BMC Oratect III HM11 User manual

1
Branan Medical Corporation Membrane: ME/TH/CO test strip: Methamphetamine, THC and Cocaine-protein
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, Phencyclidine or
Amphetamine, Morphine, Benzodiazepine protein conjugates are coated onto the
test region of the membrane.
Oratect®III Oral Fluid Drug Screen Device 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.
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: Collection Pad: The collection pad consists of an absorbent material.
Materials Provided
Each Oratect®III Oral Fluid Drug Screen Device kit contains:
ME
TH
CO
AM
OP
PC
BZ
d-Methamphetamine/MDMA
Delta-9-Tetrahydrocannabinol
Cocaine
d-Amphetamine
Morphine
Phencyclidine
Diazepam
25 ng/ml
40 ng/ml
20 ng/ml
25 ng/ml
10 ng/ml
4 ng/ml
5 ng/ml
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
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.
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 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®III Oral Fluid Drug Screen Device, a
more specific alternative method such as GC/MS or LC/MS must be used.
• 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.
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.
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.
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®III Oral Fluid Drug Screen Device is
designed to integrate oral fluid collection and lateral flow immunoassay screen
testing for drugs-of-abuse in one single device.
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.
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.
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.
c. Rub the collection pad on top of the tongue several times and then
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.
Fig. d Gently rub the collection pad
underneath the tongue several
(approximately 15-20) times.
Fig. a Detail regions of Oratect®III Oral Fluid Drug Screen Device
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
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.

6. Place the collection pad underneath the tongue for approximately 30 seconds
to collect saliva. Instruct the donor to hold the device in place with their hand. Specimen Collection & Handling for Confirmation Testing
• For device with any presumptive positive results, the collection pad should be
removed and sent for confirmation test.
7. The flow of the blue lines indicates the collection of a sufficient amount of
saliva. 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.
• Detach the collection pad with the blue cap by pulling. Be sure not to damage
or distort the collection pad.
• Place the collection pad into the enclosed confirmation vial.
8. 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.
• Recap the vial and send it to a lab for confirmatory testing (Specimen should
be stored at 15-30°C and tested within 2 weeks of collection).
• Follow standard chain of custody procedures.
Quality Control
The Oratect®III Oral Fluid Drug Screen Device provides two built-in control bands at
the control regions (C) to indicate that the test has performed properly. These control
bands should always appear regardless of the presence of drugs. The flow of the
blue lines indicates that a sufficient amount of oral fluid has been collected. The
presence of the purple-red bands in the control regions verifies that proper flow was
obtained. If the control bands do not appear, the test device should be discarded.
9. Re-cap the device, lay it 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 Limitations of Procedure
• The assay is designed for human oral fluid use only.
For each of the test windows, purple-red colored bands should be observed; one
band at the control region (C) and one band at the specific drug abbreviation (e.g.
AM, OP, CO) in the test region. See example Fig e.
• Positive results only indicate the presumptive presence of drugs and do not
indicate or measure intoxication.
• Technical or procedural errors as well as substances in certain foods and
certain medications may interfere with the test and cause false results.
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. Performance Characteristics
Precision
In the Fig. e below, the oral fluid sample is negative for Amphetamine, Opiate and
Cocaine because bands are visible in the AM, OP, and CO test regions. For each specific drug test, artificial oral fluid solution was spiked with a drug
standard at various concentrations (0%, 50%, 200% and 300%). For each
concentration, a total of 20 tests were performed to validate the test performance.
The results for each drug of the Oratect®III Oral Fluid Drug Screen Device Tests are
summarized below:
2
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, the result is a presumptive positive for that particular drug. In
Fig. f below, the oral fluid sample is presumptive positive for Phencyclidine,
Methamphetamine (or MDMA) and THC because no bands are visible in the test
regions of PC, ME, and TH.
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
results in the test region. If the test is invalid, check testing procedures. Repeat the
test using a new device. In Fig. g below, the test is invalid because there are no
bands in the control regions.
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 purple-red band for a specific test is
obtained in the test region along with the presence of the control line (C), the
sample should be considered negative. The Oratect®III Oral Fluid Drug Screen
Device only 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 (GC/MS or LC/MS) must be used.
Concentration
0% 50% 200% 300%
Drug
Test
Total # of Test/
Concentration
- + - + - + - +
ME 20 20 0 20 0 0 20 0 20
MDMA 20 20 0 20 0 0 20 0 20
TH 20 20 0 20 0 1 19 0 20
CO 20 20 0 20 0 0 20 0 20
AM 20 20 0 20 0 0 20 0 20
OP 20 20 0 20 0 0 20 0 20
PC 20 20 0 20 0 0 20 0 20
BZ 20 20 0 20 0 0 20 0 20
Specificity
The specificity study for each drug test was evaluated by adding structurally related
compounds to artificial oral fluid solution. The results are expressed as the amount
of the compound, in ng/ml, that produced a positive result.
