Oratect
III Oral Fluid Drug Screen Device
Training and Certification Program
Oratect
III Oral Fluid Drug Screen Device
Training
and
Certification for Test Administrators
The information
provided is intended to educate test administrators in the use of the
Oratect
III Oral Fluid Drug Screen Device.
Please
read the following information carefully. A multiple-choice test will
be
administered once the material has been reviewed.
Intended
Use
The Oratect
III Oral Fluid Drug Screen Device is a
one-step lateral flow immunoassay device for the qualitative detection
of THC
(TH), methamphetamine (ME) including MDMA (ecstasy), cocaine (CO),
amphetamine
(AM), opiate (OP), phencyclidine (PC), benzodiazepines (BZ) in human
oral fluid.
Oratect
III was developed to detect active
drugs-of-abuse present in oral fluid. Studies show that cocaine, opiate,
amphetamine, methamphetamine/MDMA, THC, phencyclidine and
benzodiazepines are
detectable in oral fluid.
The test is intended to be administered by a trained professional. It
should
not be used without supervision. This product is intended for forensic
use
only and is not for use in diagnostic procedures.
The
Oratect
III Oral Fluid Drug Screen Device
provides
only preliminary drug test results. For quantitative results or for a
confirmation of a presumptive positive drug result obtained by Oratect
III, a more specific alternative
method
such as GC/MS must be used.
Specific
Test
Cut Off Concentration
CO Cocaine 20 ng/ml
ME Methamphetamine/MDMA 25
ng/ml
TH THC
(�9-tetrahydrocannabinol) 40 ng/ml
AM Amphetamine 25 ng/ml
OP Opiate 10 ng/ml
PC Phencyclidine (PCP)
4 ng/ml
BZ Benzodiazepine 5 ng/ml
Warnings
and
Precautions
-
The Oratect III Oral Fluid Drug Screen
Device
is intended for forensic use only and is not for use in diagnostic
procedures.
-
The test device should remain in its
original
sealed pouch until ready for use.
-
Discard the test device if pouch is ripped
or
torn.
-
Do not use the test device beyond the
expiration date indicated on the kit.
-
Handle all oral specimens as potentially
infectious. Proper handling and disposal methods should be established.
Oratect
III Training
Page 2 of
8 Rev. E
� The Oratect
III Oral Fluid Drug Screen Device
pouch should
be stored at room temperature (15�-30�C or 59�-86�F).
Oratect
III Oral Fluid Drug Screen Device
The Oratect
III Oral Fluid Drug Screen Device
integrates
collection and a lateral flow immunoassay screening test for 6
drugs-of-abuse in
one single device.
Fig.
a
Sections of Oratect
III
Test
Principle
The Oratect
III Oral Fluid Drug Screen Device is
based on
a competitive immunoassay procedure in which drug derivatives
immobilized on the
membrane compete with the drug(s) which may be present in the oral fluid
for
limited antibody binding sites on the colored colloidal gold antibody
conjugate.
During testing, saliva is
collected at the collection pad and migrates across the membrane. This
is
indicated by the movement of the blue lines.
If no drug is
present in
the oral fluid, the colored colloidal gold antibody conjugate will bind
to the
drug derivatives on the membrane to form visible bands at specific test
regions.
Any presence of a
colored
band at a specific test region indicates a negative result.
The
absence of
a color band at the test region indicates a presumptive positive result
for the
particular test.
In
either
case, a color band at the control region (C) must appear and it
indicates that
the test has performed properly. If the control band does not appear,
the test
results are invalid and must be repeated with a new device.
Oratect
III Training
Page 3 of
8 Rev. E
Specimen
Collection and Handling
IMPORTANT:
At least 10 minutes prior to administering the test, instruct the donor
not to
eat, drink, smoke or chew tobacco products.
Oratect
III Oral Fluid Drug Screen Device
Procedure
1. Remove the test device
from the sealed pouch.
2. Carefully remove the
blue cap by holding the sides and pull gently. This will expose the
collection
pad.
3. Ensure that the blue
line is present in each test window.
4. The oral fluid
collection process must be observed. Instruct the subject to hold the
top portion of the
device
(above the two windows).
Do not touch the test window area.
5. When placing
device into
the mouth, keep
head level.
a. Open mouth and
rub the
collection pad inside mouth against one cheek in a circular motion
several
(approximately 15-20) Verdana.
(Fig. b)
b. Still keeping
head
level, rub the collection pad against the opposite cheek in a circular
motion
several (approximately 15-20) Verdana.
