U.S. covid testing is broken. Here’s how to fix it.

After omicron, the U.S. can’t neglect testing again.

The United States needs a better covid testing system.

The record-breaking surge of infections driven by the omicron variant has the country once again scrambling to meet demand for tests. The federal government’s new website for ordering free tests and new rules that require insurance companies to reimburse members for test purchases are promising — but they rolled out weeks after the variant began overloading hospitals and shutting down schools.

Public health experts say the country needs a bold, long-term plan to create a testing system that can handle the next surge, or even the next pandemic, rather than lurching from crisis to crisis.

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“We can’t be complacent when [cases] go down,” said Mara Aspinall, a professor of practice and biomedical diagnostics at Arizona State University.

Grid lays out the key components of what a better national testing system would look like, and what it will take to get there.

Deciding what testing is for

Current tests fit into two basic categories: Lab-based PCR and at-home rapid antigen (see box below). PCR tests are the most accurate, which can be important for guiding the medical care of people most at risk. Rapid tests are cheaper and easier to use. Their ability to quickly and repeatedly screen large groups can help keep infected people from unknowingly spreading the virus at school, at work or among friends. But they are less accurate, especially for people who are infected but aren’t showing symptoms.

Both kinds of tests are useful, but experts said that federal health officials need to provide clearer guidance to the public about how best to use and interpret them. For instance, rapid tests rarely produce false positive results, but they are less sensitive than PCR tests. This means they can sometimes miss infections, especially early in the course of disease. But many people aren’t aware of those nuances.

“You can’t just throw tests out there and expect them to be used correctly and for people to understand how and when to test,” said Scott Becker, CEO of the Association of Public Health Laboratories. The U.S. needs a coherent vision for what testing is for and guidance that aligns with that vision, experts say.

Any long-term testing strategy would involve deciding when and how to use the various types of tests on the market. Some countries, like the U.K., have made rapid tests free and ubiquitous — encouraging their use daily or weekly to screen large swathes of the population to identify and isolate infectious individuals.

Implementing that approach in the U.S. would require an enormous investment in manufacturing and distributing rapid tests — beyond the 1 billion tests the Biden administration recently said it would purchase.

“It comes back to what’s the purpose of testing, which we really haven’t clearly delineated,” said Michael Osterholm, an epidemiologist at the University of Minnesota. “When is it for confirming infection status? When is it being used to determine infectiousness? When is it being used to clear someone saying that today, you’re not infected? Each have a different purpose.”

Keeping the pipeline open

One thing is clear: We need more tests.

The first step is baking demand into the market with big federal investments, to avoid being caught flat-footed when cases surge. As vaccines rolled out last spring and summer, the number of people seeking tests fell. Testing sites closed, laboratories let staff go, and manufacturers destroyed unused materials. Then came the delta variant, followed by omicron — and testing struggled to keep up.

Biden’s pledge to secure 1 billion rapid tests “is a great start,” Aspinall said. “Is it enough? Likely not. We’ll have to see what comes after.” Large, long-term purchase agreements are needed, she said, akin to Operation Warp Speed, the federally funded program that helped bring multiple covid vaccines to market in record time. It did so in part by reducing the financial risk of vaccine development and manufacturing. That kind of investment in testing will keep manufacturers in the game and able to ramp up production quickly if necessary, she said.

Ensuring steady availability will also require shoring up the complicated supply chain for items as varied as nasal swabs and genetic sequencers. That might mean investing more in domestic production of some materials. “There are so many components that go into the testing process,” Becker said. “We need a body to focus on coordinating and matching supply and demand.”

The U.S. also needs more kinds of tests. “FDA has been conservative and very focused on ensuring the highest possible quality for authorizations of any tests,” Aspinall said. As a result, there are only 12 at-home tests authorized for use in the U.S., compared with over 40 in Europe. “To be fair, they’ve had more quality problems that we have, but there has to be a balance,” she said.

Speeding up the authorization process would bring more manufacturers, which could lower the cost of most U.S. tests (anywhere from $12 to $34) down to European levels (a few euros, or free). It could also help usher better tests onto the market, especially if the government funds more research in this area.

“There are exciting advances in testing that could bring us closer to tests that are both lower-cost and higher-sensitivity,” said Gigi Gronvall, an immunologist at the Johns Hopkins Center for Health Security.

