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LumiraDx's COVID-19 antigen test detects Omicron variant

Christian Fernsby |
LumiraDx announced that results from ongoing testing and monitoring of COVID-19 variants show its SARS-CoV-2 Antigen test detects the Omicron Variant.

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Topics: LUMIRADX   

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 (“EUA”) 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.

The LumiraDx SARS-CoV-2 Antigen test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

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