Zymo Research Granted CE IVD Mark for Quick SARS-CoV-2 rRT-PCR Kit
Zymo Research received CE marking authorization for its Quick SARS-CoV-2 rRT-PCR Kit.
IRVINE, Calif., (Aug. 19, 2020) — Zymo Research announced that it was recently granted the CE IVD Mark for its Quick SARS-CoV-2 rRT-PCR Kit. To obtain this certification the product had to comply 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 rRT-PCR Kit is a real-time reverse transcription PCR (rRT-PCR) test used for the qualitative detection of nucleic acids from SARS-CoV-2 in upper and lower respiratory specimens. The test has been previously authorized by the Food & Drug Administration (FDA) under an emergency use and it is widely used in the U.S.A. for the diagnosis of COVID-19. With a limit of detection as low as 15 GEC/reaction (250 GEC/ml of sample) and a robust control system, this test outperforms most SARS-CoV-2 molecular tests currently on the market. Unlike many other molecular tests, the Quick SARS-CoV-2 rRT-PCR Kit includes ready-to-use reaction mixtures, thus reducing hands-on time and eliminating human errors during the set-up process. In addition, the test is fast and results are generated in less than 1.5 hours.
Zymo Research can readily scale the production as needed, without the reliance on other vendors that can influence the supply chain. Millions of tests per day can be manufactured, as needed, to support the fight against COVID-19. Moreover, with a worldwide network of distributors, as well as subsidiaries in Germany and China, Zymo Research is logistically set up to supply the Quick SARS-CoV-2 rRT-PCR Kit rapidly and efficiently throughout the world. This vast established distributor network has been instrumental in getting reagents delivered where most urgently needed during this worldwide pandemic.
“Receiving the CE IVD Mark for our Quick SARS-CoV-2 rRT-PCR Kit means we can better support COVID-19 testing on a global level, something that Zymo Research has been deeply committed to since the start of the pandemic,” said Dr. Paolo Piatti, Senior Scientist at Zymo Research.
For more information about Zymo Research’s Quick SARS-CoV-2 rRT-PCR Kit and workflow, please visit their website or contact them via email at covid19requests@zymoresearch.com.
ABOUT ZYMO RESEARCH CORP.
Zymo Research Corp. is a privately held company based in Irvine, California, USA. Since its inception in 1994, it has been serving the academic and biopharmaceutical scientific communities by providing DNA and RNA purification products. Their goal is to help scientists reduce time in the lab by eliminating steps and making the entire DNA/RNA extraction process simpler and faster. In addition to their nucleic acid purification products, Zymo Research also offers genetic, epigenetic, and transcriptome analysis products and services that are high quality and simple to use yet robust in performance. Follow Zymo Research on Facebook , LinkedIn, Twitter, and Instagram.
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