POC™ Panel Urine Drug Test –3
3.
Dip the strip end of the device into the urine sample for at least 10
seconds. After 10 seconds, the device can either be left in the
sample cup or be placed on a flat surface.
4.
Wait for test results to develop. Negative test results may appear as
soon as 1 minute. However, a preliminary positive result needs to
be read at 5-10 minutes (see Figure 1).
POC-0403
THC-MET-OPI
Name and Intended Use
The POC Panel Urine Drug Test – 3, qualitatively detects
tetrahydrocannabinols (THC), methamphetamine (MET), opiates (OPI),
and/or their derivatives in human urine. The results obtained are of a
preliminary nature; preliminary positive results should be confirmed by way
of a non-immunological method, such as gas chromatography mass
spectrometry (GC/MS).
Summary of Test
Do not interpret results after 10 minutes.
Sensitivity Cut-off Levels
The test detects urine samples containing drugs or drug analogues at the
following concentration cut-off levels.
Tetrahydrocannabinol, psychoactive component of marijuana, is a central
system stimulant relaxant. THC in marijuana is strongly absorbed by fatty
tissues in various organs and a metabolite form of THC,
delta-9-tetrahydrocannabinol, is present in urine 48-72 hours after a
smoking-section. This is what denotes a marijuana user.
Methamphetamine is a central nervous system stimulant leading to increased
alertness and energy, as well as euphoria. Methamphetamine is excreted as
various derivatives in the urine, including amphetamine.
However,
approximately 40% of consumed methamphetamine is excreted unaltered,
discerning a methamphetamine user from an amphetamine user.
Opiates test detects morphine and morphine analogues at a concentration
equivalent to or higher than 300ng/ml of morphine. Morphine is an opiate
compound, as well as a metabolite of heroin. These compounds function as
analgesics by depressing the central nervous system. Most of heroin injected
is metabolized to morphine and codeine; morphine can be detected in a user’s
urine several days after ingestion.
Cut-off (ng/ml)
THC
50
MET
1000
OPI
300
Interpretation of Results
a.
PRELIMINARY POSITIVE (PP): A PP result is observed when
there is a control line (C) and no test line (T) and indicates a minimum
drug concentration of the test’s detection cut-off level. At
concentrations less than the cut-off level, there may be weak signal
appearing at the test line area.
b.
NEGATIVE: If there is no drug or drug analogue present in urine,
there will be a rose-color band appearing on both the control and the test
section.
c.
INVALID: If there is no rose-color band visible in the control window,
then the test result is invalid. It is recommended that the urine be
retested.
Principle of Procedure
The POC panel urine drug test is an immunochromatography device based on
the principle of competitive immunoassay. Each test strip in the device
specifically detects one drug of abuse or its analogues. The nitrocellulose
membrane on each interior test strip is immobilized with drug-carrier protein
conjugate on the test zone (see Figure 1). Anti-drug antibodies, which have
been conjugated with colloidal gold, are impregnated on a sample filter pad
overlapping the bottom of the membrane. When the sample pad of a test
strip is dipped into the urine sample to perform the test, the urine will diffuse
upwards through the pad. The antibody-gold conjugate will flow with the
liquid front-end, in the absence of the substance to be tested, will bind to the
immobilized drug conjugate causing a visible red band to appear on the test
zone. However, when a sufficient concentration of drug present in the urine
sample, antibody-gold conjugate will bind with the free drug; thus, due to
competitive binding, no visible band will appear on the test zone.
Test
Fig. 1 Illustration of an example test result.
Sample Collection
Urine samples should be collected in either plastic or glass containers.
Refrigerate samples after collection, until ready to test. Samples should be
tested within 3 days of collection. Freeze the samples that must be stored
long-term. Highly turbid urine should be centrifuged and save the clear fluid
for testing.
Warnings and Precautions
1.
The test device is for in vitro diagnostics use only.
2.
All specimens are considered health hazardous.
when handling.
Interpretation: test No. 1 and 2: negative, test No. 3 and 4: preliminary
positive, test No. 5: invalid.
Use proper protection
Storage and Stability
Store the test below 28oC, do not freeze.
Assay Procedure
1.
Prior to use bring test sample and device components to room
temperature.
2.
Remove the device from the pouch and remove the cap.
Performance Data
a.
Interference Study
The following substances have been tested at the indicated
concentration and found not to interfere with the tests.
Acetaminophen (100 ug/mL)
Ibuprofen (200 ug/mL)
Acetone (100 ug/mL)
(+/-)-Isoproterenol (100 ug/mL)
Albumin (500 ug/mL)
Ketamine (100 ug/mL)
Ampicillin(100 ug/mL)
Levorphanol (100 ug/mL)
Ascorbic Acid (500 ug/mL)
Lidocaine (100 ug/mL)
Aspartame(100 ug/mL)
(+)-Naproxen (100 ug/mL)
Aspirin (100 ug/mL)
Niacinamide (100 ug/mL)
Atropine (100 ug/mL)
Nicotine (100 ug/mL)
b.
