LumiraDx’s new test achieves CE Marking

A next-generation point of care diagnostics company, LumiraDx, has announced that it has achieved CE marking for its SARS-CoV-2 & Flu A/B Antigen Test which is a microfluidic immunofluorescence assay.  The test is used primarily to test patients with suspected influenza or COVID-19 infection and then differentiate the underlying cause for respiratory distress allowing for a specific treatment plan.

Some of the other respiratory tests by the LumiraDx platforms are SARS-CoV-2 Antigen, SARS-CoV-2 Antibody, and SARS-CoV-2 Antigen Pool tests that have already achieved their CE marking too.

The test has a positive percent agreement of 95.5% whilst having a negative percent agreement of 99.2% for SARS-CoV-2 when compared to the RT-PCR. On the other hand, for influenza, the test has a positive percent agreement of 83.3% for FluA and 80% for FluB whilst having a negative percent agreement of 97.5% for FluA and 95.3% for FluB, again, when compared to RT-PCR.

The shipment for these tests will begin shortly. This comes at a timely need as Europe has now entered the respiratory illness season which usually lasts from November to April. On top of that, the increasing cases of SARS-CoV-2 are a huge concern as well. The test is important as it helps distinguish the type of respiratory function affecting the person. It helps differentiate between SARS-CoV-2 and influenza, while also distinguishing influenza A and influenza B. This is very important as many of the symptoms observed in either of the cases are similar and the correct knowledge of the underlying infection is required for the correct treatment of the patient. The samples are collected via a nasal swab from suspected patients by their healthcare providers and then tested.

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.

LumiraDx has also stated after performing a detailed analysis of mutations in the Omicron Variant, that its test won’t be affected by the mutations.



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