Promega has secured CE mark approval for its novel antibody bioluminescent immunoassay called Lumit Dx SARS-CoV-2 Immunoassay.

Lumit Dx SARS-CoV-2 Immunoassay is a qualitative in vitro diagnostic test designed for the identification of antibodies to SARS-CoV-2 in serum.

The assay will help identify antibodies against the receptor-binding domain (RBD) antigen within the SARS-CoV-2 spike (S) protein in serum within one hour at room temperature.

Promega’s new assay offers a simple add-incubate-read workflow with no wash steps, as well as boosts testing of large patient populations by adapting to high throughput on multiple automated platforms.

The assay is said to leverage Promega NanoBiT bioluminescence complementation technology for the emission of a measurable glowing signal when SARS-CoV-2 antibodies are present.

Promega chief medical officer Dr Ashley Anderson said: “Bioluminescence, when applied to antibody detection, offers laboratories several advantages including a simple and fast workflow.”

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

Promega is offering its reagents, assays and benchtop instruments for Covid-19 testing, research, and vaccine development across the world.

Some of the products include Maxwell RSC 48 and CSC 48 instruments, Maxwell RSC Viral Total Nucleic Acid Purification Kit, GoTaq Probe 1-Step RT-qPCR System and XpressAmp direct amplification reagents.

In April last year, Promega received approval to use its GoTaq Probe 1-Step RT-qPCR System in the Centers for Disease Control and Prevention’s (CDC) Covid-19 Emergency Use Authorisation (EUA) diagnostic panel.