Reaching people in need

All the tests in the world do little good if they don’t reach people in need.

As omicron cases swelled late last year, people seeking at-home rapid tests routinely ran into empty pharmacy shelves. Taking a PCR test often required standing in long lines, with results delivered days later.

“If you’re standing in line for 2 hours waiting for a test, that’s not a [supply] issue as much as an access issue,” says KJ Seung, a senior technical adviser to Partners In Health, a global health nonprofit organization. “There aren’t enough testing sites.”

Mass testing sites, run by FEMA or state governments, have been key in meeting demand during surges — serving hundreds to thousands of people each day. “But as soon as the surge is over, everyone says the pandemic is over, and sites get completely dismantled,” Seung said. Policymakers should plan out how to rapidly scale up these sites before a surge, not amid one, he added.

But mass testing sites can’t serve everyone, so governments also need to invest in maintaining smaller, more distributed options. The Biden administration has promised to expand distribution of free PCR tests by working with 10,000 pharmacies.

That still may not be enough to reach some of the communities hit hardest by the virus, which have often had less access to testing. “Low-income workers have been left behind by every aspect of the pandemic response,” including testing, said Julia Raifman, a public health policy researcher at Boston University.

Households can now get free at-home tests shipped to them through covidtests.gov. But logging onto a website is still a logistical hurdle for many — and unhoused people are shut out of the process. To fill those gaps, trusted community centers, like schools or churches, could become testing hubs. Mobile testing labs could target lower-income areas, and public health workers could go door to door with free tests.

“We need to develop systems for delivering vaccines, masks and tests to our lowest-income populations routinely, and we should be prepared to do this at the start of every surge,” Raifman said.

Modernizing how we track outbreaks

Testing isn’t just about diagnosing infection. It’s also about tracking how a pathogen — in this case, the coronavirus — spreads. The pandemic has revealed how woefully ill-equipped the United States’ patchwork public health system is for that task.

“There are no real federal guidelines for states to report testing,” said Emily Pond, an epidemiologist at Johns Hopkins Center for Health Security. That means some states may only report positive tests once a week, while others report positive and negative results daily. This mishmash of data isn’t always shared seamlessly; some localities still rely on fax machines or even snail mail. The rise of at-home tests further complicates the situation, as the results of these tests often go unreported. The incomplete picture that results limits our capacity to spot and stop surges early.

The Centers for Disease Control and Prevention has received hundreds of millions of dollars in emergency covid funding to address the situation. But it will take years, and continued spending, to modernize data systems across the country.

The agency is also trying to beef up its ability to sequence the genomes of coronavirus samples collected during regular testing. That can help virologists identify new variants and suss out whether they have worrying mutations. And epidemiologists use the data to trace chains of transmission in outbreaks.

The number of samples the U.S. sequences has gone from a few thousand each week in January 2021 to over 50,000 each week this month, but still trails what many other nations are doing. Denmark, for instance, sequences every positive test suspected to arise from a variant. South Africa’s network of public and private laboratories and universities were first to report the omicron variant, despite its circulation elsewhere.

“Before the pandemic, the amount of funds for genomic sequencing for the CDC and all the states was $30 million,” Becker said. In April, the Biden administration allocated $1 billion to expand genomic sequencing and support data sharing. But it will take sustained funding to maintain a surveillance system capable of quickly identifying new variants and new viruses, Becker said.

Will this time be different?

Better testing isn’t a silver bullet. “Tests by themselves are not going to solve this problem,” said Gronvall. But they’re a crucial tool in the country’s pandemic arsenal — one that can signal when someone needs to isolate or start a round of antivirals that could save their life, or when a dangerous new variant is beginning to spread.

Only time will tell whether the Biden administration’s scramble to buy and distribute rapid tests, and to set up another round of mass-testing sites, is the start of a new approach to testing.

“In the short term, I’m pessimistic, because once the surge passes people will say we don’t need testing anymore, so why improve [the] infrastructure” said Seung. “In the long term, I’m optimistic that we’ll fix the system, because this is just going to keep happening over and over again until we do it.”

Jonathan Lambert

U.S. covid testing is broken. Here’s how to fix it.