Tagged CDC

New California Coronavirus Case Reveals Problems with U.S. Testing Protocols

Just weeks into the federal government’s efforts to contain the novel coronavirus, a new California case has exposed weaknesses in the testing procedures that could be masking more widespread reach of the disease.

A woman in Solano County, California, who hadn’t traveled abroad or had contact with another known patient with the illness was diagnosed with the virus Wednesday, raising concerns that cases are going undetected because of the federal government’s narrow testing protocols.

The patient sought care at a local hospital before being transferred to UC Davis Medical Center in Sacramento because of the severity of her case, according to a letter hospital officials sent to members of the campus community. Suspecting coronavirus, doctors at UC Davis asked public health officials about testing for COVID-19, the name given to the illness believed to have originated in Wuhan, China.

But the request did not meet protocols laid out by the federal Centers for Disease Control and Prevention: The woman didn’t have a history of travel or contact with a person with a known infection. So no test was administered. The patient continued to receive treatment at UC Davis for four more days, without a diagnosis. Finally, on Sunday, the CDC requested the test, according to the letter.

It came back positive.

Multiple experts interviewed said the case underscores the need for more widespread community testing of the new coronavirus, which has sickened tens of thousands of people in more than 45 nations around the globe. It also highlights how the CDC’s narrow testing protocols, combined with the agency’s continued delays in getting functional coronavirus test kits to state and local public health agencies, have hindered the public health system’s ability to respond to the outbreak.

To date, the CDC has tested fewer than 500 people in the U.S. for the virus. By contrast, South Korea, which is several days into an outbreak, had tested more than 66,000 people and confirmed more than 1,700 cases as of Thursday morning.

The Northern California case mirrors what some experts have been warning for weeks: that infected people might be circulating undetected in the general population because the testing criteria are too narrow. It’s highly likely the Solano County case is not unique, and that other cases of what is called community transmission are going undetected, said Dr. Amesh Adalja, a senior scholar at John Hopkins Center for Health Security. He stressed, however, that the risk of infection remains low in the U.S.

Officials declined to provide details about the patient’s age or condition, citing privacy concerns. Some health care workers at the facility have been asked to stay home “out of an abundance of caution,” hospital officials wrote, and public health officials are working to locate others who may have come into contact with the patient over the last couple of weeks.

At a news conference Thursday, California authorities called for the federal government to ramp up testing of the broader population in light of the Solano County case, thought to be the first evidence in the U.S. of community transmission.

“We need to substantially increase access and availability of testing, and we need to do that today,” said Gov. Gavin Newsom.

Newsom noted that more than 8,400 people in California were being monitored for coronavirus and that 28 people still in the state were confirmed to be infected. Newsom said he had received assurances from CDC officials that they would expand testing protocols, which they did later Thursday.

Until Thursday, testing criteria for COVID-19 said the person should have fever and signs of lower respiratory infection, as well as a recent history of travel to mainland China; or a fever or signs of lower respiratory infection and close contact with someone already diagnosed with the virus. On Thursday, those guidelines were expanded to include people who had those symptoms and had recently traveled to Iran, Italy, Japan or South Korea, in addition to China; or people with fever and acute lower respiratory illness that isn’t explained by flu or other viruses.

Like other experts, Adalja believes the testing protocol should be even broader. About 80% of people diagnosed with the virus have only mild symptoms, according to early research out of China, and even under the expanded CDC guidelines, few of those people would qualify for testing.

While the risk to the general population is still believed to be low, finding mild illnesses is the key to understanding how deadly the virus is, and how big a risk it poses.

Given the high rate of travel into and out of the U.S., there’s reason to believe the virus reached the U.S. before there was even a testing protocol in place, Adalja said. He said clinicians need more autonomy to order tests on patients they suspect have the virus.

In addition to the delayed testing in California, news outlets in Hawaii have reported that some tests ordered by physicians there were never processed because they didn’t meet the testing criteria.

And the test kits themselves have had substantial problems. After they were sent to labs three weeks ago, numerous states reported trouble verifying the tests because one component of the kit was flawed. Officials aren’t yet sure of the exact cause of the problem. Meanwhile, all testing has continued to be routed through the CDC in Atlanta, a process that can take several days between packaging, shipping and analyzing.

In the weeks since the faulty kits were sent out, public health agencies have gotten so desperate for a functional test that they took the extraordinary step of asking the FDA to allow them to develop their own. “We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories,” the Association of Public Health Laboratories, which coordinates responses from local labs during health emergencies, wrote in a letter to the FDA. The FDA replied, outlining a process for a public health lab-developed test that the APHL plans to use in future outbreaks.

