Intended Use
The Oasis Diagnostics® Corporation SimplOFy™ Whole Saliva DNA Collection Kit is intended for the collection and stabilization of whole saliva for subsequent extraction of DNA downstream testing. The SimplOFy™ Whole Saliva DNA Collection Kit is For Research Use Only. Not for use in diagnostic procedures.
For research use only in the United States. The performance characteristics of this device have not been evaluated by the FDA.

Introduction
Use of oral samples for the isolation of DNA has become a very attractive
alternative to isolation from blood or tissue for a number of compelling reasons: oral collection is fast, cost effective and noninvasive and may be performed by individuals with minimal training. In addition, no specialized equipment is required.
Human genomic DNA extracted from whole saliva collected using the proprietary SimplOFy™ Whole Saliva DNA Collection Kit can be used in a growing number of applications in the research and life sciences areas. Examples include the use of DNA in PCR-based molecular assays for the detection of disease or the determination of susceptibility to disease, applications in microarray technology, genotyping, personal genomics, genome wide association studies, next generation sequencing, and others. The ease of use of the SimplOFy™ kit makes it an ideal candidate for services requiring home collection and long term DNA stabilization
at the point of collection.

Principles of the Device
The SimplOFy™ kit is a proprietary, patented system intended for the collection and stabilization of whole saliva DNA. To collect a specimen, subjects are requested to pool saliva in the mouth and ‘expectorate’ (spit) into the Collection Funnel until the sample reaches the brightly marked Indicator Line.
Once sample collection is complete, the Collection Tube is separated from the Collection Funnel by carefully rotating the Collection Tube until it is completely detached from the Collection Funnel. The Collection Funnel is then discarded and the Tube Cap is removed from the bottom of the Collection Tube and screwed tightly closed to the top of the Collection Tube.
The Tube Cap has dried-down stabilizing reagents inside, so the Collection Tube is continually inverted for at least 1 [one] minute, which results in adequate mixing of the stabilizing reagent with the saliva sample. The sample is now ready for transportation to a laboratory or storage for later testing.

Materials Provided
1. SimplOFy™ Whole Saliva DNA Collection Device

Materials Recommended but Not Provided
1. Disposable exam gloves
2. Container for proper disposal of used materials
Instructions for Use
PLEASE READ THE COMPLETE INSTRUCTIONS BEFORE PROCEEDING TO
COLLECT ORAL FLUIDS / SALIVA USING THE SIMPLOFY™ WHOLE SALIVA
DNA COLLECTION KIT. FAILURE TO FOLLOW THESE INSTRUCTIONS
CAREFULLY COULD PRODUCE LESS THAN SATISFACTORY RESULTS.
Do not eat, drink, smoke, or use oral hygiene products for at least 30 minutes before you start the collection process.
Prior to collection, review the detailed instructions for the SimplOFy™ Whole Saliva DNA Collection Kit below.