Point-of-care diagnostics company LumiraDx says its SARS-CoV-2 Antigen test detects the Omicron variant.
In-house wet testing with live Omicron virus demonstrated that the LumiraDx SARS-CoV-2 Antigen test detects the Omicron variant with comparable sensitivity to other variants. In the original U.S. Food and Drug Administration (FDA) Emergency Use Authorization clinical studies, the test demonstrated 100% agreement with RT-PCR up to Ct 33.0.
These latest testing results confirm the company’s previous announcement based on in-silico and recombinant protein analysis of the specific mutations in the Omicron variant that it was confident that the performance of its antigen and molecular tests will not be impacted by these mutations.
“Testing is a critical tool to control the spread of the virus and we have been committed to conducting research that confirms the sensitivity of our tests as soon as new variants emerge,” says Nigel Lindner, PhD, chief innovation officer, LumiraDx. “We continuously monitor for COVID-19 variants and evaluate new ones as they appear through our in-house testing as well as through our collaborations with laboratory partners globally. The ability of our test to detect Omicron and other variants of concern, combined with both CE Marking and EUA from FDA with the intended use that includes the screening of asymptomatic individuals makes the LumiraDx SARS-CoV-2 Antigen test a valuable tool at this stage of the pandemic.”