Zymo Research announced that the US Food and Drug Administration (FDA) has approved its Quick SARS-CoV-2 rRT-PCR Kit (R3011) for Emergency Use Authorization (EUA) for the detection of SARS-CoV-2, the virus that causes COVID-19.
The kit is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens taken from patients who are suspected, by their healthcare provider, of having COVID-19. This emergency use authorization comes at a critical time when approved laboratories need an accessible workflow to perform COVID-19 testing.
The EUA covers Zymo Research's SARS-CoV-2 testing workflow, from specimen collection to purification, and virus detection. Specimen collection using Zymo Research's DNA/RNA Shield™ allows biological samples to be transported and stored in a medium that preserves the genetic integrity of the sample. The Quick-DNA/RNA™ Viral MagBead Kit is designed for high-throughput purification of viral DNA and features a buffer system that facilitates complete viral particle lysis. The Quick SARS-CoV-2 rRT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in upper and lower respiratory specimens. High-complexity labs can use this inclusive workflow with manual or automated solutions.
"The Covid-19 pandemic is a global crisis and Zymo Research is committed to using its resources and technology to help stop the global spread of this coronavirus. This new FDA Emergency Use Authorization for our kit will help many laboratories meet increased demands for COVID-19 testing," said Dr. Larry Jia, Founder and President of Zymo Research.
"Accessible testing is a critical step in fighting the COVID-19 pandemic, and that includes having an easily accessible workflow," said Dr. Paolo Piatti, Senior Scientist at Zymo Research. "Having a simple and easy-to-use workflow means labs can start processing samples quickly to help meet the demands for COVID-19 testing. Zymo Research is ready to support these labs in their efforts and together we can make a difference in the fight against this devastating virus."
About the Emergency Use Authorization:
The Quick SARS-CoV-2 rRT-PCR Kit has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For more information about Zymo Research's SARS-CoV-2 testing workflow, please visit their website www.zymoresearch.com.