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The
OraLine® IV s.a.t. (substance of abuse test) is an
immunoassay designed for the qualitative detection of the
listed four (4) drugs of abuse in human oral fluid. The
OraLine® IV is ideal for use in drugs of abuse clinics, law enforcement
agencies, company employee screening programs, and other point
of contact test sites.
The
OraLine IV was developed to achieve optimal test results using
fresh oral fluid samples. The manufacturer does not recommend
using altered or aged saliva samples, as these samples may
have inconsistent flow patterns and yield unsatisfactory
results with the test.
The
OraLine® IV assay provides only a preliminary screening test
result. A more specific alternative method must be used to
obtain a confirmed analytical result. Although other chemical
confirmation methods are available (1, 2), Liquid or Gas
Chromatography/Mass Spectrometry (LC or GC/MS) are the
preferred confirmatory methods (1).
Clinical
considerations and professional judgment should be applied to
the analysis involving drugs of abuse, particularly when
positive results are indicated (3).
SUMMARY
In
drug analysis, oral fluid drug screening has certain
advantages over the screening of other biological fluids such
as urine and blood. Oral fluid is readily accessible, and is
less likely to be adulterated. With oral fluid tests, the
drugs may be detected immediately after ingestion, even before
they are metabolised and would show up in urine.
In
general, OraLine® IV is designed to work at a lower detection
level for all test drugs than those detected in urine samples.
OraLine® IV oral fluid screening for drugs of abuse detects
the presence of parent compounds and drug metabolites (3,4).
The OraLine® IV uses an immunochromatographic technique that
provides the accuracy of an immunoassay without the need for
laboratory equipment
The
concentrations of the drugs or drug metabolites are at levels
greater than or equal to the cut off value of the assay
specified on the attached table. The immunoreaction causes a
displacement in the antibody-antigen complex that is visually
detected on a chromatographic membrane. The test is designed
to use a fresh oral fluid sample directly, and to provide
rapid test results for on-site testing purposes.
The
OraLine® IV detects recent drug usage, and is particularly
useful for screening of drug intoxication related to any
impairment situations.
The
OraLine® IV is designed to detect the presence of the
following drugs (at levels equal to or greater than the cut
off level as indicated):
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THC
– Cannabinoids delta 9-THC
11-nor-delta
9-COOH-THC
(Marijuana,
Hash, Pot)
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4
ng/mL
4
ng/mL
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COC
– Cocaine
Benzoylecgonine
(Crack,
Coke)
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25
ng/mL
10
ng/mL
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MET
– Methamphetamine
(Speed,
Crank, Ecstasy)
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50
ng/mL
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OPI
– Morphine
(Heroin,
Morphine, Codeine)
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40
ng/mL
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