NC is set to receive 3.1 million COVID-19 ‘rapid tests.’ Will you be able to take one?
North Carolina plans to send most of the 3.1 million COVID-19 “rapid tests” it has been told to expect from the federal government by the end of the year to local health departments.
The rapid “antigen tests” are different from most of the COVID-19 tests that have been conducted in North Carolina so far. Antigen tests look for a COVID-related protein on the surface of the virus cells. “Molecular tests,” which North Carolina has been relying on, looks for the presence of the virus itself.
Antigen tests are faster than molecular tests sent to a lab — they can produce results in minutes instead of days — but molecular tests are more accurate.
“The challenge with the antigen test is really how well they work. They’re not as sensitive as our (molecular) tests, which means you’re going to have false negative results,” Melissa Miller, the director of the University of North Carolina’s clinical molecular biology laboratory, said in an interview with The News & Observer. False negatives tell people that they are not carrying the virus when in fact they are.
The tests the federal government is distributing come from the Abbott drug company and are called BinaxNOW. DHSS will send out shipments weekly with local health departments in counties with more than 10 cases per 100,000 people or test positivity rates of at least 5% receiving tests.
The N.C. Department of Health and Human Services is telling local health departments that the BinaxNOW test is most accurate when used on people who are already showing symptoms, a stance backed by the Food and Drug Administration’s emergency use authorization of the test. The FDA says the test is most effective when it is used on people who started showing symptoms five to seven days earlier, a period when the virus levels are expected to be at their highest.
But state and federal health officials as well as outside experts all say that the test can and likely will be used to screen people who are not showing symptoms but are likely to have been exposed to the virus.
That is not ideal, Miller said, but may be necessary to ramp up testing among COVID-19 clusters and in schools.
“It’s an imperfect test, but we are in an imperfect situation,” Miller said. “It helps to fill some of the gaps left by (molecular) testing.”
DHHS told local health departments that BinaxNOW can be used on clusters or outbreaks where molecular testing is not available. It could also be used in places where people are living or working close together, like meat processing plants, farm worker camps or prisons. Tribal communities that lack access to testing are also on the DHHS list.
At colleges and universities, DHHS said the tests could be used on people who came into contact with a known case of COVID-19 or to do surveillance testing of random people without symptoms.
At K-12 schools, DHHS said the tests could be used in places where there have been clusters of five or more cases, or as surveillance testing at schools that are holding in-person classes in counties designated as red, orange or yellow zones by the Centers for Disease Control and Prevention.
That would cover well more than half of the state’s 100 counties, according to documents obtained by the Center for Public Integrity.
Ultimately, though, the use of the tests will be up to local health officials.
DHHS said it will distribute the tests based on population.
So far, 1.32 million BionaxNOW tests have been shipped to North Carolina. Amy Ellis, a DHHS spokeswoman, wrote in an email that the state expects about 836,000 of them to arrive by the end of this week.
About 340,000 test kits have already been sent to health departments, Ellis wrote, but she did not immediately respond to a follow-up asking which counties have received them.
As of Wednesday afternoon, Wake County had not received any of the tests, Dara Demi, a county spokeswoman, wrote in an email.
Durham County has received antigen tests from the state, Alecia Smith, a spokeswoman for the county’s health department, wrote in an email to The News & Observer. Smith did not specifiy how many tests Durham has received or if they have been sent to specific locations. Smith did write that the county will follow DHHS guidelines for their use.
In September, nursing homes, assisted living centers and historically black colleges and universities started receiving weekly shipments of the Abbott test from the federal government. So far, about 552,000 tests have been sent to North Carolina, with 231,560 tests sent to nursing homes, 198,840 to assisted living facilities and about 52,000 to HBCUs, according to the federal Department of Health and Human Services. From July to September, the federal government sent about 70,000 rapid tests from other manufacturers to North Carolina’s nursing homes.
DHHS has told local health officials that they should check lists of where those resources were sent to “avoid overdistribution” wen passing out the Abbott antigen tests.
During a press call Wednesday, Adm. Brett Giroir, a medical doctor who is the national COVID-19 testing coordinator, said the Abbott tests are “clearly” meant to be used as a widespread screening tool.
“When you heard people talking about, ‘We want a test that everybody can get whenever they want it,’ we’re not there yet, but these are the class of test that will do it,” Giroir said, referring to antigen tests.
Abbott received its emergency use authorization for the test in late August. A day later, the FDA announced it would buy 150 million tests from the company for $760 million, sending them to each of the 50 states to be used at governors’ discretion.
Abbott touts its test as having results available in 15 minutes and costing $5. As of Tuesday, N.C. DHHS reported the average turnaround time for molecular testing in North Carolina has averaged two days over the last 32 days.
During Wednesday’s call, Giroir pointed to the test’s emergency use authorization as proof of its effectiveness. To determine its accuracy, Abbott tested BionaxNOW on 102 people showing symptoms of COVID-19. Of those, the test correctly identified 34 of 35 positive cases and 66 of 67 negative results.
While Giroir touted that data, Miller said 102 people is an “incredibly small” sample size and indicative of an issue surrounding many of the COVID-19 tests being developed, both antigen and molecular.
“We don’t really know how well these tests perform, and it’s only when you roll them out on a large scale into the real world that you see how they perform in terms of sensitivity and specificity,” Miller said, referring to both the levels of virus at which a test identifies COVID-19 and how accurate the test is.
Miller called for local health departments to make sure that people actually administering the tests at nursing homes and other places know how to do it. The procedure is different from the molecular swabs they might be used to, she said.
“We have an ability to test people at an increased capacity and we should do that,” Miller said, “but it needs to be coupled with education by public health officials and experts on these issues.”
This story was originally published October 28, 2020 at 2:53 PM.