LumiraDx Five-Minute SARS-CoV-2 Ag Ultra Test Aids Fast Clinical Decision-Making at POC

A new COVID-19 antigen test delivers results in just five minutes from sample application and aids in fast clinical decision-making at point of care (POC), helping to inform treatment decisions and prevent the further spread of infection, while also increasing testing throughput.

The SARS-CoV-2 Ag Ultra Test from LumiraDx (London, UK) provides digital and connected results in just five minutes with high sensitivity, making it one of the fastest and most sensitive COVID-19 antigen tests available. The reduced time allows clinicians to treat patients much faster, and increases throughput on the LumiraDx Platform, now enabling users to complete up to 80 SARS-CoV-2 Antigen tests per eight-hour day, or up to 10 per hour, on a single LumiraDx instrument.

The LumiraDx SARS-CoV-2 Ag Ultra Test matches the same high-performance of the LumiraDx SARS-CoV-2 Ag 12 minute 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.

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 has received the CE mark.

"Our SARS-CoV-2 Ag Ultra Test exemplifies our mission to increase access to testing and provide rapid diagnostics without sacrificing accuracy," said Ron Zwanziger, LumiraDx's Chief Executive Officer. "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."

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