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Coronavirus Patient in California Was Not Tested for Days Coronavirus Diagnosis in California Highlights Testing Flaws
(about 8 hours later)
A California coronavirus patient had to wait days to be tested because of restrictive federal criteria, which include travel to China or contact with someone known to be infected. Already in deep distress, the patient was rushed last week to a hospital in Northern California, severely ill and unable to breathe on her own.
Yet the patient tested positive, and may be the first person to be infected through community spread in the United States, the Centers for Disease Control and Prevention said Wednesday. Doctors at the University of California, Davis Medical Center, near Sacramento, provided the woman with critical care but also considered an unlikely diagnosis: infection with the coronavirus.
C.D.C. officials said it was possible the patient was exposed to a returning traveler who was infected. At the moment, however, the new case appears to be one in which the source of infection is unknown, suggesting that the virus may be spreading within the community. Hospital administrators said they immediately requested diagnostic testing from the Centers for Disease Control and Prevention, but the procedure was not carried out because the case did not qualify under strict federal criteria: She had not traveled to China and had not been in contact with anyone known to be infected.
Following mounting bipartisan criticism that the administration’s response to the spread of the coronavirus had been sluggish, President Trump on Wednesday named Vice President Mike Pence to coordinate the government’s response, even as he repeatedly played down the danger to the United States of a widespread domestic outbreak. The announcement on Wednesday that the patient was indeed infected left health officials in California searching for other cases and raised difficult questions about whom should be tested for the infection and whether the nation was prepared to shoulder a burden necessary to keep the virus under control.
“The risk to the American people remains very low,” said Mr. Trump. “We have the greatest experts, really in the world, right here.” The California woman’s case may also offer the first indication that the virus has spread beyond Americans who traveled outside the country, or had contact with someone who had.
C.D.C. officials were present at the news briefing, but there was no mention of the possibility of a community-acquired coronavirus infection. Frustration has been mounting among health providers and medical experts that the agency is testing too few Americans, which may slow preparations for an outbreak and may obscure the scope of silent infections in this country.
Doctors at the University of California, Davis Medical Center considered the novel pathogen a possible diagnosis when the patient was first admitted last week. “I think the diagnostic issue is the single most important thing that keeps me up at night right now,” said Lauren Sauer, director of operations at the Johns Hopkins Office of Critical Event Preparedness and Response.
But the federal agency that conducts the testing did not administer the test until days later because the case did not fit the agency’s narrow testing criteria, university officials said in a letter to the campus community late Wednesday. C.D.C. officials said that they had been unaware that doctors in California made an urgent appeal for diagnostic testing of the woman. Then on Thursday, the agency revised and broadened its testing criteria, adding to the number of Americans who qualify.
The C.D.C. has restricted testing to patients who either traveled to China recently or who know they had contact with someone infected with the coronavirus. In California, health officials are tracing close contacts of the woman, who lives in Solana County but has not otherwise been identified. Health care workers who have treated her are being monitored for the infection, and some employees at the medical center have been told to stay home.
The C.D.C. could not be immediately reached for comment. Officials are bracing for a larger outbreak in Northern California. “There’s almost assuredly going to be a significant number of people testing positive,” said Dr. Peter L. Beilenson, the director of Sacramento County’s Department of Health Services.
The patient was transferred to the medical center from another hospital in Northern California with a suspected viral infection, and was already on a ventilator upon arrival, according to the university’s letter. Updated Feb. 26, 2020
The case has heightened concerns about the nation’s ability to test large numbers of people. Only the C.D.C. performs the tests that confirm a novel coronavirus diagnosis and guide treatment, a process that often takes days.
And the fact that state and local health departments cannot definitively diagnose the virus has left too many blind spots in the nation’s surveillance for the coronavirus, some experts say.
Ms. Sauer said Johns Hopkins had treated several patients who did not fit the testing criteria, and for whom it requested coronavirus testing. In all but one case, the hospital was able to persuade the C.D.C. to run a test, or eventually identify another cause for the patient’s illness.
The C.D.C. is “pretty much the only place we can access testing,” she added, and the agency has been unwilling to grapple with cases that don’t fit its criteria.
“The idea that we would have to really fight to get that test done, when C.D.C. is saying they have capacity, is alarming.” Ms. Sauer said.
“It is a challenge when the most important piece of information — does this person have this disease, yes or no — is not accessible, and there’s no timeline for improved accessibility,” she said.
