Zymo Research has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its collection/transport device for Covid-19.

The regulator has approved the company’s DNA/RNA Shield collection tube as a Class II medical device. It is developed for use as an in-vitro diagnostic (IVD) device for Covid-19 testing.

Zymo’s DNA/RNA Shield collection device is claimed to be the first FDA-cleared technology, which inactivates the virus and protects the SARS-CoV-2 RNA.

The SARS-CoV-2 virus will be efficiently inactivated to safely handle, transport and store the sample, the company said.

The viral RNA is stabilised at ambient temperature for longer periods for better analysis through downstream RT-PCR.

Zymo Research business development vice president Dr Marc Van Eden said: “DNA/RNA Shield had a proven track record in various infectious disease applications prior to the current pandemic, facilitating its rapid adoption and deployment in the early stages of the COVID outbreak.

“The 510(k) is the result of the FDA’s active collaboration with Zymo Research in bringing this technology to the forefront of current testing and future  surveillance efforts.”

The DNA/RNA Shield collection tube has been developed for the stabilisation and inactivation of upper and lower respiratory human specimens suspected of containing SARS-CoV-2. It includes a tube filled with the company’s DNA/RNA Shield transport medium.

The transport medium helps to maintain the stability of the SARS-CoV-2 RNA during sample transportation and storage for up to 28 days at ambient temperatures between 20°C and 25°C.

Zymo’s DNA/RNA Shield transport media will be provided with a swab, sputum collection kit or as a tube alone. Specimens collected and stored in a DNA/RNA Shield collection are used with suitable molecular diagnostic tests.

In November last year, Zymo Research secured CE IVD mark approval for its Quick-DNA/RNA Viral MagBead Kit, which is used for high-throughput purification of viral DNA or RNA from biological samples.