Researchers at UC San Diego are evaluating a new diagnostic testing system designed by an Orange County company that holds promise for identifying the novel coronavirus in as little as 45 minutes and typically within one hour.
Initial tests by Irvine-based Fluxergy using a synthetic COVID-19 virus suggest this system has the potential to dramatically reduce the time it takes to get results and deliver those results directly at the patient bedside. Such a test, if validated by physician-scientists at UCSD, would potentially eliminate the need to send patient samples to centralized labs, significantly speeding up the time it takes to get results.
"The best thing it could do is triage patients pretty quickly," said Dr. Davey Smith, UCSD professor of medicine and doctor leading the research team. "In someplace 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."
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Smith said that 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.
Last week, the UCSD research team began an initial evaluation of the Fluxergy system using actual virus samples from patients in San Diego. This evaluation is expected to be completed within one week, according to Smith, head of the UCSD Division of Infectious Diseases and Global Public Health. Smith is a member of the Fluxergy Medical Advisory Board. If the performance of the Fluxergy testing system is validated, the UCSD team plans to use the Fluxergy system to test for COVID-19 at patient bedsides at UCSD Medical Center in accordance with the Food and Drug Administration's guidance.
"We'll do some positive and negative samples, it's a very simple test to run," Smith said of his labs plans in the next week. "But it's looking promising."
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. Samples are placed directly on a disposable sample-to-answer Fluxergy test card, which uses printed circuit board technology and microfluidics to automate various sample processing steps.
"Our vision is to make it possible for clinicians to quickly perform sophisticated diagnostic tests and quickly get back results right at the patient's bedside or in accessible urgent care settings where this information is needed the most," said Fluxergy co-founder and President Tej Patel.
The Fluxergy system is currently available only for research purposes to develop new diagnostic products. The system has not yet been reviewed or approved by the FDA. However, if the researchers at UCSD obtain promising results using the system, they intend to begin immediate use of the system.
COVID-19 is the infectious disease caused by the novel coronavirus, which was first discovered in Wuhan, China in December 2019 and now has been declared by the World Health Organization to be a pandemic. In humans, coronaviruses are known to cause respiratory infections ranging from moderate to severe symptoms; over 181,000 people in 162 countries have already been diagnosed with COVID-19, and more than 7,000 deaths have been attributed to the highly contagious viral disease.
