After a busy day of grocery shopping and other errands, Diane Bell slid into a kitchen chair and took out her at-home coronavirus test kits. She swabbed both her nostrils and mixed a few chemicals, and within a few minutes, a blue line materialized on an indicator strip.
Bell’s testing is part of one of the largest, most ambitious and high-stakes scientific experiments of the coronavirus pandemic — to persuade families and whole communities to incorporate home kits into their everyday routines to identify and stop infections as the nation inches toward full reopening. Sponsored by the National Institutes of Health and the Centers for Disease Control and Prevention, it aims to distribute 2 million free at-home test kits to 80,000 families in Greenville, N.C. and the rest of Pitt County, and in Chattanooga, Tenn., to conduct regular testing from now until around June.
Researchers hope that by encouraging people to test themselves even if they feel perfectly fine, the country will be able to slow down — and eventually extinguish — the spread of the virus.
The project is part of a larger pivot in the nation’s coronavirus testing strategy to focus on prevention, and it is a recognition that one of the biggest mistakes made early on was underestimating the impact of asymptomatic or pre-symptomatic spreaders.
County officials in North Carolina and Tennessee will monitor the level of virus in wastewater and track emergency room visits, hospitalizations and other indicators of community spread in hopes they will see those go down. Early results should be available sometime in the summer, and if the results are positive, the model could be replicated across America.
“We could really change the game here,” said NIH Director Francis Collins. “Even after we get to a high level of vaccination, we will still not be 100 percent, so testing is going to be with us for quite a long time.”
Routine at-home testing is one of many models being tried throughout the country to stop community transmission.
Tulane University in New Orleans, for example, is using a multilayered approach to test all staff and students regularly, with undergraduates tested three times each week. Montgomery County Public Schools is conducting weekly pooled testing, in which whole classrooms are tested together — a practice that is less expensive and can provide faster results. In Michigan, the state is recommending weekly testing for youth athletes. And the National Basketball Association and National Hockey League have partnered with Clear, the airport security company that operates expedited lanes, to use digital health passports to verify the testing and vaccination status of fans and employees before they enter stadiums and other indoor areas.
With millions of Americans still reluctant to get vaccinated, the reality of breakthrough infections, and new threats from emerging variants, testing is an essential part of the new normal as the country moves to reopen schools, workplaces and other areas of daily life.
Officials say the NIH-CDC initiative is especially important for minority communities, which make up a disproportionate portion of essential workers but have lower vaccination rates.
As part of his $1.9 trillion coronavirus plan, President Biden has dedicated $50 billion to a large-scale expansion of testing that includes mass deployment of rapid tests that return results within minutes, expansion of lab capacity, and creation of testing protocols for schools, local governments, workplaces and other place people gather.
“In the next few weeks to months, you’ll see a lot of tests being done in places where it’s never been done before,” said Wilbur Lam, an Emory University medical researcher who helps run a lab that is verifying various testing technologies for the coronavirus.
Testing ‘Shark Tank’
One year ago, as images of the horror in New York City and other hot spots were broadcast across the world amid an almost national lockdown, access to coronavirus testing in the United States was limited mostly to the obviously ill and involved sending off nasal swabs to distant laboratories that often took days or weeks to deliver results.
Rapid tests with low accuracy emerged soon after, but many Americans knew of them only through the stories about the White House coronavirus cluster that sent then-President Donald Trump to the hospital.
Today, the landscape looks radically different. A more diverse array of tests are being deployed in different settings in every corner of the country.
Greg Martin, director of the Emory/Georgia Tech Predictive Health Institute, said this is possible because rapid tests are becoming more accurate, and PCR (polymerase chain reaction) lab tests, faster, “blurring the line” between the two. A single rapid test using a nasal swab or saliva, which takes as little as 10 to 15 minutes, can still produce roughly 15 percent false negative results and 1 to 2 percent false positives, studies show — but that accuracy improves dramatically when testing multiple times in a short period.
“That allows us to move the testing to where people are needing to be together for some reason,” he said. That includes workplaces such as stock exchanges, factories and universities, as well as museums, convention centers and concert halls.
FREE at-home COVID-19 test kits are now available for all workers who interact with the public at their jobs with results available in just 20 minutes. Enroll now!https://t.co/hPws7S24Fn#Covid19Colorado pic.twitter.com/6THA6FRduM— Colorado Department of Public Health & Environment (@CDPHE) April 18, 2021
Experts imagine a near future where each person will be able to access tests multiple times a week.
Glimpses of that reality can already be seen in Britain, where starting this month, every person is being given two rapid coronavirus tests a week. Similar ideas are being introduced in Germany, the Netherlands and other parts of Europe, with “test and shop” measures in some jurisdictions that require people to submit evidence of negative tests before being allowed inside.
