A coronavirus test was developed and is being used in North Carolina
A new test for COVID-19, developed by scientists at UNC-Chapel Hill, is now being used for UNC Health patients after a wait for federal guidance.
North Carolina has more than four dozen cases of coronavirus, which causes COVID-19. The number of cases has risen sharply in recent days. The number of cases in North Carolina could reach 4,000 by early April, at least one epidemiologist said.
The lack of testing across the United States has been “a failing,” according to the nation’s top infectious disease official.
But the new test developed by UNC doesn’t rely on supplies from the Centers for Disease Control and Prevention. UNC began using the test Monday after getting updated guidance from the Food and Drug Administration.
“The benefit for our test is really our turnaround time,” said Melissa Miller, the director of the Clinical Microbiology and Molecular Microbiology Labs at UNC Medical Center. “We reserve the test for patients for whom that makes the biggest difference.”
The test, for now, is available for inpatient use at UNC Medical Center, UNC REX Hospital, UNC Health affiliate hospitals and some UNC Health clinics.
UNC Health is made up of 11 hospitals and hundreds of clinics across the state. The test was developed by clinical microbiology experts at UNC Medical Center and the UNC School of Medicine.
How does the test work?
The highly complex test starts with a swab from a patient at a health-care facility, which is then shipped to UNC’s lab.
The lab is able to run the test on several swabs at a time and the entire process takes less than 24 hours from the time the sample is collected, compared to a 3- or 4-day process at LabCorp, according to Miller.
The time frame is shorter when testing patients who are on site at UNC. The lab is doing the test for hospitals all over the state, prioritizing their inpatient and emergency departments.
The lab ran 48 tests on the first day and estimates it can do about 120 each day. It plans to ramp up those efforts soon to get to about 300 tests per day, but it’s waiting on additional equipment to arrive.
The UNC lab is required by the FDA to send its first five negative and first five positive tests to the state lab for confirmation. It doesn’t need to send them to the CDC. The results are considered “presumptive” until then.
Once those results prove the test is accurate enough, UNC can report its cases on its own.
UNC will report its positive cases to the state, as required, and those will be added to North Carolina’s overall count.
Most of the mobile respiratory diagnostic clinics set up across the state for UNC are still sending their specimens to LabCorp for testing.
“We’re chipping away at getting lab tests available but we’re nowhere near the capacity we need.”
More coronavirus testing is still needed
UNC began developing the test in February, but evolving rules from the FDA in the midst of the ongoing coronavirus outbreak caused some delays. Miller said a six-week process from development to use is very fast.
With UNC Health using its test, it should allow for more testing capacity in the state. The NC State Laboratory of Public Health has run more than 1,100 total tests — a sharp increase in recent days and a figure that does not include those run at university or commercial labs.
Miller commended the state public health lab on the number of tests it has done given the amount of supplies they’ve received.
“In a tough time like this we have to be partners,” Miller said. “Public health and private entities can work together.”
With this new testing capability, hospitals aren’t relying on the state lab or LabCorp for tests, which means patients are served more quickly. It also alleviates some of the pressure that’s been put on the state by reducing the number of tests going through that lab.
“When all the dust settles ... we have to figure out how this never happens again,” Miller said. “We need the testing capability earlier in a pandemic situation.”
The U.S. Department of Health and Human Services declared a public health emergency in late January. The World Health Organization declared COVID-19 a global pandemic on March 11, and President Donald Trump declared a national emergency on March 13.
Sen. Thom Tillis, a North Carolina Republican, wrote a letter to FDA Commissioner Stephen Hahn on March 12 touting the state’s “cutting edge medical institutions” and asking the FDA to “exercise maximum flexibility when considering innovative diagnostic solutions.”
“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,” Tillis said in a statement.