(Fig. b)
c. Rub the
collection pad
on top of the tongue several (approximately 15-20) Verdana and then
underneath the
tongue several (approximately 15-20) Verdana. (Fig
c. and Fig d.). Do not chew, suck, bite or bend the collection pad.
Fig. b
Rub the
collection pad against each cheek several (approximately 15-20) Verdana.
Oratect
III Training
Page 4 of
8 Rev. E
6. Place the collection
pad underneath the tongue to collect saliva. Instruct the donor to hold
the
device in place with their hand.
7. The flow of the blue
lines indicates the collection of a sufficient amount of saliva.
8. If blue lines are
present after placing the collection pad underneath the tongue for 30
seconds,
repeat the instructions in steps 5 and 6 until the blue lines flow.
Remove the
device from mouth as soon as the blue lines start moving at both test
windows.
Note: The flow of the
blue lines should appear in the test windows within 5 minutes. If no
flow is
observed after 5 minutes in the mouth, discard the device, review
procedures 4-7
above with the donor and repeat the test using a new device.
9. Re-cap the
device,
lay on a flat surface and
read results in 5
minutes
after removing device from mouth. Do not read results after 30 minutes.
Interpreting
Test Results
Negative
Results
For each drug test, two
(2) colored bands should be observed in the result window; one band at
the
control region (C) and a band at the specific drug abbreviation (i.e.
AM, OP,
PC) in the test region (T).
The color of the
test band
may be slightly darker or lighter than the control band. Any band that
can be
seen visually, no matter how faint, is a
negative
result. Read each test independently. Do not
compare color
intensity of one test to another.
In the
Fig. e
below, the oral fluid sample is negative for
Amphetamine,
Opiates and Cocaine
because bands are visible in the AM, OP, and CO test regions.
Fig. d
Rub the
collection pad underneath the tongue several (approximately 15-20)
Verdana.
Fig. c
Rub the
collection pad on top of the tongue several (approximately 15-20)
Verdana.
Oratect
III Training
Page 5 of
8 Rev. E
Fig.
e
Example of
negative test results
Presumptive
Positive Results
When the control
band is
visible in the control region (C) and
no
band appears at the specific test region (T), the result is
presumptive positive
for that particular drug. In
Fig. f
below, the oral fluid sample is presumptive
positive for
Methamphetamine/MDMA
because there is no band visible in the test region of ME.
Fig.
f
Example of
presumptive positive test results
Invalid
Results
When
no
band appears in the control (C) region,
the test is invalid
regardless of the test results in the test region.
If the
test is invalid, check testing procedures, and samples.
Repeat the test using a
new
device. In
Fig. g
below, the test is invalid because there are no
colored
bands in the control regions.
Oratect
III Training
Page 6 of
8 Rev. E
Fig.
g
Example of
invalid test results
Important:
Read each test independently. Do not compare color intensity of one
test
band to another. When a faint color band for a specific test is
obtained in
the test region of the test window, the sample should be considered
negative. Results are stable and may be interpreted for up to 30
minutes
after the control bands (C) form. The Oratect
III Oral Fluid Drug Screen Device
provides
qualitative results for the presence of drug(s) at specified cut-off
concentration(s). For confirmation of a presumptive positive result, a
more
specific quantitative method (i.e. Gas Chromatography/Mass
Spectrometry)
must be used.
Specimen Collection and Handling for Confirmation
-
After reading the test results, re-attach the blue cap by
sliding
the collection pad inside the blue cap and gently pushing the cap in
place.
Make sure not to damage or distort the collection pad.
-
Detach the collection pad with the blue cap by pinching the cap
on
the pad and pulling gently. The collection pad should easily fall into
the
blue cap.
-
Drop the collection pad into the confirmation vial of buffer
supplied in the kit.
-
Send vial along with appropriate chain-of-custody document to
your
approved laboratory for confirmatory testing. (Chain-of custody
documents
provided by laboratory)
Limitations of the Procedure
-
The assay is designed for use with human oral fluid only.
-
Presumptive positive results only indicate the presence of
drug/metabolites
and do not indicate or measure intoxication.
-
Technical errors as well as other substances in certain foods and
medication
may interfere with the test and cause false results.
-
If a drug/metabolite is found present in the oral fluid, the assay does
not
indicate.
frequency of drug use nor
does it distinguish between drugs-of-abuse and certain
foods and/or medications.
Oratect
III
Training
Page 7 of 8 Rev. E |