Drug Test Approximate
Concentration(ng/ml)
Approximate %
Cross Reactivity
ME/MDMA
Desipramine
d,l-Ephedrine
1R, 2S l-Ephedrine
p-Hydroxymethamphetamine
MDEA
MDMA
d,l-Methamphetamine
d-Methamphetamine
l-Methamphetamine
Methoxyphenamine
Phenylephrine
d-Pseudoephedrine HCl
Trimethobenzamide
10000
1000
1000
1000
300
25
30
25
500
2500
5000
5000
4000
0.25%
2.5%
2.5%
2.5%
8.3%
100%
83%
100%
5%
1%
0.5%
0.5%
0.6%
TH
Cannabinol
∆-8-tetrahydrocannabinol
∆-9-tetrahydrocannabinol
11-nor-∆-8-THC-9-COOH
11-nor-∆-9-THC-9-COOH
11-hydroxy-∆9-THC
80
100
40
10
10
400
50%
40%
100%
400%
400%
10%
CO
Benzoylecgonine
Cocaine
Ecgonine
18
20
5000
110%
100%
0.4%

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Drug Test Approximate
Concentration (ng/ml)
Approximate %
Cross Reactivity
AM
d-Amphetamine
d,l-Amphetamine
d,I-p-Chloramphetamine
MDA
MDEA
Phentermine
β-Phenylethylamine
Tyramine
25
40
200
40
100
100
8000
8000
100%
62.5%
12.5%
62.5%
25%
25%
0.3%
0.3%
OP
6-Acetylcodeine
6-Acetylmorphine
Codeine
Dihydrocodeine
Ethyl morphine
Heroin
Hydrocodone
Hydromophone
Morphine
Morphine-3-beta-D-
Glucuronide
Nalorphine
20
12
10
10
60
15
60
70
10
25
100
50%
83%
100%
100%
17%
67%
17%
14%
100%
40%
10%
PC
Phencyclidine 4 100%
BZ
Alprazolam
Bromazepam
Chlordiazepoxide
Clobazam
Clonazepam
Delorazepam
Diazepam
Estazolam
Flunitrazepam
Flurazepam
Lorazepam
Lormetazepam
Nitrazepam
Nordiazepam
Oxazepam
Prazepam
Temazepam
Triazolam
4
4
50
10
20
5
5
3
8
10
10
15
4
3
5
10
5
10
125%
125%
10%
50%
25%
100%
100%
167%
63%
50%
50%
33%
25%
67%
100%
50%
100%
50%
Interference
The following compounds were spiked into artificial oral fluid solution and found not
to cross-react with the Oratect®III Oral Fluid Drug Screen Device when tested at
concentration of 10µg/ml (10,000ng/ml)
Acetaminophen
Acetoacetic acid lithium salt
Acetone
Acetylsalicylic acid
6-Acetylcodeine (except OP assay)
6-Acetylmorphine (except OP assay)
Albumin
Allobarbital
Alphenal
Alprazolam (except BZ assay)
Amitriptyline
Amobarbital
Amoxapine
Amoxicillin
d-Amphetamine (except AM assay)
d,l-Amphetamine (except AM assay)
l-Amphetamine (except AM assay)
Ampicillin
Apomorphine
Aprobarbital
l-Ascorbic Acid
Aspartame
Atropine
Barbital
Benzillic acid
Benzocaine
Benzoylecgonine hydrate
(except CO assay)
Benzoic acid
Bilirubin
Bromazepam (except BZ assay)
d-Brompheniramine
Buprenorphine
Butalbital
Butethal
Caffeine
Cannabinol (except TH assay)
Cannabidiol
Chloral Hydrate
Chlordiazepoxide (except BZ assay)
Chloroquine
d-Chlorpheniramine
Chlorpromazine
Chloroamphetamine (DL-p-)
Hydrochloride (except AM assay)
Cholesterol
Clobazam (except BZ assay)
Clomipramine
Clonazepam (except BZ assay)
Cocaine (except CO assay)
Codeine (except OP assay)
Cortisone
l-Cotinine
Creatine
Creatinine
Cyclobenzaprine
Delorazepam (except BZ assay)
Deoxycortisone acetate
Desipramine (except ME/MDMA assay)
Dextromethorphan
Diazepam (except BZ assay)
Dihydrocodeine (except OP assay)
4-Dimethylaminoantipyrine
Diphenhydramine
Dopamine
Doxepin hydrochloride
Doxylamine
Ecgonine (except CO assay)
Ecgonine Methyl Ester
l-Ephedrine
d,l-Ephedrine (except ME/MDMA assay)
1R, 2S l- Ephedrine (except ME/MDMA
assay)
1S, 2R d-Ephedrine
l-Epinephrine
Erythromycin
Estazolam (except BZ assay)
β-Estradiol
Estrone-3-sulfate potassium salt
