LumiraDx has obtained CE Marking for its point-of-care assay, SARS-CoV-2 & Flu A/B Antigen Test.
The microfluidic immunofluorescence assay is designed for the detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral antigen simultaneously.
It uses nasal swab samples and provides results within 12 minutes.
Based on clinical data, the new LumiraDx SARS-CoV-2 & Flu A/B Antigen Test has up to 95.5% of positive and 99.2% of negative percent agreement for Covid-19, compared to the RT-PCR.
It showed 83.3% (Flu A), and 80% (Flu B) of positive and 97.5% (Flu A), and 95.3% (Flu B) of negative percent agreement for Influenza.
The company intends to commence the shipment of its Covid-19 & Flu A/B Rapid Antigen Test in the coming days.
LumiraDx CEO Ron Zwanziger said: “Our SARS-CoV-2 & Flu A/B Test builds upon the same microfluidic technology used with our highly sensitive SARS-CoV-2 Ag test which has demonstrated market-leading clinical performance.
“This season, we are not only experiencing increased rates of Covid-19 with the Omicron variant, but also beginning to see influenza activity throughout the European Region for the first time since the pandemic began.
“Rapid identification of the underlying cause of respiratory illness is important in guiding appropriate clinical decisions, helping to improve patient outcomes and patient workflows.”
The company stated that the new LumiraDx SARS-CoV-2 & Flu A/B Antigen Test runs on the LumiraDx platform.
The existing respiratory tests that run on the platform include the SARS-CoV-2 Antigen, and SARS-CoV-2 Antibody tests which received CE Marking in August and September last year, respectively.
The company’s SARS-CoV-2 Antigen Pool test also runs on the same platform and obtained CE Marking in March this year.
Recently, LumiraDx’s business unit LumiraDx Fast Lab Solutions collaborated with digital health non-profit Audere to improve access to Covid-19 tests.