Rapid coronavirus tests are still hard to find in many places, despite Biden’s vows

President Joe Biden announced last week that rapid coronavirus tests were a pillar of his plan to fight the new and potentially more transmissible omicron variant, now confirmed in at least 21 states.

But nearly a year into his administration, the availability of low-cost coronavirus tests that return results in as little as 15 minutes remains an oft-promised but still unrealized capability in large swaths of the country — a far cry from the situation in countries such as Britain and Singapore where the government purchased the kits last spring and distributed millions of them free or at low cost.

Many people in the United States cannot find the tests online or at retail stores because the kits are often out of stock — and when they do see them, consumers may be unable to buy them in quantity because of the cost, typically around $25 for a packet of two. That makes it impractical to urge all Americans to incorporate the tests into their daily routines — especially before going to work, traveling or gathering indoors with family members and friends — to avoid spreading the virus unintentionally, as many health experts now advise.

In some states, supply issues have also affected the tests' availability for schoolchildren and residents of long-term care facilities, homeless shelters and prisons. A recurring theme on a call of state health officers last week "was the challenge at the state level with obtaining rapid tests," said Nirav D. Shah, director of Maine's Center for Disease Control and Prevention. Maine, Kansas, North Carolina and Washington officials are among those who have complained of difficulty procuring sufficient test kits and the need for more federal funds to help states purchase them.

The scattershot availability and high cost of the rapid tests are the latest issues in a nearly two-year saga of stumbles that have plagued coronavirus testing in the United States across two administrations, undercutting efforts to curb the spread of the virus and keep schools and businesses open safely. One of the biggest mistakes early in the pandemic was underestimating the impact of asymptomatic or presymptomatic spreaders. Rapid tests can identify such people and if widely used, help stop chains of transmission that turn viral flare-ups into conflagrations, say health experts.

While the Biden administration arrived late to its commitment to increase the U.S. supply of rapid tests, it has taken steps to increase their availability in recent months, including investing billions of dollars to buy the tests directly from manufacturers. Public health experts welcome those initiatives, but say more needs to be done.

"Our testing infrastructure has been horrendous since the first day of the pandemic," said Eric Topol, director of the Scripps Research Translational Institute, adding that the nation's production of diagnostic tools has consistently lagged the need for them.

Biden announced a plan last week to make the tests more affordable and accessible as part of his strategy to fight the new variant by requiring private insurers to reimburse consumers for their purchases. For those without such coverage, the president said the government would provide 50 million free tests starting this month to convenient locations around the country, including federally qualified health centers and urban and rural community centers.

But Topol called the plan a "nonstarter," because it requires consumers to lay out money for the tests and then submit receipts to insurers to be paid back. And he argued that for the strategy to be successful, many more free tests need to be made available to those covered through public programs or without insurance.

"There needs to be a revamped regulatory approach to get more and better tests out at scale, immediately, and free distribution to all Americans," Topol said.

Administration officials defend their approach, saying they are taking aggressive steps to build the nation's capacity, citing $3 billion in new investments this fall focused on purchases of rapid tests. As a result of those efforts, the U.S. supply of the over-the-counter tests has risen from 40 million a month in August to more than 200 million for December, and it continues to grow, they said. The government has prioritized about 3 million rapid tests a week for the nation's 15,000 long-term care facilities, and free testing in more than 10,000 pharmacies.

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A White House official also noted that over-the-counter tests are just one part of the nation's testing infrastructure, saying the number of PCR tests, typically performed in a health-care setting, has increased.

In addition, the Food and Drug Administration moved last month to streamline its review process and prioritize at-home tests after months of criticism that its requirements were onerous, building on steps it first took in March. Yet despite these efforts, the United States has continued to lag European and Asian countries, which have been much more aggressive in buying, subsidizing and distributing tests. A senior administration official said government subsidies and large purchasing agreements are the main drivers of test availability in other countries.

"Our approach is not to send everyone a test … independent of their need or desire to get tested," White House COVID-19 Response Coordinator Jeff Zients said at a briefing Tuesday in response to a reporter's question about whether the United States would follow the British model to send kits to every household. "Everyone in America has access to free testing in an efficient and effective way, and we've developed multiple access points for free testing."

Zients said the administration would continue its efforts to make the tests more affordable and available.

"There are now 13 [rapid] tests approved from the FDA," he said. "That's up from none at the beginning of the administration. And that leads to innovation. That leads to prices coming down [through] competition. So we're going to continue to increase the access to free testing to everyone in America."

In the meantime, consumer demand for rapid tests far exceeds their availability in many places. When New Hampshire officials announced Nov. 29 that residents could apply to get rapid tests delivered free to their door, about 800,000 of the 1 million available were gone in less than 24 hours, according to federal health officials.

The trial program, which began in April to evaluate how to use rapid tests across the country, was available in select counties with high infection rates in states including Hawaii, Georgia, North Carolina, Tennessee and Washington. The pilot by the National Institutes of Health and the CDC has distributed just under 5.5 million free rapid tests made by Quidel, and is ending in a few weeks, said Rachael Fleurence, special assistant to NIH Director Francis Collins for COVID-19 diagnostics. "We're out of budget," she said.

Experts say testing — using both rapid and PCR tests administered by health-care providers — is certain to become more crucial as scientists and government officials race to get more information on the transmissibility of omicron and its ability to evade vaccines. Regulators say they're confident that most of the rapid tests authorized in the United States will detect omicron infections because they do not rely on the spike protein, where many of its mutations have been identified.

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Additional testing will also be integral to Biden's push to have private and public sector employers require their workforces undergo regular testing if they are not vaccinated, as well as to "test to stay" school policies that enable children potentially exposed to infections to remain in class if they test negative.

