Zymo Research’s Quick SARS-CoV-2 rRT-PCR Kit Receives CE-IVD Mark

Zymo Research (Irvine, CA, USA) 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 company has already received Emergency Use Authorization for the test from the US Food and Drug Administration. Zymo’s Quick SARS-CoV-2 rRT-PCR Kit is a real-time reverse transcription PCR (rRT-PCR) test for the qualitative detection of RNA from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is responsible for the coronavirus disease (COVID-19).

The Quick SARS-CoV-2 rRT-PCR Kit targets three different regions of the viral nucleocapsid (N) gene and a host-specific target region (human RNase P gene) to assess sample quality. The kit also includes CV Positive Control that enable assay performance monitoring, and a No-Template Control to confirm the absence of contamination in the reagents. It can be used on purified RNA samples isolated from upper respiratory and lower respiratory systems.

The Quick SARS-CoV-2 rRT-PCR Kit has High Sensitivity, with a Limit of Detection as low as 15 viral genome equivalent copies per reaction, a fast turnaround time of less than 1.5 hours, and a simple workflow in which RNA is simply added to the Quick SARS-CoV-2 rRT-PCR Kit reagents and directly analyzed. Due to its simplicity, set-up up can be performed in an automation and it is compatible with high-throughput platforms. The kit is compatible with multiple Real-Time PCR instruments and technical support is available for all steps of the setup process and data interpretation.

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