out using commercially

available standards. Each standard was diluted in normal, drug-free urine to give the

appropriate concentration. Each specimen, at each concentration of analyte, was tested

four times daily, in duplicate, for five consecutive days. A total of 40 determinations were

made at each concentration.

REI products detect substances such as cannabinoids marijuana, hashish , cocaine, benzoylecognine, cocaethylene, amphetamine, methamphetamine, opiates, heroin, opium, codeine, morphine, barbiturates, benzodiazepines, codeine, phencyclidine, alcohol, cotinine, nicotine, morphine, heroin, lsd, methadone plus other drugs of abuse.