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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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