The Oral Fluid Drug Screen Device is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in human oral fluid at the following cut-off concentrations:
This assay provides only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
Product Format: Cassette
1. Test device
4. Package insert
DIRECTIONS FOR USE
Allow the test device, and urine specimen to come to room temperature [15-30℃ (59-86℉)] prior to testing. Instruct the donor to not place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection.
1. Bring the 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 collector from the sealed pouch and give it to the donor.
3. 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.
4. The sponge is saturated when no hard spots can be detected. Collect for a total of three (3) minutes before removing the sponge.
5. Remove the collector from the mouth. With the test device on a flat surface, insert the collector into the test device by pushing it into the chamber and turning the collector clockwise until engaged. Wait 1 minute.
6. After 1 minute, rotate the collection chamber counterclockwise and set the timer for 5 minutes.
7. Read results at 5 minutes. Do not interpret the result after 10 minutes.