WASHINGTON — A confluence of risk factors, including the rise of a new coronavirus variant, could have the United States on the cusp of a surge in COVID-19 cases, but wider and more consistent deployment of rapid, at-home diagnostic testing could provide a key boost in the coming months, experts say.
Rapid tests have never emerged as a leading public health tool in the United States, the way masks and vaccines have, despite the fact that their promise is routinely touted. “Rapid testing for COVID-19 is the way back to ‘normal’ life,” went the headline of a recent Seattle Times op-ed by Katharine Liang, a local physician.
As it happens, that article was published on the same day the World Health Organization announced that a new, potentially more virulent and transmissible strain of the coronavirus was spreading around the world. Although Centers for Disease Control and Prevention Director Rochelle Walensky said on Wednesday that the variant had not yet been detected in the U.S., public health officials concede that is likely to change in a matter of days.
The timing couldn’t be worse. Vaccination rates for adults and adolescents are stalling, while masks have come off in many parts of the country. Winter is nearly here, and people are preparing to travel and gather for the holidays. Together, those factors could deprive public health officials of the measures they’ve relied on since the start of the pandemic, most recently during the Delta surge.
The latest on the Omicron variant
And the most onerous of those measures — that is, lockdowns — is “off the table,” President Biden said on Monday, meaning that public health officials will have to figure out how to keep an increasingly exasperated public safe during what is bound to be a third pandemic winter.
“The American public is rightfully exhausted, and therefore the amount of risk we’re willing to take goes up,” University of Pennsylvania physician Ezekiel Emanuel told the Washington Post this week. “People are willing to take more risks and accept more challenges, but they’re not willing to accept more restrictions.”
The scenario is challenging, to say the least, but some public health officials and elected leaders believe that this could be a moment for rapid diagnostics to emerge from the shadows and shine. Using a technology called lateral flow, these tests can be purchased at a pharmacy and administered by anyone without any expertise or specialized equipment. They return results within 15 minutes, whereas more sensitive polymerase chain reaction (PCR) tests have to be sent off for laboratory analysis, which still takes several days in most parts of the country.
“They are essentially ‘contagiousness tests’ and are a powerful public health tool that the U.S. is underutilizing,” said Dr. Lucy McBride, a physician in Washington, D.C., who writes about the coronavirus pandemic.
While rapid tests are less effective than PCR tests at confirming whether an individual is harboring the coronavirus, they are vastly superior at revealing whether a group of people could be sickened by someone in their midst. With large public events and offices increasingly reopened, those kinds of snapshots could prove critical in keeping the virus at bay.
“PCR is almost too sensitive for public health,” Michael Mina, until recently a Harvard epidemiologist and perhaps the nation’s most vociferous proponent of rapid testing, told Harvard magazine earlier this month.
A study last year found that regular rapid testing could beat back the coronavirus to nearly the point of “extinction,” even without any vaccination, by quickly identifying — and isolating — people who are likely to be spreading the disease.
The first rapid test was approved by the Food and Drug Administration last November, but some have charged that the agency has been far too slow to recognize the public cost of its cautious pace. “They’re neither denying the bad ones or approving the good ones,” a former FDA official recently complained to ProPublica.
The FDA vowed earlier this month to speed the process. “Since the start of the pandemic, the FDA has taken numerous steps to help expedite the review and authorization of COVID-19 diagnostic tests, including rapid point-of-care and at-home tests,” FDA spokesperson James McKinney told Vivaraenews News in an email.
Rapid tests are much more available than they were a year ago. Yet there is widespread agreement that they are not yet cheap enough, or easy enough to find, to make an appreciable difference.
As deeply unwelcome as Omicron’s advent has been, it could provide an opportunity to institute a rapid-testing regime that could also work against future variants, which are all but certain to arise. Though much work remains to be done by virologists on the Omicron variant, early indications are that it might partially evade vaccines — but not a diagnostic test (of either the PCR or lateral assay variety). That could make rapid tests increasingly important in the coming weeks and months, as the United States tries to fend off a new coronavirus wave.
“I believe very firmly that a vaccine-only approach is not the right approach, having vaccines as your number one, two and three objectives,” said Mina, who believes that vaccination in concert with rapid testing could be a more effective strategy than continuing to highlight vaccination at the expense of other approaches.
According to the CDC, about 1.1 million people are getting vaccinated daily, a number that reflects high interest for newly approved vaccines for children between the ages of 5 and 11. Among adults, vaccine hesitancy has hardened into a highly politicized resistance that seems to have more to do with antipathy for the president than any health concern about the vaccine itself (the vaccines have consistently been shown to be safe and effective).
Rapid tests certainly aren’t pleasant, involving the by-now-familiar nasal swab. But they are also less fraught than either masks or vaccines, meaning that even someone opposed to those measures could be prevailed upon to endure a momentary nasopharyngeal inconvenience.
