Industry News: Zymo Research obtains CE IVD mark for its Quick SARS-CoV-2 Multiplex Kit

The kit promises to be a low cost, high-sensitivity diagnostic test for COVID-19 detection

12 Nov 2020


Zymo Research has announced 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 health care providers suspect have contracted COVID-19.

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 make 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 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 in stopping the spread of SARS-CoV-2 through 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.

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

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