QUANTISAL™ II ORAL FLUID COLLECTION DEVICE COLLECTION PROCEDURE

How to collect a specimen: Quantisal™ II

SPECIMEN COLLECTION PROCEDURE

The following instructions are written for the operator to administer the collection procedure. The operator must instruct and observe the donor using the Quantisal™ II device.

It is advised to use gloves to prevent skin irritation.

1. Ensure donor has refrained from eating, drinking, or smoking for at least 10 minutes prior to specimen collection.
2. Check the expiration date of the device before use.
3. Inspect the packaging for integrity. Do not use the device if the package or device is broken or the Transport Tube leaks.
4. Remove cap from each Transport Tube by holding the Transport Tube in an upright position and pushing up with thumb(s).
5. Secure each Transport Tube in an upright position.
6. Remove the Collector from the pouch.
7. To maximize saliva accumulation and speed up the collection process, instruct the donor to pool saliva in their mouth prior to collection. Operator can advise the donor to move their tongue side to side with their head tilted down for up to 4 minutes. The collection can begin 4 minutes after starting saliva accumulation.
8. Instruct the donor to position the Collector under the tongue and to close mouth. The donor should keep the head down to allow gravity to help with saliva collection.
   Warning: the donor must not chew or suck on pads or stem, remove the stem cover, separate collector into two split pads/stems, talk, pull on or remove collector from mouth.
9. The donor should keep the pads under the tongue until indicators on both sides turn completely blue. The blue color indicates that the Collector has collected 1 mL ± 10% of oral fluid on each pad. The collection time may take from 2 to 10 minutes. If the indicator has not turned blue within 10 minutes, the pads should be removed from the mouth and discarded. Re-collection with a new device may begin immediately, but only after oral fluid has accumulated in the mouth.
10. When the indicators on both sides of the stem completely turn blue, remove the Collector from mouth.
11. Hold the Collector by its “wings” with both thumbs and twist to pull apart, separating the split Collector into two separate pads/stems.
12. Insert each saturated separate pad into separate transport tubes (specimens A and B). Do not spill or empty liquid from tube.
    Warning: do not ingest the buffer. Do not place collector into mouth after it has been in the preservative buffer.
13. Carefully place cap over the top of each Collector stem in both tubes. Forcefully push cap downward until cap “snaps” flush with top of tube.
14. Follow all lab-provided instructions and applicable regional regulations for labeling. Record donor information and collection date and time on tube labels and/or the custody and control form or requisition form associated with the specimen.
15. Ship both oral fluid samples (A and B) at ambient temperature via overnight courier service to a laboratory for testing as soon as possible. Follow all lab-provided instructions and applicable regional regulations packaging the Transport Tubes for shipment. Studies performed on representative drug samples demonstrate that samples can withstand temperature excursion down to -20°C and up to 40°C, not to exceed 24 hours.

Product Demonstration Video

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