Benzocaine (100 ug/mL)
Bilirubin (100 ug/mL)
Caffeine (100 ug/mL)
Chloroquine (100 ug/mL)
(+)-Chlorpheniramine (100
ug/mL)
(+/-)-Chlorpheniramine (100
ug/mL)
Creatine (500 ug/mL)
Dexbrompheniramine (100
ug/mL)
Dextromethrophan (100
ug/mL)
Diphenhydramine (100
ug/mL)
Dopamine (100 ug/mL)
(+/-)-Epinephrine (100
ug/mL)
Erythromycin (100 ug/mL)
Ethanol (0.2%)
Furosemide (100 ug/mL)
Glucose (500 ug/mL)
Guaiacol Glyceryl Ether (100
ug/mL)
Hemoglobin (500 ug/mL)
Specificity Study
(+/-)-Norephedrine (100 ug/mL)
Oxalic Acid (100 ug/mL)
Penicillin-G (100 ug/mL)
Pheniramine (100 ug/mL)
Phenothiazine (100 ug/mL)
1-Phenylephrine (100 ug/mL)
 -Phenylethylamine (100 ug/mL)
Procaine (100 ug/mL)
Quinidine (100 ug/mL)
Ranitidine (100 ug/mL)
Riboflavin (100 ug/mL)
Sodium Chloride (10,000ug/mL)
Sulindac (100 ug/mL)
Theophylline (100 ug/mL)
Tyramine (100 ug/mL)
4-Dimethylaminoantipyine (100
ug/mL)
(1R, 2S)-(-)-N-Methyl-Ephedrine
(100 ug/mL)
Heroin
750
Hydrocodone
1,200
Hydromorphine
1,500
Morphine-3-ß-D-glucrronide
750
c. Accuracy
Drug negative and positive urine specimens was tested with the
tests and the results were compared with those of GC/MS
analysis.
THC Test
GC/MS
Rapid Test
Negative
Positive
Negative
63
4
Positive
7
46
The agreement with GC/MS negative specimens: 90%
The agreement with GC/MS positive specimens: 92%
MET
Rapid Test
Negative
Positive
Substances that are structurally related to the target drugs of the tests
have been tested and the results are listed as the lowest concentration
that causes a positive result in the following.
Concentration
(ng/ml)
d-Methamphetamine
1,000
d-Amphetamine
Not detected
l-Amphetamine
Not detected
(+/-)3,4-MDEA
Not detected
(+/-)3,4-methylenedioxyamphetamine (MDA)
Not detected
(+/-)3,4-methylenedioxymethamphetamine (MDA)
2,000
l-Methamphetamine
10,000
Ephedrine
Not detected
MET
Rapid Test
Negative
Positive
1.
2.
3.
5.
Compound
Concentration (ng/ml)
11-nor- -9-THC-9-COOH
50
6.
11-hydroxy- -9-THC
1,000
7.
-8-tetrahydrocannabinol
5,000
8.
-9-tetrahydrocannabinol
5,000
Cannabinol
10,000
9.
Cannabidiol
>100,000
10.
11.
OPI Test
12.
Morphine
300
Codeine
300
Ethylmorphine
150
Positive
2
48
BIBLIOGRAPHY
4.
Concentration )ng/ml)
GC/MS
Negative
67
3
The agreement with GC/MS negative specimens: 96%
The agreement with GC/MS positive specimens: 96%
THC Test
Compound
Positive
1
49
The agreement with GC/MS negative specimens: 96%
The agreement with GC/MS positive specimens: 98%
Methamphetamine Test
Compound
GC/MS
Negative
67
3
13.
14.
Baselt, R. C., Disposition of Toxic Drugs and Chemicals in Man,
Biomedical Publications, Davis, CA, 1982.
Urine testing for Drugs of Abuse. National Institute on Drug Abuse
(NIDA), Research Monograph 73,1986.
Fed. Register, Department of Health and Human Services,
Mandatory Guidelines for Federal Workplace Drug Testing
Programs, 53, 69, 11970-11979, 1988
Liu, Ray H. and Goldberger, Bruce A., Handbook of Workplace
Drug Testing, AACC Press (1995)
Gilman, A. G. and Goodman, L.S., The Pharmacological Basis of
Therapeutics, eds. MacMillan Publishing, New York, NY, 1980
Baselt, R. C., Disposition of Toxic Drugs and Chemicals in Man,
Biomedical Publications, Davis, CA, 1982.
Urine testing for Drugs of Abuse. National Institute on Drug Abuse
(NIDA), Research Monograph 73,1986.
Fed. Register, Department of Health and Human Services,
Mandatory Guidelines for Federal Workplace Drug Testing
Programs, 53, 69, 11970-11979, 1988
Liu, Ray H. and Goldberger, Bruce A., Handbook of Workplace
Drug Testing, AACC Press (1995)
Gilman, A. G. and Goodman, L.S., The Pharmacological Basis of
Therapeutics, eds. MacMillan Publishing, New York, NY, 1980.
Baselt, R. C., Disposition of Toxic Drugs and Chemicals in Man,
Biomedical Publications, Davis, CA, 1982.
Urine testing for Drugs of Abuse. National Institute on Drug Abuse
(NIDA), Research Monograph 73,1986.
Fed. Register, Department of Health and Human Services,
Mandatory Guidelines for Federal Workplace Drug Testing
Programs, 53, 69, 11970-11979, 1988
Liu, Ray H. and Goldberger, Bruce A., Handbook of Workplace
Drug Testing, AACC Press (1995)
15. Gilman, A. G. and Goodman, L.S., The Pharmacological Basis of
Therapeutics, eds. MacMillan Publishing, New York, NY, 1980.