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2. disease

Onsite
ToxStick K2™
6650 Lusk Blvd. Suite B108
San Diego, CA 92121 USA
Tel: (800) 559-2490
(858) 622-1958
Email: [email protected]
Website: www.oranoxis.com
Qualitative Detection of Drugs of Abuse in Urine:
K2/Synthetic Cannabinoids
INTENDED USE
Onsite ToxStick K2™ is a rapid one-step lateral flow immunoassay designed for the qualitative detection of
major K2/synthetic cannabinoids derived from JWH-018, JWH-073, and AM-2201, in human urine.
Onsite ToxStick K2™ Cut-off Concentrations:
Calibrator
Cut-off (ng/ml)
JWH-018 4-Hydroxypentyl Metabolite
50
JWH-018 5-Pentanoic Acid Metabolite
10
JWH-073 3-Hydroxybutyl Metabolite
25
JWH-073 4-Butanoic Acid Metabolite
5
AM-2201 4-Hydroxypentyl Metabolite
250
K2 Parent Drug Mixture 1*: (±)-CP 47, 497; (±)-CP 47, 497 C8 Homologue;
HU-211; JWH-200; and JWH-250
10
K2 Parent Drug Mixture 2*: AM-2201, JWH-019, JWH-081, and JWH-122
20
up to 5 ng/ml or higher of JWH-018 5-Pentanoic Acid Metabolite and JWH-073 4-Butanoic Acid Metabolite in a
urine sample. ToxStick K2™ also screens for JWH-018 4-Hydroxypentyl Metabolite at a concentration of 50
ng/ml or higher, JWH-073 3-Hydroxybutyl Metabolite at a concentration of 25 ng/ml or higher, AM-2201 4Hydroxypentyl Metabolite at a concentration of 250 ng/ml or higher, and combinations of popular K2 parent
drugs such as the mixture of (±)-CP 47, 497, (±)-CP 47, 497 C8 Homologue, HU-211, JWH-200, and JWH-250
at a concentration of 10 ng/ml or higher, and the mixture of AM-2201, JWH-019, JWH-081, and JWH-122 at a
concentration of 20 ng/ml or higher.
Urine testing remains the standard for drugs of abuse testing and is the most widely used method due to the
ease and simplicity of collecting urine samples. In addition, rapid lateral flow immunoassay testing of drugs of
abuse is superior over many other chemical or immunological assay methods for onsite screening due to its
non-invasive approach, its ability to quickly screen a large population, and its ease of use5.
TEST PRINCIPLE
*K2 Parent Drug Mixtures include all of the specified synthetic cannabinoid compounds in combination.
Individual detection limits of such compounds have not been established.
ToxStick K2™ is a preliminary onsite screening test for synthetic cannabinoids. To confirm the test
result, a more specific Chromatography Mass Spectrometry (GC/MS or LC/MS) method should be used.
ToxStick K2™ is for forensic or research use only, not for medical diagnostic purposes. The test is
intended to be administered by trained professionals.
SUMMARY AND EXPLANATION OF TEST
Synthetic cannabis is a psychoactive, man-made designer drug that contains synthetic cannabinoids that
mimic the effects of THC. Synthetic cannabis is made of a mixture of herbs that have been treated with
synthetic cannabinoid compounds, and is commonly known as “K2” or “Spice.” Synthetic cannabinoids JWH018 and JWH-073 are among the most commonly used ingredients in K2.1. The effects of K2 include agitation,
delusions, disorientation, hypertension, psychosis, paranoia, sedation, hallucinations, and seizures. In extreme
cases, K2 has been linked to several deaths2. Perhaps due to structural dissimilarities, K2 can be up to 100 to
3
800 times more potent than THC . Because K2 is a relatively new drug, there is a lack of research and
information on the possible effects it may have on humans.2 K2 has gained widespread popularity regardless of
its potential to cause harm to personal health and public safety. As a result, K2 has been illegalized and
banned in many countries around the world.
Drugs are eliminated from the body as unchanged drug or drug metabolites. Most drugs are extensively
4
metabolized in the body and excreted in the urine as metabolites . JWH-018, JWH-073, and AM-2201
metabolite compounds are excreted in urine after consumption or inhalation and can be detected in urine
samples by ToxStick K2™ up to 72 hours after use. ToxStick K2™ is a highly sensitive assay that can detect
ToxStick K2™ is a competitive lateral flow immunoassay in which K2/synthetic cannabinoids, which may be
present in the urine sample, compete with the drug conjugate for antibody binding sites. On the nitrocellulose
membrane, the control zone contains goat anti-rabbit IgG antibody and the test zone contains K2 antigen drug
conjugate. K2 drug antibodies were conjugated to colloidal gold nanoparticles and immobilized on the
conjugate pad of the test strip. When a sufficient amount of urine is applied to the sample pad of the test strip,
the sample will flow up the device via capillary action.
