Novel bioluminescent Lumit™ Dx SARS-CoV-2 Immunoassay enables simple, scalable antibody detection

A SARS-CoV-2 antibody test developed by Promega Corporation, the Lumit™ Dx SARS-CoV-2 Immunoassay, has received CE marking and is now available in Europe. The novel bioluminescent immunoassay is a qualitative in vitro diagnostic test intended to detect antibodies to SARS-CoV-2 in serum.

Promega designed the Lumit™ Dx SARS-CoV-2 Immunoassay to be reliable, simple and scalable, enabling labs to:

• Detect antibodies against the receptor-binding domain (RBD) antigen within the SARS-CoV-2 spike (S) protein in serum in less than one hour at room temperature.
• Conserve resources with a simple add-incubate-read workflow with no wash steps.
• Accelerate testing of large patient populations by adapting the assay to high throughput on many automated platforms.

The assay leverages Promega NanoBiT® bioluminescence complementation technology to emit a measurable glowing signal when SARS-CoV-2 antibodies are present. NanoBiT® technology has received awards from The Scientist and the European Laboratory Research and Innovation Group.

“Bioluminescence, when applied to antibody detection, offers laboratories several advantages including a simple and fast workflow,” says Promega Chief Medical Officer Ashley Anderson, MD.

The Lumit™ Dx SARS-CoV-2 Immunoassay is also available in the US under a policy allowing developers of serological tests to make them available while awaiting US Food and Drug Administration (FDA) review.

Promega COVID-19 Support

Promega reagents, assays and benchtop instruments are being used around the world for COVID-19 testing, research, and vaccine development.

• Reagents to enable testing an estimated 800 million samples: Since January 2020, Promega has rapidly increased production to support labs testing for SARS-CoV-2 worldwide.
• Products in the US Centers for Disease Control (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay for emergency use: Maxwell® RSC 48 and CSC 48 instruments; Maxwell® RSC Viral Total Nucleic Acid Purification Kit
• Products in the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel for emergency use: GoTaq® Probe 1-Step RT-qPCR System; Maxwell® RSC 48 and CSC 48 instruments; Maxwell® RSC Viral Total Nucleic Acid Purification Kit
• Technology to accelerate COVID-19 testing: XpressAmp™ Direct Amplification Reagents allow labs to skip the RNA extraction step of the workflow.

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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