Coronavirus testing is key to reopening NC. Here’s what we know about testing
For several months, since the coronavirus outbreak began impacting every aspect of daily life for millions of North Carolinians, the availability, reliability and capacity of testing has been a top issue for local, state and federal officials.
North Carolina Gov. Roy Cooper created a Testing Surge Workgroup, his Department of Health and Human Services released statistics and guidelines on testing and he made testing data vital to the state reopening plans.
Questions about testing — because of its central role in everything from the virus’ spread to its containment to peace of mind for individuals who suspect they might have COVID-19 — have been among the top concerns for readers.
State epidemiologist Zack Moore and state laboratory director Scott Shone answered questions about coronavirus testing in a lengthy interview session with reporters and editors from The News & Observer on April 30.
Cooper announced on May 5 that the state would move to Phase 1 of its gradual reopening on May 8, citing, in part, progress on testing. The amount of testing, the number of positive tests and the percentage of positive tests will remain key benchmarks for state officials moving forward to additional phases. Add in the possibility of additional waves of infections from the virus, and testing will remain a key part of the state’s response for quite a while.
“We do not see this as a short-term effort,” Shone said. “We’re ramping up with the expectation that we will want people to be able to continue to have access to testing across the state for months or potentially beyond.”
The answers below reflect our interview with Moore and Shone as well as other reporting.
The answers deal with diagnostic testing — testing to see if someone is currently infected with the coronavirus — and not antibody testing, which detects if someone may have had COVID-19 in the past. Many companies and universities are working on developing antibody tests. More than 200 are now on the market, but the FDA has given Emergency Use Authorizations to just 12, CBS News reported.
If you have additional questions about testing, let us know.
Q: Why 5,000 to 7,000 tests per day?
A: As part of their benchmarks for reopening, Cooper and NC DHHS Secretary Mandy Cohen want the state to complete 5,000 to 7,000 coronavirus tests per day. North Carolina has about 10.5 million people.
“That number is an assessment based on ramp-up capacity, the supply chain, as well as where we feel we need be to get an accurate assessment,” Shone said.
North Carolina had completed more than 151,000 tests as of May 5. It averaged 4,765 tests per day over the previous seven days.
“From the beginning of the pandemic there’s been well-documented supply chain issues, and we feel comfortable that the current supply chain ... can sustain that volume,” Shone said.
But it’s not just tests. It’s the ability of local health departments to follow up with those who test positive.
“It’s testing in combination with what we do with the results and the ability to go out and do the contract tracing,” Moore said. “And once you find the contacts to have interventions with them that are going to be effective at slowing the spread.”
Laboratories across the state are processing tests.
“The capacity of the clinical labs in the state is quite substantial,” Shone said, indicating it is far above the the 5,000 to 7,000 goal.
The state has a 12-person Testing Surge Workgroup that includes executives from LabCorp and Quest Diagnostics, doctors from Duke and UNC-Chapel Hill as well as private practice, and several public health officials.
That group is tasked with identifying the capacity of labs across the state and working out logistics to maximize the use of that capacity.
Q: Who should get tested?
North Carolina changed its guidelines on April 20 to indicate that doctors could test patients with mild symptoms.
The guidance from Moore and Shone to all North Carolina clinicians and laboratories said “clinicians can consider testing for any patient in whom COVID-19 is suspected,” a change from previous March 29 guidance.
Further, the April 20 guidance said clinicians can submit samples to the state lab for any persons with COVID-19 symptoms who fit in one of the following categories:
• Hospitalized patients
• Health care workers or first responders
• Patients who live in or have regular contact with a high-risk setting (including long-term care facilities, homeless shelters, correctional facilities or migrant farmworker camps)
• Persons who are at a higher risk of severe illness
• Post-mortem specimens from patients in whom COVID-19 was suspected but not confirmed prior to death
Q: How many different tests are being used in the state? And how reliable are they?
There is currently no Food and Drug Administration-approved test for COVID-19, according to the agency. But the FDA has issued many Emergency Use Authorizations to get testing into the market and labs. The FDA does not check the accuracy of a test prior to issuing an EUA; it relies on information from each test’s developer.
“I think that the vast majority of tests that are performed by our clinical labs are of high quality when it comes to the diagnostic testing,” Shone said.
North Carolina does not have the regulatory authority or the capability of validating tests.
The FDA has approved a host of EUAs relate to coronavirus testing:
• For lab tests: At least 127 laboratories have notified the FDA that they have validated their own diagnostic test. The FDA has authorized at least 12 of them, including the University of North Carolina Medical Center McLendon Clinical Laboratories in Chapel Hill. It authorized UNC’s test on April 10.
• For test kit manufacturers: The FDA has given EUAs to at least 60 test kit manufacturers and commercial laboratories, including LabCorp, which is headquartered in Burlington.
