Promega Corporation’s Maxwell® RSC 48 Instrument and Maxwell® RSC Viral Total Nucleic Acid Purification Kit (Maxwell Extraction System) are now in the Centers for Disease Control and Prevention’s (CDC) COVID-19 diagnostic protocol for emergency use. In a letter dated July 13, 2020, the U.S. Food and Drug Administration (FDA) authorized an amendment to the CDC’s 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel stating the Promega Maxwell Extraction System is an authorized solution for laboratories that use the testing protocol.
The Promega Maxwell® RSC 48 Instrument and Maxwell® RSC Viral Total Nucleic Acid Purification Kit are now authorized RNA extraction options in the Centers for Disease Control and Prevention’s (CDC) COVID-19 diagnostic protocol for emergency use. Image Credit: Business Wire
This announcement further validates why the Maxwell Extraction System is in such high demand by clinical testing labs seeking consistent and reliable benchtop automation. We are happy our Maxwell customers that use the CDC’s protocol now have the flexibility of one more authorized RNA extraction option in the SARS-CoV-2 testing process.”
Heather Tomlinson, Promega Director of Clinical Diagnostics
The Maxwell RSC 48 Instrument and Maxwell RSC Viral Total Nucleic Acid Purification Kit work together as an automated sample preparation solution that extracts RNA and DNA from viral samples. The small, benchtop Maxwell instrument is capable of processing and purifying approximately 400 samples in a typical 8-hour shift.
In addition to the CDC’s EUA assay, many other assay developers have incorporated the Maxwell instrument and reagents into their own COVID-19 EUA assays. Some developers who are targeting extremely high-throughput testing have leveraged Promega Maxwell HT reagents that are used with high-throughput robotics to automate the extraction of thousands of samples per day.
Promega supplies automation, sample extraction and diagnostic reagents to customers around the world. The company’s reagents are currently incorporated in 29 COVID-19 diagnostic tests produced by other global diagnostic manufacturers. The Promega GoTaq® Probe 1-Step RT-qPCR System is also authorized for use in the CDC’s 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel for emergency use.