INTENDED USE
The DrugCheck® K2/Spice Test is an immunochromatography based one
step in vitro test. It is designed for qualitative determination of synthetic
cannabis JWH-018 and JWH-073’s major metabolites in human urine
specimens at cut-off level of 50 ng/ml. This assay has not been evaluated
in the point of care location and is for forensic use only.
This assay provides only a preliminary analytical test result.
SUMMARY AND EXPLANATION
Synthetic cannabis is a psychoactive herbal and chemical product that,
when consumed, mimics the effects of cannabis. It is best known by the
brand name K2 and Spice, both of which have largely become genericized
trademarks used for refer to any synthetic cannabis product. The studies
suggest that synthetic cannabinoid intoxication is associated with acute
psychosis, worsening of previously stable psychotic disorders, and also
may have the ability to trigger a chronic (long-term) psychotic disorder
among vulnerable individuals such as those with a family history of mental
illness. A large and complex variety of synthetic cannabinoids, most ofter
cannabicyclohexanol, JWH-018, JWH-073, or HU-210, are used. As of
March 1, 2011, five cannabinoids, JWH-018, JWH-073, CP-47, JWH-200
and cannabicyclohexanol are illegal in US because these substances have
the potential to be extremely harmful and, therefore, pose an imminent
hazard to the public safety.
Drugcheck K2/Spice product insert #1 or #2 (coming soon)
PROCEDURE
For Test Strip
1. Bring all materials and specimens to room temperature.
2. Remove the single test strip or device from the sealed foil pouch.
3. Dip the strip into the urine specimen with the arrow pointing toward
the sample. The sample level should not be higher than the arrow pointed
maximum line.
4. Hold the strip in the urine until a reddish color appears at the test area
(approximately 20 seconds).
5. Withdraw the strip and place it face up on a clean, non-absorptive
surface or leave the strip in urine if the urine level is not higher than arrow
pointed maximum line.
6. Read the results at 5-10 minutes minutes after adding the sample.
Test results may not be accurate after 10 minutes.
INTERPRETATION OF RESULTS
Negative: Two colored bands form. The appearance of two colored
bands, one in test line zone and the other in control line zone, indicates
negative results. The negative result indicates that the methylphenidate
concentration in the specimen is either zero or less than cut-off level.
Positive: One colored band forms. One colored band appears in control line
zone. No colored band is found in test line zone. This is an indication that
the methylphenidate level in the specimen is above the cut-off level.
Invalid: If there is no colored band in control line zone, the test result is
invalid. Retest the sample with a new device.
Note: A borderline (+/-) in test line zone should be considered negative
result.
LIMITATION OF PROCEDURE
The assay is designed for use with human urine only. A positive result with
any of the tests indicates only the presence of a drug/metabolite and does
not indicate or measure intoxication.
There is a possibility that technical or procedural error as well other
substances in certain foods and medicines may interfere with the test
and cause false results.
Please refer “SPECIFICITY” section for lists of
substances that will produce either positive results, or that do not interfere
with test performance. If a drug/metabolite is found present in the urine
specimen, the assay does not indicate frequency of drug use or distinguish
between drug of abuse and certain foods and medicines.
PERFORMANCE CHARACTERISTICS
A. Sensitivity
The cut-off concentration (sensitivity level) of K2/Spice Test is determined
to be 50 ng/ml of JWH-018 5-pentanoic acid metabolite and JWH-73
4-butanoic acid metabolite respectively.
B. Accuracy
The accuracy of the K2/Spice Test was evaluated in K2 spiked urine
specimens. Forty (40) K2 urine specimens were spiked with JWH-018
pentanoic acid or JWH-73 butanoic acid from 10 to 150 ng/ml. 30
samples with JWH-018 pentanoic acid or JWH-073 butanoic acid
concentration between 50 and 150 ng/mL were all found positive (100%
agreement ), 10 samples with JWH-018 pentanoic acid or JWH-073
butanoic acid concentration between 10 and 37.5 ng/mL were found
negative.
C. Precision
The precision study was performed by three individuals observing the
test result to determine the random error of visual interpretation. The test
results were found to have no significant differences between the three
observers.
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