• For commercial manufacturers: At least 13 commercial manufacturers have notified the FDA that they have validated and intend to distribute diagnostic test kits.
Q: Is there a backlog of collected samples waiting to be tested? How quickly can patients expect to get results?
State officials said there is no backlog of samples waiting to be tested. Most labs in North Carolina are reporting a 24-to-48 hour turnaround time for results with the majority being closer to 24 hours.
Q: What happens after my sample is collected?
It varies depending on where the sample was collected and what lab it is being sent to, but generally here is what happens.
The sample is put into a “transport media” that helps preserve the virus so the sample is still of high quality when it gets to the lab. The sample is transported by ground or by air to the lab.
COVID-19 is a reportable communicable disease, meaning the laboratories are required to immediately report positive results to the physician who submitted the sample and to notify the state. The state then contacts local health departments so they can begin their investigation and contact tracing.
North Carolina mandated on Feb. 3 that physicians and laboratories in the state were required to immediately report suspected or confirmed cases of coronavirus to the state or local health department. As of March 23, all COVID-19-associated deaths must be reported within 24 hours.
Most of those results are delivered electronically to the state’s communicable disease system. Some labs, however, report their results via fax machine or as a password-protected email. Those results must be hand-entered into the state’s electronic system.
Q: The state reports new data each morning by 11 a.m. How current are those results?
Those numbers are pulled every morning and publicly available.
The data, however, is constantly changing. Cases are attributed to counties based on the residence of the patient. Sometimes that information will need to be updated; a case that was originally attributed to Alamance County, for example, may be reclassified as a Guilford County case.
Local health departments often release their numbers later in the evening, leading to some discrepancies between the state’s numbers and those from the counties.
Q: Why are some cases missing demographic data such as race, ethnicity, age or gender?
Thousands of cases do not have race or ethnicity data associated with them, according to the state’s database.
Sometimes that information is included with the sample sent to laboratories, and if it is, then it is also forwarded to the state. But if it is not, then it is the responsibility of local health departments to gather that information from the patient or family members.
“There is, of course, time required for the investigator to reach that person and start gathering that information either from getting a medical record or making a phone call to a person or family member, to knocking on a door. Whatever is required,” Shone said. “There is a lot of gathering specific information about each of those cases that still takes time. That’s why you see a lot of data are missing when you look at race and ethnicity.
“There’s a lot missing because a lot of those cases are still open, still being investigated, and that process still requires workforce out there in our local health departments tracking down all those details.”
North Carolina has 250 people working as contact tracers across the state. It wants to hire 250 more people to help with COVID-19. The state, through a collaborative, has received more than 4,000 applications.
Q: If I have tested positive for COVID-19, how many of my contacts will be queried?
It is based on the type of contact that you had. Anyone in your household will be contacted. For others, contact is defined as being within six feet for more than 10 minutes.
Those in congregate care facilities, such as nursing homes or prisons, are handled differently.
The state’s guidance to congregate living facilities is if they identify a case to test all residents and staff. The state recommends “cohorting,” which is separating residents and staff by COVID status to prevent mixing.
Q: Are North Carolina’s numbers skewed by testing in congregate living facilities?
More people who live or work in congregate care facilities have died from COVID-19 in North Carolina than those who do not, according to May 5 data from the state.
At least 263 people from congregate living facilities — nursing homes, residential care facilities and prisons — have died compared to 150 in the general population.
“That’s a really important thing for us to be tracking,” Shone said.
More testing is being done in those facilities than in the community so “they are probably over-represented in our data,” Shone said.
Q: Will there be at-home testing soon?
LapCorp has received an Emergency Use Authorization for an at-home diagnostic test called Pixel. The sample is collected at home, then sent to LabCorp for testing.
It is the first at-home sample collection test authorized by the FDA.
But it is currently limited to health-care workers and first responders.
“I don’t see that that limitation is going to change anytime soon, and I would only assume other commercial parties will look to bring on similar products,” Shone said.
Testing at home does not expose health-care workers to exposure and it helps conserve personal protective equipment (PPE).
Q: Does your immigration status matter when it comes to testing?
No. “Our reporting is unrelated to residency or nationality. It is related to address. If you’re actually living in North Carolina, regardless of visa status or anything else, you’re a North Carolina resident for the purposes of our surveillance,” Shone said.
News & Observer reporters David Raynor, Richard Stradling and Zachery Eanes contributed to this story.
For more North Carolina government and politics news, listen to the Domecast politics podcast from The News & Observer and the NC Insider. You can find it on Megaphone, Apple Podcasts, iHeartRadio, Stitcher or wherever you get your podcasts.
This story was originally published May 7, 2020 at 11:51 AM.
