BMC Oratect III HM11 User Manual

Branan Medical Corporation
®
Oratect III Oral Fluid Drug Screen Device
ME/TH/CO/AM/OP/PC or BZ
Catalog No. HM11 and HM12

Intended Use

®
The Oratect III Oral Fluid Drug Screen Device is a one-step lateral flow
immunoassay device for the qualitative detection of methamphetamine, MDMA, THC,
cocaine, amphetamine, opiates, phencyclidine or benzodiazepines in human oral
®
fluid. The Oratect III Test detects these drugs at the following cut-off concentrations:
ME d-Methamphetamine/MDMA
TH Delta-9-Tetrahydrocannabinol
CO Cocaine
AM d-Amphetamine
OP Morphine
PC Phencyclidine
BZ Diazepam
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 a quantitative result or for a confirmation of a presumptive
positive result obtained by the Oratect
more specific alternative method such as GC/MS or LC/MS must be used.

Summary and Explanation

Illegal drug consumption contributes to many accidents, injuries and medical
conditions. Screening individuals for drugs of abuse is an important method in
identifying those who may cause harm to themselves and to others.
®
Oratect III Oral Fluid Drug Screen Device is developed to detect active drugs-of-
abuse present in saliva. Studies on methamphetamine, MDMA, cocaine, opiate,
amphetamine, phencyclidine, benzodiazepine and cannabinoid show that all of these
drugs are detectable in oral fluid. Oratect
designed to integrate oral fluid collection and
testing for drugs-of-abuse in one single device.

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 oral fluid for limited antibody
binding sites on the colored colloidal gold antibody conjugate. During testing, oral
fluid is collected at the collection pad and migrates across the membrane. 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.
Therefore, the presence of a purple-red band at a specific test region indicates a
negative result. If any drug(s) is (are) present in the oral fluid, it competes with the
immobilized drug conjugate for limited antibody binding sites of the colored colloidal
gold conjugate. When a sufficient amount of drug is present, the drug will saturate
the antibodies, and the colored colloidal gold conjugate cannot bind to the drug
derivative on the membrane. Therefore, the absence of a purple-red band at the
test region indicates a presumptive positive result for that particular test.
Oratect
Fig. a Detail regions of
The presence of a blue line in each window indicates that the device is unused. The
flow of the blue lines indicates that a sufficient amount of oral fluid has been
collected. A control band at the control region (C) indicates the test has performed
properly. This control band should always appear regardless of the presence of drug
or metabolite.

Reagents

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The Oratect III Oral Fluid Drug Screen Device contains two membrane strips and a
collection pad. Each strip consists of a membrane, a colloidal gold conjugate pad, a
sample pad and an absorbent pad.
25 ng/ml
40 ng/ml
20 ng/ml
25 ng/ml
10 ng/ml
4 ng/ml
5 ng/ml
®
III Oral Fluid Drug Screen Device, a
®
III Oral Fluid Drug Screen Device is
lateral flow immunoassay screen
®
III Oral Fluid Drug Screen Device
Membrane: ME/TH/CO test strip:
conjugates are coated onto specific region on the membrane known as the "Test
Region".
AM/OP/PC or AM/OP/BZ test strip:
Amphetamine, Morphine, Benzodiazepine protein conjugates are coated onto the
test region of the membrane.
Colloidal Gold Conjugate Pad: The colloidal gold conjugate pad for the ME/TH/CO
test strip contains anti-methamphetamine, anti-THC and anti-cocaine antibody
colloidal gold conjugates coated onto a fibrous pad. The colloidal gold conjugate pad
for the AM/OP/PC or AM/OP/BZ test strip contains anti-amphetamine, anti-morphine,
anti-phencyclidine or anti-amphetamine, anti-morphine, anti-benzodiazepine antibody
colloidal gold conjugates.
Collection Pad: The collection pad consists of an absorbent material.

Materials Provided

®
Each Oratect III Oral Fluid Drug Screen Device kit contains:
1. 1 Package Insert.
2. 1 Reference Guide.
3. 25 test devices. Each device consists of a plastic holder and a detachable
cap. The devices are packaged individually in a foil pouch with a desiccant.
4. 1 plastic vial containing buffer for confirmation test.

Materials Required but Not Provided

• Timing device

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 package 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.

Product Storage

®
The Oratect III Oral Fluid Drug Screen Device pouch should be stored at room
temperature (15°-30°C). Do not open pouch until ready to perform the assay.

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.

Test 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 donor to hold
the top portion of the device (above the test windows).
5. When placing device into the mouth, keep head level.
a. Open mouth and rub the collection pad inside mouth against one cheek
gently in a circular motion several (approximately 15-20) times. (Fig. b)
b. Still keeping head level, gently rub the collection pad against the opposite
cheek in a circular motion (approximately 15-20) several times. (Fig. b)
Fig. b Gently rub the collection pad against each cheek several (approximately 15-20) times.
Rub the collection pad on top of the tongue several times and then
c.
underneath the tongue several (approximately 15-20) times. (Fig c. and
Fig d.). Do not chew, suck, bite or bend the collection pad.
Fig. c Gently rub the collection pad on
top of the tongue several (approximately
15-20) times.
1
Methamphetamine, THC and Cocaine-protein
Amphetamine, Morphine, Phencyclidine or
Fig. d Gently rub the collection pad
underneath the tongue several
(approximately 15-20) times.