K2 One Step Synthetic Cannabis Test Device (Urine) Package Insert

		K2 One Step Synthetic Cannabis Test Device (Urine) Package Insert
Cat:	DK2-A02	Specimens: 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.

• For professional in vitro diagnostic use only.
• Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to performing any tests.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• The used testing materials should be discarded in accordance with local, state and/or federal regulations.

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Do not freeze.
• Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

• The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.
• Collected urine specimens must be put in clear and dry containers.
• Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 48 hours. For long term storage, specimens should be kept below -20°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.

Bring tests, specimens and/or controls to room temperature (15-30°C) before use.

1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100 mL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S).
3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.

NOTE:

1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered negative. Besides, the concentration level can not be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique.
• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

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 erroneous results.
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 medications.

A. Sensitivity

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.

B. Reproducibility

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.

C. Precision

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.

D. Specificity

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.

2. Specificity

K2 One Step Synthetic Cannabis Test is specific with JWH-018 pentanoic acid and JWH-073 butanoic acid.

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.

1. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed. Biomedical Publ., Davis, CA. 1982; 488
2. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986

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 10^th and 11^th 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.

Our mission:

• Always best of all and always pay attention to innovation.
• Special customized service tightly following customers’ requests.
• Integrated excellent quality, competitive prices and super service together.