Experts say that some 20 million people per day would have to get tested to bring the pandemic to an end; the Biden administration hopes to have 200 million doses per month available by the end of the year. In a nation of 320 million people, that won’t suffice, especially if distribution challenges continue to exacerbate production woes.
“It’s a process that ramps in steps, not instantly,” former top White House pandemic adviser Andy Slavitt wrote in an email to Vivaraenews News.
A White House spokesperson pointed out that the Biden administration has spent $3 billion on rapid tests, in part to galvanize a market that had gone quiescent in the early summer, when it seemed the pandemic was coming to an end. The spokesperson said the FDA had approved 13 rapid tests and that, as a result, supply will have quadrupled between September and December.
“This is tremendous progress that will help ensure readily available testing for the holiday season, and we are confident that testing will continue scaling up,” the spokesperson told Vivaraenews News in an email.
Still, finding rapid tests at a pharmacy can be difficult. And though prices are expected to fall, such tests remain expensive, often costing more than $20 for a two-test package. Those challenges make frequent, widespread testing a financial and logistical impossibility for many Americans.
“As COVID winter season is arriving, policymakers should take steps to make these tests more widely available and cheap,” Dr. Jayanta Bhattacharya, a professor of medicine at Stanford, told Vivaraenews News. The Biden administration hopes its investments will galvanize production, which will in turn flood the market and drive down the price. But that remains hope, not reality.
The lack of rapid testing has even been called “the greatest public policy failure of the pandemic.” And while the United States has been reluctant to rely on rapid testing, a test-fast, test-often approach has helped Germany return to normal life, even as it experiences many of the same dynamics (millions of unvaccinated; new variants) that have buffeted the United States in recent months.
Some would say that closing schools is a vastly bigger failure of policy than neglecting rapid testing, but in fact the two are closely related. In the United Kingdom, rapid tests are widely used to keep kids in school, a strategy known as test-in-place. Some districts have embraced the strategy in the United States in an effort to make the 2021-22 school year more normal than the preceding one.
Schools are now open in the United States, but disruptive quarantines persist — and could intensify with the arrival of Omicron. Federal quarantining rules require students to miss as much as two weeks of school while waiting for PCR test results, even if they show no signs of COVID-19 illness.
“No symptom-free child should miss school due to an exposure,” said McBride, the Washington internist, who has been an advocate of in-person instruction.
Absent a more focused federal push, a few elected officials have acted on their own. Maryland Gov. Larry Hogan, who has received praise for his handling of the pandemic, announced last week that his administration had purchased 500,000 rapid tests, which would be distributed for free.
“We had a chance to buy these in bulk, and we want to get them out to the community,” Hogan spokesman Michael Ricci told Vivaraenews News. “We’ve gotten a good amount of interest, especially with the holidays coming up.” Ricci said that some counties are making the rapid tests available in public libraries or at vaccination sites.
Sen. Maggie Hassan recently managed to acquire 60,000 rapid tests for the state she represents, New Hampshire. But with 1.4 million residents, New Hampshire would need many more tests than that, on a weekly basis, for the practice to make an appreciable difference.
Critics of rapid testing point out that those tests return a high degree of false negatives, informing people who do have coronavirus in their systems that they do not. Those people, however, are likely to be infected but not infectious — that is, they are keeping the virus to themselves at the moment of testing, meaning they aren’t at risk of passing it on.
In addition, supporters of rapid testing counter by arguing that rapid tests simply have a different purpose than their PCR counterparts. The comparison, they say, makes about as much sense as between a burger joint and a steakhouse. Each has a purpose, and while the purposes are related, they are not the same.
“It frustrates me that rapid tests get a bad rap for ‘missing’ many cases — when the ones they miss are not the ones we care about,” the geneticist Chana Davis recently lamented on Twitter. “Testing should always be fit for purpose!”
Delta spurred a renewed interest in rapid tests, and Omicron is likely to do the same. “We continue to see increased demand for over-the-counter COVID-19 tests across the country and are working with our suppliers to ensure customers have access to self-test kits through the holidays,” a Walgreens representative wrote in an email to Vivaraenews News.
A representative for another large pharmacy chain, CVS, said rapid tests are “widely available” and can also be administered directly at 1,000 CVS stores across the country.
Thanksgiving was a kind of test run, the first in-person pandemic holiday for people who had been living cautiously for nearly two years. For those fortunate enough to find and afford rapid tests, they proved an easy means of having a safe dinner without resorting to face masks or open windows, not to mention the undercurrent of anxiety that has become a kind of staple for all too many Americans.
The next day brought news of the Omicron variant and, with it, new concerns about the months ahead. There will be new calls for masking, as well as research into a new, Omicron-specific booster. Meanwhile, the rapid test stands ready to potentially save the day, if only finally given the chance to do so.
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