If the goal is to encourage more people to act responsibly to protect one another, distributing millions of free tests would make that more far likely, said Carole Moss, a patient-safety advocate who lost her 15-year-old son due to delayed diagnosis of an antibiotic-resistant infection.

"We all need multiple self-test kits weekly that are free, to entice everyone to test," she said. "Often, at $23 for two tests, many families don't have the extra cash to pay for the tests in advance."

Some state officials agree more needs to be done, citing their own difficulty obtaining tests that are supposed to go to the most vulnerable Americans.

Kansas health officials say they ordered 1,500 boxes of over-the-counter rapid coronavirus test kits in October to share with homeless shelters and groups that help migrant workers and other communities who don't have access to testing locations, but "we've only received 350" of the boxes, said deputy health officer Joan Duwve.

Maine officials say they've ordered tens of thousands of Abbott's rapid at-home tests through the end of the year for schools, group homes, long-term care facilities and prisons, but have not received them in a timely fashion. As a result, they are prioritizing rapid tests for schools, a Walgreens program that offers free tests, and facilities experiencing outbreaks, said Shah, the state's CDC director. He said he has one staff person whose full-time job now is procuring tests; the state is also working with another manufacturer to diversify supply.

Abbott spokesman John Koval said the company scaled up manufacturing of its BinaxNOW test kits since the CDC re-prioritized testing at the end of July as the delta variant exploded in the United States. Abbott now produces more than 50 million rapid tests a month, and has hired additional workers in Maine and Illinois, he said.

Biden campaigned on his commitment to jump-start coronavirus testing, unveiling a "Pandemic Testing Board" proposal in June 2020 that he compared to President Franklin Roosevelt's War Production Board, which oversaw the rapid conversion of civilian factories to make supplies for the U.S. military during World War II.

On his first full day as president, Biden signed an executive order officially creating the testing board, vowing that he would put the "full force of the federal government" behind churning out more diagnostics after criticizing his predecessor for failing to build that capacity.

But the testing board's operations fell far short of that vision, said three current and two former administration officials who spoke on the condition of anonymity to discuss internal meetings. Roosevelt's war-supplies board included multiple cabinet members and empowered the chairman to overrule government agencies. Biden's panel became another cog in the federal bureaucracy, deferring decisions to officials in the Department of Health and Human Services (HHS), failing to argue for long-term investments and competing for influence with other groups working on the virus response, the current and former officials said.

"It wasn't clear whether they were setting testing policy or just listening to everyone's ideas for policies," said one former health official. "The board may have been a good idea, but in practice, it was a real missed opportunity."

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Carole Johnson, whom Biden named as the nation's coronavirus testing czar last year, defended the board's record in an October interview, saying it had been split into groups focused on testing supplies and testing policy.

"It is a real coordinating function and body, but … because some of the decision-making is regulatory, it rests with the various agencies," said Johnson, who is considering leaving the role to become administrator of the federal Health Resources and Services Administration, a change first reported by Politico and confirmed by two officials.

Another White House official said the board deferred to the HHS because Congress appropriated testing money to that agency, but that the board helps coordinate testing efforts planned across the government.

Separately, a group of Biden administration health-agency officials approached the White House last spring — before the arrival of the delta variant in the United States — urging it to purchase millions of the rapid tests, according to five senior administration officials who spoke on the condition of anonymity to share internal discussions. They warned that without doing so, the kits would remain hard to find and exorbitantly priced.

But White House officials never followed up on the proposal. Back then, they were focused on vaccination as the path out of the pandemic and believed that breakthrough infections were rare in vaccinated people — a notion that the delta variant would turn on its head. Administration officials also thought the price of the tests was too high and feared such a purchase would lock other manufacturers out of the market.

Guidance from the CDC in May affirmed the thinking that once Americans were vaccinated they need not worry about testing. It advised people that once they were vaccinated, they did not need to get tested even if exposed to the virus, unless they were experiencing symptoms. Officials point to that guidance as a turning point, arguing it dismantled incentives for manufacturers or the government to increase the production of tests.

As the delta variant stampeded through the South over the summer, causing a growing number of breakthrough infections, the CDC would change that guidance. By that point, however, valuable time had been lost.

"We did not prioritize rapid tests the way we did vaccines," said Neil J. Sehgal, assistant professor of health policy and management at the University of Maryland School of Public Health. "Both the former and current administration banked on vaccines ending the pandemic."

Faced with a huge falloff in sales just before the delta variant took hold, meanwhile, test manufacturer Abbott laid off thousands of workers and told employees to destroy excess test kits in June and July, the New York Times first reported.

"We did this year what we did early in the pandemic, which was put enormous effort into scaling up our U.S. manufacturing facilities because we know people depend on BinaxNOW and Abbott," Abbott spokesman Koval said in an email, adding that the company did not destroy finished products and kept usable components "so that we could have them in the event that we needed to scale back up, which is exactly what's happening now."

"We rehired workers, reassembled manufacturing lines and critical machinery, and asked our suppliers to work with us again to beat back delta and prepare for the winter months," Koval wrote.

Two industry officials said the testing response to the delta variant might have been more robust had the administration stockpiled tests in the months when demand softened. Instead, when the White House committed to investing in the rapid tests, manufacturers had to spend weeks ramping production back up, hiring employees and opening new plants, said the officials, who spoke on the condition of anonymity to discuss the issue candidly.

“It would have been good if when we saw a drop in demand this summer, there had been a more aggressive plan to shore up the supply side to make sure we were prepared if the surge came back,” one of the officials said.