RAPID CANNABINOID (THC) TEST CARD

FOR THE QUALITATIVE ASSESSMENT OF THC IN HUMAN URINE

For In Vitro Diagnostic and Forensic Use Only

INTENDED USE

Rapid THC Test is an immunochromatography based one step in vitro test.  It is designed for qualitative determination of THC in human urine specimens.

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.

PRINCIPLE

Rapid THC Test is based on the principle of specific immunochemical reaction between antibodies and antigen to analyze particular compound in human urine specimen. The assay relies on the competition for binding antibody. 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.

PROCEDURE

1. Bring test device and specimens to the room temperature (15-28ºC) if they have been refrigerated.

2. Remove the test card from the sealed foil pouch and place the test card on a flat surface..

3. Hold the pipette in a vertical position over the sample well marked as “S” on the test card and drip 3

drops (120-150mL) sample into the sample well.

4. Read the results at 5 minutes after adding the sample.     

Do not interpret the results after 10 minutes.