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The DNA/RNA Shield™ SafeCollection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield™ SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected and preserved in a DNA/RNA Shield™ Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices.

The DNA/RNA Shield SafeCollect Saliva Tube consists of a tube pre-filled with DNA/RNA Shield transport media. DNA/RNA Shield is a transport media that ensures stability of SARS-CoV-2 RNA during sample transport/storage at ambient temperatures (20-25 ℃) and is intended to inactivate SARS-CoV-2, effectively lyses cells from collected saliva specimens. The DNA/RNA Shield SafeCollect Saliva Tube contains a foil seal barrier that sequesters the DNA/RNA Shield transport media inside of the tube, until the cap, with a Safe Puncture tip is used to seal the DNA/RNA Shield SafeCollect Saliva tube. When the foil seal barrier is broken by the Safe Puncture Tip, the specimen is then, and only then mixed with the DNA/RNA Shield™ transport media. The DNA/RNA Shield SafeCollect Saliva Collection Kit consists of a DNA/RNA Shield SafeCollect Saliva Tube, a funnel designed for the collection of human saliva samples, and a cap with a Safe Puncture tip. Sample collection is conducted under the supervision of a healthcare provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the Safe Puncture tip cap, the DNA/RNA Shield is released into the tube and mixes with the saliva.

The DNA/RNA Shield™ collection tube is intended for the stabilization and inactivation of upper and lower respiratory human specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at ambient temperatures (20-25°C). Specimens collected and stored in a DNA/RNA Shield™ collection tube are suitable for use with legally marketed molecular diagnostic devices.

The DNA/RNA Shield™ collection tube and reagent consist of a tube pre-filled with DNA/RNA Shield™ transport media. DNA/RNA Shield™ is a transport media that ensures stability of SARS-CoV-2 RNA during sample transport/storage at ambient temperatures and is intended to inactivate SARS-CoV-2, effectively lyses cells from collected upper and lower respiratory biological specimens. The DNA/RNA Shield™ transport media may be kitted with a swab, sputum collection kit or as a tube alone.