What we know (and don't) about coronavirus testing across North Carolina

Among the biggest questions of the novel coronavirus pandemic is how rapidly the federal government, state agencies and private labs have been able to roll out testing for the disease – and appropriately target their efforts to slow its spread.

The answers change from day to day, but here's what we now so far based on interviews, public statements and publicly posted information. We'll update this page with new details – as well as with new questions and answers – as we get them.

Hospitals are also getting the green light for internal tests so they don't have to rely on outside labs.

UNC Health, for example, received FDA approval to test its own hospital patients through its microbiology lab, but still needs to apply for official FDA approval through its emergency rules to allow for more widespread testing, a spokesperson said March 17.

The term "test kit" over the past week has been used somewhat interchangeably to refer both to the supplies needed to collect samples from patients – the throat or nasal swabs and the storage vial to keep them viable – and the diagnostic materials needed to test the samples.

Doctors offices, clinics and county health departments are collecting samples. Private labs like LabCorp and public ones like the N.C. State Laboratory of Public Health state lab are processing those specimens to actually diagnose coronavirus.

The contents of the test kits differ depending on the manufacturer, says Rachel Roper, associate professor at East Carolina University's Department of Microbiology and Immunology.

"The CDC really was sending out kits with a complete set of stuff," Roper said in a phone interview March 18. "But that isn't always how you have to do it."

Health directors in some counties said they're able to put together sampling kits using materials they have on hand, like those designed to test for the flu or whooping cough.

"They aren't the COVID-19 kits, but they are basically the same viral media," Craven County Health Department Director Scott Harrelson said in an email March 18. "So in a pinch we could just use that, box it up with ice packs and send it through the same channels."

Wake County is also looking at expanding test kits by creating their own or working with private labs, county spokesperson Kelly Owens said in an email March 18.

Samples are processed in lab facilities, like those operated by LabCorp or the N.C. State Laboratory of Public Health, to determine if they are positive for COVID-19.

But how fast labs can turn those tests around depends on the availability of technicians, equipment and the chemical compounds – called reagents – needed to process samples.

LabCorp says it can take three to four days from the pickup of a sample before it releases a test result.

At the state lab, meanwhile, State Health Director Betsey Tilson said March 18 that they've been able to process every sample they're getting within the same business day.

Roper said a shortage of reagents, rather than the materials needed to collect samples with nose or throat swabs, is one big concern.

"Doctors could take swabs before," Roper said in a phone interview March 18. "But if you can't get it tested, you're not going to do it."

On the collection side, clinicians taking samples also need to have enough personal protective gear – masks and suits – to prevent the potential spread of the virus to healthcare workers.

"If we can test as many people as possible, we have a better snapshot of where we're going and what we need to do," Cooper said at a news conference March 25. "But until this country can build up the supply chain for both personal protection equipment and testing that we need, we've got to concentrate it on the greatest need right now. the overall objective is to save lives."

As of its last update on March 25 at about 11 a.m., the N.C. Department of Health and Human Services reported that it had supplies to process samples for about 1,200 patients at the state lab.

That does not include any testing capacity in hospitals or commercial labs, like LabCorp.

In short, in North Carolina as of March 25, the priority is no longer on people most likely to be sick.

Guidelines from the Centers for Disease Control and Prevention issued March 24 largely focus testing on patients 65 and older, people with underlying health conditions, first responders and healthcare workers.

North Carolina – and county health departments – are following those guidelines.

People in low-risk groups with mild coronavirus symptoms – fever, cough and difficulty breathing – are no longer advised to seek testing. Instead, they should isolate at home for seven days and remain there three days after their symptoms clear up, according to the revised rules.

"A test will not change what someone with mild symptoms will do," Dr. Betsey Tilson, state health director, said in a news conference Tuesday. "The vast majority will recover at home."

Health providers – doctor's offices, clinics and hospitals – have more freedom.

N.C. DHHS guidelines to these providers say that testing "should not be done for asymptomatic persons." But the agency no longer require providers to get prior approval to test people.

Patients should test negative for flu first, the guidelines say, before getting a doctor to recommend a test for coronavirus.

"The patient should then be tested for COVID-19 by the healthcare provider at their facility," the March 16 guidance from Wake County says.

County health departments with clinicians on staff are collecting samples from patients that meet certain criteria – like close contact with positive coronavirus cases, symptoms of fever and respiratory distress and negative flu tests.

But for patients who make it through the screening questions, Wake county's public health lab takes a sample from each patient using the test kits on hand to send to the state lab for processing.

Some healthcare providers – clinics, doctor's offices and hospitals – can test patients if they have sample kits acquired from private labs like LabCorp.

At a news conference on March 17, N.C. DHHS Secretary Mandy Cohen said the agency was working with its healthcare partners to expand the number of sample collection sites.

"If someone is experiencing symptoms and they think they may be due to COVID-19 – meaning fever and cough – they should call their doctor. And if they don't have a doctor, they can call their local health department or their local community health center," Cohen said at the news conference. "If we see a need for more sample collection sites, we'll be working with our community partners to stand them up."

At another press conference March 19, Cohen said the state does have community based testing sites aimed at preventing people with mild symptoms from going to hospitals. She didn't elaborate on those sites, and we asked DHHS for clarification on the afternoon of March 19.

UNC Health announced it began using its own test on March 16 for in-house patients at UNC Medical Center, Rex Hospital and other affiliated hospitals and clinics.