If K2/synthetic cannabinoids are present above the cut-off concentration, these compounds will saturate the
antibody binding sites and the antibody-gold nanoparticle conjugate will not bind to the drug conjugate in the
test zone. Therefore, a colored line will not form in the test line region for positive results. If K2/synthetic
cannabinoids are not present or are present below the cut-off concentration, the antibody-gold nanoparticle
conjugate will flow and bind to the drug conjugate located in the test zone, causing a red colored line to form in
the test line region.
A control line will be present for all functional tests as a procedural control. A red colored line will appear in the
control line region if the test device is stored and performed properly. A test with no control line will have invalid
results, regardless of the appearance of or absence of a test line.
MATERIALS
Each package contains:
1. ToxStick K2™ device
2. Device cap
3. Desiccant pack
Materials required but not provided:
1. Urine collection container
2. Disposable gloves
3. Timer
Page 1 of 3
Catalog No. KU-100300
Onsite
ToxStick K2™
6650 Lusk Blvd. Suite B108
San Diego, CA 92121 USA
Tel: (800) 559
559-2490
2490
(858) 622
622-1958
1958
Email: [email protected]
Website: www.oranoxis.com
Qualitative Detection of Drugs of Abuse in Urine:
K2/Synthetic Cannabinoids
PRECAUTIONS AND WARNINGS
1. Interpretation of Test Validity
1. ToxStick K2™ is to be used for forensic use or research purposes only.
2. Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is
damaged. Do not reuse tests. Read the entire procedure carefully prior to testing.
3. Handle all specimens as if they contain infectious agents. Follow established precautions against
microbiological hazards throughout the procedure and follow standard procedures for the proper disposal
of specimens.
4. Wear protect
protective
ive clothing such as laboratory coats, disposable gloves and eye protection when specimens
are assayed.
5. Humidity and temperature can adversely affect results.
6. This test is for single use. Used testing materials should be discarded in accordance with local regulations.
An intact, incomplete, faint or strong line at 10 minutes in the area next to the letter “C” (stands for Control)
indicates that the test is valid. The test is invalid if the control line is not visible at 10 minutes. If a test is
invalid, please review th
thee procedure and repeat with a new test device.
2. Interpretation of Negative Results
An intact, incomplete, faint or strong line at 10 minutes in the test zone next to the letter “T” indicates that
the K2/synthetic cannabinoid level is negative or below the cut
cut-off
off level in that urine sample. One colored
line in the control zone and one colored line in the test zone in
indicate
dicatess preliminary negative test results.
3. Interpretation of Positive Results
The absence of a line at 10 minutes in the test zone next to the lletter
etter “T” indicates that the K2/synthetic
cannabinoid level is above the cut-off
off level in that urine sample. One colored line in the control zone and no
line in the test zone indicates preliminary positive rresults.
esults.
STORAGE AND STABILITY
Store the original package at 22-30
30˚C.
C. Check the expiration date on the foil pouch. Do not use if the package is
damaged or expired. The test device should remain in its original sealed pouch until use.
The examples below demonstrate proper interpretation of test validity and results. Please reference these
examples when interpreting test validity and results.
SPECIMEN COLLECTION AND STORAGE
ToxStick K2™ is intended for use with human urine specimens only. The urine specimen should be collected
directly into the test cup. Urine collected at any time of the day may be used. Do not leave specimens at room
temperature for prolonged periods. Urine specimens m
may
ay be stored at 22-8°C
8°C for up to 2 days. For long term
storage, specimens should be kept below -20°C.
20°C.
Invalid Results
Negative Results
Positive
ositive Results
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and
mixed well prior to testing. Do not use urine specimens with bacterial contamination. Avoid repeated freezing
and thawing of specimens. If specimens are to be shipped for confirmatory testing, pack them in compliance
with all applicable regulations for transportation of etiological agents.
TEST PROC
PROCEDURE
EDURE
1. Equilibrate the urine specimen to room temperature (15
(15-30
30˚C;
C; 59
59-86˚F),
F), if necessary.
2. Remove the test device from the sealed foil pouch.
3. Dip the test device into the urine specimen and immerse the absorbent tip with the sample for 5 seconds
or until sample migration occurs. The urine sample should only touch the absorbent tip. Do not dip the test
device at any point above the visible outer absorbent pad.
