Medical company Fluxergy LLC revealed on Monday that it is seeking Fluxergy LLC Emergency Use Authorization (EUA) approval under the US Food and Drug Administration (FDA) Center For Devices and Radiological Health for use of its one-hour COVID-19 test at POC.

This authorisation would permit medical professionals to begin using the company's high-speed Research Use Only (RUO) test system as a COVID-19 diagnostic at the point-of-care (POC). The Fluxergy Analyzer and the single-use consumable Fluxergy Cards are designed to be very cost-effective and scalable, using proprietary printed circuit board (PCB) manufacturing and microfluidics technologies.

According to the company, its Fluxergy Analyzer system has accurately identified the SARS-CoV-2 virus in under one hour in bench lab tests and in follow-up validation tests at University of California San Diego. The validation was led by Dr Davey Smith, professor of Medicine and head of the UCSD Division of Infectious Diseases and Global Public Health and member of Fluxergy Medical Advisory board.

Advanced rapid point-of-care PCR tests for COVID-19, including the company's Fluxergy Analyzer system, may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing.

The company's on-site sample-to-answer test for COVID-19 requires a very small sample, typically a nasal swab. This swab is mixed with a reagent solution, loaded onto the Fluxergy card and inserted into the Fluxergy Analyzer in a convenient two-step procedure.