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LumiraDx Gets CE Mark for POC, Pooled Sample SARS-CoV-2 Antigen Test

NEW YORK — LumiraDx said on Thursday that it has received CE marking for its SARS-CoV-2 Ag Pool Test.

The point-of-care, microfluidic, immunofluorescence assay is designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal or nasopharyngeal swab specimens pooled from up to five symptomatic or asymptomatic individuals. It runs on the portable LumiraDx platform and provides results within 12 minutes.

LumiraDx said that the test has been used by pilot customers in Italy and Germany to manage entry to sporting events, museums, and festivals. It is now commercially available across Europe.

"The ability to test five individuals simultaneously makes the SARS-CoV-2 Ag Pool Test an efficient, accurate and economical way to implement a high-quality and thorough screening program," David Walton, LumiraDx's chief commercial officer, said in a statement.

Late last year, Waltham, Massachusetts-based LumiraDx received Emergency Use Authorization from the US Food and Drug Administration for a PCR-based SARS-CoV-2 test that does not require nucleic acid extraction or purification.