“Next time, we will go straight to the FDA,” said Scott Becker, CEO of the APHL.

Meanwhile, on a call Wednesday with public health labs around the country, the CDC and FDA said that the handful of labs that had verified that the CDC kits they received were fully or largely functional could begin performing tests using those kits. As of Thursday morning, eight labs in seven states fit that category.

California is one of those states. Newsom said that he was concerned by the small number of test kits the state currently had, and that the CDC had assured him more were coming. APHL expects some 40 labs will have testing capabilities by the end of next week, Becker said.

Still, some states flush with international travelers, like New York, have not been able to successfully use the flawed kits. On Wednesday, Gov. Andrew Cuomo called on the federal government to allow testing in New York using a locally developed test that follows CDC protocol.

Too much testing can be a bad thing, which means officials must find an appropriate balance. During the 2009 H1N1 outbreak, local labs were overwhelmed with tests, Becker said, some of which were unnecessary since the virus already was known to be circulating in some communities. “We can’t have every mildly ill person flood the health system.” Newsom echoed this sentiment, urging people to stay calm.

Several weeks ago, the CDC said it would roll out expanded testing through a surveillance network used to test for the flu, but the problems with the tests have delayed the start of the program.

The delays with testing also highlight the need for more consistent funding, so that health departments can be prepared for an outbreak, said Becker. Funding waxes and wanes with epidemics, but public health has to be as ready as your local fire department, he said. “We are that important to the health, safety and economy of the country.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

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California Global Health Watch Public Health

New California Coronavirus Case Reveals Problems with U.S. Testing Protocols

Just weeks into the federal government’s efforts to contain the novel coronavirus, a new California case has exposed weaknesses in the testing procedures that could be masking more widespread reach of the disease.

A woman in Solano County, California, who hadn’t traveled abroad or had contact with another known patient with the illness was diagnosed with the virus Wednesday, raising concerns that cases are going undetected because of the federal government’s narrow testing protocols.

The patient sought care at a local hospital before being transferred to UC Davis Medical Center in Sacramento because of the severity of her case, according to a letter hospital officials sent to members of the campus community. Suspecting coronavirus, doctors at UC Davis asked public health officials about testing for COVID-19, the name given to the illness believed to have originated in Wuhan, China.

But the request did not meet protocols laid out by the federal Centers for Disease Control and Prevention: The woman didn’t have a history of travel or contact with a person with a known infection. So no test was administered. The patient continued to receive treatment at UC Davis for four more days, without a diagnosis. Finally, on Sunday, the CDC requested the test, according to the letter.

It came back positive.

Multiple experts interviewed said the case underscores the need for more widespread community testing of the new coronavirus, which has sickened tens of thousands of people in more than 45 nations around the globe. It also highlights how the CDC’s narrow testing protocols, combined with the agency’s continued delays in getting functional coronavirus test kits to state and local public health agencies, have hindered the public health system’s ability to respond to the outbreak.

To date, the CDC has tested fewer than 500 people in the U.S. for the virus. By contrast, South Korea, which is several days into an outbreak, had tested more than 66,000 people and confirmed more than 1,700 cases as of Thursday morning.

The Northern California case mirrors what some experts have been warning for weeks: that infected people might be circulating undetected in the general population because the testing criteria are too narrow. It’s highly likely the Solano County case is not unique, and that other cases of what is called community transmission are going undetected, said Dr. Amesh Adalja, a senior scholar at John Hopkins Center for Health Security. He stressed, however, that the risk of infection remains low in the U.S.

Officials declined to provide details about the patient’s age or condition, citing privacy concerns. Some health care workers at the facility have been asked to stay home “out of an abundance of caution,” hospital officials wrote, and public health officials are working to locate others who may have come into contact with the patient over the last couple of weeks.

At a news conference Thursday, California authorities called for the federal government to ramp up testing of the broader population in light of the Solano County case, thought to be the first evidence in the U.S. of community transmission.

“We need to substantially increase access and availability of testing, and we need to do that today,” said Gov. Gavin Newsom.

Newsom noted that more than 8,400 people in California were being monitored for coronavirus and that 28 people still in the state were confirmed to be infected. Newsom said he had received assurances from CDC officials that they would expand testing protocols, which they did later Thursday.

