LumiraDx Limited a next-generation point of care diagnostics company, announced today that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing (EUL) by the World Health Organization (WHO) in their latest response effort to combat COVID-19.
The LumiraDx antigen test is a microfluidic immunofluorescence assay that delivers results for the direct and qualitative detection of nucleocapsid protein antigen in nasal swab specimens collected from the patient. Used with the LumiraDx multi-assay Platform, the test delivers rapid results at the point of care enabling physicians to immediately commence appropriate treatment and patient management to maximize health outcomes and minimize further spread of infection.
“The ongoing complexities of the evolving pandemic require multiple lines of defense,” said Dr Nigel Lindner, Chief innovation Officer. “This important milestone lets us offer a reliable and affordable, high-performance testing alternative to better manage the pandemic burden and help reduce the strain on health systems worldwide.”
Through a partnership with the Bill and Melinda Gates Foundation, LumiraDx has already distributed 5,000 Platforms in 49 African countries in a variety of care settings, including field clinics, airports, primary healthcare facilities, occupational health settings, and walk-through clinics. In addition to its SARS-CoV-2 Ag test, other assays in LumiraDx’s pipeline for TB, diabetes, HIV-AIDS and other health conditions have the potential to make a meaningful impact on global health.
The decision by the WHO to include the LumiraDx SARS-CoV-2 antigen test in its EUL was based on an essential set of available quality, safety, and efficacy and performance data. In clinical studies the test demonstrated 95% positive agreement versus RT-PCR in patients tested within 12 days of the onset of symptoms. The LumiraDx antigen test joins a select group of antigen tests the WHO has included in its Emergency Use Listing and represents the first microfluidic assay to meet the criteria.