The Test’s the Thing

T he White House is now balancing the risk to public health and the risk to economic welfare posed by the coronavirus crisis. Yet a solution could be on the horizon. The key is to make cheap, rapid testing available to every individual, regardless of symptoms.

Up to now, the White House has called for health-care providers to focus limited testing resources on those people most likely to be infected, so that COVID-19 cases can be isolated and treated appropriately. But constraining testing in this way comes at a cost: We have no idea how many people are actually infected and how likely they are to become ill or die, making it impossible to determine who should be isolated and how many people will need treatment.

Studies suggest that the overwhelming majority of people infected with the new virus show only mild symptoms or none at all. The actual number of infected is thus likely far higher than the number of confirmed cases, because many may never realize they were infected. So the real mortality rate is likely a fraction of what we thought it was just a few weeks ago, and “herd immunity” could be spreading faster than we thought.

The absence of widespread testing has forced officials to both balance public health against economic well-being and allocate urgently needed health-care resources based on inadequate data. The optimal way to impose social-distancing measures and direct scarce ventilators and personal protective equipment to the places that need them most is to know where the infections are before more people get sick. That’s why it is urgent to move to population-survey testing.

The FDA’s adoption of more flexible Emergency Use Authorization guidance has freed up large and small manufacturers and laboratories to develop new, rapid tests for the virus. The FDA guidance is also allowing states to certify their own laboratories without FDA involvement. Following the new FDA guidance, the daily number of tests in the U.S. doubled, to more than 10,000, and it will keep rising as we move forward. The widespread availability of testing will create an opportunity for nationwide random sampling to ascertain where the infections are and where onerous health measures and limited resources are most needed.

The government cannot readily require people to undergo a medical test. But it can call for volunteers to get tested across the country, and from among those volunteers, select a sample that is normalized for key population factors. Based on the lines forming at testing sites, there should be no shortage of test-takers. The result would be an immeasurable improvement in the value of the government’s epidemiological surveillance.

Ultimately, expanded testing for the virus, which indicates an acute infection, must be paired with testing for antibodies to the virus. The latter will indicate whether a person has ever been infected and, if they no longer test positive for the virus, show that they have recovered and are now immune, so that they can resume their normal life. Knowing the total number of people infected will generate valuable information on how contagious the virus is, how likely it is to make people sick versus remaining asymptomatic, and how many of those sick people will become seriously ill.

While a transition to population-survey testing would be a dramatic improvement, the ultimate goal should be to move from population-survey testing to universally available testing, so that every individual can get a rapid, cheap test on demand. This will allow individuals to provide health planners with more complete information and make informed decisions about their health care and behavior. Those who test positive for the virus and do not need hospitalization could be required to self-quarantine on pain of tort liability or criminal penalties. Test kits linked to smartphone apps could allow manufacturers to both report anonymized data to the CDC and verify your identity so that you can certify that you are not infectious at the entrance to an airport, restaurant, or football stadium.

The next step will be to move testing out of the lab and into the home, making it more affordable, rapid, and widely utilized. The British government recently announced that it is ordering millions of “finger-prick” immunoassay tests, which detect antibodies to the coronavirus. The same immunoassay technology is also being adapted to test for coronavirus antigens, which will, like the current lab-based PCR tests for the virus, reveal active infections.

Universally available, rapid testing for both the virus and antibodies will give individuals and officials the crucial information they need to end the pandemic and return the country to normal. The FDA should relax its guidelines for new testing technology as much as possible to allow our innovative private sector to find the solution to the COVID-19 crisis.

Joel Zinberg is an associate clinical professor of surgery at the Mount Sinai Icahn School of Medicine. Mario Loyola is a senior fellow at the Competitive Enterprise Institute and a program affiliate scholar at the Classical Liberal Institute of New York University School of Law.