The Centers for Disease Control and Prevention (CDC) recently announced a $10 billion plan for frequent school COVID testing but there are questions about how the funds will be distributed and testing availability, plus concerns that current FDA regulations could slow down the speed at which school COVID tests are administered.
What Does the School COVID Testing Plan Call For?
Funds from the American Rescue Plan will be allocated to states and certain cities for school COVID testing. The goal is for regular testing of all students to limit outbreaks and allow schools to continue in-person learning.
Before he took office, President Joe Biden pointed to frequent school COVID testing as an important component of his plan to have all K-8 U.S. schools open for in-person learning this spring. The plan calls for deploying more rapid antigen tests and building infrastructure to more quickly analyse pooled PCR tests, which measure the RNA of the virus. These are technically more sensitive than antigen tests, which measure a protein that is part of the virus. But antigen tests can be better at detecting contagious individuals and are inexpensive, can provide results within minutes, and do not need to be analysed at a lab.
The announcement of the school COVID testing funding came the same week as the CDC updated its guidance on testing to encourage more testing of non-symptomatic individuals and the Food and Drug Administration moved to allow some developers of COVID-19 tests to market their products for at home use.
Why is School COVID Testing Still An important Strategy?
Michael Mina, MD, PhD, professor at Harvard T.H. Chan School of Public Health, says the school testing plan along with the CDC and FDA updates are a step in the right direction.
“This is all really good news that I think is at least helping us stay on the coattails of our peer nations,” says Mina, a prominent advocate for more rapid testing. “Many countries have moved forward already with getting these types of tests out.”
Even with American vaccination levels rapidly increasing, quick and frequent testing may be important longterm to help combat variants of the virus. “Mutations are increasingly worrying and so having other tools in our pocket to be able to mitigate spread, if and when that's needed [is important]. If vaccines aren't doing all that we're hoping that they will, this is going to be increasingly helpful,” Mina says.
How Will School COVID Testing Work?
The CDC will work with regional and local health departments to help schools implement COVID screening programs but details are still forthcoming. “Every state is really going to be handling school testing very differently,” Mina says. “Each state has their own HHS or some other public health authority that's making decisions, and that does make it a complicated mix.”
School officials should continue to work closely with state and county officials to see what types of tests are available, but supply could be an issue as existing manufacturers can’t keep up with demand. “Even if the CDC wants to give really clear guidance, which they just did, there's just no tests available for the schools to really be able to purchase,” Mina says.
What Are Some Hurdles to Implementing Widespread School COVID Testing?
Schools still need Clinical Laboratory Improvement Amendments (CLIA) waivers to conduct testing.
“CLIA waivers are still needed by every school and prescriptions are still needed,” Mina says. But some states are figuring out workarounds. “Texas, for example, just said, ‘We're giving a blanket CLIA waiver to every school for asymptomatic testing.’ Essentially, that's Texas’ way of getting around the FDA requirements as a whole state.”
Mina doesn’t think waivers or prescriptions should be necessary. “At this point in the pandemic nobody, no American, especially school kids, should have to be prescribed a test by a physician and have extra cost added and complexity,” he says. “I would like the President to make a presidential order that declares these tests as public health tools that don't require prescriptions. That all of a sudden takes a big burden off of the schools. Right now, the schools have to go and apply for CLIA waivers and find physicians to write their prescriptions.”
Will These Regulations Change?
A reporter asked about these waivers at a CDC press conference on March 17 announcing the new funds for school testing. “We’re putting these resources out to help schools plan, but we continue to work on the policy background here. And there continues to be work to do,” said Carole Johnson, the White House Testing Coordinator. “We have seen some states do some creative work around CLIA waivers, and we have seen some work from the Department of Health and Human Services to make it easier to access CLIA waivers. And we’re going to continue to work on that issue.”
How Do We Know School COVID Testing Works?
The Biden Administration plan grew from the calls of public health experts who touted the benefits of frequent screening tests of non-symptomatic individuals as well as the Rockefeller Foundation’s rapid school testing plan that was published in December. Early results from six K-12 testing pilots, funded by the Rockefeller Foundation and an independent assessment of school testing programs across the country, found weekly testing of all students, teachers, and staff reduces in-school infections by an estimated 50 percent. Since January San Antonio ISD has tested about 70 percent of its staff with a mix of PCR and rapid tests, and the positivity rate in schools has been only 0.8 percent. Other districts in the U.S. with aggressive testing strategies have also had positive outcomes.
“Since we released the findings from our report in December, the data is encouraging: schools are reopening safely around the country,” said Dr. Rajiv J. Shah, president of The Rockefeller Foundation in an email. “We appreciate President Biden’s commitment to building on this early success and making it sustainable, and we look forward to working with the HHS as well as our partners in public health, education and governments around the country to continue to implement our plan’s recommendations and get children back in the classroom.”