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LumiraDx’s SARS-CoV-2 & Flu A/B Antigen Test receives CE marking

London, UK
Friday, December 24, 2021, 15:00 Hrs  [IST]

LumiraDx, a next-generation point of care diagnostics company, announced its SARS-CoV-2 & Flu A/B Antigen Test has achieved CE Marking.

The microfluidic immunofluorescence assay can quickly verify potential infection for patients suspected of influenza and/or Covid-19, helping to identify and differentiate the underlying cause of respiratory illness and to inform treatment decisions at the point of care. Existing respiratory tests on the LumiraDx Platform include the company’s SARS-CoV-2 Antigen, SARS-CoV-2 Antibody and SARS-CoV-2 Antigen Pool tests which achieved CE Marking in August 2020, September 2020 and March 2021, respectively.

For SARS-CoV-2, the test has a positive percent agreement of up to 95.5% and a negative percent agreement of up to 99.2% versus RT-PCR, based on clinical data collected 0-12 days since symptom onset. For Influenza, the test demonstrated a positive percent agreement of 83.3% (Flu A) and 80% (Flu B) and a negative percent agreement of 97.5% (Flu A) and 95.3% (Flu B) versus RT-PCR, based on retrospective samples collected during 2019-2020 influenza season. The company has initiated prospective clinical studies to determine clinical performance.

Shipments of the LumiraDx SARS-CoV-2 & Flu A/B Antigen Test will begin shortly. The test’s availability comes at a critical time as Europe has entered respiratory illness season, which typically runs November to April, while continuing to deal with increasing rates of Covid-19. The SARS-CoV-2 & Flu A/B Antigen Test helps distinguish between the viral respiratory infections SARS-CoV-2 and influenza while also differentiating between influenza A and influenza B. This is important as the presenting symptoms overlap and guidance of underlying infection is required in determining appropriate interventions and treatments. The detection of SARS-CoV-2, influenza A, and influenza B viral antigen is direct from nasal swab specimens collected from individuals suspected of viral infection consistent with Covid-19 or influenza-like illness by their healthcare provider.

Ron Zwanziger, LumiraDx’s chief executive officer explained, “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.”

“In Primary Care, the ability to make fast decisions when your patient is displaying respiratory symptoms will be a great tool. A single test at the point of need that allows us to identify and differentiate the underlying cause, whether it is Covid-19 or influenza, with accuracy – is just what we need,” stated Dr. Matthew Fay, clinical chief executive, Affinity Care and GP Principal, The Willows Medical Practice in the UK.

Last month, LumiraDx announced that based on detailed analysis of the specific mutations in the Omicron variant, it was confident that the performance of the company’s antigen and molecular tests would not be impacted by these mutations.


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