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DIRECTIONS FOR USE
Allow the iScreen Oral Fluid Drug saliva drug test to come to room temperature [15-30 C (59-86 F)] prior to testing. Instruct the donor not to place anything in the mouth including food, drink, gum, or tobacco products for at
least 10 minutes prior to collection.
1. Bring the iScreen Oral Fluid Drug Test pouch to room temperature before opening it. Remove the test and Cap from the sealed pouch and use the test as soon as possible.
2. Remove the iScreen Oral Fluid Device Sample Collector Protector from the collection Sponge. Instruct the donor to insert the Sponge end of the collector into the mouth and actively swab the inside of the mouth and the top of the
tongue. As soon as the Sponge softens slightly, the donor should gently press the Sponge between the
tongue and teeth to ensure complete saturation.
3. The Sponge is saturated when no hard spots can be felt. Collect for a total of at least three (3) minutes before removing the Sponge. Remove the collector from the mouth
4. Align the Red Arrow on the iScreen Oral Fluid Device with one of the White Marks on the Cap. Insert the collector
vertically into the Cap and press down firmly. Twist the Cap clockwise 180�� until the Red Arrow lines
up with the other White Mark.
5. Place the test device horizontally on a clean and level surface with facing up.
6. Read results at 10 minutes. Do not read results after 1 hour.
7. If positive results are observed, secure Cap with security seal and send the iScreen Oral Fluid Device to a laboratory for
confirmation. The laboratory can access the reservoir through the Sample Port.
8. For detailed operating instructions, please refer to the Procedure Card.
INTERPRETATION OF RESULTS
(Please refer to the previous illustration)
NEGATIVE: All test lines appear. One colored line should be in the control region (C), and other
apparent colored line should be adjacent in the test region (Drug/T). This negative result indicates that the
drug concentration is below the detectable level or drug free.
*NOTE: The shade of color in the test region (Drug/T) will vary, but it should be considered negative
whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control region (C). Any test line not appears in the test
region (Drug/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 panel. If the problem persists, discontinue using the lot immediately and contact the manufacturer.
Procedural control is included in the test. A colored 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.
LIMITATIONS
1. The iScreen Oral 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) are 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 cutoff level of the assay.
Cross-Reactivity
A study was conducted to determine the cross-reactivity of the test with compounds spiked into drug-free
PBS stock. The compounds demonstrated no false positive results on the iScreen Oral Fluid Drug Test when
tested with concentrations up to 100 g/mL.
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