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Oralert 6 Oral Fluid Multi-Drug Test multi saliva
test Device is an immunoassay based on the principle
of competitive binding. A rapid, screening test for
the simultaneous, qualitative detection of drugs and
their metabolites in human oral fluid. The OraLert 6
Oral Fluid Test multi saliva test is a lateral flow
chromatographic immunoassay for the qualitative
detection of drugs and their metabolites in oral
fluids. The OraLert 6 Oral Fluid Test for drugs and
their metabolites is a rapid, oral fluid-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 human oral fluid. |
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OraLert
Oral Fluid Multi-Drug Test -THC
#O-DSF-765-011 OraLert 6
(COC,AMP,mAMP,THC(100),OPI,PCP). The
Oralert 6 Tests for the Parent Drug
THC and can detect THC for up to 24
hours. OraLert 6 Oral Fluid Drug
Screen Device Test for Oral Fluid.
$225.00 (BX/25)
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Oralert
Oral Fluid Multi-Drug Test - BZO
#0-DSF-765-011
(COC, THC, OPI, AMP, mAMP, BZO).
The Oralert 6 Tests for the Parent
Drug THC and can detect THC for up
to 24 hours.
The OraLert Oral Fluid Drug Screen
Device is a lateral flow
chromatographic immunoassay for the
qualitative detection of drugs and
their metabolites in oral fluids.
$225.00
(BX/25) |
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REAGENTS
The Oralert 6 Oral Fluid Drug Screen Device contains
membrane strips coated with drug-protein conjugates
on the test line, polyclonal antibody against
gold-protein conjugate at the control line, and a
dye pad which contains colloidal gold particles
coated with antibody specific to the drugs being
tested.
SPECIMEN COLLECTION AND PREPARATION
The Oralert 6 Oral Fluid Drug Screen Device saliva
drug test specimen should be collected using the
collecting swab provided with the kit, following the
detailed instructions under Directions for Use. No
other collection devices should be used with this
assay. Oral fluid collected at any time of the day
may be used.
DIRECTIONS FOR Using Oralert 6
Allow the Oralert 6 Oral Fluid saliva Drug test to
come to room temperature (59-86¨F) prior to testing.
Instruct the donor not to place anything in the
mouth including food, drink, gum, or tobacco
products for at least 10 minutes prior to
collection.
1. Bring the Oralert 6 Oral Fluid saliva Drug Screen
pouch to room temperature before opening it. Remove
the test and Cap from the sealed pouch and use the
test as soon as possible.
2. Remove the Oralert 6 Oral Fluid saliva Drug
Screen Device Sample Collector Cap from the
collection Swab. Instruct the donor to insert the
Swab end of the collector into the mouth and
actively swab the inside of the mouth and the top of
the tongue. As soon as the Swab softens slightly,
the donor should gently press the Swab between the
tongue and teeth to ensure complete saturation.
3. The Swab is saturated when no hard spots can be
felt. Collect for a total of at least three (3)
minutes before removing the Swab. Remove the
collector from the mouth
4. Align the Red Arrow on the Oralert 6 Oral Fluid
Drug Screen Device with one of the White Marks on
the Cap. Insert the collector vertically into the
Cap and press down firmly. Twist the Cap clockwise
180 degrees until the Red Arrow lines up with the
other White Mark.
5. Place the test device horizontally on a clean and
level surface with facing up.
6. Read results at 10 minutes. Do not read results
after 1 hour.
7. If positive results are observed, secure Cap with
security seal and send the Oralert 6 Oral Fluid Drug
Screen Device to a laboratory for confirmation. The
laboratory can access the reservoir through the
Sample Port.
How to Read Oralert Results
NEGATIVE: Two lines appear.
One colored line should be in the control region
(C), and another apparent colored line should be
adjacent in the test region (Drug/T). This negative
result indicates that the drug concentration is
below the detectable level.
NOTE: The shade of color in the test region (Drug/T)
will vary, but it should be considered negative
whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control
region (C). No line appears in the test region
(Drug/T). This positive result indicates that the
drug concentration is above the detectable level.
INVALID: Control line fails to appear.
Insufficient specimen volume or incorrect procedural
techniques are the most likely reasons for control
line failure. Review the procedure and repeat the
test using a new test panel. If the problem
persists, discontinue using the lot immediately and
contact the manufacturer. A procedural control is
included in the test. A colored line appearing in
the control region (C) is considered an internal
procedural control. It confirms sufficient specimen
volume, adequate membrane wicking and correct
procedural technique.
LIMITATIONS
1. The OraLert 6 provides only a qualitative,
preliminary analytical result. A secondary
analytical method must be used to obtain a confirmed
result. Gas chromatography/mass spectrometry (GC/MS)
or gas chromatography/tandem mass spectrometry
(GC/MS/MS) are preferred confirmatory methods.
2. A positive test result does not indicate the
concentration of drug in the specimen or the route
of administration.
3. A negative result may not necessarily indicate a
drug-free specimen. Drug may be present in the
specimen below the cutoff level of the assay.
Cross-Reactivity
A study was conducted to determine the
cross-reactivity of the test with compounds spiked
into drug-free PBS stock. The compounds demonstrated
no false positive results on the Oralert 6 when
tested with concentrations up to 100 mL.
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