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.