UK-based point of care diagnostics company LumiraDx has obtained a CE mark for its SARS-CoV-2 Ag Ultra Test, which provides the digital results within five minutes.

The test runs on the multi-assay LumiraDx Platform and leverages an advanced test strip, designed based on the company’s microfluidic immunofluorescence technology.

LumiraDx said that its other tests, including SARS-CoV-2 Antigen, Flu A/B, SARS-CoV-2 Antibody, SARS-CoV-2 Antigen Pool as well as INR, D-dimer and CRP tests run on the same platform.

The microfluidic immunofluorescence technology enables the strip to retain higher sample volumes in its chambers to achieve enhanced detection and faster reaction times without compromising on sensitivity.

By providing the test results within five minutes, the test is said to reduce the clinical decision-making time at the point of care (POC) and prevent the further spread of infection.

Also, it enhances throughput on the LumiraDx Platform, enabling up to 80 SARS-CoV-2 Antigen tests per eight-hour day, or up to 10 per hour, on a single device, said the company.

LumiraDx chief executive officer 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 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.”

According to the LumiraDx, its new SARS-CoV-2 Ag Ultra test provides comparable performance to its previous SARS-CoV-2 Ag 12 min test.

Based on clinical data collected in symptomatic individuals, the test provides a 92.7% positive agreement and a 100% negative agreement compared to the RT-PCR test.

The LumiraDx SARS-CoV-2 Ag Ultra test demonstrated a sensitivity of 97.4% up to a CT of 35, indicating high coverage of potentially infectious individuals.

Also, the test showed a 95.7% positive agreement compared to the RT-PCR in samples collected from asymptomatic individuals.