Widespread coronavirus testing could still be weeks away

By David Lim and Adam Cancryn

It could be weeks before the United States can meet the demand for coronavirus testing because doctors, hospitals and some public health labs say they aren’t set up yet to do the tests.

Ratcheting up the country’s ability to detect the disease is crucial to understand how the coronavirus — now confirmed in at least 12 states — is spreading. But testing so far has been severely limited by problems with a diagnostic test developed by CDC.

The CDC has fixed its test and is working to get more test kits to labs. At the same time, the FDA has given some local labs and hospitals permission to develop their own tests. But many labs aren’t yet ready to analyze samples from patients.

FDA Commissioner Stephen Hahn said Monday that, by the end of the week, U.S. labs would have enough materials to perform close to 1 million tests. Public health experts say that figure is misleading because it is far larger than the number of samples that can be processed in labs in the coming weeks.

The realistic estimate is now likely around 5,000 each day, according to a public health lab industry group.

“The number the public wants to know is the number of people that can be tested per day, not the number of tests sitting in a warehouse,” said Michael Mina, associate medical director of molecular diagnostics at Brigham and Women’s Hospital in Boston. “They really want to know how likely it is they can be tested if they show up at their doctor’s office.”

Democrats on Tuesday slammed the administration’s handling of the botched CDC tests, and the pace of efforts to increase testing capacity, after meeting Tuesday with Vice President Mike Pence and officials from CDC, FDA and HHS.

“They could not answer how soon people will be able to get the test,” said Senate Minority Leader Chuck Schumer.

Sen. Patty Murray, whose home state of Washington has seen nine deaths from the virus, was similarly blunt. “We know there are not enough tests out there,” she said. “People cannot get access to them.”

Hahn’s forecast depends on additional CDC tests being produced by commercial test manufacturer Integrated DNA Technologies, according to the Association of Public Health Laboratories.

About 2,500 test kits from IDT — each containing supplies to test 500 people — will be available for ordering by the weekend, said Robin Patel, president of the American Society for Microbiology.

Patel, who also directs the Infectious Diseases Lab at Mayo Clinic, declined to speculate how many tests labs will be able to run over a given period. But she stressed that widespread access to testing, and rapid sample turnaround, are critical to limiting the coronavirus’ spread.

Public health labs using CDC’s latest diagnostic test can perform 100 tests per day under normal conditions, according to the Association of Public Health Laboratories. But only 54 such labs have verified the test for use as of Tuesday morning, and testing one person requires testing at least two samples.

An FDA spokesperson tells POLITICO that state and local public health labs currently have the capacity to test 15,000 people. New tests CDC is distributing this week will bring that figure up to 75,000 people, FDA said.

But quickly increasing the number of tests done each day will require private laboratories to pitch in. The American Clinical Laboratory Association, Quest Diagnostics and LabCorp are slated to talk with HHS about the coronavirus in the coming days, an industry source tells POLITICO.

Mina estimates that once all public health labs and 200 academic labs that have developed in-house tests are running at capacity, they will be able to process a maximum of 30,000 tests per day. But that assumption “is quite unreasonable at the moment,” he added, noting it will be weeks before most academic labs can begin analyzing patient samples.

Public health labs also need more time to increase their capacity beyond the current 10,000-test target, says Kelly Wroblewski, APHL director of infectious diseases. “Over time, there is the ability of labs to surge — run extra shifts, pull staff from different parts of the lab in to test, commandeer different equipment parts of the lab,” she said.

Murray is tired of waiting. She blasted the administration’s handling of the situation, telling federal health officials Tuesday that it’s “unacceptable” Americans are having trouble getting tested. In some cases, she said during a Senate HELP Committee hearing, they have reportedly been turned away when they seek clarity on whether they've been infected.

"The administration has had months to prepare for this," Murray said. "We are now seeing community transmission of this virus. Families deserve to know — and fast — when testing will actually be ready to scale up."

Senate HELP Chairman Lamar Alexander (R-Tenn.) also pressed for a faster increase in screenings, telling administration officials that "there need to be more test kits available."

Hahn reiterated his estimate that materials for 1 million tests would be available by the end of the week — emphasizing that the number includes commercial tests still under development.

Under questioning from Murray, he denied that HHS delayed issuing guidance allowing private labs to use their own coronavirus tests.

The government has been reluctant to allow labs to create their own tests during emergency situations, Alberto Gutierrez, former director of the FDA office that oversees diagnostic tests, told POLITICO. “In previous emergencies, we always saw bad actors,” he said.

CDC Principal Deputy Director Anne Schuchat told lawmakers at the Senate hearing she is optimistic the U.S. will ultimately have enough coronavirus tests but warned that emerging infectious diseases can present surprises.

“I want to remain humble,” she said.

Sarah Owermohle contributed to this report.