Until Thursday, testing criteria for COVID-19 said the person should have fever and signs of lower respiratory infection, as well as a recent history of travel to mainland China; or a fever or signs of lower respiratory infection and close contact with someone already diagnosed with the virus. On Thursday, those guidelines were expanded to include people who had those symptoms and had recently traveled to Iran, Italy, Japan or South Korea, in addition to China; or people with fever and acute lower respiratory illness that isn’t explained by flu or other viruses.

Like other experts, Adalja believes the testing protocol should be even broader. About 80% of people diagnosed with the virus have only mild symptoms, according to early research out of China, and even under the expanded CDC guidelines, few of those people would qualify for testing.

While the risk to the general population is still believed to be low, finding mild illnesses is the key to understanding how deadly the virus is, and how big a risk it poses.

Given the high rate of travel into and out of the U.S., there’s reason to believe the virus reached the U.S. before there was even a testing protocol in place, Adalja said. He said clinicians need more autonomy to order tests on patients they suspect have the virus.

In addition to the delayed testing in California, news outlets in Hawaii have reported that some tests ordered by physicians there were never processed because they didn’t meet the testing criteria.

And the test kits themselves have had substantial problems. After they were sent to labs three weeks ago, numerous states reported trouble verifying the tests because one component of the kit was flawed. Officials aren’t yet sure of the exact cause of the problem. Meanwhile, all testing has continued to be routed through the CDC in Atlanta, a process that can take several days between packaging, shipping and analyzing.

In the weeks since the faulty kits were sent out, public health agencies have gotten so desperate for a functional test that they took the extraordinary step of asking the FDA to allow them to develop their own. “We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories,” the Association of Public Health Laboratories, which coordinates responses from local labs during health emergencies, wrote in a letter to the FDA. The FDA replied, outlining a process for a public health lab-developed test that the APHL plans to use in future outbreaks.

“Next time, we will go straight to the FDA,” said Scott Becker, CEO of the APHL.

Meanwhile, on a call Wednesday with public health labs around the country, the CDC and FDA said that the handful of labs that had verified that the CDC kits they received were fully or largely functional could begin performing tests using those kits. As of Thursday morning, eight labs in seven states fit that category.

California is one of those states. Newsom said that he was concerned by the small number of test kits the state currently had, and that the CDC had assured him more were coming. APHL expects some 40 labs will have testing capabilities by the end of next week, Becker said.

Still, some states flush with international travelers, like New York, have not been able to successfully use the flawed kits. On Wednesday, Gov. Andrew Cuomo called on the federal government to allow testing in New York using a locally developed test that follows CDC protocol.

Too much testing can be a bad thing, which means officials must find an appropriate balance. During the 2009 H1N1 outbreak, local labs were overwhelmed with tests, Becker said, some of which were unnecessary since the virus already was known to be circulating in some communities. “We can’t have every mildly ill person flood the health system.” Newsom echoed this sentiment, urging people to stay calm.

Several weeks ago, the CDC said it would roll out expanded testing through a surveillance network used to test for the flu, but the problems with the tests have delayed the start of the program.

The delays with testing also highlight the need for more consistent funding, so that health departments can be prepared for an outbreak, said Becker. Funding waxes and wanes with epidemics, but public health has to be as ready as your local fire department, he said. “We are that important to the health, safety and economy of the country.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Related Topics

California Global Health Watch Public Health

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! The gloves came off and the knives came out at the debate this week, so let’s jump right into the fray.

Sen. Elizabeth Warren (D-Mass.) came out swinging on Wednesday night in an all-around livelier debate than most we’ve seen this primary season. When it came to health care, few were safe from Warren’s jabs — South Bend, Indiana, Mayor Pete Buttigieg’s plan was deemed “paper-thin,” Minnesota Sen. Amy Klobuchar’s was so short it could fit on a Post-it note. Even Vermont Sen. Bernie Sanders (whose plan Warren supports) was criticized as not being realistic or a team player.

Warren wasn’t the only one on the attack. Former Vice President Joe Biden hit at new-comer and billionaire Mike Bloomberg for once upon a time labeling the Affordable Care Act “a disgrace.” But Biden left out some context in that particular attack — such as the fact that Bloomberg was commenting that the law wasn’t enough to fix the deeply flawed health system.

