One Step Synthetic Cannabis Test Device (Urine) Package Insert
Format: Strip, Cassette, Cup,and Panel
The K2 One Step Synthetic Cannabis 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. A
more specific alternative chemical method must be used in order to
obtain a confirmed analytical result. Gas chromatography/mass
spectrometry (GC/MS) has been established as the preferred
confirmatory method by the Substance Abuse Mental Health Services
Administration (SAMHSA). Clinical consideration and professional
judgment should be applied to any drug of abuse test result,
particularly when preliminary positive results are indicated.
The K2 One Step Synthetic Cannabis Test is based on the principle of specific immunochemical reaction
between antibodies and antigens to analyze particular compounds in
human urine specimen. The assay relies on the competition for
binding antibody between drug conjugate and free drug which may be
present in the urine specimen being tested. When drug is present in
the urine specimen, it competes with drug conjugate for the limited
amount of antibody-dye conjugate. When the amount of drug is equal
or more than the cut-off it will prevent the binding of drug
conjugate to the antibody. Therefore, a positive urine specimen
will not show a colored band on the test line zone, indicating a
positive result, while the presence of a colored band indicates a
A control line is present in the test window to work as procedural
control. This colored band should always appear on the control line
zone if the test device is stored in good condition and the test is
POSITIVE: Only one colored band appears in the control region (C). No
apparent colored band appears in the test region (T).
NEGATIVE RESULT:Two colored bands appear on the membrane. One band appears in the
control region (C) and another band appears in the test region (T).
INVALID RESULT:Control band fails to appear. Results from any test which has not
produced a control band at the specified reading time must be
disgarded. Please review the procedure and repeat with a new test.
If the problem persists, discontinue using the kit immediately and
contact your local distributor.
1.The K2 One Step Synthetic Cannabis Test Device (Urine) provides only a qualitative, preliminary
analytical result. A secondary analytical method must be used to
obtain a confirmed result. Gas chromatography/mass spectrometry
(GC/MS) is the preferred confirmatory method. 1,2
2. It is possible that technical or procedural errors, as well as
other interfering substances in the urine specimen may cause
3. Adulterants, such as bleach and/or alum, in urine specimens may
produce erroneous results regardless of the analytical method used.
If adulteration is suspected, the test should be repeated with
another urine specimen.
4. A positive result indicates presence of the drug or its
metabolites but does not indicate level of intoxication,
administration route or concentration in urine.
5. A negative result may not necessarily indicate drug-free urine.
Negative results can be obtained when drug is present but below the
cut-off level of the test.
6. Test does not distinguish between drugs of abuse and certain
Contact Rebecca Yan