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SPLIT-SPECIMEN CUP™

Instruction Sheet for testing of any combination of the following drugs: AMP/BAR/BZO/COC/THC/MTD/mAMP/MDMA/MOP/OPI/PCP/TCA

Some cup configurations are available with adulteration strips that may include tests for Oxidants/Pyridinium Chlorochromate, pH and Specific Gravity, Nitrite, Glutaraldehyde and Creatinine

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

For healthcare professionals including professionals at point of care sites. Immunoassay for in vitro diagnostic use only.

INTENDED USE

The Split-Specimen Cup    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 (BZO)

Oxazeparn

300 ng/mL

Cocaine (COC)

Benzoylecgonine

300 ng/mL

Marijuana (THC)

11-nor-A”-THC-9 COOH

50 ng/mL

Methadone (MTD)

Methadone

300 ng/mL

Methamphetamine (mAMP)

D-Methamphetamine

1,000 ng/mL

Methylenedioxymethamphetamine (MDMA)

D,L-Methylenedioxymethamphetamine

500 ng/mL

Morphine (MOP 300)

Morphine

300 ng/mL

Opiates (OPI 2000)

Morphine

2,000 ng/mL

Phencyclidine (PCP)

Phencyclidine

25 ng/mL

Tricyclic Antidepressants (TCA)

Nortriptyline

1,000 ng/mL

Configurations of the Split-Specimen Cup™ come with any combination of the above listed drug analytes. 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 indicated.

SUMMARY

The Split-Specimen Cup™ 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.

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 Split-Specimen Cup™ 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). 4

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 400 mg/day for 2-3 months can produce 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 the 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 Split Specimen Cup™ yields a positive result when the Barbiturates in urine exceed 300 ng/mL.

BENZODIAZEPINES (BZO)

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.