UC San Diego researchers and Orange County-based medical diagnostic company Fluxergy have taken the next step toward getting a high-speed test for COVID-19 available for use, the company announced Monday.
Irvine-based Fluxergy submitted an emergency use authorization request to the U.S. Food and Drug Administration Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company's test system as a COVID-19 diagnostic at the point-of-care.
The Fluxergy Analyzer system, which uses microfluidics technology, has been shown by company and UCSD tests to identify the SARS-CoV-2 virus in under one hour with patient samples completed this past week.
The UCSD physician-scientist research team that conducted the validation, completed Friday, was led by Dr. Davey Smith, a professor of medicine and head of the UCSD Division of Infectious Diseases and Global Public Health. Smith is a member of the Fluxergy Medical Advisory Board.
"The best thing it could do is triage patients pretty quickly," Smith said. "In some place like a nursing home or hospital, if you see someone who may be transmitting the disease, do you have to quarantine all those people he interacted with? Maybe, but you can test that person and quickly know.''
Smith said UCSD can currently get test results back in around eight hours. San Diego County was taking a day or longer to get results and other labs sending to central labs could range from three days to two weeks.
Advanced rapid point-of-care tests for COVID-19 may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing.
Fluxergy's on-site sample- to-answer test for COVID-19 requires a very small sample, typically a nasal swab, which is mixed with a reagent solution, loaded onto a card and inserted into the analyzer in a two-step procedure.
"The worldwide shortage and inaccessibility of COVID-19 tests have been major impediments to containing the pandemic in the U.S. and globally," said Dr. Ali Tinazli, chief commercial officer at Fluxergy. "We are gratified to be progressing toward the next important milestone in the development of our point-of-care diagnostic technology.''
The Fluxergy Analyzer is about the size of a small desktop computer. The system does not require the virus RNA to be purified before the test can be performed.