CDC COVID-19 / Influenza Combined Test Modified to Include Promega Maxwell® RSC 48 and CSC 48 Instruments, Maxwell® RSC Total Viral Nucleic Acid Purification Kit
Expanded List of Authorized Instruments and Reagents Provides More Options for Laboratories Running the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
Laboratories performing the Centers for Disease Control (CDC) Flu SC2 Multiplex Test, a single test to diagnose infection caused by SARS-CoV-2, influenza A, or influenza B, can now use two Promega instruments and a Promega nucleic acid purification kit in the protocol. In a letter dated January 8, 2021, the United States Food and Drug Administration (FDA) authorized an amendment to the Emergency Use Authorization (EUA) for the CDC Influenza SARS-CoV-2 multiplex test ( Flu SC2) which adds the Maxwell® RSC 48 and Maxwell® CSC 48 instruments, as well as Maxwell® RSC Total Viral Nucleic Acid Purification Kit, as options for the test procedure.
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Promega Maxwell® CSC 48 (pictured), Maxwell® RSC 48, and Maxwell® RSC Viral Total Nucleic Acid Purification Kit are now licensed options for labs running SARS-CoV-2 (Flu SC2) from the Centers for Disease Control (CDC) from the United States. Multiplex dosing. (Photo: Business Wire)
The Promega Maxwell® RSC 48 benchtop instrument is an automated nucleic acid purification platform that processes up to 48 samples simultaneously. The Maxwell® CSC 48 Nucleic Acid Extraction System is an in vitro diagnostic medical device specially designed for clinical laboratories. The Maxwell® RSC Total Viral Nucleic Acid Purification Kit can be used with either instrument to purify viral RNA from SARS-CoV-2 test samples.
Multiplex tests for SARS-CoV-2, influenza
Multiplex assays, such as the Flu SC2 Multiplex Assay, can detect and differentiate SARS-CoV-2, influenza A virus, and influenza B virus RNA from a single patient sample. This allows:
laboratories to conserve materials while processing more tests
clinicians to tell the difference between COVID-19 and the flu, as symptoms may be similar
health officials to conduct ongoing influenza surveillance while testing for SARS-CoV-2
“Multiplex molecular testing is crucial as influenza season overlaps with the COVID-19 pandemic, and we are pleased that Promega is able to continue to support labs by providing them with more options as testing evolves and are progressing, ”said Heather Tomlinson, Director of Clinical Diagnostics at Promega.
Management of SARS-CoV-2 from Promega
Maxwell® RSC 48, Maxwell® CSC 48, Maxwell® RSC Viral Total Nucleic Acid Purification Kit and GoTaq® Probe 1-Step RT-qPCR System are already included, for emergency use, in the CDC 2019 Novel Coronavirus (2019- nCoV) Real -Time RT-PCR Diagnostic Panel, which only tests for COVID-19.
Promega reagents, tests and benchtop instruments are used worldwide for the testing, research and development of SARS-CoV-2 vaccines.
Bioluminescent immunoassay to detect SARS-CoV-2 antibodies: The Lumit ™ Dx SARS-CoV-2 Immunoassay is a qualitative IVD test designed to detect anti-SARS-CoV-2 antibodies in serum or plasma.
Technology to speed up COVID-19 testing: XpressAmp ™ Direct Amplification Reagents allow laboratories to skip the RNA extraction step of the workflow.
Reagents for testing approximately 550 million samples: Since January 2020, Promega has rapidly increased production to support laboratory testing for SARS-CoV-2 worldwide.
The tools used for COVID-19 applications are a small subset of the 4,000 products that Promega manufactures and distributes around the world, serving the research, pharmacy, clinical, forensic and applied medicine markets. These products are used for a myriad of applications in human health, disease, genetic identity, drug development, clinical diagnostics and more.
To learn more about Promega SARS-CoV-2 products and Promega technical support, visit: www.promega.com/covid19
About Promega Corporation
Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s product portfolio of more than 4,000 products supports a range of life science work in areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification and molecular diagnostics. For more than 40 years, these tools and technologies have developed in their application and are today used by scientists and technicians in laboratories for academic and government research, forensics, pharmaceuticals, clinical diagnostics and agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 distributors worldwide. For more information visit www.promega.com
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