President Joe Biden seeks to reset the nation’s inconsistent coronavirus testing efforts with a $50 billion plan and more federal oversight.
Biden’s plan calls for a newly created Pandemic Testing Board to coordinate a “clear, unified approach” to testing for COVID-19, a marked difference from the Trump administration’s policy of states establishing their own plans with federal support.
Laboratories have ramped up production to more than 2 million tests each day, but stubborn problems persist. Some labs struggle to complete timely tests – particularly when demand surges – because of shortages of critical supplies.
Public health labs largely are not equipped to detect new coronavirus variants such as ones first identified in the United Kingdom and South Africa. And there's debate among testing experts on whether wider use of cheaper but less sensitive rapid tests will be the smartest path out of the pandemic.
Biden issued a flurry of executive orders Thursday, from mask mandates on federal property to reopening schools and accelerating vaccine shipments. Fixing the nation’s disparate testing system "will be the most challenging" of all, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.
Former Centers for Disease Control and Prevention Director Tom Frieden said Biden’s testing initiative fits with his broader, science-based plan to curb a pandemic that’s killed more than 415,000 people in the USA.
“This is a really challenging pandemic to deal with,” said Frieden, president and CEO of Resolve to Save Lives, an initiative of Vital Strategies. “Important as executive orders are, they are only the start of a major effort.”
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Calling a national testing strategy the "cornerstone to reducing the spread of COVID," Biden’s plan calls for more rapid antigen tests, supplies, lab capacity and genomic sequencing to keep better track of hot spots and new variants.
There are also tidbits for consumers. One executive order requires federal agencies to clarify insurers’ obligation to cover testing, even for people who have no symptoms. For those without health insurance, testing will be free, the order says.
Just as important as a national testing plan is the president's call for better data reporting and a willingness to level with the American public, Frieden said.
“President Biden has been very clear: We’re in it together,” he said. “It’s going to get worse before it gets better. These are all hard truths and important facts that need to be shared and lived. And they have been ignored for a year.”
The plan calls for federal agencies to use the wartime Defense Production Act to fix persistent shortages of testing and vaccine supplies, as well as protective equipment such as gowns, gloves and N95 masks.
When labs run out of critical supplies such as chemical reagents, plastic tips or swabs, it delays or prevents a lab’s ability to complete a test, said Dr. Patrick Godbey, president of the College of American Pathologists.
Godbey said labs finish tests within hours when all supplies are on hand. When labs can’t get supplies, some must ship samples to other labs to test, which delays results two days or more.
“I still can’t do all the tests I’d like to do,” said Godbey, laboratory director of Southeast Georgia Regional Medical Center in Brunswick. “If we can’t get the reagents necessary, we measure turnaround time in days.”
When testing demand surged this summer in Sun Belt states, labs in communities hard hit by COVID-19 routinely took one week or longer to complete results. Supply shortages snarled results at small and large labs alike.
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Public health labs have faced persistent shortages in testing materials since the beginning of the pandemic.
“Those are the kinds of situations where having the federal government step in can make a big difference,” Plescia said.
Biden’s plan calls for federal agencies to use the Defense Production Act or other “appropriate authorities” to accelerate manufacturing of a dozen types of supplies: N95 masks, gowns, gloves, test swabs, reagents, plastic pipette tips, testing machines, swabs, needles and syringes, rapid test kits and material for rapid antigen tests. The federal government can use the act to compel private companies to make critical supplies for national defense or national emergencies.
"We still have supply chain issues that we hope this (Biden's plan) will address," Godbey said.
Biden calls for wider use of rapid tests to complement lab testing in settings such as schools.
Molecular PCR (polymerase chain reaction) tests processed at labs remain the gold standard of accurate testing, but they are more expensive and results can take days to process. Rapid antigen tests can be performed outside labs and deliver results in 15 minutes.
Under the Trump administration, the U.S. Department of Health and Human Services purchased rapid testing machines for use in nursing homes nationwide. HHS bought 150 million Abbott BinaxNow portable, rapid tests tests for states, nursing homes, the Indian Health Service and historically Black colleges and universities.
Only one rapid test, made by Australia-based Ellume, has gained U.S. Food and Drug Administration authorization for home use without a medical provider's prescription. Several other companies are developing tests they hope to sell directly to consumers.
The Biden plan will establish a CDC support team to "fund rapid test acquisition and distribution for priority populations, work to spur development and manufacturing of at-home tests and work to ensure that tests are widely available."
The rapid tests are typically less sensitive than lab tests, which means they might not detect the virus in some cases. It's a scenario that concerns lab experts such as Godbey.
"I worry about inaccurate testing," Godbey said. "Bad tests are worse than no tests at all."
Others argue rapid testing makes sense when done frequently because they are likely to quickly detect when a person is infectious and prone to spread the virus to others.
"Even if the individual test lacks a certain sensitivity, you do that test on a frequent basis, that can really add a great deal of population security," said William Schaffner, a Vanderbilt University School of Medicine professor of preventive medicine and an infectious disease doctor.
He said it makes sense to deploy rapid tests in settings such as schools. If students, teachers and other employees are tested frequently with rapid tests, parents can gain confidence the school is safe.
"All of the sudden, the economy gets stimulated again because the parents can go to work," Schaffner said.
Michael Mina, a Harvard epidemiologist who has advocated for rapid antigen tests, said such testing can be quickly deployed. If the Biden administration authorizes the purchase and widespread use of these tests, they can be shipped directly to Americans homes, and "we can start seeing cases plummet."
"If we can do that, we can start to see cases come down dramatically across the country within weeks in a way that vaccines could never do in these first 100 days," Mina said.