DIRECTIONS FOR USE
Instruct the donor to not place anything in the mouth including food, drink, gum, and tobacco products for at least 10 minutes prior to collection.
Step 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.
Step 2: Remove the collector from the sealed pouch, insert the sponge into the mouth. Close mouth and move the sponge around for oral fluid collection. Soak sponge in oral fluid and swab the inside of the mouth and tongue (Do not bite, suck, or chew on the sponge). Collect oral fluid for 7 minutes or until sponge is soft and fully saturated. No hard spots should be felt on the sponge when saturated.
Step 3: Place the test device on a clean and flat surface. Remove the collection sponge from the mouth and insert the sponge gently into the screening device, press until the collector cap sealed with the device tightly. Keep upright when inserting and pressing the sponge.
Step 4: Keep test device upright on flat surface and keep upright while test is running. Wait for the colored signal to appear in test result area. Read saliva alcohol pad at 3 minutes, do not interpret saliva alcohol result after 4 minutes. Read drug results at 10 minutes, do not interpret drug results after 15 minutes.
Note: 1, Once the collection sponge locks in place, the device is airtight, tamper evident, and ready to be disposed or sent to lab for confirmation (on presumptive positive result).
In the case of no flowing even with enough saliva specimen, or the saliva is too thick to run, please move the device (keep upright, don’t tilt) back and forth on a flat surface for several times until saliva flows up. Do not tilt the device when the test is running before reading results.
Note: Once the collection sponge locks in place, the device is airtight, tamper evident, and ready to be disposed or sent to lab for confirmation (on presumptive positive results)
INTERPRETATION OF RESULTS
NEGATIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). Certain lines may appear lighter or thinner than other lines. A line is to be considered a line whether it is faint, light or dark.
*NOTE: The shade of red in the test line region (Drug/T) will vary, but it should be considered negative whenever there is even a faint pink line.
|Preliminary Positive Result:
POSITIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specific read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at room temperature. The test device is stable through the expiration date printed on the sealed pouch.
The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.