Zymo Research obtains CE IVD mark for viral DNA/RNA purification kit

23 November 2020 (Last Updated November 23rd, 2020 11:21)

Zymo Research has received CE IVD mark for its Quick-DNA / RNA Viral MagBead kit designed for purification of viral DNA and / or RNA from biological samples stored in its DNA / RNA Shield.

Zymo Research obtains CE IVD mark for viral DNA/RNA purification kit
Zymo Research’s Quick-DNA/RNA Viral MagBead Kit has been cleared for in vitro diagnostic applications for use by EU member states. Credit: Zymo Research.

Zymo Research has received CE IVD mark for its Quick-DNA / RNA Viral MagBead kit designed for purification of viral DNA and / or RNA from biological samples stored in its DNA / RNA Shield.

The company can now distribute the kit in the European Union (EU) common market.

The kit can be used for the purification of viral DNA and / or RNA like SARS-CoV-2, the virus that causes Covid-19, or other pathogenic sample types.

It can perform high-throughput purification from samples such as plasma, serum, urine, cell culture media, blood, saliva, cellular suspensions, biopsies, swab and faecal, stored in DNA / RNA Shield.

The shield is used for sample collection, nucleic acid preservation and inactivation of pathogens.

The Quick-DNA / RNA Viral MagBead kit also has a buffer system to aid in complete viral particle lysis for efficient nucleic acid isolation.

Small and large DNA and RNA bound to magnetic beads can be washed and eluted.

These isolated nucleic acids can be used for downstream applications like Next-Gen Sequencing and RT-qPCR detection.

Zymo Research scientist Dr Stanislav Forman said: “Zymo Research has played a significant role in combating the current Covid-19 pandemic.

“All products in our Covid-19 testing workflow are now CE IVD marked; thus, helping our clinical customers in the EU and beyond.”

The kit is one among many US Food and Drug Administration (FDA) EUA granted SARS-CoV-2 test workflows developed by firms like Illumina and Fulgent Genetics.

Veritas Bio business development director Thiago Pinto Nogueira said: “We are very pleased that Zymo Research’s Quick-DNA/RNA Viral MagBead Kit has received the CE IVD Mark from the EU.

“In Brazil, our health regulatory agency (ANVISA) welcomes products designated with the CE Mark. To our customers, the mark indicates this product has conformed with health and safety standards.”