Engineering 101

Bluetooth Solution FDA-authorized COVID-19 Home Test   

Nordic Semiconductor has announced that Ellume Health, a Valencia, CA and Brisbane, Australia-based digital diagnostic company, has selected Nordic’s nRF52810 Bluetooth LE System-on-Chip (SoC) for the ‘Ellume COVID-19 Home Test’.

The COVID-19 Home Test has been shown to be a safe and simple-to-use self-test that enables individuals to check for an active COVID-19 infection in 15 minutes or less. The antigen test has demonstrated 96 percent accuracy compared to an Emergency Use Authorization (EUA) molecular test in an independently-run, US clinical study in five states.

Ellume has received an EUA from the U.S. Food and Drug Administration (FDA) for their COVID-19 Home Test. The test will be available over-the-counter for symptomatic and asymptomatic detection of SARS-CoV-2. (SARS-CoV-2 is the coronavirus that causes COVID-19).

The test uses ultra-sensitive optics, electronics and proprietary software to analyze a nasal swab with the results automatically transmitted to the user’s smartphone via Nordic-powered Bluetooth connectivity. From the associated smartphone app, the results can be transmitted through a secure cloud connection for sharing with healthcare professionals and others.

In addition to the wireless connectivity, Nordic’s nRF52810 SoC—an ARM Cortex M4 processor-based Bluetooth LE chip manufactured by Taiwan Semiconductor Manufacturing Company (TSMC) using an advanced 55-nanometer wafer fabrication process—powers the home test’s diagnostic software. The ultra low power SoC also extends the battery-powered home test’s shelf life and ensures instant operation when the test is needed.

The test will help reduce the impact of the pandemic by providing a readily available and simple-to-use method to acquire the information needed to reduce risk of transmission. Users will be able to safely recommence group activities at work, school, on the sports field or in the church. Further, real-time reporting of test results to health authorities, employers and educators will enable efficient COVID-19 mapping and rapid reaction to outbreaks.

Ellume has expanded its Australian manufacturing facility and is rapidly expanding its manufacturing efforts and supply chain in the U.S. with the aid of a US$30million award from the U.S. National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative. The company plans to ship over 100,000 tests per day from January 2021 and plans to deliver 20 million Ellume COVID-19 Home Tests to the US within the first half of 2021.

“The Ellume COVID-19 Home Test is the perfect example of how advanced digital diagnostics and IoT connectivity can help address the worst impacts of the SARS-CoV-2 pandemic,” said Geir Langeland, Director of Sales and Marketing with Nordic Semiconductor. “Using the results of this test, we can all enjoy the benefits of group social activity safe in the knowledge that we present no risk to the vulnerable. That’s a huge step towards a return to normality.”

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