Why does the United States, with only about 4% of the world's population, account for 25% of global COVID-19 cases and 22% of deaths? Because, at the start of the pandemic, the nation failed to rapidly and widely test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Since then, the development of a testing infrastructure has been prevented by supply chain issues, political infighting, and an administration that designated meat processing plants as pandemic "critical infrastructure" but not coronavirus testing or the manufacturing of personal protective equipment (PPE).
In dozens of other countries, the virus has been contained by rapid and aggressive testing policies that made it possible to isolate infected people and quarantine their contacts. Yet, in the United States, "the federal government has consistently underestimated the need for urgency around testing for this virus," Sandro Galea, dean of the Boston University School of Public Health, told BuzzFeed News.
HOW DID THIS HAPPEN?
In mid-January, the World Health Organization (WHO) began distributing a SARS-CoV-2 diagnostic test devised by the German Center for Infection Research. As in many past infection outbreaks, the Centers for Disease Control and Prevention (CDC) chose to develop its own test for use in the United States and, on February 5, sent it to state and local public health laboratories. By February 12, it was clear that a reagent problem with the CDC test had led to inaccurate results.
Usually, well-equipped public health labs can use the technical information posted by the WHO and the CDC to devise their own tests in place of a faulty CDC kit. But Food and Drug Administration (FDA) regulatory hurdles, enacted as part of the federal government's declaration of the public health emergency, stopped both public health and private sector labs from quickly deploying start-up tests of their own. The CDC alone continued to process a limited number of diagnostic tests for the new virus, until late February, when the FDA began allowing some labs to modify the CDC test.
The inability to create a robust testing infrastructure in the United States during these first critical weeks left the country unable to track the rapidly unfolding outbreak. By the end of January, other countries had enlisted private sector labs to ramp up test production. As reported February 28 in Science, China had five commercial tests on the market in late January; a month later, it was performing 1.6 million tests each week. South Korea, with far fewer resources, had ramped up to 65,000 tests per week by the end of February. At this point, the United States had processed only 459 tests.
WHY TESTING IS SO IMPORTANT
Testing for SARS-CoV-2 has been essential during this pandemic for more than tracking infections and tracing contacts. Testing guides patient care, helps us to better understand transmission, warns hospitals of impending surges, and signals the need for increased mitigation measures in the community. Without increased testing capacity, U.S. clinicians were "flying blind" as the virus spread across the country.
By March, workarounds to the CDC test had enabled state and local public health laboratories and some academic labs to increase testing capacity. But some private labs were prevented from operating at full capacity by logistical problems, such as software incompatibility and existing contracts between labs and hospitals.
Washington State and New York, along with other northeastern states, were the first parts of the country to experience significant outbreaks of the virus and by late March were seeing exponential increases in COVID-19 cases. However, except for hospitalized patients, it was almost impossible to be tested for the virus. Many people with COVID-19 symptoms who didn't need to be hospitalized were sent home to recover and never tested. Their numbers would never be added to official case counts. Even heavily exposed health care workers, working without adequate PPE, and contacts of known cases often could not be tested. (Many experts believe that true case counts in the United States are five, 10, or even 25 times greater than posted tallies.)
As COVID-19 spread globally, the supply chain for testing materials-reagents, pipettes, and viral testing swabs, for example-was drying up. Weeks into the epidemic, the United States not only lacked a coherent testing infrastructure but also was competing globally for testing components. One of the largest manufacturers of nasopharyngeal swabs was based in Lombardy, Italy, a region that, during the early spring, was the COVID-19 epicenter of Europe. Many of the testing machines in use were not designed for round-the-clock operation. With increasing frequency, samples for COVID-19 testing were queued at commercial laboratories. For all but the highest priority tests (for example, hospitalized patients and symptomatic health care workers), waits of more than a week for results became common.
THE NEED FOR A NATIONAL STRATEGY
By the middle of this year, U.S. testing capacity had increased from 1 million to 4.5 million tests per week-nowhere near the estimated 30 million tests per week needed to suppress the virus, which, by that point, was spreading out of control nationally. And where testing was available, it was unevenly distributed. Communities of color (who are at higher risk for death from the virus), low-income families, and essential workers often couldn't access testing, while elite organizations, such as professional sports leagues, had no trouble obtaining tests.
Yet, in mid-July, as the number of new U.S. COVID-19 cases topped 60,000 per day, the Trump administration continued to deny its failure to create a testing infrastructure. Instead, the president has described U.S. testing on Twitter as "so massive and so good," while the vice president has referred to the "extraordinary national success in testing."
Experts disagreed. As Lauren Sauer, director of operations at the Johns Hopkins Office of Critical Event Preparedness and Response, told the Atlantic at the end of June, "We basically need a Manhattan Project for testing. A nationwide, systematic strategy with a clear agency lead is desperately needed."
Without a national strategy, academic organizations and private foundations attempted to fill the leadership gap. From the beginning of the pandemic, the Center for Systems Science and Engineering at Johns Hopkins University has maintained an invaluable resource, a COVID-19 dashboard displaying and analyzing COVID-19 case counts, deaths, and testing (see http://www.covidtracker.com). The Center for Infectious Disease Research and Policy at the University of Minnesota released a white paper on "smart testing," an approach that could optimize the U.S. limited testing capacity. And, in April, the Rockefeller Foundation gathered scientists, economists, technologists, industry representatives, and others to put together an action plan to expedite the development of a COVID-19 testing and tracing system.
In August, governors (three Republicans and four Democrats) of seven states-Louisiana, Maryland, Massachusetts, Michigan, North Carolina, Ohio, and Virginia-banded together to obtain their own supply of tests. With help from the Rockefeller Foundation, they hope to bypass the lab testing bottleneck by purchasing a total of 3.5 million point-of-care rapid tests for use in their states. They have invited other cities and states to join their compact.
Regardless of the outcome of such strategies, the Rockefeller Foundation estimates that an investment of $75 billion is necessary to make testing in the United States free and available to all. Although this sounds like a very large investment, the number pales in comparison to the cost of stay-at-home "shutdowns"-estimated to be $300 billion to $400 billion monthly-the only alternative in the absence of a national testing strategy and while viral transmission remains out of control. As the Rockefeller report emphasizes, "Testing is the only way out of our present disaster."-Betsy Todd, MPH, RN, clinical editor