The coronavirus has found a crack in the nation’s public health armor, and it is not one that scientists foresaw: diagnostic testing.
As of Monday afternoon, there were at least 98 people infected with the new coronavirus in the United States — a sharp rise from the 65 known to be infected on Friday. Six deaths have been reported.
Several patients, in more than one state, had not traveled to China or other epidemic centers and may have caught the coronavirus in their communities, suggesting that it already may be circulating locally.
The case numbers are rising not just because the virus is spreading, but because testing has been expanded. And the persistent drumbeat of positive test results has raised critical questions about the government’s management of the outbreak.
How is it possible that the world’s most medically advanced nation has struggled to diagnose this infection? Why weren’t more Americans tested sooner? How many may be carrying the virus now?
Most disturbing of all: Did a failure to provide adequate testing give the coronavirus time to gain a toehold in the United States?
The Centers for Disease Control and Prevention’s first attempt to produce a diagnostic test kit fell flat, after it had shipped hundreds out to the states. A promised replacement still does not permit state and local laboratories to make final diagnoses. The C.D.C. essentially ensured that Americans would be tested in very few numbers by imposing stringent and narrow testing criteria.
“Clearly, there have been problems with rolling out the test,” said Dr. Thomas Frieden, former director of the Centers for Disease Control and Prevention, which has struggled to make its diagnostic test widely available.
“There are a lot of frustrated doctors and patients and health departments.”
Dr. Frieden said he thought the situation was improving.
“The incompetence has really exceeded what anyone would expect with the C.D.C.,” said Dr. Michael Mina, an epidemiologist at Harvard University. “This is not a difficult problem to solve in the world of viruses.”
In February, the C.D.C. rolled out a three-step diagnostic test kit and distributed hundreds of kits to state and local health laboratories. But the third step in the diagnostic process was flawed, and produced some inconclusive results.
A full three-step replacement was promised but never arrived; the agency has not fully explained why, except to say that there was a manufacturing defect. As a result, diagnostic testing was only conducted at the agency’s labs in Atlanta, not state and local labs.
Getting results took days, and the C.D.C.’s criteria for testing were strict — among them, the patient must have recent travel to China or contact with someone known to be infected.
Doctors nationwide complained of a bottleneck, both because of the restrictive test criteria and because of the agency’s limited testing capacity. The agency said it had the capacity to test about 400 specimens a day.
The test criteria were “too stringent, and people aren’t getting tested,” said Lauren M. Sauer, an assistant professor of emergency medicine at Johns Hopkins Medicine.
“I’ve heard from so many colleagues that tests were turned down,” she added.
By the end of last week, as the first cases of possible community transmission began to emerge in California and Washington State, the C.D.C. broadened the number of patients who qualified for testing to include travelers returning from places like South Korea and Italy, and those with symptoms that could not be otherwise explained.
Late last week, the Food and Drug Administration broke the logjam, authorizing state and local laboratories to do initial testing on their own.
The move greatly expanded the nation’s testing capacity, as the C.D.C. also said it was shipping out new tests kits to the states as well. But final confirmatory tests must still be done at the C.D.C.
By that time, the C.D.C. had tested roughly 500 Americans with suspected infections identified by public health officials in the United States.
Other nations have tested patients by tens of thousands. China has tested millions.
“How come the South Koreans can do 10,000 tests a day and we can’t?” said Ralph Baric, who studies coronaviruses and emerging diseases at University of North Carolina.
“Once you knew you had asymptomatic spread and community spread in China, why is it that the United States of America hasn’t created tens of thousands of tests?”
‘We Can’t Get Tested’
Why the agency decided to repair its own coronavirus diagnostic kit is unclear.
An alternative test for coronavirus was devised by German researchers in January, about the same time as the C.D.C.’s, and quickly adopted by the World Health Organization for distribution to scores of nations.
Had the Food and Drug Administration approved that test, the C.D.C. could simply have distributed it instead of creating a new one from scratch, Dr. Mina said. The government could do so even now.
“It’s just a very American approach to say, ‘We’re the U.S., the major U.S. public health lab, and we’re going to not follow the leader,’” Dr. Mina said.
Instead, the agency has devised new testing kits comprising the first two steps in the diagnostic process, but not the third step, which provides final confirmation. State and local laboratories have been instructed to use this abridged version.
New kits were released over the past weekend, and more are on the way, Alex M. Azar, the secretary of health and human services, said on Sunday.
Certainly the demand for testing is growing. Clinical decisions about caring for a coronavirus patient cannot be made until final positive test results are received.
“It seems like we can’t get tested,” complained Jennifer Knight of Queens, who returned with her partner and a group of friends last Sunday from Milan, where the virus is spreading.
Several members of the group had fallen ill, either in Milan, or since returning, four members of the group said in interviews. Ms. Knight has had migraines and a sore throat, but her partner has had a fever and a bad cough as well.
Staff at urgent care clinic hospital told her they don’t do coronavirus testing. So did a hospital in Brooklyn.
Whenever we make an attempt to get tested, we’re pushed out the door,” she said. She and her partner are now largely self-quarantined in her apartment.
In Rhode Island, Onésimo T. Almeida, an author and professor at Brown University, had been coughing, sneezing and registering a fever for nearly a week after returning home to Providence from a conference in Portugal. A friend of his who attended had later tested positive for the virus.
But when Professor Almeida called the Rhode Island Department of Health and asked to be tested, he was told that he did not fit the criteria to be screened.
On Monday, however, the health department called Dr. Almeida and asked him to drive to a local hospital, where medical staff would get into his car in the afternoon and test him after all — in the parking lot.
“The first time I’m going to be out is now,” he said on Monday, about an hour before he was scheduled to be tested for the virus in the hospital parking lot. “I’m going to drive and go to the hospital.”
Testing may well become more widespread in the next few weeks. But that may not help contain the coronavirus if it is being spread by people who are asymptomatic.
“There has been a silent epidemic of Covid-19 in the United States that is not going to be silent any longer,” said Michael Osterholm, an epidemiologist at the University of Minnesota, referring to the official name of the illness. “Testing will show it. This is not a surprise — it shouldn’t have been.”
Reporting was contributed by Nicholas Bogel-Burroughs and Joseph Goldstein in New York.