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

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

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

Product Details:

Place of Origin: CHINA
Brand Name: SPAN
Certification: ISO CE
Model Number: RA0508

Payment & Shipping Terms:

Minimum Order Quantity: 100 tests
Price: Negotiated
Packaging Details: 20test/box
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 1000000 pcs per month
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Detailed Product Description
Package: 20test/box Specificity: 100%
Sensitivity: 100%

 

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

K2

One Step Synthetic Cannabis Test Strip(Urine)

Package Insert

Cat: DK2-A01 Specimens: Urine
Version: 01 Effective Date: 2013-01
     
 

For professional in vitro diagnostic use only.

: INTENDED USE

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.

: INTRODUCTION

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.

: PRINCIPLE

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 strip is stored in good condition and the test is performed appropriately.

 

: KIT COMPONENTS

Individually packed test strips Each strip contains colored conjugates and reactive reagents pre-spreaded at the corresponding regions.
Package insert For operation instruction.

: MATERIALS REQUIRED BUT NOT PROVIDED

Specimen collection container For specimens collection use.
Timer For timing use.

: PRECAUTIONS

  • 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.

: STORAGE AND STABILITY

  • 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.

: SPECIMEN COLLECTION AND STORAGE

  • 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. Ensure that a sufficient quantity of the specimen is collected to allow submerging the dipping area of the strip.
  • 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.

: PROCEDURE

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

  1. Remove the test from its sealed pouch and use it as soon as possible. To obtain a best result, the assay should be performed within one hour.
  2. Hold the strip at the handle with the product name imprints. Do not touch the membrane part of the strip to avoid contamination.
  3. Dip the test strip vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip.

As the test begins to work, you will see color move across the membrane.

  1. Take the strip out of the specimen afterwards and place it on a non-absorbent flat surface. Start the timer and wait for the colored line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

 INTERPRETATION OF RESULTS

POSITIVE RESULT:

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

Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

NEGATIVE RESULT:

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

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:

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

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.
 

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.

: QUALITY CONTROL

  • 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.

: LIMITATIONS OF THE TEST

  1. The K2 One Step Synthetic Cannabis Test Strip (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.

: PERFORMANCE CHARACTERISTICS

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.

Glucose 2000 mg/dL
Human albumin 2000 mg/dL
Human hemoglobin 10 mg/dL
Urea 4000 mg/dL
Uric acid 10 mg/dL

2. Specificity

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
Cross reactivity 100% 100%
 

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.

4-Acetamidophenol Estrone-3-sulfate Oxolinic acid
Acetophenetidin Ethyl-p-aminobenzoate Oxycodone
N-Acetylprocainamide Fenfluramine Oxymetazoline
Acetylsalicylic acid Fenoprofen Papaverine
Aminopyrine Furosemide Penicillin-G
Amitryptyline Gentisic acid Pentazocine
Amobarbital Hemoglobin Pentobarbital
Amoxicillin Hydralazine Perphenazine
Ampicillin Hydrochlorothiazide Phencyclidine
L-Ascorbic acid Hydrocodone Phenelzine
Apomorphine Hydrocortisone Phenobarbital
Aspartame p-HydroxyAmphetamine L-Phenylephrine
Atropine O-Hydroxyhippuric acid b-Phenylethlamine
Benzilic acid p-Hydroxy-methAmphetamine Phenylpropanolamine
Benzoic acid Prednisolone
Benzoylecgonine 3-Hydroxytyramine Prednisone
Benzphetamine Ibuprofen Procaine
Bilirubin Imipramine Promazine
(±) - Brompheniramine (±) - Isoproterenol Promethazine
Caffeine Isoxsuprine D,L-Propanolol
Cannabidiol Ketamine D-Propoxyphene
Cannabinol Ketoprofen D-Pseudoephedrine
Chloralhydrate Labetalol Quinidine
Chloramphenicol Levorphanol Quinine
Chlordiazepoxide Loperamide Ranitidine
Chlorothiazide Maprotiline Salicylic acid
(±) Chlorpheniramine Meperidine Secobarbital
Chlorpromazine Meprobamate Serotonin (5-Hydroxytyramine)
Chlorquine Methadone
Cholesterol D-methAmphetamine Sulfamethazine
Clomipramine (L)-methAmphetamine Sulindac
Clonidine Methoxyphenamine Temazepam
Cocaine hydrochloride 3,4-Methylenedioxyethyl-Amphetamine Tetracycline
Codeine Tetrahydrocortisone, 3 Acetate
Cortisone (+) 3,4-Methylenedioxy-methAmphetamine
(-) Cotinine Tetrahydrocortisone 3 (b-D glucuronide)
Creatinine Methylphenidate
Deoxycorticosterone Morphine-3-b-D-glucuronide Tetrahydrozoline
Dextromethorphan Thebaine
Diazepam Nalidixic acid Thiamine
Diclofenac Naloxone Thioridazine
Diflunisal Naltrexone Tolbutamine
Digoxin Naproxen Triamterene
Diphenhydramine Niacinamide Trifluoperazine
Doxylamine Nifedipine Trimethoprim
Ecgonine hydrochloride Norcodein Trimipramine
Ecgonine methylester Norethindrone D, L-Tryptophan
(IR,2S)-(-)-Ephedrine D-Norpropoxyphene Tyramine
L-Ephedrine Noscapine D, L-Tyrosine
(-)-ψ- Ephedrine D,L-Octopamine Uric acid
Erythromycin Oxalic acid Verapamil
b-Estradiol Oxazepam Zomepirac
 

: LITERATURE REFERENCES

  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
K2  One Step Synthetic Cannabis Test Strip(Urine) Package Insert Consult instructions for use   K2  One Step Synthetic Cannabis Test Strip(Urine) Package Insert Tests per kit   K2  One Step Synthetic Cannabis Test Strip(Urine) Package Insert Authorized Representative
K2  One Step Synthetic Cannabis Test Strip(Urine) Package Insert

For in vitro

diagnostic use only

  K2  One Step Synthetic Cannabis Test Strip(Urine) Package Insert Use by   K2  One Step Synthetic Cannabis Test Strip(Urine) Package Insert Do not reuse
K2  One Step Synthetic Cannabis Test Strip(Urine) Package Insert Store between 2-30°C   K2  One Step Synthetic Cannabis Test Strip(Urine) Package Insert Lot Number   K2  One Step Synthetic Cannabis Test Strip(Urine) Package Insert Catalogue number
 

 

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

 

 

 

 

 

 

 

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.

 

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.

 

 

Span Biotech Ltd.

Add: 6A, Unit 5, Building 3, Sunshine Aloha, Bantian Industrial Park, Banxuegang Road , Longgang Shenzhen 518129

Tel:+86-755-89589611

E-mail: info@spanbio.com

 

 

 

Contact Details
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Contact Person: Ms. Anna Lee

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