NEW YORK ─ Promega on Wednesday said it has obtained CE marking for its SARS-CoV-2 antibody test, the Lumit Dx SARS-CoV-2 Immunoassay, and that the assay is available in Europe.
The immunoassay detects antibodies in serum against the receptor-binding domain antigen of the SARS-CoV-2 spike protein, Promega said, adding that it has designed the test to be reliable, simple, and scalable.
The assay uses the Promega NanoBit bioluminescence complementation technology to emit a measurable glowing signal when SARS-CoV-2 antibodies are present and provides results in less than one hour at room temperature. It consists of an add-incubate-read workflow with no wash steps and enables testing in large patient populations because it can be adapted for high-throughput testing on many automated platforms, the firm said.
The Madison, Wisconsin-based life science technologies firm said its Lumit Dx SARS-CoV-2 Immunoassay is available in the US under a policy that allows developers of serological tests to make their assay available while awaiting US Food and Drug Administration review for Emergency Use Authorization.