In the United States, much of the testing innovation has grown out of an unconventional competition that is part of a project, known as RADx, launched a year ago this month. Collins described it as setting up NIH to act as a venture capital organization.
“We invited inventors in academia and small businesses to bring their best ideas for how to do this testing,” he said. “We were not disappointed.”
The NIH received over 700 applications for diagnostic and screening tools and held what he described as a “Shark Tank”-like process to select the most promising. The funded projects use the traditional nasal swabs, as well as saliva, oral swabs and blood, to detect the virus, and several have received emergency authorization by the Food and Drug Administration.
Lam, who along with Martin runs a lab at Emory that verifies the accuracy of emerging coronavirus testing technologies, said the science provides only a part of the path forward. Ongoing policy and pricing decisions will be just as critical in determining their success, he believes.
Tests could be priced as low as $10 to $15 as companies scale up, or as high as $30 to $50, depending on the technology being used. Right now, much of the costs are being borne by relief funds provided by the federal government, but it’s not clear who will pay for the testing once that runs out.
Similar questions surround who pays for the lost time of an employee who does not come to work after a positive test. “Is it the government? Insurance companies? Employers? Everybody is at the table, and it’s one of the major topics of discussion,” he said.
Collins, the NIH director, wonders about Americans’ willingness to change their habits: Will people integrate testing into their daily lives the same way they drink coffee each morning or brush their teeth? And if they test positive, will they take the responsibility to self-isolate and communicate with their health providers to monitor their symptoms and care?
“It’s not just a matter of whether the technology works,” he said. “It’s also human behavior — to what extent humans take advantage of this.”
A million test kits
The roughly 655 square miles of Pitt County, population 185,000, in the eastern part of North Carolina, is former tobacco-growing country known today for its numerous BMX X Games medalists and as a battleground in the 2020 presidential race.
In recent months, it has also become an example of the continuing challenges to surmounting the pandemic. While about half of all eligible Americans have received at least one shot of a coronavirus vaccine, the uptake in Pitt County is only about 25 percent, although everyone 16 and older became eligible in early April.
County Health Director John Silvernail said the county made a lot of progress in battling covid-19, especially in the African American population, which early on was disproportionately impacted. But he is worried the virus is “still burning in that young-adult age group.”
“There’s a lot of hope in this study,” he said. “If we can stop cases in the family unit, then there is less of a chance they will go out and give it to other members of the community.”
Giselle Corbie-Smith, director of the UNC Center for Health Equity Research, said that being able to stop transmission when people are the most contagious is key.
“We are identifying people who are at highest risk in the household,” she said, emphasizing that these individuals are at highest risk of becoming infected and passing that infection onto others. “The ones going to a physical location, those who are essential.”
Corbie-Smith, who is leading the project along with researchers from Duke University, believes some residents may be more open to at-home tests kits because of their privacy.
“This is like a pregnancy test,” she said. “There’s no requirement to upload any information. We are very clear: If there is a positive test, you need to call your health-care provider and need to make sure you and people around you are safe. But people are not obligated to share other information.”
Each enrolled family receives a box with 25 tests by Quidel Corp., which has emergency use approval from the FDA, and residents are encouraged to use them three times a week for the household member at greatest risk of exposure. That may mean an essential worker, for example, or a child attending in-person school.
In Pitt County, where kit distribution began the first week of April, officials say that 12,000, or more than a quarter, have already been claimed. The Chattanooga project will launch May 4. Families can also order kits online via sayyescovidtest.org for delivery to their homes.
“The kits are going really fast,” said Pastor Rodney Coles, 62, chief executive of the Churches Outreach Network in Greenville, who has been helping with distribution.
Although he has seen fellow religious leaders become ill or even die, Coles said he has ministered in person throughout the pandemic and has never had any symptoms or any reason to get tested.
Now, he and his wife are testing three times a week, which he describes as “mind-resetting.”
“I recommend that all folks should have it — even those that have the vaccine — because we can still catch it and be a carrier,” he said.
Bell, 62, is a child-care provider, and her live-in partner, Robert Garner, 64, works at a landfill. She has a large network of 28 grandchildren and nine great-grandchildren from her biological and foster-care kids, whom she sees regularly now that she is vaccinated.
Bell said the kits have given her “peace of mind” when she interacts with people outside her home, and last Sunday, she spoke with members of her church about it.
“Many in the African American and Black communities, they are like, ‘I don’t want it,’ when it comes to the vaccine. I said, ‘Well, wait a minute: You have to keep your body safe.’ And I told them they could start testing while they think about the vaccine,” Bell recalled.
She said she showed them the kits, explained how to use them and pretty soon, they were signing up, too.