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One Step Synthetic Cannabis Test Device (Urine)
|Version: 01||Effective Date: 2013-01|
For professional in vitro diagnostic use only.
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.
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, it has largely become genericized trademarks used for refer to any systhetic 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.
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 negative result.
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 performed appropriately.
|Individually packed test devices||Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding regions.|
|Disposable pipettes||For adding specimens use.|
|Package insert||For operation instruction.|
|Specimen collection container||For specimens collection use.|
|Timer||For timing use.|
Bring tests, specimens and/or controls to room temperature (15-30°C) before use.
|Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).|
|Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).|
|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.|
The accuracy of the K2 One Step Synthetic Cannabis Test Device (Urine) was compared and checked against commercially available tests with a threshold value at the same cut-off levels. Urine samples taken from volunteers claiming to be non-users were examined under both tests. The results were >99.9% in agreement.
The reproducibility of the K2 One Step Synthetic Cannabis Test Device (Urine) was verified by blind tests performed at four different locations. Samples with JWH-018 pentanoic acid or JWH-73 butanoic acid concentrations at 50% of the cut-off were all determined to be negative, while samples with JWH-018 pentanoic acid or JWH-73 butanoic acid concentrations at 200% of the cut-off were all determined to be positive.
Test precision was determined by blind tests with control solutions. Controls with JWH-018 pentanoic acid or JWH-73 butanoic acid concentrations at 50% of the cut-off yielded negative results, and controls with JWH-018 pentanoic acid or JWH-73 butanoic acid concentrations at 150% of the cut-off yielded positive results.
The specificity for K2 One Step Synthetic Cannabis Test was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.
1. Interference testing
The K2 One Step Synthetic Cannabis Test performance at cut-off level is not affected when pH and Specific Gravity ranges of urine specimen are at 5.0 to 8.0 and 1.005 to 1.035.
The following substances were tested and confirmed not to interfere with K2 One Step Synthetic Cannabis Test at the listed concentrations.
|Human albumin||2000 mg/dL|
|Human hemoglobin||10 mg/dL|
|Uric acid||10 mg/dL|
K2 One Step Synthetic Cannabis Test is specific with JWH-018 pentanoic acid and JWH-073 butanoic acid.
|Compounds||JWH-018 pentanoic acid||JWH-073 butanoic acid|
|Concentration||50 ng/ml||50 ng/ml|
Each listed substance that may be found in the urine was evaluated and indicated negative result at concentration of 100 μg/ml or higher unless it is specified.
|(±) - Brompheniramine||(±) - Isoproterenol||Promethazine|
|Codeine||Tetrahydrocortisone, 3 Acetate|
|(-) Cotinine||Tetrahydrocortisone 3 (b-D glucuronide)|
|Ecgonine methylester||Norethindrone||D, L-Tryptophan|
|(-)-ψ- Ephedrine||D,L-Octopamine||Uric acid|
|Index of Symbols|
|Consult instructions for use||Tests per kit||Authorized Representative|
For in vitro
diagnostic use only
|Use by||Do not reuse|
|Store between 2-30°C||Lot Number||Catalogue number|
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Contact Person: Ms. Anna Lee