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 60 seconds) 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 3-10 minutes.

If all lines are clearly visible at 3 minutes or sooner, then the test can be interpreted a 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 Cocaine concentration is below the detectable level of 50ng/ml.

*NOTE: The intensity of the colour in the test line region (T) may vary depending on the concentration of Cocaine 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 Cocaine concentration is above the detectable level of 20ng/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.

LIMITATIONS: 
1. COC Rapid Test (Oral fluid) provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method. 2
2. A positive result indicates presence of the drug or its metabolites but does not indicate the concentration of drug in the specimen or the route of administration.
3. A negative result may not necessarily indicate drug-free specimen. Negative results can be obtained when drug is present but below the cut-off level of the test.
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.

EXPECTED VALUES:
This negative result indicates that the Cocaine metabolite concentration is below the detectable level of 20ng/mL. Positive result means the concentration of Cocaine metabolite is above the level of 20ng/ml. The COC Rapid Test has a sensitivity of 20ng/ml.

For further details click here to see the package insert.