After the diagnosis in California, the C.D.C. has pledged to greatly expand the state’s ability to test patients for the coronavirus, officials said.
“Testing protocols have been a point of frustration for many of us,” Gov. Gavin Newsom said at a news conference on Thursday. California had just 200 testing kits left, he added.
The governor said Dr. Robert R. Redfield, the director of the C.D.C., promised that state physicians would have a much greater ability to test patients who were showing symptoms of the infection, a change the governor said “can’t happen soon enough.”
The C.D.C. had distributed diagnostic testing kits to state health departments, but they turned out to be flawed. Replacement kits have not yet been distributed.
The C.D.C. has committed to sending a team to California to help track people and make sure they are contacted by health officials about their possible exposure, Mr. Newsom said.
“They are being interviewed — points of contact, family members and others,” he said.
Several dozen swabs from health care workers have been sent by express courier to the C.D.C. in Atlanta for testing. Health officials have interviewed members of the patient’s family and are tracing her movements to speak with people she may have had contact with.
At a hearing in Washington on Thursday, Alex M. Azar II, the secretary of health and human services, said that the C.D.C.’s faulty kits might yet be usable, because local health departments might be able to start making diagnoses using only two components of the three-step process.
Experts are perplexed by the C.D.C.’s inability to fix the flaws altogether.
“The obvious observation is that many countries are capable of testing rather widely,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center. “Why can’t we?”
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“Upon admission, our team asked public health officials if this case could be Covid-19,” the letter said. The medical center requested testing from the C.D.C. “Since the patient did not fit the existing C.D.C. criteria for Covid-19, a test was not immediately administered. U.C. Davis Health does not control the testing process.” There has been frustration, too, among officials at the Department of Health and Human Services, who have believed for a while that the C.D.C. should be testing for the virus much more broadly, according to one person briefed on the matter.
With the new patient, the total number of known coronavirus infections in the United States is 60, including 45 cases among Americans who were repatriated from Wuhan, China — the epicenter of the outbreak — and the Diamond Princess cruise ship, which was overwhelmed by the virus after it was quarantined in Japan. The C.D.C. operates two laboratories that test for the coronavirus and can handle approximately 400 specimens per day. Agency officials say there is no testing backlog, but it is unclear whether the labs will be able to keep up with demand if the need — and eligibility — increases testing substantially.
All of those patients are in isolation and receiving treatment at hospitals. Under the new federal criteria, people with respiratory symptoms who traveled to Iran, Italy, Japan and South Korea should be tested — not just those who traveled in China. So should severely ill patients with acute lower respiratory symptoms who are hospitalized and in whom other diagnoses have been ruled out.
Until now, public health officials have been able to trace all of the infections in the country to a recent trip abroad or a known patient, and to identify the sources of exposure. A criticism of the new criteria, however, is that doctors will have to wait until someone is extremely ill to test for the virus if that person did not travel to the affected regions or have contact with a known case.
“The thing that would immediately make all of us uneasy is if this person has no direct contact with someone who comes from an affected country,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University. “If we could identify these people earlier who don’t specifically meet one of the two criteria, or some sort of broader travel criteria, we could get them tested,” Ms. Sauer said. “You have to wait until someone’s really sick to push that test now, even with this new criteria.
“That would suggest there are other undetected cases out there, and we have already started some low-grade transmission.” Kenneth E. Raske, president of the Greater New York Hospital Association, said he planned to appeal to Vice President Mike Pence on behalf of chief executives of major health care institutions in the New York area “to order the C.D.C. to develop a rapid point of care test” that hospitals could use to screen patients.
Public health officials said the infected individual was a resident of Solano County, Calif., but they have not disclosed any other information to protect the patient’s privacy. President Trump named Mr. Pence on Wednesday to lead federal preparations for a possible coronavirus outbreak.
Please check back for updates on this developing story. In the meantime, Mr. Raske said, the Wadsworth Center, New York’s public health reference laboratory, should be certified to do these tests.
If more community-acquired infections turn up, and the disease cannot be contained, the strategy will have to become one of mitigation, said Dr. Neil Fishman, associate chief medical officer for the University of Pennsylvania Health System.
“That’s a little difficult to do when you don’t have a readily available test, and when the turnaround time for the test can be days instead of hours,” he said.
Thomas Fuller contributed reporting from Solano County, Calif., Nicholas Bogel-Burroughs from New York and Michael D. Shear from Washington, D.C.