The Jefferson Health System has enough high-tech lab machines to process 10,000 diagnostic tests for the coronavirus every day.
Instead, the Philadelphia-based network of 14 hospitals is doing only about 1,000 tests a day.
The problem, Jefferson Health president Bruce A. Meyer said last week, is that hospitals across the United States are grappling with a global shortage of testing chemicals and nasal swabs.
“If we could do 10,000 tests a day, we would. We’d like to test our entire staff,” Meyer said of the system’s 25,000 employees. “We are worried we have asymptomatic virus [spreaders] in our workforce.”
Reopening the U.S. economy will trigger a resurgence in COVID-19 hospitalizations and deaths unless there is widespread, timely, repeated diagnostic testing of people with — and without — symptoms, public health and government leaders agree. Lifting shutdowns methodically also requires testing for antibodies, a sign of immunity, in people who have recovered from the respiratory disease.
Yet, three months into the crisis, this country’s testing capacity remains woefully inadequate. Even nursing homes don’t have access to enough diagnostic tests to control outbreaks that have so far killed more than 10,000 of their residents.
Last week, Congress took a step toward filling the void, passing a spending bill that includes $25 billion to expand diagnostic and antibody testing. It covers research, validation, manufacture, and administration of tests; production of related supplies; workforce training; and coronavirus surveillance.
Still, those on the front lines worry that corporate interests, lack of coordination, political wrangling, and regulatory disarray will continue to make even simple things difficult — like the medieval proverb about losing the kingdom for want of a nail.
“It’s insane that we have the country shut down because of swabs,” Ashish Jha, a physician and director of the Harvard Global Health Institute, told the Wall Street Journal. “The president could use the Defense Production Act, and he could use the Army Corps of Engineers to build testing facilities.”
President Donald Trump did invoke that 1950 act to speed up the manufacture of ventilators — but not of testing supplies.
Why has a high-income, high-tech country failed so miserably on testing? It’s complicated.
COVID-19 diagnosis relies on a molecular test, called polymerase chain reaction (PCR), that detects coronavirus genes in specimens taken from the back of patients’ throats. It’s an exacting, multistep process, but more accurate than simpler, faster tests. (Some data, however, suggest that even PCR misses as many as one in three coronavirus infections.)
Many countries, notably South Korea, quickly ramped up diagnostic testing by using a coronavirus PCR test protocol developed by Germany and disseminated by the World Health Organization.
But the U.S. Centers for Disease Control and Prevention developed its own PCR test kits, doled out the small supply to state public health labs on Feb. 5 — and then spent weeks redoing the kits because the initial tests gave inconclusive or incorrect results. Turnaround time is another issue: Results from public labs can take days or weeks.
The CDC also initially restricted diagnostic testing to probable cases — symptomatic people who had traveled to China, where the virus emerged in December. Now, data suggest that much of the spread of the disease is by people with no symptoms. Yet, because of shortages, U.S. testing remains almost exclusively limited to people with symptoms.
By mid-March, South Korea — which invented drive-thru sites for nasal swab collection — had tested about 5,200 out of every one million inhabitants, while the United States had tested about 100 per one million inhabitants, according to the COVID Tracking Project.
Under pressure from all sides to broaden diagnostic testing, federal regulators began easing their rules in February.
The U.S. Food and Drug Administration has since given “emergency authorizations” to scores of diagnostic PCR tests, according to the Coronavirus Test Tracker. Some were developed by research labs, including at Rutgers University and the Children’s Hospital of Philadelphia, but most are products of big diagnostic manufacturers such as Abbott, ThermoFisher Scientific, Cepheid, LabCorp, and Quest.
Manufacturers and industry organizations have boasted that this flood of technology would make diagnostic testing faster, easier, plentiful, and more convenient. Several companies have automated parts of their PCR tests, which can be rapidly processed in hospital labs — if those hospitals have the companies’ proprietary testing machines. Rutgers’ test is the first to use saliva spit into a tube, so patients don’t need the unpleasant nasal swab procedure.
Scott Whitaker, CEO of the Advanced Medical Technology Association, said during a news teleconference last week that the industry will have produced 25 million tests “by the end of April.”
Pressed by a reporter, Whitaker acknowledged that number is “a goal,” and depends on getting the necessary supplies.
Behind the hype, PCR testing has been hampered by myriad shortages, backlogs, and a lack of uniformity.
To overcome shortages, hospitals have reported experimenting with substitutes for the fluid used to preserve coronavirus samples, and for the chemical “reagents” used to process those samples — stopgaps that could affect accuracy, as Bloomberg reported.
The scarcity of reagents is complicated by the fact that the chemicals needed for one manufacturer’s testing machine might not be compatible with another company’s instrument.
“We realized we’d have to leverage multiple different test systems,” Meyer at Jefferson said. “But the real constraint is the vendor-specific kits and reagents.”
A different kind of test is seen as vital to tracking how far the coronavirus has spread, calculating the rates of asymptomatic infection, and, hopefully, identifying people who can safely go back to work. These rapid “serology” tests detect disease-fighting antibodies in blood samples.
On Thursday, New York Gov. Andrew Cuomo shared the surprising results of such testing on a random sample of 3,000 people: 21% of residents in hard-hit New York City had antibodies. In the rest of the state, the figure was less than 4%.
Despite the importance of antibodies, tests for these proteins have had an even rockier rollout than diagnostic PCR tests.
The FDA announced in mid-March that antibody tests could be introduced without prior agency review, prompting a flood of more than 90 onto the market — including some that didn’t work and made false claims.
The FDA and the World Health Organization issued what amounted to buyer-beware warnings. And the Securities and Exchange Commission last week suspended trading of two companies amid allegations of fraudulent claims.
“At this point, the FDA … has really swung the pendulum in the opposite direction and, in my opinion, too much,” said Michael Mina, an epidemiologist and infectious-disease expert at Harvard’s Chan School of Public Health.
Officials in both New Jersey and Pennsylvania have said that before stay-at-home and social distancing orders can be lifted, additional testing will be needed — but not how that will be achieved.
It is possible, of course, to reopen an economy without safeguards, then see what happens. That’s what Georgia’s Gov. Brian Kemp is now doing, despite the misgivings of public health experts and some mayors in his state.
For Meyer, at Jefferson, it comes down to “a risk tolerance question.”