The United States’ Covid-19 testing system is once again struggling to keep pace with surging infections, amid the monthslong push by the Biden administration and states to increase the country’s vaccination rate.
Testing labs nationwide have capacity to spare, but the closure of mass-testing sites run by cities, states or the federal government has resulted in many people waiting longer or traveling further to get a test. Nor have many schools or businesses implemented the widespread rapid testing that President Joe Biden called for last year, and that has helped countries such as Germany reopen while limiting infection.
Now test manufacturers, commercial and public health labs and public health experts are pushing the administration to do more to increase access to testing, amid fears that the highly transmissible Delta variant will continue to drive up infection rates this fall. These groups want to preserve hard-fought gains made during the pandemic’s first year — and to ensure that the lessons learned during earlier surges aren’t forgotten.
Biden will address the testing situation on Thursday afternoon, in what the White House is billing as a major speech laying out the next phase of the federal pandemic response. But it’s not clear how quickly any new initiatives to bolster testing would take effect. Although opening new mass-testing sites would be relatively easy, increasing production of over-the-counter rapid tests could take weeks or months because of supply-chain challenges.
“Communities moved away from mass testing sites because there was not the demand, and that needs to be reversed,” said Scott Becker, CEO of the Association of Public Health Laboratories. “And we need to have a consistent approach to easy access for testing, be it rapid testing or lab-based testing with an increase in collection sites.”
Tests were unavailable to many Americans early in the pandemic, a failure that helped fuel the first wave of infections. Over the intervening months, private companies and government at all levels worked to make tests easier to come by — reaching a point where U.S. labs were evaluating millions of samples each day.
But as vaccines rolled out this year and the number of new infections dropped, so did demand for testing. By July, U.S. labs were processing fewer than 200,000 tests per day. That trend has flipped in recent weeks with Delta’s rise, with the nation now recording more than 1.5 million tests daily.
Yet in many hard-hit states there are signs that testing is falling behind the virus. Test-positivity rates, one measure of availability, have soared above 20 percent in some parts of the Southeast. That’s well beyond the target of 5 percent or less recommended by many public-health experts.
“The shift of testing sites to mass vaccination centers drove access to critically needed vaccinations,” trade groups representing Covid-19 test makers and testing laboratories wrote to the White House last week. “However, reopening sample collection/testing sites is necessary to leverage the laboratory capacity available to increase testing, particularly in the two dozen states with over ten percent positivity during this surge.”
Asked about the country’s current capacity, the Department of Health and Human Services pointed to the approximately 8,275 pharmacies and 235 federal sites that are part of the department’s community-based testing program. And 1,602 institutions have signed up to participate in “Operation Expanded Testing,” the federal network of regional coordinating hubs tasked with expand access to tests in K-8 schools and congregate settings like homeless shelters, according to an HHS spokesperson.
But the effort to expand testing in schools has fallen short of the administration’s original vision. The coordinating hubs have helped conduct more than 500,000 tests to date — but the public-private partnership once aimed for 25 million tests per month. And with students back in classrooms across the country, some public health experts are concerned that the return to in-person schooling will drive up infection levels in more regions of the country in the coming weeks and months if testing is not expanded.
“Delta is highly contagious and hard to control,” Scott Gottlieb, who led the Food and Drug Administration under President Donald Trump, tweeted Wednesday. “With more schools reopening in northeast, we must double down on efforts to prevent outbreaks. A missed opportunity is use of routine screening tests to identify outbreaks, avoid quarantines.”
But supply of the rapid tests has been not been able to keep up with demand, and results from the tests are reported to public health authorities infrequently. CVS recently limited how many of the rapid tests customers can purchase at one time, citing supply problems. The 51.5 million Covid-19 tests recorded by the CDC in August included 11.5 million rapid antigen tests. But HHS estimates that the number of rapid tests actually performed was much larger: 80.2 million.
Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials, noted that many federal and state-supported testing sites were converted to vaccination centers in recent months. Now some state and local public-health departments have reopened testing sites.
“States, particularly where they’re having sort of the biggest surges are beginning to reopen and expand some of those sites,” Plescia said. “Most of our conversations with the state health officials has been that the testing has been manageable until recently. There is also a lot more private sector testing going on, and then the advent of at home testing. So I think that’s taken some of the demand off as well.”
Major commercial labs continue to report fast average turnaround times for Covid-19 testing: Quest Diagnostics says it is returning a majority of results within one day despite the Delta surge. The company announced last week that it was adding more testing machines to labs that serve regions with “comparatively high” demand.
But industry sources said testing capacity remains high in part because it has become more difficult for Americans to access testing. As a result, lab capacity is not being fully used.
“What we need is a continued aggressive focus on vaccinations, but at the same time, make sure that testing is a priority,” one industry source said.
The Biden administration has begun to address the current testing shortfalls. Last week, it listed the ability to rapidly deploy daily at-home tests — in part by stockpiling supplies — as a priority of its proposed $65.3-billion overhaul of the nation’s pandemic preparedness efforts.
In their letter to the White House last week, labs and test manufacturers argued that the Centers for Disease Control and Prevention should directly contract with specialized labs to retain staff, equipment, testing supplies and facilities needed to scale up capacity when necessary during an emerging pathogen threat.
“Strengthening public-private preparedness collaboration with the CDC and private sector laboratories and diagnostics manufacturers is critical to ensure up to date diagnostics are available and rapidly deployed, and laboratory capacity is maintained,” the American Clinical Laboratory Association and AdvaMedDx wrote.
Sung-Dae Hong, vice president and general manager of laboratory plastics essentials at Thermo Fisher Scientific, told POLITICO that the availability of pipette tips and other disposable plastic supplies needed for lab-based Covid-19 testing has been limited since mid-2020. When demand for Covid-19 testing fell earlier in the year, non-Covid-related orders for many of the same products surged.
“Now with the impact of the Delta variant and the increase in testing, demand obviously continues to be very strong,” he said. “For a lot of our products, we’ve been out of capacity for well over 12 months. And we continue to have a significant gap between what we would love to serve, versus what we are able to serve.”
The Biden administration recently announced it was awarding a $192.5 million contract to a Thermo Fisher Scientific subsidiary aimed at increasing monthly production of pipette tips at a North Carolina factory to 160 million a month. That project is not expected to be completed until August 2024.