The United States still lacks a comprehensive COVID-19 testing strategy more than a year into the pandemic, as the spread of variants and increasing case counts threaten to undermine the effects of the vaccine rollout.
Some public health experts say the rise in new cases underscores the importance of a single, adaptable strategy as states lift restrictions amid spreading variants.
President Joe Biden is facing pressure to finish producing a national plan. In January, Biden signed an executive order creating a pandemic testing board that would develop a national strategy. Experts point to recent moves like a study on the use of free at-home tests and the pending formation of regional testing hubs as likely pieces of an administration plan that could come together this spring.
But developing a comprehensive national strategy isn't easy. The Department of Health and Human Services must walk the line between standardizing protocols and allowing flexibility for an endless number of scenarios as the pandemic evolves.
Experts say a successful strategy would condense guidance on an array of testing topics for the public, in addition to monitoring and working directly with individual states to respond to outbreaks that arise. The Trump administration faced backlash from Democrats over the lack of a national strategy, but calls waned after Biden took office and focus shifted to vaccines.
“The evolution of the pandemic means that your testing strategies have to evolve to keep with it,” said Ashish Jha, dean of the Brown University School of Public Health. “And I don't know that that's happening. I don't know that states know how to do that.”
Trump administration testing czar Brett Giroir oversaw monthly testing plans from state governments and launched federal testing sites in surge areas around the country. But many federal testing sites were abandoned in favor of vaccination sites.
In Michigan, case positivity rates are currently exceeding 15 percent, far above the recommended 5 percent threshold that suggests testing is keeping pace with the virus. The White House announced April 12 that it is deploying more federal resources to assist Gov. Gretchen Whitmer, a Democrat, including manpower and supplies related to testing.
The state tests around nearly 57,000 people per day and has all of the resources it needs, according to a Michigan Department of Health and Human Services spokesperson. But Jha said the testing numbers are extremely low considering that the state is home to nearly 10 million people. HHS should have acted to “flood the zone” with testing weeks ago, he said.
“There should have been a massive surge of testing in Michigan in the last few weeks because it would have been a really important part of breaking the cycle of infection,” he said. “There wasn’t.”
A spokesperson for HHS did not answer questions on when conversations began with Michigan about increasing testing resources, but pointed to existing guidance and funding the administration has released.
A successful strategy would shift to target populations where cases are occurring, Jha said. Right now, that means younger people, many of whom are not yet vaccinated.
“In my mind, it’s guidance about an overall strategy — where you should be deploying your tests, how much tests do you need on a per capita basis. How does it change based on your underlying infection rates — because the more infections you have, the more tests you need,” he said. “And what is the right mix of proactive and reactive testing? It's all available in little bits and pieces here and there but it's not pulled together in a coherent strategy.”
There is also still confusion around the differences between various types of testing and when to use them. Answers to testing questions are scattered throughout information from the Centers for Disease Control and Prevention and the Food and Drug Administration. The disjointed approach makes it difficult for local leaders and the public to find answers on common questions like what type of test is best for what situation and how to understand the results.
“The problem right now is that you have to spend most of your waking day searching on the website to figure out what to do with what test,” said American Public Health Association Executive Director Georges Benjamin, adding a comprehensive plan would "help people think through what they need to do.”
These questions are evolving with the pandemic. People can contract the virus after they have been vaccinated, particularly as the virus mutates. Schools are being inundated with testing supplies from the federal government that they’re sometimes unsure how to use. People also can buy testing kits themselves for use at home.
“What are they used for? When do you use them?” Benjamin said of at-home tests, adding that while the FDA website has some information, "people are making it up as they go along because they don't quite know.”
Harvard University epidemiologist Michael Mina pointed to a monthlong study the National Institutes of Health announced this month as evidence that the administration is beginning to answer these questions. Residents of two counties in North Carolina and Tennessee will get three free at-home tests per week for a month to gauge their success in reducing transmission.
“Had we had these tests in a widely scalable, at-home, simple-to-use fashion last summer we could have prevented hundreds of thousands of deaths. We could have prevented surges of cases,” he said. “Now we’re finally getting there. And some people might say it's a little too late, but it's not.”
Mina said regulatory restrictions, which the FDA has started loosening in recent weeks, are partly to blame for the lack of a national strategy. Last month, the agency opened a pathway for developers to earn emergency authorization for tests designed for repeat screening purposes. That type of action, combined with recent CDC guidance on serial screening programs, is laying the groundwork for a broader national strategy.
Confusion is especially obvious in schools. In March, the White House announced a $10 billion investment to help reopen in-person learning, sending a wave of testing supplies to school districts across the country. But guidance on how to set up testing programs is scarce.
Andrew Sweet, managing director of COVID-19 response and recovery at The Rockefeller Foundation, told CQ Roll Call that Biden’s testing czar, Carole Johnson, has been very active in discussions with a state testing network the group set up. But schools were still left with plenty of operational questions, prompting the group to release a targeted testing plan in March covering everything from workflows to testing types to communication techniques. (Kids at one school are instructed to put the swabs “boogers down” into the test tube.)
Examples of unanswered questions include how to find certified health care personnel if the school has no nurse on duty, how to report data on results and how to properly dispose of some materials.
“How can you make sure these additional burdens aren’t on the school?” Sweet said.
The administration is expected to finalize contracts this month for regional testing hubs to help fill some gaps. While much of the reopening focus is currently on schools, other congregate settings like offices will need more detailed guidance, too.
Long-term surveillance will be needed even as vaccinations increase. Genomic sequencing in particular is needed to track the virus’ evolution and the vaccines’ effectiveness against new variants.
A variant with two different mutations was recently identified in India, which increases concerns about its ability to evade detection.
“I really believe that the testing strategy is a system strategy, but it also has to fit in with the surveillance strategy, and the surveillance strategy is going to change,” Association of Public Health Laboratories Executive Director Scott Becker said.
Bart Buxton, president and CEO of McLaren Health Management Group, which provides testing services to McLaren’s hospitals and clinics throughout Michigan, said the virus even has the ability to mutate against antibodies in a test tube.
The amount of samples he is sending to the state lab for sequencing climbed 20 to 25 times in the past three weeks, he told CQ Roll Call. Standardization on genomic sequencing and data reporting are needed, in addition to funding, he said.
“We need more visibility on what's going on with these variants,” he said.
The White House on Friday announced a $1.7 billion investment to improve genomic sequencing.
Becker warned against putting out a “quick and dirty” plan simply for the sake of producing a strategy. A comprehensive plan should also foresee supply chain shortages that limited testing in the early days of the pandemic.
“My advice to Carole Johnson was don't rush into it,” he said. “Do look back on what's worked, what hasn't and move on from there.”