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.
