The plan could help make home and point-of-care testing a more routine part of the nation’s strategy for managing the pandemic, which so far has relied largely on lab-based testing to detect cases and steer public health decisions.
Instead of waiting days for results from slower but more accurate PCR tests, more Americans could test themselves before returning to school, going to weddings or attending conferences, and get a reading in minutes. It’s part of a broader shift away from the restrictions that upended life last year and toward individual mitigation measures intended to help people protect themselves against a virus that isn’t going away anytime soon.
“Testing has been an underappreciated and under-resourced tool,” said Mara G. Aspinall, a biomedical diagnostics professor at Arizona State University. “This is a recognition of the importance of testing as part of our public health response.”
Demand for at-home tests has risen as the delta variant has caused cases to surge to levels not seen since the worst point of the pandemic last winter. Pharmacy shelves have been cleared of the popular BinaxNOW test and other consumer kits approved by health regulators in recent months. Google searches for “home coronavirus test” and related queries have also shot up, tracking with the surge in cases and the start of the new school year.
Nationwide, PCR testing has neared an all-time high, approaching 2 million per day at the end of August and topping 7.7 million in total in the past week. The number is still below what many experts have said is necessary to stay ahead of the virus. And it masks disparities in testing availability around the country.
Scott Becker, chief executive officer of the Association of Public Health Laboratories, said the lack of rapid testing became apparent last month as schools made them pivotal to their reopening plans, stretching an already limited supply. And the nation was already starting to neglect testing as a key flank of pandemic management.
“We don’t have the mass-testing sites we once did because those resources have gone to the mass-vaccination sites,” Becker said. “Quite frankly in the early part of the summer the trend was looking really good pre-delta, and there hasn’t been the demand for testing. Now here we are with delta and with the depletion of rapid tests, and it makes us very concerned we are in a very constrained environment.”
In his speech Thursday, Biden put the problem bluntly: “From the start, America has failed to do enough covid-19 testing.”
To boost the nation’s stock of rapid and at-home tests, the administration is harnessing its powers under the Defense Production Act, a wartime law used to ensure critical supplies are available during emergencies. The law has come up throughout the pandemic; Biden first invoked it in February to speed up production of vaccines, at-home tests and surgical gloves.
The administration is planning to spend $2 billion on about 280 million rapid tests and distribute them to a range of facilities, including community health centers, food banks, testing sites and shelters. Retail pharmacy test sites are also being expanded, and Medicaid will start covering at-home tests free for beneficiaries.
The private sector is also playing a role in the plan. Starting next week, Walmart, Amazon and Kroger will sell at-home rapid test kits at cost — up to a 35 percent discount — for the next three months, Biden said. (Amazon founder and executive chairman Jeff Bezos owns The Washington Post.)
“This is important to everyone, particularly for a parent or a child, with a child not old enough to be vaccinated,” Biden said Thursday. “You’ll be able to test them at home and test those around them.”
Officials declined to comment in detail Friday on how they intend to distribute the tests or why it was necessary to invoke the Defense Production Act, which allows the federal government to compel manufacturers to prioritize certain supply orders.
“The DPA ensures that the suppliers have prioritization across their supporting supply chains to ensure they can produce the tests the nation needs,” a Department of Health and Human Services spokesperson said in an emailed statement.
“Industry is primed to ramp-up production and tests will be distributed to support vulnerable populations and help control and reduce the spread of COVID,” the statement added. “The investments outlined as part of the President’s six-pronged plan are critical to keep communities safe, save lives and prevent transmission and potential outbreaks and get the pandemic under control.”
Aspinall, of Arizona State University, estimated that there were about 277 million rapid and at-home tests available in the U.S. supply this month. She expected a similar capacity next month.
She and others cautioned that the expanded testing would have only a marginal impact without a continued push for vaccinations and mask requirements. And its success in preventing infections and deaths will be limited if the tests don’t make it to the places most in need, said Julia Raifman, a health professor at Boston University.
“Testing is helpful, it’s another sort of individualistic approach. But I worry it won’t be accessible and people won’t be informed,” she said. “I think we have a long way to go to make sure they’re carried out in populations continuing to get hardest hit by covid.”
One testmaker, Abbott, says it is already revving up manufacturing and hiring additional employees to help with the workload.
“This surge in testing capacity means tens of millions more tests will be available in the coming weeks and months where they’re needed most to help stop the spread of this virus,” read an emailed statement from the company, which makes the BinaxNOW and ID NOW tests.
Another manufacturer, Quidel, said it was reviewing Biden’s plan and considering how it will respond “to the challenge for COVID-19 testing.”
“In the meantime, we continue to dedicate significant resources to further expand our manufacturing capability as we have been doing now for some time,” a Quidel spokesperson said.
Most take-home tests, including BinaxNOW and Quidel’s QuickVue test, are antigen tests that look for protein pieces of the virus. PCR tests detect the virus’s genetic material.
Home tests are less sensitive than PCR tests and tend to be better at turning up positive results in people who are symptomatic than those without obvious signs of illness. But they offer some key advantages. Results usually show up in 10 to 15 minutes. And they can be administered at the point of care — nursing homes, clinics, schools, private residences. Most PCR tests are administered at testing sites and need to be sent to labs, meaning turnaround time is almost always 48 hours or more.
Experts say they can also be an important tool for curbing asymptomatic spread of the virus, especially as evidence suggests breakthrough infections are more common than thought among the vaccinated, although overwhelmingly mild.
Expanding access to at-home tests would be a “game-changer” for physicians with small practices, especially those in areas where testing of any kind is hard to get, said Gerald E. Harmon, president of the American Medical Association.
“If you’re symptomatic on a Saturday, all we have in small-town communities is an emergency room,” said Harmon, who has a family practice in Georgetown County, S.C. Physicians could get a head start on recommending treatments, he said, without having to wait for PCR results.
“If somebody calls me and says, ‘Doc I’ve done this test at home,’ I know what the results are,” he said, “I don’t have to say, ‘Let’s get you tested and wait 72 hours.’”
Community health centers could benefit, too. Rapid test kits are not widely available at community health centers, which tend to rely on laboratories to process samples, according to Ron Yee, chief medical officer for the National Association of Community Health Centers. He envisions health centers prioritizing the highest-risk patients, such as the immunocompromised or people with preexisting conditions who face greater danger from even breakthrough infections, to send home with rapid testing kits that would be used by relatives and other members of their households when they return from trips or other places they could have been exposed to the virus.
“We are still working on the vaccines, but on the other side, the rapid tests are key to mitigating spread,” said Yee.
But testing at home instead of at doctors offices, drive-throughs and labs could also backfire if people aren’t reporting their cases for quarantine guidance and contact tracing. Some may not necessarily stay at home and avoid others even after testing positive for the coronavirus, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.
“We have a long-standing norm in this country that you go to work when you’re sick,” Plescia said, “so it is a bit of an uphill fight.”