The Trump administration's latest effort to use COVID-19 rapid tests — touted by one senior official as a "turning point" in arresting the coronavirus's spread within nursing homes — is running into roadblocks likely to limit how widely they'll be used.
Federal officials are distributing point-of-care antigen tests — which are cheaper and faster than tests that must be run by a lab — to 14,000 nursing homes to increase routine screening of residents and staff. The initial distribution targets nursing homes in hot spots and those with at least three COVID-19 cases, senior Trump administration officials said in July, hailing it as a tool that could root out asymptomatic carriers who might still infect others.
But there's a hitch: Two manufacturers that have received Food and Drug Administration authorization and whose instruments are being delivered — Becton, Dickinson and Co., known as BD, and Quidel — say their antigen tests are intended for patients with symptoms, calling into question how valuable the tests would be for broad screening purposes. The Centers for Disease Control and Prevention estimates 40% of infected people may be asymptomatic.
"It's important always to use a diagnostic in the way that it has been designed to be used," said Elizabeth Talbot, New Hampshire's deputy state epidemiologist. "We simply don't know how [the tests] will perform in persons who are asymptomatic."
Perhaps the highest-profile example of the problem occurred in Ohio this month, when Gov. Mike DeWine had no symptoms and tested positive for COVID-19 with Quidel's antigen test. Within hours, the Republican governor's diagnosis was reversed after he got a PCR test.
"People should not take away from my experience that testing is not reliable or doesn't work," DeWine said on CNN after his false-positive diagnosis. "The antigen tests are fairly new," he said. "We're going to be very careful in how we use it."
The bigger problem is false-negative results, which show someone isn't infected when they actually are. BD's false-negative rate — how often a test incorrectly says someone isn't infected — is about 15%; Quidel's is 3%.
Quidel and BD say their tests are intended to be used for people within the first five days of showing symptoms. A spokesperson for BD said its test should not be used on asymptomatic individuals. Quidel through a spokesperson deferred to FDA guidelines, which allow asymptomatic testing in certain scenarios.
"For routine surveillance, this is a great tool and these are our best tools that we have available," said Adm. Brett Giroir, assistant secretary for health at the Department of Health and Human Services, on a July call with nursing home officials, according to a recording obtained by KHN. Seema Verma, the administrator of the federal Centers for Medicare & Medicaid Services, on the call referred to the effort as a "turning point" in the fight against the virus.
A month after the initial announcement, the Trump administration invoked the Defense Production Act to bump its contracts with the two companies to the front of the line and expedite shipments. BD will send roughly 11,000 devices and 3.75 million tests to nursing homes; Quidel and HHS declined to answer questions about its volume.
As states and the federal government move to mandate COVID testing inside nursing homes, whose patients are deemed highly vulnerable to infection and severe complications, several industry officials have said they hoped to use the tests on asymptomatic people. But many states restrict the use of antigen tests or still require lab-based testing because of accuracy concerns.
If a person with a negative test result has to default to getting a more accurate PCR test, "then we simply have just added time and cost," Talbot said. "That's a problem."
Officials said the antigen test announcement caught them by surprise, underscoring the administration's chaotic testing strategy. Separate from the federal effort, 10 states have banded together through the Rockefeller Foundation to secure 5 million tests from the two companies in hopes of curbing the virus's spread this fall.
After nursing homes receive an initial batch of tests — each facility gets between 150 and 900 — they would have to buy future supplies. Medicare will cover the costs of diagnostic tests but not expenses for routine surveillance.
"I just have a lot of skepticism," said Brendan Williams, president of the New Hampshire Health Care Association, which represents nursing homes and assisted living facilities in the state. "Basically you're giving some lousy tests for nursing homes and you're making them pay for them. I don't see that as a win; I see that as a risk."
Public health experts have become increasingly vocal that frequent rapid testing is the best tool for stopping the virus — which has killed more than 174,000 Americans including tens of thousands in nursing care — rather than relying on more accurate lab-based tests that have been plagued by delays and shortages. In a call this month with the industry, Verma estimated that half of the country's nursing homes have experienced cases.
"I don't see an avenue where these will not help to stop transmission chains, and I don't see another option on the table for us," said Dr. Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health and a proponent of rapid tests. "It is what we need to be doing right now."
"This is better for the folks in our buildings, without a doubt," added Jason Belden, director of emergency preparedness and physical plant services for the California Association of Health Facilities.
In theory, antigen tests can serve dual purposes — diagnosing a person with a suspected infection or screening a group of people to more quickly identify sick individuals. The tests by Quidel and BD, under their FDA authorizations, can be used on certain asymptomatic individuals, including those suspected of having COVID-19 after exposure to an infected person. The companies would need additional FDA authorization to screen any asymptomatic person regardless of whether they're suspected of being sick, according to agency guidelines.
The CDC has suggested antigen tests could be useful in high-risk settings if performed repeatedly. It said there was limited data to guide using them to screen asymptomatic people.
Nonetheless, HHS recommends universal screening of nursing home residents at least once and regular screening of staff regardless of symptoms, said agency spokesperson Mia Heck, citing the fact that COVID-19 viral loads are similar between patients with and without symptoms. "Only one test in the U.S. is authorized for asymptomatic individuals," she said, referring to a PCR test from LabCorp, "yet the overwhelming majority of testing is being done on asymptomatic individuals."
"If the world were ideal we'd say, 'Oh, we want the more accurate test.' But the more accurate test takes forever to get the results back," said Peter Van Runkle, executive director of the Ohio Health Care Association, which represents the state's nursing homes.
All targeted nursing homes will receive tests by the end of September, according to federal officials, who recently announced that facilities in states with a positivity rate of at least 5% must test staff each week.
"I don't see this as a federal strategy so much as a stopgap method to bring a little relief to nursing homes," said Katie Smith Sloan, president of LeadingAge, which represents nonprofit nursing homes. "It's really tragic that we are where we are right now."
Boosted by $71 million in federal funds for Quidel and $24.3 million for BD, Quidel plans to produce 1.8 million tests weekly by September; BD will produce similar volumes by October.
"The situation is much too urgent to wait a few months so we can put bows and lipstick on the program. So we're going to build this plane a little bit while we're flying it," Giroir told nursing homes in July. "Just work with us. We want to get you what you need. And then in September, October you can get what you want."
States take different approaches in deploying antigen tests in nursing homes; in at least seven — including California, Illinois and Maryland — officials say PCR tests should still be used to confirm results or to screen patients without symptoms. In Massachusetts, nursing homes must use PCR tests to meet surveillance requirements.
In Maryland, "our goal is to screen out staff who are positive as quickly as possible, particularly asymptomatic folks," said Dennis Schrader, chief operating officer of the health department.
Maryland nursing homes can use antigen tests for weekly staff testing if there isn't an outbreak. But if at least one person tests positive for the coronavirus, all staff and residents must be tested with PCR tests.>