4. Secure the dipped portion of the test device with the provided cap. Horizontally place the test device on a
flat surface. Set a timer to 10 minutes.
5. Read the test results at 10 minutes. Test results may not be accurate after 10 minutes.
INTERPRETAT
INTERPRETATION
ION OF TEST VALIDITY AND RESULTS
Interpret test validity and result at 10 minutes
minutes.. Test results may not be accurate after 10 minutes.
4. Further confirmation test
testing
ing maybe required when test results are positive. Transport the urine specimen to
a toxicology laboratory for confirmation of preliminary positive results.
5. If the test does not run or the test is invalid, retest with another test device.
6. The color intensity of the line in the test zone may vary depending on the concentration of analytes present
in the urine specimen. Therefore, variable intensity of color in the test zone should be considered negative
except for a very faint “shadow” w
which
hich indicates a positive result
result.
Page 2 of 3
Catalog No. KU
KU-100300
100300
Onsite
ToxStick K2™
6650 Lusk Blvd. Suite B108
San Diego, CA 92121 USA
Tel: (800) 559-2490
(858) 622-1958
Email: [email protected]
Website: www.oranoxis.com
Qualitative Detection of Drugs of Abuse in Urine:
K2/Synthetic Cannabinoids
TEST LIMITATIONS
1. There is a possibility that technical or procedural errors as well as interfering substances may cause false
results. Rare false positive or negative results may occur due to medicine or food components in the saliva
that contain compounds with a similar or identical structure to the drugs or drug metabolites being tested. If
such false results are suspected, further confirmation testing using GC/MS is recommended. If drugs or
drug metabolites are detected in the saliva sample, the assay does not distinguish between drugs of abuse
and other interfering substances.
2. ToxStick K2™ is a qualitative test only, and cannot determine the frequency of drug use or concentration of
K2/synthetic cannabinoids in the urine sample. The test is intended to distinguish a preliminary positive
result from a negative result.
3. A positive result indicates the presence of a drug or metabolite only, and does not indicate or measure
intoxication.
4. A negative result does not at any time rule out the presence of drugs or metabolites in urine, as they may be
present below the minimum detection level.
5. Urine specimens with bacterial contamination should not be used for testing, as such contamination can
cause false results.
4. Hawks, R.L. and C.N. Chiang, Eds. Urine Testing for Drugs of Abuse. National Institute on Drug Abuse
(NIDA) Research Monograph 73. 1986.
5. Wolff, K., M. Farrell, J. Marsden, M.G. Monteiro, R. Ali, S. Welch, and J. Strang. A Review of Biological
Indicators of Illicit Drug Use, Practical Considerations and Clinical Usefulness. Addiction. 1999, 94(9): 12791298.
QUALITY CONTROL
The control line of the test device is a built-in quality control feature. The quality control
test serves to validate that the sample volume is sufficient and the testing procedure,
liquid flow and general antibody-antigen binding are properly functional. This control
line should appear regardless of the presence of drug or metabolite.
Although all ToxStick K2™ product lots undergo strict quality surveillance and control,
Good Laboratory Practice recommends the daily use of control materials to validate the
reliability of a device. Contact our customer support department for positive and
negative test standards by phone at (800) 559-2490, by email ([email protected]) or
visit us at our website, www.oranoxis.com, for more information. Quality control testing
is also recommended for new lots or if the product has been stored outside of the
recommended storage conditions.
REFERENCES
1. Elsohly, M.A., W. Gul, K.M. Elsohly, T.P. Murphy, V.L.M. Madgula, and S.I. Khan. Liquid ChromatographyTandem Mass Spectrometry Analysis of Urine Specimens for K2 (JWH-018) Metabolites. Journal of
Analytical Toxicology. 2011, 35(7): 487-495.
2. Shanks, K.G., T. Dahn, G. Behonick, and A. Terrell. Analysis of First and Second Generation Legal Highs
for Synthetic Cannabinoids and Synthetic Stimulants by Ultra-Performance Liquid Chromatography and
Time of Flight Mass Spectrometry. Journal of Analytical Toxicology. 2012, 36(6): 360-371.
3. Devane, William A., A. Breuer, T. Sheskin, T.U.C. Jaerbe, M.S. Eisen, and R. Mechoulam. A Novel Probe
for the Cannabinoid Receptor. Journal of Medicinal Chemistry. 1992, 35(11): 2065-2069.
Page 3 of 3
Catalog No. KU-100300