Zymo Research has been 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; and unlike many other molecular tests, the Quick SARS-CoV-2 rRT-PCR Kit includes ready-to-use reaction mixtures 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.
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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.
"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.