Zymo Research’s Quick-DNA/RNA Viral MagBead Kit has been cleared for in vitro diagnostic applications for use by EU member states. The kit is a reliable and sensitive viral purification used for SARS-CoV-2 detection and analysis.
“Zymo Research has played a significant role in combating the current COVID-19 pandemic,” said Dr. Stanislav Forman, a scientist at Zymo Research. “All products in our COVID-19 testing workflow are now CE IVD marked; thus, helping our clinical customers in the EU and beyond.”
Available both in the USA and internationally, the product is designed for high-throughput purification of viral DNA and/or RNA from biological samples that are stored in the company’s DNA/RNA Shield which is used for sample collection, nucleic acid preservation, and inactivation of pathogens. The isolated high-quality nucleic acids are ready for all downstream applications such as Next-Gen Sequencing and RT-qPCR detection.
The CE IVD marking recognizes that the kit meets EU safety, health, and environmental requirements. It can be used for the purification of viral DNA/RNA, such as SARS-CoV-2, the virus that causes COVID-19, or other pathogenic sample types. The kit is a part of several FDA EUA SARS-CoV-2 test workflows developed by prominent companies such as Illumina and Fulgent Genetics.
“We are very pleased that Zymo Research’s Quick-DNA/RNA Viral MagBead Kit has received the CE IVD Mark from the EU,” said Thiago Pinto Nogueira, Veritas Bio’s business development director. “In Brazil, our health regulatory agency (ANVISA) welcomes products designated with the CE Mark. This facilitates our work when we register products locally. To our customers, the mark indicates this product has conformed with health and safety standards.”
Based in Irvine, CA, Zymo Research is a privately owned company that has been serving the scientific and diagnostics community with molecular biology tools since 1994. Its portfolio includes an extensive array of magnetic bead-based purification products including magbead solutions and kits, as well as accessory handling and separation devices.