Diagnostic Kit for Marijuana

Intended Use:
The THC One-Step Marijuana Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of Marijuana in urine at the cut-off concentrations of 50ng/ml.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Summary:
HC (D9-tetrahydrocannabinol) is the primary active ingredient in cannabinoids (marijuana). When smoked or orally administered, it produces euphoric effects. Users have impaired short term memory and slowed learning. They may also experience transient episodes of confusion and anxiety. Long term relatively heavy use may be associated with behavioral disorders. The peak effect of smoking marijuana occurs in 20-30 minutes and the duration is 90-120 minutes after one cigarette. Elevated levels of urinary metabolites are found within hours of exposure and remain detectable for 3-10 days after smoking. The main metabolite excreted in the urine is 11-nor-D9-tetrahydrocannabinol-9-carboxylic acid (D9-THC-COOH).
The THC One-Step Marijuana Test Cassette yields a positive result when the concentration of marijuana in urine exceeds 50ng/ml. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA)3.
Warnings and Precautions:
· For in vitro diagnostic use only.
· For healthcare professionals and professionals at point of care sites.
· Do not use after the expiration date.
· Please read all the information in this leaflet before performing the test.
· The test panel should remain in the sealed pouch until use.
· All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
· The used test panel should be discarded according to federal, state and local regulations.
Storage and Stablity:
· Store as packaged in the sealed pouch at room temperature (2-30℃ or 36-86℉). The kit is stable within the expiration date printed on the labeling.
· once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.
Specimens:
· 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 precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear supernatant for testing.
· Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing.
Test Procedure:
Allow the test and urine samples to equilibrate to room temperature (15-30℃or 59-86℉) prior to testing.
1. Remove the test cassette from the sealed pouch.
2. Hold the dropper vertically and transfer 3 full drops (approx. 100ml) of urine to the specimen well of the test cassette, and then begin timing. See the illustration below.
3. Wait for colored lines to appear. Interpret the test results at 3-5 minutes. Do not read results after 10 minutes.


Interpretation of Result:
Negative: *Two lines appear. One red line should be in the control region (C), and another apparent red or pink line adjacent should be in the test region (T). This negative result indicates that the drug concentration is below the detectable level.
*NOTE:The shade of red in the test line region (T) will vary, but it should be considered negative whenever there is even a faint pink line.
Positive: One red line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the drug concentration is above the detectable level.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact your local distributor.
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