STATSWAB Direction

STATSWAB Oral drug tests

Directions for Use

Allow the test device to reach room temperature [15-30°C (59-86°F)] prior to testing. Do not place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection of oral fluid specimen.

1. Bring the pouch to room temperature before opening it. Remove the test from the sealed pouch and use it as soon as possible.
2. Remove the test device from the sealed pouch and screw the Collector Cap counterclockwise to pull out the whole piece of collection stick with Sponge from the Collection Chamber. (Step 1)
3. Insert the sponge end of the collection stick into the mouth. Close mouth and gently chew the sponge for saliva excretion. Soak sponge into saliva in mouth and swab the inside of the mouth and tongue to collect oral fluid for a total of 3 minutes until the sponge becomes completely soft and fully saturated with saliva. No hard spots should be felt on the sponge when saturated. (Step 2)
4. Remove the sponge from the mouth. With gentle pressure, place the collection stick with saturated sponge into Collection Chamber. (Step 3)
5. Screw the Collector Cap clockwise to secure the cap and start the timer. (Step 4)
6. Mark patient ID on the test device. Peel off the label to read test results. Wait for the color line(s) to appear on the test strips. Read results of alcohol test at 2 minutes and drug tests at 10 minutes. Do not read drug test results after 1 hour and alcohol test result after 5 minutes. (Step 5)
7. Send the collector with collected oral fluid to the laboratory for GC/MS confirmation if necessary.

INTERPRETATION OF RESULTS

(Please refer to the previous illustration) Drug Test Results
NEGATIVE:
Two lines appear. * One color line should be in the control region (C), and another apparent color 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 color in the test line region (T) will vary, but it should be considered negative whenever there is even a faint distinguishable color line.
POSITIVE:
One color 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 device. If the problem persists, discontinue using the lot immediately and contact your supplier.
(Please refer to the color chart)
Alcohol Test Results

Alcohol Negative Result: The alcohol pad shows no color change (remains white or cream colored); it should be interpreted as a negative result (no alcohol present). A result where the outer edges of the alcohol pad produces a slight color but the majority of the pad remains colorless should be repeated to ensure complete saturation of the alcohol pad with oral fluid. If the second result is the same, the results should be interpreted as being negative (no alcohol present).

Alcohol Presumptive Positive Result: The Alcohol test produces a color change to green to blue in the presence of salivary alcohol 0.02 % B.A.C. or higher. At higher alcohol concentration near 0.30% B.A.C., the color may change to a dark blue-gray.

QUALITY CONTROL

A procedural control is included in the test. A color 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.

 

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