US grapples with rapid Covid test crunch as vaccine mandate looms

The US is grappling with a critical shortage of rapid Covid-19 antigen tests amid a surge in demand from consumers and companies ahead of a deadline next month when workers must prove they are vaccinated or submit to weekly testing.

Pharmacy chains have imposed limits on customer purchases and a few test suppliers have told some employers they cannot provide additional kits ahead of the Biden administration’s vaccine mandate deadline on November 22.

In the past few weeks, the Biden administration has announced it will spend $3bn to expand US capacity to about 200m rapid tests a month by December. But experts are warning this may not be enough to steer the US through the early part of winter when supplies will remain tight.

“Demand is off the charts. We are telling employers of any significant size that we will not be able to support them until January,” said Douglas Bryant, chief executive of Quidel, one of the biggest suppliers of rapid tests.

He said the US had fallen behind the UK in the rollout of lateral flow tests, which can be bought over the counter and provide a result within 20 minutes. The government had focused too heavily on vaccines and PCR tests, which are more accurate but take much longer — at least 24 hours in most cases — to provide a result, said Bryant.

Employers are concerned a lack of rapid tests could dent their ability to enforce effective vaccine mandates, which they worry will be difficult to implement and could disrupt employee morale.

“Ensuring an adequate supply of tests to meet the demand of once a week testing for unvaccinated employees could be a deal breaker for companies’ ability to implement the impending mandates,” said Lori Esposito Murray, president of the Committee for Economic Development of the Conference Board.

Lateral flow tests look for protein antigens that live on the virus’s surface, and work by adding a liquid reagent to a saliva or nasal swab. Unlike PCR tests, which look for the virus’s genetic material, they do not have to be analysed in a laboratory. Experts say they can play a critical role in enabling a safe return to work, school and college.

The US fell behind many other developed countries in its testing capacity early in the pandemic, when US regulators insisted healthcare providers only use the Covid-19 test designed by the Centers for Disease Control and Prevention, which then turned out to have a fault. Donald Trump then urged his officials to “slow the testing down”, while his administration changed public health guidance to ensure fewer people would receive one.

“Tests have historically been neglected as a part of the US pandemic playbook. It’s frustrating that testing has always been viewed as a secondary tool to fight the pandemic,” said Thomas Tsai, an assistant professor of health policy at Harvard University.

“In order for the tests to be effective, they have to be accessible and affordable.”

Since taking office, president Joe Biden has announced about $4bn in extra spending to boost testing capacity. That included a $232m contract with Ellume, the Australian company that was forced to recall nearly 200,000 at-home tests in the US after high rates of false positives.

A White House spokesperson said: “As newly authorised tests come online and production scales, we expect at-home tests to quadruple by December while we expand access to free testing, reaching 30,000 sites nationwide.”

But critics say other decisions taken by his administration have hampered supply.

Demand for rapid testing fell off a cliff in June when the CDC exempted people who had been vaccinated from testing when exposed to Covid-19, one industry executive told the Financial Times. Last month the agency restored its previous guidance when it became clear vaccines did not always prevent infection.

But the sudden collapse in demand caused Abbott, the largest provider of rapid tests in the US, to lay off hundreds of workers and dispose of millions of test components. Three months later Abbott is rehiring workers and racing to make hundreds of millions of kits following a contract last month worth between $44m and $554m from the US government.

“We’ve always said that vaccines are the most effective tool we have to combat Covid-19 — but it’s important to recognise the critical role that testing plays too,” said an Abbott spokesman. “This isn’t a situation of either/or — it has to be both: vaccines and testing.”

A Food and Drug Administration official said the government had not done enough to shore up consistent demand for test kits to incentivise manufacturers to boost production or submit their products for regulatory approval in the US. The official said the Biden administration’s recent investment should help to redress that and encourage more companies to enter the market.

US spending on rapid antigen tests pales in comparison to that of the UK. The UK government has invested about £15bn to provide free lateral flow tests to schools, workplaces and members of the public, according to an FT analysis of data compiled by government public procurement database Contracts Finder.

In England, rapid antigen tests have detected more than a million cases of Covid-19, or about one in every seven cases, according to data from NHS Test & Trace. In the US officials are not even sure how many rapid antigen tests are used on a daily basis, according to Mara Aspinall, a professor at Arizona State University and a board member of OraSure Technologies, a test kit provider.

“Americans are excited about the ability to do what they want to and when they want to with the advent of these tests. But the challenge is availability and affordability . . . many Americans can’t afford tests that can cost a family of four $56 every week,” said Aspinall, who estimates at least 800,000 rapid test results go uncounted daily.

Sheldon Campbell, professor of laboratory medicine at Yale School of Medicine, warned that inequality in access to rapid turnround tests could limit their effectiveness.

“I fear inequality will be a problem as most infections are among poorer demographics, but they will be the least likely to access expensive tests,” said Campbell. “If the testing remains expensive . . . it won’t be able to reach deprived communities where infections are highest [and] who need it most.”

But Campbell said rapid testing could still play an important role alongside vaccinations to reduce Covid-19 risk.

“[People] said the vaccine hasn’t done what we wanted it to do because there’s uptake problems and there’s still transmission . . . let’s invest in some other strategies that will also help,” he said.