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Saliva Collection Device for Lab Based Testing

The Only Saliva Sampler With a Volume Adequacy Indicator Intended for the use with the Immunalysis Drug Screen Panel!

> Buffer formulated to
release THC from

cellulose ester pad

> Buffer formulated to

assist in breakdown of

saliva proteins

> Buffer stabilizes drugs

at low concentrations

Collection Procedure

FAQ's

Intended use: The saliva sampler is intended for the collection and the transport of oral fluid for forensic and research purposes. Not for home use.

Summary and Explanation of Function:

Collection: A saliva specimen is collected by placing a cellulose pad affixed to a polypropylene stem (Collector) under the tongue of an individual until a define volume of saliva has saturated the cellulose pad. The defined volume taken up by the cellulose pad is indicated by coloration (blue) in a window on the stem (volume adequacy).

Preservation: The collector is transferred into a provided polypropylene tube containing a preservative buffer. The tube is stoppered with a provided cap. The specimen is ready for storage or transport.

Volume adequacy: The cellulose pad placed under the tongue for collection is extended into a cellulose tail accommodated in the interior of the polypropylene stem. Blue dye is placed on the cellulose tail below the window in the stem. Upon saturating the cellulose pad with specimen, aqueous medium migrates along the cellulose tail by capillary action and dissolves the dye. Upon further migration of liquid, the dye becomes visible in the window of the stem.

Materials provided:
a) Saliva collector with volume adequacy indicator.
b) Transport tube with snap cap. The tube contains 3 mL of buffer with non azide preservative

INSTRUCTIONS
Warning do not put buffer fluid of transport tube into mouth.

1) Do not use device beyond expiration date printed on package.
2) Record patient information and collection date on tube label.
3) Remove collector from pouch.
4) Position collector under tongue. Close mouth. DO NOT CHEW OR SUCK ON PAD! Do not move pad during collection
5) The collector should remain under tongue until indicator turns completely blue. Blue color indicates collector is saturated with 1 ml of saliva. The collection time may take from 2 - 10 minutes. If the indicator has not turned blue within 15 minutes the pad should be removed from the mouth and discarded. Recollection with a new device may begin immediately but only after saliva has accumulated in the mouth. The collector may be place in the same position.
6) Open mouth and lift tongue. Remove collector from mouth.
7) Remove cap from transport tube. Insert the saturated collector into the tube. Do not place collector into mouth after it has been in the buffer liquid.
8) Carefully place cap over the top of the collector stem in tube. FORCEFULLY PUSH CAP DOWNWARD UNTIL CAP "SNAPS" FLUSH WITH TOP OF TUBE.
9) Mix saturated collector with buffer by gently shaking tube.
10) Ship saliva specimen to laboratory as soon as possible.

PERFORMANCE CHARACTERISTICS:

Saliva collection volume and collection time: The collection volume is 1 mL., with a variation of about 10%. It takes on an average about 3 minutes to collect this volume ( n=302; first time users) The individual collection time may exceed 10 minutes (2 cases in 302)