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Rapid Oral
Screens >
OrAlert 6 Oral Fluid Drug Screen |
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Oralert
6 oral saliva test performs as an immunoassay
based oral fluid screen on the principle
of competitive binding. A rapid 6 panel
drug parameter screening test for the
simultaneous, qualitative detection
of drugs and their metabolites in human
oral fluid.
•OraLert oral
saliva screen picks up THC up-to 24
hours instead of 10-12 hours like it's
competitors
•Observe collections
without donor privacy issues
•Non-invasive
•OraLert oral fluid screen eliminates
collection site costs.
•OraLert is
difficult to adulterate.
•OraLert
test results take only 10 minutes
•OraLert 6 has a 12-18 month shelf life |
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(Total Items: 2) |
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REAGENTS
The Oralert 6 Oral saliva screen 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 saliva specimen should be collected
using the saliva swab provided with the kit. 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 saliva screen 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 saliva screen foil 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 device samplecollector 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 oral fluid
screen 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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Alco-Screen 02
