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. [...] 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.
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“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.
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.
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.
