INTENDED USE
The PocTell® K4 Synthetic Cannabinoids Rapid Test Device (Urine) is an immunochromatography-based one step in vitro test. It is designed for qualitative determination of synthetic cannabis UR144 major metabolites in human urine specimens at cut-off level of 20 ng/ml,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..
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Cut-off |
Shelf life |
Kit Size |
|
K4 |
Cassette |
Urine |
5 mins |
20ng/mL |
24 months |
25T/Kit |
TEST PRINCIPLE
The PocTell® K4 Synthetic Cannabinoids Rapid Test Device (Urine) 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..
DIRECTIONS FOR USE
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 L) 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.
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