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OratectPlus
Oral Fluid Drug and Alcohol Screen Device
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Training and Certification Program
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OratectPlus
Training
Page 1 of 10 Rev. A
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OratectPlus
Oral Fluid Drug and Alcohol Screen Device
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Training and Certification for Test Administrators
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The information provided is intended to educate test administrators in
the use of the OratectPlus Oral Fluid Drug and Alcohol Screen Device.
Please read the following information carefully. A multiple-choice test
will be administered once the material has been reviewed.
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Intended Use |
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The OratectPlus Oral Fluid Drug and Alcohol 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) and benzodiazepines
(BZ) in human oral fluid. In addition, it is a one-step enzymatic color
test for the qualitative detection of alcohol in human oral fluid.
OratectPlus
was developed to detect active drugs-of-abuse present in
the oral fluid. Studies show that cocaine, opiate, amphetamine,
methamphetamine/MDMA, phencyclidine, benzodiazepines, THC and alcohol
are detectable in oral fluid.
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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.
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The OratectPlus Oral Fluid Drug and Alcohol Screen Device provides only
preliminary drug test results. For quantitative results or for a
confirmation of a presumptive positive drug test result obtained by
OratectPlus, a more specific alternative method such as GC/MS must be
used. Presumptive positive alcohol results should be confirmed either
with a breathalyzer
or a blood test. |
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Specific Test Cut Off Concentration |
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CO Cocaine 20 ng/ml |
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ME Methamphetamine/MDMA 25 ng/ml |
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TH THC (��9-tetrahydrocannabinol) 40 ng/ml |
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AM Amphetamine 25 ng/ml |
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OP Opiate 10 ng/ml
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PC Phencyclidine (PCP)
4 ng/ml
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BZ Benzodiazepine 5 ng/ml |
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AL Alcohol �� 0.02% B.A.C. |
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Warnings and Precautions |
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The OratectPlus Oral Fluid Drug and Alcohol Screen Device is
intended for forensic use only and is not for use in diagnostic
procedures
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The test device should remain in its original sealed pouch until
ready for use.
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Discard the test device if pouch is ripped or torn.
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OratectPlus
Training
Page 2 of 10 Rev. A
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Do not use the test device beyond the expiration date indicated on the
kit.
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Handle all oral specimens as potentially infectious. Proper handling
and disposal methods should be established.
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The OratectPlus Oral Fluid Drug and Alcohol Screen Device pouch
should be stored at room temperature (15��-30��C or 59��-86��F) and
not to exceed 30��C or 86�� F.
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OratectPlus Oral Fluid Drug and Alcohol Screen Device |
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The OratectPlus Oral Fluid Drug and Alcohol Screen Device integrates
collection and a lateral flow immunoassay screening test for 6
drugs-of-abuse plus alcohol in one single device.
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Fig. a Sections of OratectPlus |
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Fig. a Sections of Oratect
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Test Principle |
| The OratectPlus
Oral Fluid Drug and Alcohol 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 line.
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| 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. |
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Any presence of a colored band at a specific test region indicates a
negative result.
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The absence of a color band at the test region indicates a presumptive
positive result for the particular test. |
| OratectPlus |
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Training
Page 3 of 10 Rev. A
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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. |
| During testing,
oral fluid collects on the alcohol pad and saturates it. The alcohol pad
is coated with enzymes which turns shades of green and blue on contact
with alcohol in the oral fluids. |
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If alcohol is not
present in the oral fluid, the alcohol pad will remain white or cream
colored because there is no alcohol in the oral fluid to react with
enzymes to start the color reactions. |
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If alcohol is
present in the oral fluid, the alcohol pad changes to a green or blue
color |
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alcohol reacts with the enzyme alcohol oxidase to produce an aldehyde
and a peroxide. The peroxide then reacts with the enzyme peroxidase in
the presence of a hydrogen donor to produce a blue color. Therefore, the
presence of a green or blue color in the alcohol pad window indicates a
presumptive positive result for alcohol. |
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Specimen Collection
and Handling |
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IMPORTANT |
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minutes prior to administering the test, instruct the donor not to eat,
drink, smoke or chew tobacco products.
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OratectPlus Oral
Fluid Drug and Alcohol Screen Device Procedure |
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1. Remove the test
device from the sealed pouch. |
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2. Carefully
remove the clear cap by holding the sides and pulling gently. This
will expose the collection pad and a round alcohol pad.
