LumiraDx SARS-CoV-2 Ab Test Receives FDA EUA, Allowing COVID-19 Antigen and Antibody Testing on Single POC Platform

LumiraDx (London, UK) 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 test has been commercially available in Europe since achieving CE mark in September of 2020. 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 test demonstrated 100% positive and negative agreement in samples collected from 8 days post RT-PCR test. In an independent study, 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.

"We know providing results at the point of care can make an incredible impact on the control of this virus and health of our communities," said Ron Zwanziger, LumiraDx CEO. "We have seen this impact firsthand with our SARS-CoV-2 Antigen test which received an EUA last year. Now, with the addition of our Antibody test on the LumiraDx point of care Platform, we believe we can make it even easier for healthcare providers to provide the best in COVID testing to their patients by providing fast and trusted results to support treatment decisions."

"The LumiraDx SARS-CoV-2 Ab test delivers rapid, lab-comparable performance at the clinical point of care," added Dr. Paul Drain, Associate Professor of Global Health, Medicine (Infectious Diseases), and Epidemiology at the University of Washington. "In the current stage of the global pandemic, when nations are dealing with varying rates of infection, vaccination and risk of variant spread, we need many more testing and surveillance options. Antibody testing builds on current diagnostic testing programs to create solutions for surveillance of COVID-19 infection and seropositivity at an individual as well as a population level."