Oralert 6 Procedure and Test Instructions

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	Test Instructions

Oralert 6 Oral Saliva Screen

OraLert6 Procedure - Test Instructions

Instructions

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Oralert Procedure 1: Remove the Oralert 6 cap.

Ensure the Oralert reservoir is locked in testing position by turning counterclockwise as far as possible.

Insert Sponge Collector into Mouth

Oralert Procedure 2: Insert the Oralert 6 sponge end of collector into mouth.
Actively swab the inside of the mouth and tongue with sponge. As soon as the sponge softens slightly, gently press the sponge between the tongue and teeth to ensure complete saturation.
The sponge is saturated when no hard spots can be detected. Collect for a total of (3) minutes before removing sponge.

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Oralert Procedure 3: Insert the Oralert 6 collector into device as shown.
Push collector down into chamber.
Turn collector clockwise to lock into chamber.

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Oralert Procedure 4: Wait 9 minutes, remove the Oralert collector from device and read results.

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Oralert Procedure 5: Secure cap back onto collection chamber.
Turn reservoir clockwise as far as possible to lock.
If results are positive, secure reservoir with tamper evident tape and send to laboratory for confirmation

Oralert Oral Fluid Drug Test Procedure:

DIRECTIONS FOR USE
Allow the OrALert oral fluid screen to come to room temperature (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 OrALert 6 oral test screen - saliva 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 OrALert 6 oral test screen - saliva Drug test Device Sample Collector Cap from the collection Swab. Instruct the donor to insert the Swab 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 Swab softens slightly, the donor should gently press the Swab between the tongue and teeth to ensure complete saturation.
3. The Swab is saturated when no hard spots can be felt. Collect for a total of at least three (3) minutes before removing the Swab. Remove the oral fluid screen collector from the mouth
4. Align the Red Arrow on the Oralert 6 oral fluid screen 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 degrees 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 Oralert 6 oral drug screen to a laboratory for confirmation. The laboratory can access the reservoir through the Sample Port.

LIMITATIONS
1. The OrAlert 6 oral test screen 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 OrAlert 6 when tested with concentrations up to 100 mL.