Some providers have started up drive-up or drive-through testing of patients, although State Health Director Betsey Tilson said in a news conference March 18 that her agency didn't have a total number of such testing sites across the state.

At Preston Medical Associates in Cary, for example, a stop sign is on the front door of the small family practice. Anyone with fever, a cough or trouble breathing is asked to stay outside and call, and a nurse will likely bring the tests out to the parking lot.

Duke Health said it was launching "a limited pilot of a drive-up testing approach" on March 18 for a small group of patients referred by medical professionals. The testing is not open to the public.

Duke Health spokesperson Sarah Avery said in an email on March 25 that in-house testing at the hospital began earlier this week.

Although companies like LabCorp and Quest are manufacturing test kits and processing tests, they are not collecting samples at any of their facilities.

The State Laboratory of Public Health could process samples for around 150 patients a day as of March 16, according to N.C. DHHS spokesperson SarahLewis Peel.

"We anticipate this capacity to increase to approximately 200 patients per day by the end of this week," Peel said in an email at about 4 p.m. on March 16.

We reached out to DHHS on March 25 to confirm whether the lab has increased its capacity, but have not yet heard back.

Most private providers and even some county health departments are using LabCorp to process samples for testing out of the company's Burlington, N.C., facility.

In a statement on March 24, Quest Diagnostics said it had expanded testing capacity from 10,000 tests a day to 25,000 per day.

Between when they started conducting tests on March 9 and March 23, Quest said it had completed 106,000 COVID-19 tests. About 24,000 of those, a statement said, were performed and reported March 23.

For both private labs, those numbers reflect testing nationally, not just for North Carolina.

Given North Carolina's population, that would amount to about 100 tested patients per 100,000 residents.

On average, as of March 25, an average of about 1,200 North Carolina residents have been tested a day since the state started reporting total numbers.

It's not immediately clear whether that daily average will start to decrease as a result of March 24 CDC guidelines focusing testing on seniors, those with underlying conditions and healthcare workers.

For the state lab on its own, N.C. DHHS reported completing tests for 1,071 patients as of March 25 at about 11 a.m.

N.C. DHHS began releasing the number of tests completed by the state lab daily on March 13, updating the information every morning. In the last seven days, as of March 25, those figures show the state has tested an average of 92 patients a day – about two-thirds the capacity the agency said it had in its labs as of March 16.

State Health Director Betsey Tilson told reporters on March 18 that the agency currently had no backlog, she said.

"The good news is we have more capacity for testing," Tilson said at a news conference.

Nationwide, federal officials have acknowledged that testing in the U.S. ramped up far too slowly.

CDC test kits originally had technical issues, which delayed the arrival of the material labs needed to diagnose samples.

The availability of testing materials – both in the public labs and the private ones – has expanded since then. But the guidelines on who can be tested remains strict.

"We do believe that more people need to be tested," Janet Clayton, Person County health director and president of the N.C. Association of Local Health Directors, said in a phone interview March 18. "However, the priority still needs to be with the symptomatic individuals."

She noted that the CDC has expanded the test criteria since its original guidance, and health departments are working to meet those recommendations.

It's unclear when and if those guidelines will change further, although health providers will have more flexibility to order and administer tests as they stand up more sampling sites.

For now, though, the state health lab is adhering to CDC guidelines, even though it has the capacity to process more tests than they have at least through March 22.

"We are just one piece of the puzzle," State Health Director Betsey Tilson said of the public lab, which .

On March 18, the state started including the number private lab tests conducted, providing the best figures so far on how well health officials have been able to monitor for the disease.

Tilson noted in the March 18 news conference that not all providers are reporting, meaning the true number of patients tested may actually be higher.

And guidance from N.C. DHHS issued at least as early as March 13 says providers who test patients should alert the local health department by filling out a CDC form. But that's not a legal requirement, Tilson said.

In Wake County, for example, a statement on March 16 said the county "doesn't have access to the numbers of tests LabCorp is processing each day."

"The issue is all providers conducting COVID-19 testing are not filling out these PUI forms and submitting them to our Public Health Division as the guidance dictates, so the number of PUIs that we have is not a complete picture," Dara Demi, a spokesperson with Wake County, said in a 5 p.m. email on March 17.

A LabCorp spokesperson said in an email on March 17 she could not provide the number of tests performed.

We've also reached out to UNC Health to request figures on the number of patients tested.

Nationally, the Trump administration has pointed to total sampling numbers as evidence testing is ramping up.

At a press conference March 17, Admiral Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services said state labs across the country had conducted 31,800 tests. In private labs and clinics, that number was 27,000.

About one-third of those tests in private labs were completed just the day before.

That information can lag behind based on inconsistently reported information by state health departments, but it does provide at least some measure for state-by-state comparison.

By that count, North Carolina as of March 25 has the 15th highest number of tested patients in the U.S. Adjusted for population, North Carolina's testing ranks 29th out of 52 states, Puerto Rico and the District of Columbia.

Although "presumptively positive" cases originally needed to be sent to the Centers for Disease Control and Prevention for confirmation, ProPublica reported this week that the federal government no longer requires that step as of a rule change on March 15.

"Our state lab tests no longer need to be confirmed by CDC, so they are no longer presumptive positive, just positive," N.C. Department of Health and Human Services spokesperson SarahLewis Peel said March 18.