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Portable, Handheld COVID-19 Test Produces Laboratory-Quality Results within 15 Minutes in Any Setting

By LabMedica International staff writers
Posted on 12 Feb 2021
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Image: Nanomix eLab analyzer (Photo courtesy of Nanomix, Inc.)
Image: Nanomix eLab analyzer (Photo courtesy of Nanomix, Inc.)
A portable, handheld test produces laboratory-quality results in 15 minutes in any setting to increase access and availability of COVID-19 testing.

Nanomix, Inc. (Emeryville, CA, USA) has submitted an Emergency Use Authorization request to the US Food and Drug Administration (FDA) for the eLab COVID-19 rapid antigen test. The assay runs on the portable Nanomix eLab analyzer, which provides results in just 15 minutes and can be used in a wide range of settings, including hospitals, nursing homes, assisted living facilities, urgent care centers, and emergency medical care. The fully automated point-of-care Nanomix eLab platform consists of a handheld reader and an integrated, self-contained assay cartridge with a proprietary biosensor. The system weighs two pounds, and is about the size of a brick.

The device is simple to operate via an intuitive user interface on a color touch screen. All test functions are controlled and automatically processed by the device. Results are available on the screen, via Bluetooth, or a connected printer. The robust design supports the system’s use in almost any setting, inside or outside of the traditional laboratory environment. The Nanomix eLab platform uses a proprietary nano-biosensor formatted into a disposable microfluidics test cartridge for high-quality, reliable performance.

The Nanomix eLab platform and COVID-19 rapid antigen test will enable medical professionals, emergency workers, and employers to test individuals for antigens that indicate COVID-19 infection. The assay uses a nasal swab sample that can be self-administered, and is designed to complement existing test methods by expanding access to rapid, laboratory-quality results outside of hospital facilities.

“While the global healthcare community has made tremendous progress in COVID-19 testing, there is still significant need for rapid, accurate, and affordable testing that can be conducted outside of laboratory settings,” said David Ludvigson, president and CEO of Nanomix. “By completing this EUA filing, we are one step closer to making our antigen test available to help address this remaining gap.”

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