Gima 24555 Manual De Uso página 8

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One Step Multi-Line Screen Test Device (Oral Fluid)
A rapid, screening test for the simultaneous, qualitative detection of multiple drugs and metabolites in
human oral fluid. For medical and other professional in vitro diagnostic use only.
INTENDED USE & SUMMARY
The Multi-Drug One Step Multi-Line Screen Test Device (Oral Fluid) is a lateral flow chromatographic
immunoassay for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine,
Opiate, and Phencyclidine and their metabolites in oral fluid at the following cut-off concentrations.
The detection window, when drugs can be detected in oral fluid specimens using this test, is also
indicated.
This test will detect other related compounds, please refer to the Analytical Specificity table in this
package insert.
AMP: Amphetamine is a sympathomimetic amine with therapeutic indications. The drug is often self-
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administered by nasal inhalation or oral ingestion.
COC: Cocaine is a potent central nervous system (CNS) stimulant and a local anesthetic derived from
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the coca plant (erythroxylum coca).
THC: Tetrahydrocannabinol, the active ingredient in the marijuana plant (cannabis sativa), is detectable
in oral fluid shortly after use. The detection of the drug is thought to be primarily due to the direct
exposure of the drug to the mouth (oral and smoking administrations) and the subsequent sequestering
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of the drug in the buccal cavity.
MET: Methamphetamine is a potent stimulant chemically related to amphetamine but with greater
CNS stimulation properties. The drug is often self-administered by nasal inhalation, smoking or oral
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ingestion.
OPI: The drug class opiates refers to any drug that is derived from the opium poppy, including naturally
occurring compounds such as morphine and codeine and semi-synthetic drugs such as heroin. Opiates
control pain by depressing the CNS, and demonstrate addictive properties when used for sustained
periods of time. Opiates can be taken orally or by injection routes including intravenous, intramuscular
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and subcutaneous; illegal users may also take the intravenously or by nasal inhalation. *The window
of detection varies for different opiates. Codeine can be detected within one hour and up to 7-21 hours
after a single oral dose. Morphine is detectable for several days after a dose.
PCP: Phencyclidine is a hallucinogen and, can be detected in oral fluid as a result of the exchange of
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the drug between the circulatory system and the oral cavity. 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) and gas chromatography/
tandem mass spectrometry (GC/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.