U.S. to Expand Coronavirus Tests After Delay in Surveillance

(Bloomberg) -- U.S. health officials will let state and local health labs modify a test for the coronavirus that has been plagued by weeks of delays, in an effort to better keep watch for cases that may be quietly arising in some parts of the country.

Officials from the Centers for Disease Control and Prevention and the Food and Drug Administration held a conference call Wednesday in which they gave permission for state and local labs to drop a troublesome step in the tests that stopped them from being used, said Scott Becker, CEO of the Association of Public Health Laboratories. Becker’s group represents state and local testing labs.

The change should speed testing and allow state and local labs to start using hundreds of kits that were sent out earlier this month, rather than having to wait for an new version of the test to be sent by federal health authorities. The government and private companies are also developing new, improved tests for use by hospitals and public health labs.

“In the next week we are going to have much more testing,” Becker said in a phone interview. “It is going to increase capacity across the country.”

The CDC and FDA didn’t immediately respond to a request for comment.

On Wednesday, the CDC announced that a California patient had tested positive for the virus -- the first patient without a known link to China or another coronavirus patient. It took at least a week for the patient, who had been put on a ventilator to help breathe when they arrived at UC Davis Medical Center in Sacramento from another hospital, to be confirmed positive.

Officials at the CDC have struggled to roll out a test for the coronavirus to local and state health departments since announcing the plan to widen testing on Feb. 5 and sending kits to 200 labs.

About 40 public health labs can currently test for the virus using the modified version of the existing tests, Health and Human Services Secretary Alex Azar said in Washington Thursday. A new test kit the government is developing could be sent to more than 90 public-health labs as soon as Monday, he said.

President Donald Trump said Wednesday night during a press conference that U.S. health authorities are “testing everybody we need to test and we’re finding very little problem.” But officials at the CDC have said that’s not the case.

“I am frustrated like I know many of you are that we have had issues with our test,” Nancy Messonnier, director of the CDC’s Center for the National Center for Immunization and Respiratory Diseases, said on a call with reporters earlier this week. “We are working to modify the kit and hope to send out a new version to state and local jurisdictions soon.”

Test Limits

While local health authorities and hospitals have been able to ship samples to the CDC for confirmation, the agency until Thursday also put relatively tight limits on who should be tested -- opting to focus on people with early symptoms who have recently traveled to China, or had contact with a known or likely patient. That’s allowed them to quickly confirm or rule out cases in what was thought to be the highest-risk group. But it hasn’t enabled the broad, community-wide search for the disease that the agency has said is its goal.

Late Thursday afternoon, the CDC moved to greatly expand the number of people who will be tested for the coronavirus, adding travelers from several new countries with outbreaks as well as people with unexplained, severe respiratory illnesses.

As the nature of the outbreak shifts, diagnosis of the coronavirus in the U.S. has yet to catch up. A case of unknown origin, surfacing only once the patient got sick enough to go to the hospital, resembles how other outbreaks outside China have emerged. The disease’s mild nature in most people makes it possible for it to spread from people who may think they have a cold or flu, then come to frightening fullness in vulnerable patients who are among the small percentage to fall severely ill or die.

That appears to be what happened with the California patient, according to a statement by the hospital sent to staff and posted online Thursday. Versions of the statement were also posted on Twitter by hospital staff, and reported by Davis Enterprise newspaper.

The hospital said the patient arrived on Feb. 19 with an unknown illness from another facility after being intubated and put on a ventilator, according to the statements. The hospital said it immediately asked the CDC to test the patient for the coronavirus, but was told by public health officials the person didn’t fit the criteria.

“Since the patient did not fit the existing CDC criteria for COVID-19, a test was not immediately administered. UC Davis Health does not control the testing process,” the hospital said in the statement. The CDC ordered a test of the patient four days later, on Feb. 23. It would take another three days to get a positive result. The hospital says it’s working to save the patient’s life.

CDC officials said any delay in testing wasn’t caused by the agency. It was informed about the case for the first time on Feb. 23, the same day it requested samples to test, the agency said in an emailed statement. The swabs were sent out the next day, arrived in Atlanta on Feb. 25, and the results were confirmed and communicated on Feb. 26.

Testing is permitted even if the person doesn’t have any ties to China or close ties to those infected, provided they have severe disease, the statement said.

Exposure

There have been consequences to that delay. The hospital has upgraded protections for staff caring for the person, but days went by without those increased precautions in place. While the hospital says it believes there’s minimal likelihood that health staff were exposed, it’s asked a “small number of employees to stay home and monitor their temperature.”

The existing test, built by CDC just a few weeks after the virus was sequenced, is able to detect small amounts of the virus found in swabs taken from the nose and throats of potential patients. It’s called a real-time polymerase chain-reaction test, or real-time PCR, and it takes about four to six hours to run.

Local labs have run into issues performing what’s called validation -- a crucial step to determine if the tests are reliable. The test looks at the genetic material of the virus to confirm the pathogen is present. It involves a series of three sub-tests, all of which have to be positive for the full test to be considered positive. State and local labs have run into problems with the third of the sub-tests. Becker, from the lab association, said federal health officials were going to let them drop that part and use only two.

State Problems

Some localities said the change in the testing procedure isn’t enough to solve the problems with the kits.

“Testing for coronavirus is not available yet in New York City,” said Stephanie Buhle, spokeswoman for the New York City Department of Health and Mental Hygiene, the largest U.S. municipal public health agency. “The kits that were sent to us have demonstrated performance issues and cannot be relied upon to provide an accurate result.”

In California, Governor Gavin Newsom said state officials had spoken with the CDC earlier Thursday, who assured them that more testing kits were on the way without giving a specific number.

“We expect that those kits will be here any day now,” said Mark Ghaly, secretary of the California Health and Human Services Agency, speaking at a press conference with Newsom.

Newsom said the CDC had assured them that the number of labs allowed to process the tests would be rapidly expanded to speed up response times.

In the meantime, health experts have expressed worries that the expanding number of independent outbreaks around the world will make it harder to keep the disease from the U.S.

“Someone in China exposed somebody, who exposed this patient,” Greg Poland, director of the Vaccine Research Group at the Mayo Clinic in Rochester, Minnesota, said in a phone interview. “We haven’t seen that here yet, but it’s very widespread in China.”

It will be nearly impossible to cut off all paths of potential entry of the virus to the U.S. To best contain its spread locally, health workers and doctors need to be able to quickly diagnose and isolate patients and contacts who might also be infected.

“Should there be an outbreak here, we would want every state lab to have that testing available,” said Patricia Whitley-Williams, chief of the allergy, immunology and infectious diseases division at Rutgers University.

--With assistance from Henry Goldman and David R. Baker.

To contact the reporters on this story: Robert Langreth in New York at rlangreth@bloomberg.net;Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett

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