NEW YORK — Zymo Research said on Tuesday that it has received CE-IVD marking for its Quick SARS-CoV-2 Multiplex Kit.
The real-time reverse transcription PCR test is designed for the qualitative detection of SARS-CoV-2 nucleic acid in upper and lower respiratory specimens. According to the Irvine, California-based company, the kit has a limit of detection of 10-virus copies per reaction and up to 382 samples can be analyzed for each RT-PCR run.
In August, Zymo received CE-IVD marking for its Quick SARS-CoV-2 rRT-PCR kit, which received Emergency Use Authorization from the US Food and Drug Administration in May.