Promega announces combined COVID-19/ influenza clinical test expansion

Labs performing the Centers for Disease Control’s (CDC) Flu SC2 Multiplex Assay, 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 US Food and Drug Administration (FDA) authorized an amendment to the Emergency Use Authorization (EUA) for the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay that adds the Maxwell^® RSC 48 and Maxwell^® CSC 48 instruments, along with the Maxwell^® RSC Viral Total Nucleic Acid Purification Kit, as options for the test procedure.

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 specifically designed for clinical laboratories. The Maxwell^® RSC Viral Total 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 tests, such as the Flu SC2 Multiplex Assay, can detect and differentiate RNA from SARS-CoV-2, influenza A virus, and influenza B virus from a single patient sample. This enables:

• labs to conserve materials while also processing more tests
• clinicians to differentiate between COVID-19 and flu, since symptoms can be similar
• health officials to conduct ongoing flu surveillance while also testing for SARS-CoV-2

“Multiplex molecular tests are crucial as the flu season overlaps with the COVID-19 pandemic, and we’re glad that Promega is able to continue to support laboratories by providing them more options as testing evolves and advances,” says Heather Tomlinson, Director of Clinical Diagnostics at Promega.

Promega SARS-CoV-2 Support

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 tests for COVID-19 only.

• Bioluminescent immunoassay to detect SARS-CoV-2 antibodies: The Lumit™ Dx SARS-CoV-2 Immunoassay is a qualitative IVD test intended to detect antibodies to SARS-CoV-2 in serum or plasma.
• Technology to accelerate COVID-19 testing: XpressAmp™ Direct Amplification Reagents allow labs to skip the RNA extraction step of the workflow.
• Reagents to enable testing an estimated 550 million samples: Since January 2020, Promega has rapidly increased production to support labs testing for SARS-CoV-2 worldwide.

Tools used for COVID-19 applications are a small subset of the 4,000 products Promega manufactures and distributes globally, serving research, pharma, clinical, forensic and applied markets. These products are used for a myriad of applications in human health, disease, genetic identity, drug development, clinical diagnostics and more.

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