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3. Ensure that there
is a blue line present in each test window. |
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4. Observe the
alcohol-pad. The pad should be a light cream color. If it is dark tan in
color or otherwise discolored, this device should not be used.
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5. The oral fluid
collection process must be observed. Instruct the subject to hold the
top portion of the device (above the two windows). |
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Do not touch the
test |
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window area.
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6. When placing
device into the mouth, |
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keep head level.
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a. Open mouth and
rub the collection pad inside mouth against one cheek in a circular
motion several (approximately 15-20) Verdana. |
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(Fig. b)
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b. Still keeping
head level, rub the collection pad against the opposite cheek in a
circular motion several (approximately 15-20) Verdana. |
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(Fig. b)
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| OratectPlus |
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Training
Page 4 of 10 Rev. A
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| 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. ( |
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Fig c. and Fig d.). Do not chew, suck, bite or bend the collection pad.
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Fig. b Rub the collection pad against each cheek several (approximately
15-20) Verdana. |
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. Fig. dc Rub the collection pad on top of the tongue several
(approximately 15-20) Verdana
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Fig. d Rub the collection pad underneath the tongue several
(approximately 15-20)
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| 7. Place the
collection pad underneath the tongue to collect saliva. Instruct the
donor to hold the device in place with their hand. |
| 8. The flow of
the blue lines indicates the collection of a sufficient amount of
saliva. If blue lines are still present after placing the collection pad
underneath the tongue for 30 seconds, repeat steps 6 and 7 until the
blue lines flow. Note: the flow of the blue lines should appear in the
test window within 5 minutes. If no flow patterns are observed after 5
minutes in the mouth, discard the device, review procedures 3-7 with the
donor and repeat using a new device. |
| OratectPlus |
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Training
Page 5 of 10 Rev. A
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| 9. Re-cap the
device, lay on a flat surface and read results: (a) Read |
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alcohol test
at
5
minutes after
removing device from the mouth.
Do not read
results after 10 minutes. |
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drug tests at
5
minutes after
removing device from mouth.
Do not read
results after 30 minutes. |
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Interpreting Test
Results |
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Alcohol Test Results
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Alcohol Negative
Result |
| When the alcohol
pad shows no color change (remains white or cream colored) the results
should be interpreted as negative (no alcohol present). In |
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Fig. e below,
the oral fluid sample is negative for alcohol
because there is no color change on the alcohol pad. |
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Fig. e Example of negative
alcohol test |
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Alcohol Presumptive
Positive Result |
| When the alcohol
test produces a color change to green or blue the test result is
presumptive positive. At higher alcohol concentration near 0.30% B.A.C.,
the color may change to a dark blue-gray. In |
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Fig. f below,
the oral fluid sample is presumptive positive for alcohol
because there is a color change (green/blue to dark green) from the
alcohol pad. |
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OratectPlus |
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Training
Page 6 of 10 Rev. A
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Fig. f Example of
presumptive positive alcohol test |
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Invalid Test Results
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Fig. g below,
a result where the outer edges of the alcohol pad produce a slight color
but the majority of the pad remains colorless should be repeated to
ensure complete saturation of the alcohol pad with oral fluid.
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Fig. g Example of invalid
alcohol test |
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OratectPlus |
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Training
Page 7 of 10 Rev. A
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Drug Test Results |
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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 |
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negative
result. Read each test independently. Do not compare color intensity of
one test to another. |
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Fig. h, the
oral fluid sample is negative for Amphetamine, Opiates and Cocaine
because bands are visible in the AM, OP, and CO test regions.
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Fig. h Example of negative
test results |
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Presumptive Positive
Results |
| When the control
band is visible in the control region (C) and |
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no band
appears at the specific test region (T), the result is
presumptive positive
for that particular
drug. In
Fig. i below,
the oral fluid sample is presumptive positive for Methamphetamine/MDMA
because there is no band visible in the test region of ME. |
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Fig. i Example of
presumptive positive test results |
| OratectPlus |
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Training
Page 8 of 10 Rev. A
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Invalid Results |
| When
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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. j below,
the test is invalid because there are no colored bands in the control
regions. |
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Fig. j Example of invalid
test results |
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Important |
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: 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 OratectPlus Oral Fluid Drug and
Alcohol 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. |
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Specimen Collection
and Handling for Confirmation |
Single Drug Tests
