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The ORAL·SCREEN™ System is formulated for use with oral
fluid specimens. Make sure that the person being tested has had nothing in
their mouth for at least 5 minutes before sample collection. Directly
observe the person during sample collection.
NOTE: If the person being tested is experiencing dry mouth prior to
sample collection, have them drink a glass of water, wait 5 minutes, then
start the collection process.
Collect the oral fluid sample by removing the collector from the package, sliding the plastic hood back, and exposing the foam.
Have the person pucker their mouth and accumulate oral
fluid before inserting the swab collector. Place the foam end in the mouth
and move it around gently for at least 2 minutes to allow the oral fluid to
enter the foam. Press gently with one's tongue may help the oral fluid to
enter the collector foam. Do not chew or suck on the collector.
Remove the collector and hold it in a slightly upright
position (not straight up). Slide the hood forward gently until the foam is
completely surrounded by the hood.
NOTE: The foam piece should swell in size after sample collection. If
you suspect an insufficient amount of sample was collected prior to loading
the sample, simply reinsert the collector into the person's mouth for additional
time, or use a new collector and start the collection process over again.
Remove the test device from the foil pouch immediately prior to loading the sample. Complete the specimen ID section on the test device label. Note the presence of green indicator lines in the result window before sample is added.
With one hand, hold the hood in place over the foam. Firmly squeeze and hold the foam and the middle of the hood between your index finger and your thumb. This will dispense the oral fluid from the foam toward the end of the hood.
Carefully tip the collector downwards and add one
individual drop of oral fluid into the sample well.
NOTE: Continue to squeeze and hold the foam, keeping the collector
level in order to prevent the oral fluid from absorbing back into the foam.
After loading the first drop, wait 10 seconds and then add an additional drop of oral fluid.
Repeat this process until a total of 4 drops of oral fluid
have been added, making sure that you wait 10 seconds between each additional
drop.
NOTE: If insufficient or excess oral fluid is added then the device and
collector should be discarded and another package opened and the process
repeated.
Interpretation of Results
The test results are determined by the presence or absence of red lines. It is possible that line intensity may vary for reach drug line. Do not compare line intensities when interpreting results. OralScreen is a qualitative test. Variations in line intensity do not reflect drug concentration.
A drug negative interpretation may be made once a red line is clearly visible at the control position and at the position indicated for the drug.
A non-negative interpretation must be made at 15 minutes after sample addition.
Do not read results beyond 15 minutes after sample addition.
A
NEGATIVE test result for all four drugs is indicated by the presence of five red
lines.
A NON-NEGATIVE test result is indicated by the absence of a red line at the position indicated for the drug. More than one line may be absent indicating a multiple non-negative.
In
order to be VALID, all test results must have a red Control line present. If
there is no red Control line, the test is INVALID and the device and collector
should be discarded. Open another package and repeat the process.
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