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K2 Synthetic Marijuana(K2)Test
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Synthetic Marijuana(K2) Urine Cassette
INTENDED USE
PERFORMANCE CHARACTERISTICS
LIMITATIONS

Catalog No.          Product Name               

ABT-DOA-B165        Synthetic Marijuana(K2) Urine Cassette

 

INTENDED USE

ACCU-TELL® K2 Rapid Test Cassette (Urine) is a rapid visual immunoassay for the qualitative presumptive detection of K2 in human urine specimens at the cut-off concentrations listed below:

Parameter

Calibrator

Cut-off (ng/mL)

Synthetic cannabis     （K2）

JWH-073/JWH-018

50


PERFORMANCE CHARACTERISTICS

A. Accuracy

The accuracy of the K2 Rapid 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 Rapid Test Device (Urine) was verified by blind tests performed at four different locations. Samples with K2 concentrations at 50% of the cut-off were all determined to be negative, while samples with K2 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 K2 concentrations at 50% of the cut-off yielded negative results, and controls with K2 concentrations at 150% of the cut-off yielded positive results.

D. Specificity

The following tables list the concentrations of compounds (ng/mL) above which the K2 Rapid Test Device (Urine) identified positive results at 5 minutes.

K2 related compounds                  Concentration (ng/ml)

WH-018 5-pentanoic acid metabolite

50

JWH-073- Butanoic acid

50

The following compounds yielded negative results up to a concentration of 100 µg/mL:

Acetaminophen

Diazepam

Morphine Sulfate

Acetone

4-Dimethylaminoantipyrine

Myoglobin

Acetylsalicylic acid

Diphenhydramine

Nalophine

Albumin

Dopamine

Nicotine

Amitriptyline

Ecgonine HCL

Niacinamide

Amobarbital

Ecgonine Methyl Ester

Nortriptyline

Amphetamine

EDDP

Omeprazole

Ampicillin

Efavirernz

Oxalic Acid

Ascorbic Acid

Ephedrine

Oxycodone

Atropine Sulfate

(+/-)-Epinephrine

Oxymorphone

Benzocaine

Erythromycin

Oxazepam

Benzoylecgonine HCL

Ethanol

Pantoprazole

Bilirubin

Furosemide

Penicillin-G

Bup-3-B-glucuronide

Glucose

Pentobarbital

Buprenorphine

Hemoglobin

Pheniramine

Butalbital

Hippuric acid

d-Propoxyphene

Caffeine

Hydrocodone

Phencyclidine

Cannabidiol

Hydromorphone

Phenylephrine

Cannabinol

HU-211

B-Phenylethylamine 

Chloroquine

Ibuprofen

Procaine

(+)-Chlorpheniramine

Immipraime

Pseudoephedrine

(+/-)-Chlorpheniramine

(+/)-Isoproterenol

Quinidine

+/-  CP 47,497

11-hydroxy-delta-9-THc

Ranitidine

Cocaine

11-nor-Ae-THC-9-COOH

Riboflavin

Codeine

Ketamine

RSC-4-N-5-hydroxlpenfyl

Cotinine

Lansoprazole

Secobarbital

Creatine

Lidocaine

Sodium Chloride

Delta-8-tetrahydrocannabinol

MDA

Sulindac

Dexbrompheniramine

MDMA

Theophylline

Dextromethorphan

Methadone

Trimipramine

Dextrose

Methamphetamine

Tyramine

JWH-200

JWH-250

Urea

LIMITATIONS

  1. ACCU-TELL® K2 Rapid Test Cassette (Urine) is for professional in vitro diagnostic use, and should be only used for the qualitative detection of K2.

  2. This assay provides a preliminary analytical test result only. 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 National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are indicated.

  3. There is a possibility that technical or procedural errors as well as other substances and factors may interfere with the test and cause false results.

  4. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. Therefore, please preclude the possibility of urine adulteration prior to testing.

  5. A positive result indicates the presence of a K2 only, and does not indicate or measure intoxication.

  6. A negative result does not at any time rule out the presence of K2 in urine, as they may be present below the minimum detection level of the test.