LumiraDx receives EUA for COVID-19 antibody test

Aug. 10, 2021

LumiraDx has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SARS-CoV-2 Ab test.

The test, which detects antibodies to SARS-CoV-2, is intended to be used to help identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The LumiraDx SARS-CoV-2 Ab test has been commercially available in Europe since achieving CE mark in September of 2020.

The test, which returns results in 11 minutes, utilizes a combination RBD and S1 spike SARS CoV-2 antigen for the detection of total antibody (Ab) elicited in response to SARS-CoV-2 infection.

In a study performed at the Frederick National Laboratory for Cancer Research (FNLCR), a center sponsored by the National Cancer Institute (NCI), the LumiraDx SARS-CoV-2 Ab test demonstrated 100% sensitivity and 100% specificity for detection of IgM and IgG antibodies against SARS-CoV-2 in serum and plasma samples.

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