The Biden administration is under pressure to quickly expand rapid coronavirus testing to curb the latest wave of the pandemic.
The current system is being strained, and at-home tests are increasingly rare commodities.
Manufacturers who cut supply as infections dropped during the spring and summer are now scrambling to ramp up operations as demand spikes. But that shift is likely to take weeks.
The benefits of using rapid tests as part of an arsenal to help fight COVID-19 have been known since the beginning of the pandemic, yet the U.S. has not taken advantage of them.
President BidenJoe BidenBiden to provide update Monday on US response to omicron variant Restless progressives eye 2024 Emhoff lights first candle in National Menorah-lighting ceremony MORE recently acknowledged that testing efforts have fallen short.
“From the start, America has failed to do enough COVID-19 testing," Biden said in a speech earlier this month outlining the administration's revamped COVID-19 response plan.
As part of that plan, the White House this week announced the purchase of $2 billion worth of tests, both over-the-counter and point-of-care tests, which can be used in schools, nursing homes, local medical clinics and prisons. It’s unclear exactly how the kits will be distributed.
But advocates and testing experts argue the administration is still too focused on vaccines, and needs to be much more aggressive in promoting the use of rapid antigen tests.
They point to the fact that much of Biden's plan is centered on vaccine mandates for businesses.
"It's a terrific first start, but it is not enough," said Mara Aspinall, a diagnostics expert and professor at Arizona State University.
The administration’s plan "needs to recognize that testing, in addition to vaccination, is the way to end this pandemic. We can't just rely on testing for the unvaccinated. Sadly, we thought we could. But we can't. Because we know that despite the great vaccines, there are a significant number of breakthrough cases," Aspinall said.
The U.S. strategy to date has mostly relied on lab-based testing to detect cases, and experts say that's been reflected in the lack of support for rapid tests. The results from labs are more accurate, but results can take days.
At-home tests, which can deliver results in as little as 15 minutes, are seen as a key tool to use for schools, workplaces and large events like conferences, concerts and weddings. They're regularly used overseas, but the U.S. has been far more cautious in allowing rapid tests to come to the market.
Despite repeated pleas from experts, the U.S. continues to rely on strict, and often cumbersome, regulations from the Food and Drug Administration (FDA) that treat rapid tests as medical devices. That means they are held to the same approval standards as lab tests, even though they are designed for different purposes.
As a result, "there's only been a handful of rapid diagnostic tests that have been authorized by FDA," said Josh Michaud, associate director of global health policy at the Kaiser Family Foundation.
"And you can compare that to hundreds of tests that have been authorized by governments in, say, the U.K. or Germany or across Canada, the European Union. So we're really very far behind compared to other countries," Michaud added.
The FDA has authorized tests from only about six different companies, compared with more than 400 laboratory tests.
As the delta variant pushed infections to levels approaching last winter's surge, demand for at-home tests rose substantially. Schools also made testing an integral part of their opening plans, which has further exacerbated the strain.
Major retailers like Walmart, CVS and Amazon can't keep enough tests in stock, and some have even placed limits on how many kits customers can buy.
But that hasn't always been the case.
Once the vaccines started widely rolling out in the spring and infections began falling, testing demand dropped. States shifted resources from testing sites to vaccine sites, and manufacturers shrunk their supply chains.
"In June, some combination of overconfidence and over-optimism led to many of the manufacturers saying, 'you know what, we're not going to need all these tests,' and they scaled back," Aspinall said. "And while it may have seemed like a really good idea at the time, in hindsight, both for the U.S. and around the world, it's very awkward."
Scott Becker, CEO of the Association of Public Health Laboratories, which represents state and local government labs, said the shortages were predictable and could have easily been avoided.
"We need to be better at predicting what the needs and the demand might be. And when you let the market determine that, like we did back through the summer, we, the nation, was caught without the supply that we needed, for opening schools, for being able to use rapid tests when we needed them," Becker said.
Abbott Labs, the country's largest diagnostic manufacturer, is one of the companies the government is contracting with for rapid tests. The company will deliver 3.8 million of its BinaxNOW test kits beginning in October, at a price of $47.8 million.
"Today, there are tens of millions of BinaxNOW tests available and we’re ramping up production to bring more tests to retail and professional use settings to help end this pandemic," spokesman John Koval said.
The federal government is also paying Abbott $554.4 million for point-of-care tests, described as an open-ended contract.
The New York Times reported last month that over the summer, Abbott shut down one of its factories, laid off employees and destroyed testing components.
In a statement, Abbott said it "had significant amounts of finished test kits in inventory," and only disposed of components at the end of their shelf lives that couldn't be used anywhere else.
Becker and others said the administration's investment should help stabilize inventory as companies like Abbott ramp back up. It might even help to bring prices down, but the funding needs to be consistent.
"We need to have investment in industries to keep supply going, or to ensure that there's the ability to quickly ramp back up. Shuttering factories is not .... we can't have a boom and bust cycle," Becker said. "We need a steady stream of supply, be it in a stockpile, or where the manufacturers agree that they will be able to ramp up quickly if they're supported to do that."