SARS-CoV-2 Antibody Test Developed by Promega Receives CE Mark

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The Lumit™ Dx SARS-CoV-2 Immunoassay by Promega has received CE marking. The novel bioluminescent immunoassay is a qualitative in vitro diagnostic test intended to detect antibodies to SARS-CoV-2 in serum. (Photo: Business Wire)

MADISON, Wis.– 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.

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