DIRECTIONS FOR USE:
Allow the test Device, specimen and/or controls to reach room temperature (15-30ºC) prior to testing. Instruct the donor to not place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection.
1. Bring the pouch to room temperature before opening it. Remove the test from the sealed pouch and use it within one hour.
2. Take off the Device cap and collect oral fluid specimen as follows.
Important: Place the tongue against the upper and lower jaws and roots to enrich the oral fluid. Insert the sponge end into the mouth, actively swab around the gums on both sides of the mouth (10-15 times) to assist saturation.
Put the absorbent wick under the tongue to collect oral fluid until the flow appear in the test windows (approximately 60seconds) and then take out the Device and start a timer.
If no flow appeared repeat the procedure in steps above until the flow appear. If no flow appeared after triplicate of steps above, discard the device, review procedures with the donor and repeat the test using a new device.
3. Place the test Device on a clean and level surface.
4. Read the test result at 3-10minutes.
If all lines are clearly visible at 3 minutes or sooner, then the test can be interpreted as negative and discarded. If any lines are not visible at 3 minutes, then the test should be re-read at 10 minutes.
INTERPRETATION OF RESULTS:
NEGATIVE:* Two coloured lines appear. One coloured line should be in the control region (C), and another apparent coloured line should be in the test region (T). This negative result indicates that the Marijuana concentration is below the detectable level of 12ng/mL.
*NOTE: The intensity of the colour in the test line region (T) may vary depending on the concentration of Marijuana present in the specimen. Therefore, any shade of colour in the test line region (T) should be considered negative.
POSITIVE: One coloured line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Marijuana concentration is above the detectable level of 12ng/mL
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 with a new test Device. If the problem persists, discontinue using the test Device immediately and contact your local distributor.
A procedural control is included in the test. A coloured line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
1. The THC Rapid Test 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) or gas chromatography/tandem mass spectrometry (GC/MS/MS) is preferred confirmatory methods.
2. A positive test result does not indicate the concentration of drug in the specimen or the route of administration.
3. A negative result may not necessarily indicate a drug-free specimen. Drug may be present in the specimen below the cut off level of the assay.
4. Test does not distinguish between drugs of abuse and certain medications.
5. A positive test result might be obtained from certain foods or food supplements.
This negative result indicates that the Marijuana metabolite concentration is below the detectable level of 12ng/mL. Positive result means the concentration of Marijuana metabolite is above the level of 12ng/ml. The THC Rapid Test has a sensitivity of 12ng/ml.
For further information please click here to view the package insert.