The coronavirus has found a crack in the nation’s public health armor, and it is not one that scientists foresaw: diagnostic testing.
The Centers for Disease Control and Prevention botched its first attempt to mass produce a diagnostic test kit, a discovery made only after officials had shipped hundreds of kits to state laboratories.
A promised replacement took several weeks, and still did not permit state and local laboratories to make final diagnoses. And the C.D.C. essentially ensured that Americans would be tested in very few numbers by imposing stringent and narrow criteria, critics say.
On Monday, following mounting criticism of the federal response, Trump administration officials promised a rapid expansion of the country’s testing capacities. With the help of private companies and academic centers, as many as a million diagnostic tests could be administered by the end of this week, said Dr. Stephen Hahn, commissioner of the Food and Drug Administration.
But many scientists wonder if the moves come too late.
As of Monday afternoon, 100 Americans were infected with the coronavirus in the United States. Six deaths have been reported. Dozens of patients, in several states, may have caught the virus in their communities, suggesting that pathogen already may be circulating locally.
The case numbers are rising not just because the virus is spreading, but because federal officials have taken steps toward expanded testing. The persistent drumbeat of positive test results has raised critical questions about the government’s initial management of the outbreak.
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?
“Clearly, there have been problems with rolling out the test,” said Dr. Thomas Frieden, former director of the C.D.C. “There are a lot of frustrated doctors and patients and health departments.”
Still, Dr. Frieden said he thought the situation was improving. Other experts, although supportive of the agency, were mystified that federal officials could have committed so many missteps.
“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.”
Officials at the C.D.C. did not respond to repeated requests for comment. The agency abruptly canceled a news conference on Monday just as it was to begin. Officials appeared to have removed figures on the agency website counting how many Americans had been tested.
In February, the C.D.C. rolled out a three-step diagnostic test and distributed testing kits — each of which could run about 800 tests — to state and local health laboratories. But some of the components of the diagnostic kits were flawed, and produced inconclusive results.
A 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.
The C.D.C. eventually rolled out a two-step replacement and permitted a few laboratories, where the kits had been working, to continue using their tests. But those with only one working component of the test still could not diagnose patients on their own.
Getting results from the C.D.C. took days, however, and in any event the criteria for testing were strict — among them, the patient must have had 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 hospitalized patients who were very ill and whose symptoms could not be otherwise explained.
“We have been really frustrated, because one of the things that is a hallmark of public health labs is that we are usually ‘ready, set, go,’ and here we were — ‘ready, set, wait’,” said Scott Becker, chief executive of the Association of Public Health Laboratories.
Late last week, the Food and Drug Administration broke the logjam, authorizing state and local laboratories to do initial testing on their own. If labs had developed and validated a test, they could use it for diagnosis instead of relying on the C.D.C.’s version or waiting for a replacement.
The move greatly expanded the nation’s testing capacity, and the C.D.C. also said it was shipping out new test kits to the states as well.
At the time, however, the agency had tested just under 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 probably 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’
Soon after the virus surfaced in China, the C.D.C. got to work on its own test. “Generally, C.D.C. provides these tests for the world,” said Dr. Frieden.
But German researchers were devising their own test, which was quickly adopted by the World Health Organization for distribution around the world.
After the C.D.C.’s version turned out to be flawed, the agency continued to pursue it, despite the fact that another diagnostic test was already in wide use.
With F.D.A. approval, the agency could simply have distributed the test used by the W.H.O. 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.
New kits were released over the past weekend, and more are on the way, Alex M. Azar II, the secretary of health and human services, said on Sunday.
The demand for testing is continuing to grow.
“It seems like we can’t get tested,” complained Jennifer Knight of Queens, who returned with her partner and a group of friends more than a week ago from Milan, near 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 an urgent care clinic told her over the phone that they did not 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 hospital, where medical staff would get into his car in the afternoon and test him after all — in the parking lot.
A doctor swabbed his mouth, nose and throat through the driver’s side window, in what he imagined looked like a drunk-driving test.
He is now waiting for the test results. “I’m looking forward to getting back to teaching, and I’m looking forward to going outside,” he said.
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 coronavirus 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.