Some government officials and researchers are pinning their hopes for an economic recovery on the creation and widespread utilization of antibody tests that can identify who has immunity to COVID-19.
People who contract the novel coronavirus report varying degrees of illness; some are asymptomatic, others are sick but able to recover at home on their own, and about one-fifth are severely ill enough to be hospitalized. For the individuals who are asymptomatic or those who do recover, a serological test that can identify COVID-19 antibodies could allow them to return to work or reduce the level of social and economic lockdown restrictions that many Americans face today.
“This would be a game-changer in restarting parts of the economy more quickly and safely,” Dr. Harvey Fineberg, a professor in the Harvard T.H. Chan School of Public Health, wrote in an April 1 editorial in the New England Journal of Medicine.
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The Food and Drug Administration has said there are two use cases for serological tests: they could one day help decide whether people can return to work, and they could identify who has recovered to see if they can donate plasma that may be used as a treatment for people with severe forms of the disease caused by the novel coronavirus.
In the U.S., more than 402,000 people have tested positive for COVID-19 and at least 13,000 have died, according to data aggregated by Johns Hopkins University.
“We think it will be a tool to help us get people back to work,” FDA commissioner Dr. Stephen Hahn said Saturday during a press briefing. “It’ll be additional information because, as you know, if you have an antibody, that means you are exposed and have recovered from it. That, with the information about diagnosis, should help.”
A growing chorus of political leaders, both in the U.S. and abroad, have started to talk about how widespread antibody testing could help restart economies that have all but been halted by the arrival of the virus in their communities. The testing has been mentioned by a handful of U.S. governors, Trump administration officials, and leaders in the U.K. and Canada over the past week. In Singapore, which has 1,623 cases and only six deaths, health officials have been using a serology test since late February, according to Science.
“The serological tests are also something that is being looked at very, very carefully,” Canadian Prime Minister Justin Trudeau said Tuesday. “We [are] still in the early days of reflecting, not just on the medical implications but on the societal implications of those tests as well.”
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Only one antibody test has received emergency use authorization in the U.S., according to the FDA. (As part of the administration’s response to the pandemic, the FDA is using its emergency powers to grant temporary authorizations to certain tests and treatments given the lack of alternative options for COVID-19. An EUA doesn’t indicate that the FDA approved or cleared the therapy or test.)
That company is Cellex Inc., a privately held company with research operations in Research Triangle Park, N.C. Separately, Stanford Medicine is running a project testing volunteers in California’s Santa Clara County to see if they have been exposed to the virus, with a goal of obtaining FDA authorization for its serologic test, a spokeswoman said by email. The Centers for Disease Control and Prevention has also said it is building a serological test, while New York Gov. Andrew Cuomo said this week that the state’s health department had developed an antibody testing regimen that will seek FDA authorization.
The FDA said Tuesday that more than 70 companies have told the agency that they have serological tests; however, some companies are reportedly claiming their tests are approved, authorized or can diagnose COVID-19 when they are not or cannot.
That said, questions about fraudulent tests aren’t the only concern when it comes to serological testing. Other experts have raised questions about the downstream effects of tests that are sometimes inaccurate as well as the feasibility of testing many millions of people. So far, the U.S. has conducted a total of 1.7 million tests to diagnose COVID-19, counting tests performed by both public and private laboratories, in a population of roughly 330 million.
Cuomo has talked up the potential to allow people in New York to return to work or school but also acknowledged the challenges within that process. “You have to have that testing on a scale, right?” he said during a news conference. “You have 19 million people in the state of New York. Just think of how many people you would need to be able to test and test quickly.”
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Last week, Evercore ISI’s Josh Schimmer argued that a serological testing-based strategy to free up the workforce isn’t practical — the best test he’s seen so far has 90% sensitivity, meaning it is not 100% accurate in detecting the presence or lack thereof of antibodies.
“Can you imagine if it turned out that 30% to 70% of patients who were told they have COVID immunity actually didn’t?” he wrote in an April 2 investor note.
However, not all analysts share that view.
“Mass antibody testing, assuming it becomes available with a sufficiently high accuracy rate from the end of this month or from the beginning of May in some countries, could help to identify immune individuals,” J.P. Morgan analysts wrote in a note on Tuesday. “Identifying these individuals and allowing them to return to work could facilitate the normalization process.”
