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May 20, 2022

LumiraDx obtains CE mark for SARS-CoV-2 Ag Ultra Test

The SARS-CoV-2 Ag Ultra Test can deliver results in five minutes, allowing clinicians to begin treatments faster.

Point of care diagnostics company LumiraDx has announced that it has secured CE marking for its SARS-CoV-2 Ag Ultra Test.

Based on the company’s microfluidic immunofluorescence technology, the test is said to deliver digital and connected results in five minutes.

This helps users to complete up to 80 SARS-CoV-2 Antigen tests in an eight-hour day, facilitating diagnosis and subsequent treatment of patients.

The SARS-CoV-2 Ag Ultra Test can be stored at room temperatures and is available on the same point of care (POC) Platform as LumiraDx’s high sensitivity SARS-CoV-2 Antigen, SARS-CoV-2 Antibody, Flu A/B and SARS-CoV-2 Antigen Pool tests.

LumiraDx CEO Ron Zwanziger said: “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 throughput, 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.”

In clinical studies, the LumiraDx SARS-CoV-2 Ag Ultra Test had 92.7% positive agreement against RT-PCR in samples collected from symptomatic individuals. The results are based on clinical data procured up to and including 12 days since the onset of first symptoms.

The test also demonstrated 95.7% positive agreement versus RT-PCR in test samples collected from asymptomatic individuals.

Based in the UK, LumiraDx focuses on commercialising a diagnostic platform that supports an array of tests.

In January, the company announced that its LumiraDx SARS-CoV-2 Antigen test can identify the Omicron variant.

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