Zymo Research has received US Food and Drug Administration (FDA) 510(k) clearance for its DNA/RNA Shield SafeCollect Saliva Collection Kit.
This kit has received clearance as a Class II medical device intended for microbial nucleic acid storage and stabilisation.
The approval enables the use of the kit as an in-vitro diagnostic (IVD) device for the collection and transport of saliva.
The SafeCollect Saliva Collection Kit has been specifically designed for Covid-19 testing and uses DNA/RNA Shield, which is claimed to be the first FDA-cleared inactivating transport medium (ITM) to show SARS-CoV-2 RNA virus preservation and inactivation.
ITM properties simplify specimen handling, transportation and storage, besides maintaining viral RNA integrity at ambient temperature for long periods, thereby enabling downstream analysis through RT-PCR.
Furthermore, it has a user-friendly spit funnel with an advanced safety seal for preventing accidental spillage or exposure of the user to the DNA/RNA Shield preservative reagent in the tube.
The technology is said to be compatible with the saliva of humans suspected of containing SARS-CoV-2. Samples gathered and preserved are suitable for conducting relevant molecular diagnostic tests.
Zymo Research Sample Prep CTO Dr Stanislav Forman said: “Non-invasive saliva collection is vital for the molecular diagnostics field, unlocking a wealth of genetic and biomolecular information with ease and comfort, paving the way for groundbreaking advancements in personalised healthcare and disease detection.
“This 510(k) clearance highlights the FDA's initiative in bringing enabling technologies to the maturing molecular diagnostic space.
