LumiraDx Five-Minute SARS-CoV-2 Ag Ultra Test Achieves CE Marking

Advancements made with the Ultra test strip design reflect the company’s continued innovation of its microfluidic immunofluorescence technology, allowing for higher sample volumes to enter the test strip chambers to increase detection levels, achieve faster reaction times and even greater precision. This new technology is run on the existing LumiraDx Platform and can be applied to future Platform tests.

The LumiraDx SARS-CoV-2 Ag Ultra Test matches the same high-performance of the LumiraDx SARS-CoV-2 Ag 12 min test. The test has a positive percent agreement of 92.7% and a negative percent agreement of 100% versus RT-PCR in symptomatic individuals, based on clinical data collected 0-12 days since symptom onset. Within this cohort, The LumiraDx SARS-CoV-2 Ag Ultra test showed high sensitivity of 97.4% up to a CT of 35 indicating high coverage of potentially infectious individuals.

In addition, the LumiraDx SARS-CoV-2 Ag Ultra Test demonstrated 95.7% positive agreement versus RT-PCR in samples collected from asymptomatic individuals. With the Omicron variant showing a much higher rate of asymptomatic carriage compared to other variants, the high sensitivity of the LumiraDx SARS-CoV-2 Ag Ultra Test can be an important tool in breaking the chain of transmission.¹

Ron Zwanziger, LumiraDx’s Chief Executive Officer explained, “Our SARS-CoV-2 Ag Ultra Test exemplifies our mission to increase access to testing and provide rapid diagnostics without sacrificing accuracy. Now, clinicians, pharmacies and other providers can use a single platform and significantly increase throughout, making a profound impact on patient workflow supported by our Platform. This innovation and advancement of our Microfluidic technology can also be applied to other tests on our Platform which we look forward to rolling out in the coming year.”

Professor Jean-Paul Cristol,  Head of the Division of Biology Pathology at Montpellier University Hospital Center commented, “The LumiraDx SARS-CoV-2 Ag Test has been integrated in testing strategy in our institution’s adult, pediatric, obstetric and neurology emergency departments since this January. The clinical accuracy allows us to detect symptomatic and non-symptomatic patients and the traceability of the results is ensured by the connection to our middleware. In the emergency department, time is everything and being able to provide these results in a shortened time can be critical. A high-sensitivity, good traceability, and faster test will be an optimal option to screen patients in emergency departments.”

The SARS-CoV-2 Ag Ultra test follows the successful launch of LumiraDx’s SARS-CoV-2 Antigen test which has been commercially available for nearly two years.