Report’s authors claim the US needs to be testing 20-million people per day in order to achieve ‘full pandemic resilience’ by August

Medical laboratory scientists and clinical laboratory leaders know that the US’ inability to provide widespread diagnostic testing to detect SARS-CoV-2—the novel coronavirus that causes the COVID-19 illness—in the early stages of the outbreak was a major public health failure. Now a Harvard University report argues the US will need to deliver five million tests per day by early June—more than the total number of people tested nationwide to date—to safely begin reopening the economy.

The report released by Harvard’s Edmond J. Safra Center for Ethics at Harvard University, titled, “Roadmap to Pandemic Resilience,” outlines a four-phase, three-pronged plan that includes a “massive” scale-up in clinical laboratory diagnostic testing, contact tracing, isolation, and quarantine to ensure a “path to pandemic resilience for a free society.” The approach to reopening the nation would span through August, during which 20% of at-home workers would return to offices and schools.

“We need to deliver five million tests per day by early June to deliver a safe social reopening,” the report’s authors state. “This number will need to increase over time (ideally by late July) to 20 million a day to fully remobilize the economy. We acknowledge that even this number may not be high enough to protect public health. In that considerably less likely eventuality, we will need to scale-up testing much further. By the time we know if we need to do that, we should be in a better position to know how to do it. In any situation, achieving these numbers depends on testing innovation.”

The report is the work of a diverse group of experts in economics, public health, technology, and ethics, from major universities and big technology companies (Apple, Microsoft) with support from The Rockefeller Foundation.

“This is the first plan to show operationally how we can scale up COVID-19 testing sufficiently to safely reopen the economy—while safeguarding fundamental American democratic principles of protecting civil rights and liberties,” Danielle Allen, PhD (above), Director of Harvard University’s Edmond J. Safra Center for Ethics, said in a statement that noted it was “in response to the US Department of Health and Human Service’s Report to Congress on its COVID-19 strategic testing plan.” (Photo copyright: Harvard University.)

Under Harvard’s Roadmap plan, massive-scale testing would involve rapid development of:

  • Streamlined sample collection (for example) involving saliva samples (spit kits) rather than deep nasal swabs that have to be taken by healthcare workers;
  • Transportation logistics systems able to rapidly collect and distribute samples for testing;
  • Mega-testing labs, each able to perform in the range of one million tests per day, with automation, streamlined methods, and tightly managed supply chains;
  • Information systems to rapidly transmit test results; and
  • Technology necessary to certify testing status.

“The unique value of this approach is that it will prevent cycles of opening up and shutting down,” Anne-Marie Slaughter, CEO of New America, said in the statement. “It allows us to mobilize and re-open progressively the parts of the economy that have been shut down, protect our frontline workers, and contain the virus to levels where it can be effectively managed and treated until we can find a vaccine.”

Is Expanding Clinical Laboratory Testing Even Possible?

But is such a plan realistic? Perhaps not. When questioned by NBC News about the timeline for “broad-based coronavirus testing” that was suggested as part of the Trump Administration’s three-phase plan to reopen the states, former FDA Commissioner Scott Gottlieb, MD, said, “We’re not going to be there. We’re not going to be there in May, we’re not going to be there in June, hopefully, we’ll be there by September.”

Ramping up US testing has been an ongoing battle. The CDC’s flawed test kit delayed testing at public-health labs and federal regulatory red tape stymied commercial laboratories from developing their own COVID-19 diagnostic tests. In addition, as Dark Daily reported, quality issues have affected COVID-19 tests offered by some in vitro diagnostics companies and individual medical laboratories in the US and other countries. (See, “Chinese Firm to Replace Clinical Laboratory Test Kits After Spanish Health Authorities Report Tests from China’s Shenzen Bioeasy Were Only 30% Accurate,” April 3, 2020.)

In recent weeks, however, US testing capabilities have improved. Quest Diagnostics, which had come under fire for its testing backlog in California, announced it now has the capacity to perform 50,000 diagnostic COVID-19 tests per day or 350,000 tests per week with less than a two-day turnaround for results. “Our test capacity outpaces demand and we have not experienced a test backlog for about a week,” Quest said in a statement.

And the FDA authorized the first diagnostic test with a home collection option for COVID-19 to LabCorp. Dark Daily reported on this development in “FDA Issues First Approval for At-Home COVID-19 Test to LabCorp’s Pixel; Other Clinical Laboratory-Developed At-Home Test Kits May Soon Be Available to General Public.”

CDC ‘Modifies’ Its Guidelines for Declaring a Person ‘Recovered’ from COVID-19

Furthermore, the CDC modified its guidance on the medical and testing criteria that must be met for a person to be considered recovered from COVID-19, which initially required two negative test results before a patient could be declared “confirmed recovered” from the virus. The CDC added a non-testing strategy that allowed states to begin counting “discharged” patients who did not have easy access to additional testing as recovered from the virus.

Under the non-test-based strategy, a person may be considered recovered if:

  • At least three days (72 hours) have passed since recovery, defined as resolution of fever without the use of fever-reducing medications;
  • Improvement in respiratory symptoms (e.g., cough, shortness of breath); and,
  • At least seven days have passed since symptoms first appeared.

For now, however, the focus will likely remain on testing for those who are infected, rather than for finding those who have recovered. As of May 30, the COVID Tracking Project reported that only 16,495,443 million tests had been conducted in the US, with 1,759,693 of those test showing positive for COVID-19. That’s closing in on the 10% “test-positivity rate” recommended by the WHO for controlling a pandemic, but it’s not quite there.

As testing for COVID-19 grows exponentially, clinical laboratories should anticipate playing an increasingly important role in the nation’s response to the COVID-19 pandemic.

—Andrea Downing Peck

Related Information:

Roadmap to Pandemic Resilience

Pandemic Resilience Roadmap

Quest Diagnostic Media Statement about COVID-19 Testing

Ex-FDA Chief Says U.S. Not Likely to Have Broad-Based Coronavirus Testing Until September

CDC: Discontinuation of Isolation for Persons with COVID -19 Not in Healthcare Settings

Quest Diagnostics COVID-19 Diagnostic Testing Figures

Summary of Recent Changes: March 23, 2020

The COVID Tracking Project: US Historical Data

Coronavirus Testing Needs to Triple Before the U.S. Can Reopen, Experts Say

Chinese Firm to Replace Clinical Laboratory Test Kits After Spanish Health Authorities Report Tests from China’s Shenzen Bioeasy Were Only 30% Accurate

FDA Issues First Approval for At-Home COVID-19 Test to LabCorp’s Pixel; Other Clinical Laboratory-Developed At-Home Test Kits May Soon Be Available to General Public