Ethanol
Ethylidene-1,5-Dimethyl-1-3,3-
Diphenylpyrrolindine Perchlorate salt
Ethyl Morphine (except OP assay)
Flunitrazepam (except BZ assay)
Flurazepam (except BZ assay)
Furosemide
Gentisic acid
Glucose
Glutethimide
Guaiacol Glyceryl Ether
Hemoglobin
Heroin (except OP assay)
Hippuric acid
Hydrochlorothizide
Hydrocodone (except OP assay)
Hydrocortisone
Hydromorphone (except OP assay)
11- Hydroxy-D-9-Tetrahydrocannabinol
(except TH assay)
p-Hydroxymethamphetamine (Pholderin)
(except ME/MDMA assay)
3-Hydroxytyramine
Ibuprofen
Imipramine
d,l-Isoproterenol
l-Isoproterenol HCl
Lidocaine
Lorazepam (except BZ assay)
Lormetazepam (except BZ assay)
MDMA (except ME/MDMA assay)
MDA (except AM assay)
MDEA (except AM, ME/MDMA assays)
Meperidine
d,l-Methadone
d-Methamphetamine (except ME/MDMA
assay)
d,l-Methamphetamine (except ME/MDMA
assay)
l-Methamphetamine (except ME/MDMA
assay)
Methaqualone
Methoxyphenamine (except ME/MDMA
assay)
2-Methylamine-Propiophenone HCl
Methylphenidate
Morphine (except OP assay)
Morphine-3-beta -D-Glucuronide
(except OP assay)
Nalidixic acid
Nalorphine (except OP assay)
Naloxone
Naltrexone hydrochloride
d-Naproxen
Niacinamide
Nitrazepam (except BZ assay)
11-Nor-Delta 8-THC-9-COOH
(except TH assay)
11-Nor-Delta 9-THC-9-COOH
(except TH assay)
Nordiazepam (except BZ assay)
Nordoxepin hydrochloride
d,l-Norephedrine hydrochloride
Norethindrone
d-Norpropoxyphene
Nortriptyline hydrochloride
Oxalic Acid
Oxazepam (except BZ assay)
Oxolinic acid
Oxycodone
Papaverine
Penicillin-G (Benzylpenicillin)
Pentazocine
Pentobarbital
Perphenazine
Phencyclidine (except PC assay)
Pheniramine
Phenobarbital
Phenothiazine
Phentermine (except AM assay)
Phenylephrine (except ME/MDMA assay)
ß-Phenylethylamine (except AM assay)
d,l-Phenylpropanolamine hydrochloride
Prazepam (except BZ assay)
Prednisolone
Procaine
Promazine
Promethazine
d-Propoxyphene
Protriptyline
d-Pseudoephedrine HCl
(except ME/MDMA assay)
Quinidine
Ranitidine
Riboflavin
Salicylic acid
Secobarbital
Serotonin
Sodium Chloride
Sulfamethazine
Sulindac
Temazepam (except BZ assay)
Tetracycline
Delta-8-Tetrahydrocannabinol
(except TH assay)
Delta-9-Tetrahydrocannabinol
(except TH assay)
Thiamine
Thioridazine
Triazolam (except BZ assay)
Trifluoperazine
Trimethobenzamide (except ME/MDMA
assay)
Trimipramine Maleate
Tryptamine
d,l-Tryptophan
Tyramine (except AM assay)
d,l-Tyrosine
Uric Acid
Verapamil
Zomepirac
Bibliography of Suggested Reading
1. Wong, R. The Current Status of Drug Testing in the US Workforce, American
Clinical Laboratory, vol. 21(1), page 21-23, 2002.
2. Caplan, Y. and Goldberger, B., Alternative Specimens for Workplace Drug
Testing, J. Analytical Toxicology, vol. 25, p. 396-399, 2001.
3. Schramm, W., Smith, R. and Craig, P., Drugs of Abuse in Saliva: A Review, J.
Analytical Toxicology, vol. 16, p. 1-9, 1992.
4. Mandatory Guidelines for Federal Workplace Drug Testing Programs, April 13,
2004 (69 FR 19644).
5. Wong, R. On-site Oral Fluid Drug Testing by Oratect, in Drugs of Abuse: Body
Fluid Testing, Wong, R and Tse, H ed., Humana Press, p146-158, 2005.
Manufactured By:
Branan Medical Corporation
Irvine, CA 92618
USA
1-866-468-3287 (1-866-INTECT7) Domestic U.S. & Canada
1-949-598-7166 International
Part No.: PI-HM, Rev: B, 10/06