LumiraDx, a next-generation point of care diagnostics testing company announced it has received FDA Emergency Use Authorization (EUA) 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 is run on LumiraDx’s high sensitivity Platform with results available in 11 minutes, the test combines accuracy and speed at the point of care.
In clinical studies, the LumiraDx SARS-CoV-2 Ab test demonstrated 100% positive and negative agreement in samples collected from 8 days post RT-PCR test.
In an independent 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.
New uses for the antibody test are arising as different ways emerge in how the virus is spreading and being treated. LumiraDx has on-going research programs contributing to the understanding of antibody testing in serosurveillance and vaccination programs.
With its new manufacturing facility in Glasgow, LumiraDx has increased production capacity to 28 million total tests per month. With this, the company is able to provide sufficient capacity to meet current and growing demand for its portfolio of tests.
The LumiraDx SARS-CoV-2 Ag test has been authorized by FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid protein. The LumiraDx SARS-CoV-2 Ab test has been authorized by FDA under an EUA only for detecting the presence of total antibodies to SARS-CoV-2. They have not been authorized for use to detect any other viruses or pathogens.