Zymo Research Obtains CE IVD Mark for Quick SARS-CoV-2 Multiplex Kit
Zymo Research has obtained a CE IVD mark for the Quick SARS-CoV-2 Multiplex Kit. 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.
Zymo Research 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.”