FDA Elenca il kit di estrazione dell'RNA di Beckman Coulter Life Sciences per l'uso nel test COVID-19 autorizzato dall'EUA
(Indianapolis, Indiana – May 28, 2020) Beckman Coulter Life Sciences today announced RNAdvance Viral XP has been added to the list of acceptable extraction methods for use in the Centers for Disease Control’s EUA-authorized COVID-19 test referenced in the FDA’s FAQ on testing for SARS-CoV-2. Laboratories are now permitted to independently validate RNAdvance Viral XP for use.
The extraction of RNA from viral samples is a critical step for pathogen research and detection to enable accurate downstream assay results. Beckman Coulter Life Sciences has remained committed to developing high-performing, scalable reagents for laboratories testing COVID-19 patient swab samples.
“RNA extraction is essential today for reliable COVID-19 testing,” said Thomas Marshall, Ph.D., Genomics R&D Leader, Beckman Coulter Life Sciences. “RNA extraction removes contaminants from the sample, which can interfere with the qRT-PCR test and result in a false negative.”
In March, Beckman Coulter Life Sciences published two demonstrated RNA extraction methods for viral samples. Then, earlier this month, the company formally launched RNAdvance Viral XP as a reagent kit for research use.
“Our team has worked diligently with customers and government entities to develop, refine and validate proven viral extraction reagents during this time of increased need,” said Greg Milosevich, President, Beckman Coulter Life Sciences. “The entire Beckman Coulter Life Sciences family is proud our technology can now be used to expand COVID-19 testing capabilities in laboratories around the world for the foreseeable future.”
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RNAdvance Viral XP is listed as an extraction method for use with the Centers for Disease Control’s EUA-authorized COVID-19 test referenced in FDA’s FAQ on testing for SARS-CoV-2. Other than this designation, RNAdvance Viral XP is for research use, and not intended for diagnostic purposes.