NEW YORK ─ Zymo Research said on Wednesday that it has received the CE-IVD mark for its Quick SARS-CoV-2 rRT-PCR kit, enabling its use in the European Union and other countries that accept the designation.
The real-time reverse transcription PCR (rRT-PCR) kit detects SARS-CoV-2 nucleic acids in upper and lower respiratory specimens, and includes ready-to-use reaction mixtures that reduce hands-on time and eliminate human errors during the set-up process enabling results in less than 1.5 hours, the firm said.
Zymo Research added that it can readily scale the production of its test to millions per day without relying on other vendors that can influence the supply chain. The firm has a network of distributors, as well as subsidiaries in Germany and China, that enable it to supply the Quick SARS-CoV-2 rRT-PCR kit worldwide.
In May, the Irvine, California-based company received Emergency Use Authorization for the test from the US Food and Drug Administration.