Drug testing kit

6-Panel Urine Drug Screening Kit for

MOP/MET/KET/MDMA/THC/COC Instruction of Use

CY-UDS-0601

For Employment and Insurance Use Only

Intended Use

Summary

iClean® 6-Panel Urine Drug Screening Kit for MOP/MET/KET/MDMA/THC/COC offers qualitative

detection of the following drugs of abuse and their principal metabolites in human urine at specified

cut-off levels: Morphine (MOP), Methamphetamine (MET), Ketamine (KET),

Methylenedioxymethamphetamine (MDMA), Tetrahydrocannabinol (THC) and Cocaine (COC).

The 6-Panel Urine Drug Screening Kit is rapid urine screening test. The test is a lateral flow, one-step

immunoassay for the qualitative detection of specific drugs and their metabolites in human urine at

the following cut off concentrations:

This test will detect other related compounds, please refer to the Analytical Specificity table in this

package insert.

The assay provides a qualitative, preliminary test result. A more specific analytical method must be

used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or

Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are the preferred confirmatory

methods. Professional judgment should be applied to any drug of abuse test result, particularly when

preliminary positive results are indicated.

The 6-Panel Urine Drug Screening Kit for MOP/MET/KET/MDMA/THC/COC is a rapid urine

screening test that can be performed without the use of an instrument. The test utilizes monoclonal

antibodies to selectively detect elevated levels of specific drugs in urine.

Morphine (MOP): Morphine is a popular marketed drug (Serax) for treatment of moderate to severe

pain. It is also a common metabolite of opiates [morphine, codeine (methyl-morphine), and heroin

(semi-synthetic derivatives of morphine)]. The opiates are administered either by smoking,

intravenous injection, intramuscular injection or oral ingestion. Adverse or toxic effects of opiates

usage include papillary constriction, constipation, urinary retention, nausea, vomiting,

hypothermia,drowsiness, dizziness, apathy, confusion, respiratory depression, hypotension, cold and

clammy skin, coma,and pulmonary edema. Death may occur following an over dosage.

The duration of effect of morphine is 3-6 hours. Morphine is metabolized extensively, with only 2-12%

excreted as unchanged morphine in the urine.Heroin is rapidly metabolized to morphine in the body;

the pattern of urinary excretion of heroin is similar to that of morphine.Codeine is also extensively

metabolized, 10-15% of the dose is demethylated to form morphine and norcodeine. It has been

reported that the unchanged morphine may remain detectable in urine for up to one week, which

make morphine a marker of opiates abuse.

Ketamine (KET): Ketamine is a dissociative anesthetic developed in 1963 to replace PCP

(Phencyclidine). While Ketamine is still used in human anesthesia and veterinary medicine, it is

becoming increasingly abused as a street drug. Ketamine is molecularly similar to PCP and thus

creates similar effects including numbness, loss of coordination, sense of invulnerability, muscle

rigidity, aggressive/violent behavior, slurred or blocked speech, exaggerated sense of strength, and

a blank stare. There is depression of respiratory function but not of the central nervous system, and

cardiovascular function is maintained.The effects of Ketamine generally last 4-6 hours following use.

Ketamine is excreted in the urine as unchanged drug (2.3%) and metabolites (96.8%).

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 have 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.

Methylenedioxymethamphetamine(MDMA): MDMA is an abbreviation of the chemical

methylenedioxymethamphetamine. It is a designer drug first synthesized in 1914 by a German drug

company for the treatment of obesity. It also has street names such as Ecstasy,X, XTC,E, Love Doves,

Clarity,Adam,Disco Biscuits, and Shamrocks. MDMA is a stimulant with hallucinogenictendencies.

although it has, in common with amphetamine drugs, a capacity to increase blood pressure and heart

rate. It is described as an empathogen since it releases mood-alteringchemicals, such as cartooning and

L-dopa, in the brain and may generate feelingsof love and friendliness. MDMA is a Class A drug, in the

same category as heroinand cocaine. The adverse effects of MDMA use include elevated blood

pressure,hyperthermia, anxiety, paranoia, and insomnia. Overdoses of MDMA can be fatal,often

resulting in heart failure or heat stroke.

MDMA belongs to a”family”of man-made drugs;its“relatives”are MDA(methylenedioxyamphetamine), the

parent drug of MDMA,and MDEA(methylenedioxyethylamphetamine),also know as EVE, the sister of

MDMA. They all have the amphetamine-like effects. MDMA is administered either by oralingestion or

intravenous injection. MDMA tablets come in different sizes and colors, and often have logos such as

doves on them. Its clinical dose is 50-100mg;the threshold toxic dose is 500mg. The effects of the MDMA

begin 30 minutesafter taking. They peak in an hour and last for 2-3 hours. Sixty five percent (65%)of

MDMA is excreted unchanged in urine and it is detectible in the urine for up to 3 days after use.

Tetrahydrocannabinol (THC): Tetrahydrocannabinol is a hallucinogenic agent derived from the

floweringportion of the hemp plant. The active ingredients in cannabinoids, THC and Cannabinol can be

metabolized and excreted as 11-nor-△9-tetrahydrocannabinol-9-carboxylic acid with a half-life of 24

hours. It canbe detected for 1 to 5 days after use. When smoked or orally administered, THC produces

euphoric effects. Higher doses used by abusers produce centralnervous system effects, altered mood

and sensory perceptions, loss ofcoordination, impaired short-term memory, anxiety, paranoia, depres

sion, confusion, hallucinations and increased heart rate. A tolerance to the cardiacand psychotropic

effects can occur, and withdrawal syndrome produces restlessness, insomnia, anorexia and

nausea.Overdose and extended usage of cannabinoids may lead to substanceabuse,which may cause

severe and/or permanent damage to the human nervesystem.

Cocaine (COC): Cocaine is a potent central nervous system stimulant and a local anesthetic. Initially, it

brings about extreme energy and restlessness while gradually resulting in tremors, over-sensitivity and

spasms. In large amounts, cocaine causes fever, unresponsiveness, difficulty in breathing and

unconsciousness.

Cocaine is often self-administered by nasal inhalation, intravenous injection and free-base smoking. It is

excreted in the urine in a short time primarily as benzoylecgonine. Benzoylecgonine, a major metabolite

of cocaine, has a longer biological half-life (5-8 hours) than cocaine (0.5-1.5 hours), and can generally be

detected for 24-48 hours after cocaine exposure.