Clinical microbiology experts at the UNC Medical Center and UNC School of Medicine in Chapel Hill have developed a coronavirus disease 2019 diagnostic test based on the World Health Organization assay. It is now in use to conduct COVID-19 testing for UNC Health patients in accordance with the U.S. Food and Drug Administration guidance for individuals who meet criteria set by the Centers for Disease Control and Prevention.
The UNC Health test will initially be available only for inpatients at UNC Medical Center, UNC REX Hospital and UNC Health affiliate hospitals across North Carolina as well as a select number of UNC Health clinic locations. Use of this test by UNC Health entities will allow for more testing capacity at the state health department and LabCorp in North Carolina.
Melissa Miller, director of the Clinical Microbiology and Molecular Microbiology Labs at the UNC Medical Center explained, “Quickly creating and validating tests for emerging pathogens has always been part of my passion and commitment, ever since I was a fellow here during SARS. We have developed a high-quality test, we have the infrastructure to roll it out, and are ready to help the people of our state.”
Dr. Wesley Burks, UNC Health CEO and School of Medicine dean, echoed Miller’s comments.
“The ability to conduct in-house testing is a crucial step in our response to COVID-19,” Burks said. “Our ability to test patients and receive results in a matter of hours will help us to better understand the spread of the virus in our state and, most importantly, allow us to quickly move to treat positive patients and provide relief to patients who test negative. I would like to thank our US delegation who supported our efforts, especially Senator Tillis for his leadership on this critical issue and thank the many members of our UNC Health team who have worked tirelessly to develop this test and plan for its successful deployment.”
“I applaud UNC Health for once again showing that North Carolina is the tip of the spear when it comes to biomedical innovation, developing one of the fastest coronavirus test protocols while conserving reagent, which remains in critically short supply,” said U.S. Sen. Thom Tillis. “This is a major accomplishment for UNC, Dr. Miller, and the team, and a breakthrough that will help address the testing capability shortage in North Carolina. I applaud the FDA for considering our requests to expedite allowance to make innovative diagnostics available to the public without further delay.”