Zymo Research Obtains CE IVD Mark for its Quick SARS-CoV-2 Multiplex Kit

Low cost, high-sensitivity diagnostic test for COVID-19 detection

IRVINE, Calif., Nov. 10, 2020 /PRNewswire/ -- Zymo Research announced today that it obtained a CE IVD mark for the Quick SARS-CoV-2 Multiplex Kit in compliance with the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. The Quick SARS-CoV-2 Multiplex Kit is a real-time reverse transcription PCR (RT-PCR) test used for the qualitative detection of nucleic acids from SARS-CoV-2 (the virus that causes COVID-19) in upper and lower respiratory specimens taken from patients whose healthcare providers suspect have contracted COVID-19.

Zymo Research obtained the CE IVD mark for its Quick SARS-CoV-2 Multiplex Kit.

The Quick SARS-CoV-2 Multiplex Kit has a limit of detection (LoD) of 10-virus copies/reaction and up to 382 samples can be analyzed for each RT-PCR run. This high performance, combined with increased throughput, competitive pricing, and a widespread distribution network, makes this test among the best on the market.* The kit is ideal for clinical diagnostic labs that currently offer or want to offer COVID-19 testing including hospitals, universities, research centers, as well as laboratories that perform environmental surveillance for SARS-CoV-2.

The kit is easy to use in any lab equipped with RT-PCR instrumentation that is capable of detecting HEX (or VIC) and Quasar 670 (or Cy5) fluorophores. It comes in multiple formats (100-, 1,000-, or 10,000-test quantities), which make it amenable for use in small or large laboratories. With a strong international distribution network and a high production capacity, Zymo Research is capable of meeting the high-volume reagent demands of laboratories around the globe.

"With over 46 million** COVID-19 cases reported worldwide, our goal is to help stop the spread of SARS-CoV-2 by enabling increased testing," said Dr. Paolo Piatti, Senior Scientist at Zymo Research. "The CE IVD mark, along with the competitive pricing, makes this high-quality product readily accessible to laboratories and ultimately expands the availability of COVID-19 testing to many more facilities throughout the world."

For more information about Zymo Research's Quick SARS-CoV-2 Multiplex Kit and workflow, please visit their website or contact them via email at covid19requests@zymoresearch.com.

About Zymo Research Corp.Zymo Research is a privately owned company that has been serving the scientific and diagnostics community with state-of-the-art molecular biology tools since 1994. "The Beauty of Science is to Make Things Simple" is their motto, reflected in all of their products, from epigenetics to DNA/RNA purification technologies. Historically recognized as the leader in epigenetics, Zymo Research is breaking boundaries with novel solutions for sample collection, microbiomic measurements, diagnostic devices, and NGS technologies that are high quality and simple to use. Follow Zymo Research on Facebook, LinkedIn, Twitter, and Instagram.

References* https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data **https://www.statista.com/statistics/1087466/covid19-cases-recoveries-deaths-worldwide/

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