Zymo Research DNA/RNA Shield collection tube for COVID-19 testing

The US Food and Drug Administration (FDA) has cleared Zymo Research’s DNA/RNA Shield collection tube as a Class II medical device, allowing the product to be used as an in vitro diagnostic (IVD) device for COVID-19 testing.

Specifically granted for COVID-19 testing, the collection device is designed to inactivate the virus and preserve the SARS-CoV-2 RNA. The SARS-CoV-2 virus is effectively inactivated, which allows the sample to be safely handled, transported and stored. The viral RNA is stabilised at ambient temperature for prolonged periods for robust analysis via downstream RT-PCR.

The product consists of a tube filled with Zymo Research’s DNA/RNA Shield transport medium; this enables the stability of the SARS-CoV-2 RNA during sample transportation and storage for up to 28 days at ambient temperatures. The transport medium may be kitted with a swab or sputum collection kit, or as a tube alone.

The technology is compatible with upper and lower respiratory human specimens suspected of containing SARS-CoV-2. Specimens collected and stored in the collection tube are suitable for use with appropriate molecular diagnostic tests.