Does the United States really have the capacity to escalate its efforts and produce one million coronavirus tests by the end of this week, as the head of the Food and Drug Administration promised on Monday during a White House briefing?
The figure includes orders for commercial tests that companies say are still weeks away from approval, and public health laboratories say their capacities don’t come close to that.
At a press briefing on Monday, Dr. Stephen Hahn, the F.D.A.’s commissioner, said actions taken by the agency to allow private labs and companies to begin making their own tests would greatly expand the capacity to test.
“With this new policy, we have heard from multiple companies and multiple academic centers, and we expect to have a substantial increase in the number of tests this week, next week, and throughout the month,” Dr. Hahn said. “There will be — the estimates we’re getting from industry right now, by the end of this week, close to a million tests will be able to be performed.”
A spokeswoman for the Department of Health and Human Services said Tuesday that Dr. Hahn was referring to tests being produced by an outside manufacturer, Integrated DNA Technologies, which are being sent to “a variety of academic, health care and commercial labs around the country” in addition to the public health laboratories that are also receiving them.
“The process of getting a test kit out and putting it into production is not something that happens literally overnight, in particular when you’re talking about a million tests,” said Eric Blank, the chief program officer at the Association of Public Health Laboratories, which represents state and local government laboratories nationwide. “It’s a nice thing to say, and it’s a simple thing to say, but the reality is we are a couple of weeks away from being able to deploy a million tests through this process.”
Dr. Hahn repeated the estimate on Tuesday in testimony at a Senate committee hearing. He told Senator Patty Murray, Democrat of Washington, that although “this is a dynamic process,” the federal government was working with private companies to ship about 2,500 test kits to labs by the end of the week. “That should give us the capacity, in the hands of laboratories once they validate, to perform up to a million tests,” he said at the hearing.
The Association of Public Health Laboratories has said that its labs would be able to conduct about 10,000 tests a day when all of its 100 members that can conduct testing are running. Mr. Blank said that labs can run about 100 tests per day. As of Tuesday, he said 54 of those labs were able to do so, with the rest expected to be up and running by the end of the week.
Dr. Hahn and White House officials have been trying to address the lag in testing caused by botched test kits that were rolled out by the Centers for Disease Control and Prevention early last month, and that agency’s enforcement of strict testing criteria.
But as the coronavirus spread in Washington State and California, and has cropped up in the Northeast and Florida, state and federal lawmakers have clamored for expedited tests and the authority to conduct their own. So far, more than 100 people in the United States have been sickened and at least nine have died.
Public health experts have become concerned that the lack of adequate testing in several states has led to community transmission and warned there may be many undetected cases that could lead to further infections.
New York State’s public health lab, which was one of the first to receive emergency approval for its own testing, set a goal of conducting 1,000 tests a day statewide, according to a statement by Gov. Andrew M. Cuomo.
A handful of private companies have said they are working on a test for the virus, but none are yet available in the United States. Maurice Exner, the vice president of research and development for the diagnostics division at Hologic, said in an interview Tuesday that the company was weeks way from F.D.A. approval of a commercial test. If approved, the tests could be used in hundreds of labs around the country and each machine could process as many as 1,000 tests per day, he said.
Another company, Cepheid, has said it does not expect to get emergency approval from the F.D.A. for its test before April. Dr. David Persing, the company’s chief medical officer, said last week that the company still wanted to ensure its test was accurate. “We are moving aggressively,” he said.
On Monday, Darwa Peterson, a Cepheid spokeswoman, said the F.D.A. policy to allow more labs to conduct tests hadn’t changed the company’s timeline. “We still need to optimize and validate our tests because commercial vendors are held to a high standard,” she said.
Qiagen, another company working on testing, said Tuesday that it expected F.D.A. approval later this month, but that it was still gathering data and testing its product, noting that “this does take some time.”
Dr. Hahn was not the only Trump administration official to promise radically expanded testing. Over the weekend, Vice President Mike Pence made similar claims, appearing on television to say that more than 15,000 test kits — which contain materials to test between 700 to 800 samples — were being shipped to labs.
In fact, the C.D.C. said Sunday that it had shipped about 47 such kits.
The H.H.S. spokeswoman said Tuesday that the 15,000 test kits cited by Mr. Pence referred to the number of people who could be tested by kits that were being shipped, and that by later this week, enough tests would be sent to public health labs to test about 75,000 people.
About 3,300 patient specimens had been tested by the C.D.C. since the start of the outbreak, she said. More than 1,200 people had been tested as of Tuesday, the spokeswoman said. On Monday, as the testing controversy continued, the C.D.C. removed its data on how many people had been tested from its website. The numbers were removed, the C.D.C. said, because states are reporting results quickly, and the information reported by the agency would not be representative of testing being done around the country.
Other countries, like South Korea, are testing thousands of citizens per week, but in the United States testing has been more limited. The C.D.C. began shipping test kits to labs around the country in early February, but a manufacturing problem led the agency to tell most states not to use the kits, severely limiting the country’s testing capacity for weeks.
Stringent testing criteria also tied the hands of infectious disease doctors around the country, who have said they were frustrated that they were not allowed to test a broader group of patients who displayed potential symptoms of the new virus. Last week, the C.D.C. loosened its criteria and began shipping new test kits to labs around the country.
Mr. Pence said on Tuesday that the C.D.C. would issue new guidance removing restrictions on who could be tested, as long as a doctor has given an order.
During a C.D.C. news briefing on Saturday, Dr. Jeff Duchin, public health officer of the Seattle and King County Public Health agency, which has been dealing with Washington State’s outbreak, said the death of a man in his 50s who had coronavirus was only identified because the Washington State public health lab had just recently acquired test kits.
“If we had the ability to test earlier, I’m sure we would have identified patients earlier in the community,” he said.
Sheila Kaplan contributed reporting.
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