Meanwhile, Midwestern Nice was put to the test as tensions between Buttigieg and Klobuchar boiled over. “You voted to confirm the head of Customs and Border Protection under Trump, who was one of the architects of the family-separation policy,” Buttigieg pointed out. At one point, Klobuchar shot out: “Are you trying to say that I’m dumb? Or are you mocking me here, Pete?”

The Washington Post: A Guide to the Most Biting Brawls of the Contentious Las Vegas Presidential Debate

The Washington Post: Fact-Checking the Ninth Democratic Debate

Buttigieg also tried to get Sanders to take some responsibility for his supporters’ social media behavior. The issue was top of mind this week after a powerful culinary union in Nevada condemned the “vicious attacks” its members were receiving following the union’s criticism of Sanders’ “Medicare for All” plan.

The Wall Street Journal: Democratic Debate in Nevada: The Moments That Mattered

The incident between the union and Sanders’ supporters is the tip of the iceberg of a larger Medicare for All civil war roiling organized labor. On one side, you have liberal unions who argue a government-run plan would free them up to refocus and allow them to concentrate on other important matters. The other side of the coin says there’s no way the health care provided under such a system would be as good as the hard-earned plans they have now.

Politico: Labor’s Civil War Over ‘Medicare For All’ Threatens Its 2020 Clout


I was overly optimistic last week in everyone’s desire to adopt an official name for the coronavirus outbreak. Sorry scientists, “COVID-19” does not seem to have taken off, and, at least colloquially, you might be stuck with “coronavirus.” But no matter what it’s called, it is still demanding the world’s attention. Here’s a look at some of the more noteworthy and interesting stories from the week:

— The number of cases in China keeps dropping, in a sign that the outbreak might be stabilizing, at least in the epicenter. But that doesn’t mean anyone should be optimistic (heaven forbid!), because it’s likely cases outside China are on the cusp of blooming into a pandemic.

The New York Times: Coronavirus Epidemic Keeps Growing, But Spread in China Slows

— The Washington Post peels back the curtain on a fight between the State Department and the CDC over whether infected cruise ship passengers should be flown back to America without telling the other people on the plane. Guess who won …

The Washington Post: Diamond Princess: State Department Flew Coronavirus-Infected Americans to the US Against CDC Advice

— Who in our cast of characters holds the responsibility of steering the world through this crisis? (All I keep thinking is: “Responders…Assemble!” Anyone else? Or only your resident Marvel geek here?)

Stat: The Responders: Who Is Leading the Charge in the Coronavirus Outbreak

— Why is a hospital in Omaha, Nebraska, making news? Because in the early 2000s a group of doctors and scientists came up with the idea of creating a biocontainment unit there. Not everyone was on board at the time, calling it “overkill.” But nearly two decades of epidemics have proved the skeptics wrong.

The Associated Press: Why Treat People Exposed to Virus in Omaha? Why Not?

The New York Times: First Ebola, Now Coronavirus. Why an Omaha Hospital Gets the Toughest Cases.

— Are computers better at spotting an outbreak before humans’ puny minds can? Well, they’re quicker, certainly, but they lack our finesse. AI is more like an overly anxious car alarm, and disease fighters are still needed to come in and tease out the complexities of the situation.

The Associated Press: Can AI Flag Disease Outbreaks Faster Than Humans? Not Quite

— More men than women are falling victim to the coronavirus, and that might have something to do with smoking rates.

The New York Times: Why the Coronavirus Seems to Hit Men Harder Than Women

— The prejudice that tagged along with this outbreak is nothing new. Experts warn that there’s a long history of this kind of reaction, and that if we don’t heed warnings about the consequences of such behavior we’ll just be repeating mistakes of the past again.

Undark: Coronavirus Spurs Prejudice. History Suggests That’s No Surprise.

— The vast majority of coronavirus cases are mild. But in 2% of cases, it’s brutally lethal. So what’s happening?

The Washington Post: How the New Coronavirus Can Kill People or Sicken Them

— Is COVID-19 here to stay or will it disappear like its coronavirus brethren?

Los Angeles Times: SARS Killed Hundreds and Then Disappeared. Could This Coronavirus Die Out?

— And, something I had not considered, but with the Olympics coming up, experts say the world needs to have a better grip on the virus before countries should think about attending.

The Associated Press: Virologist: Tokyo Olympics Probably Couldn’t Be Held Now


As the Trump administration pushes to increase patients’ access to their electronic health records, tech companies wait hungrily in the wings for the data to slip out from under the protection of HIPAA. Supporters of the administration’s moves say that Big Tech will be mindful of their own brands and reputations and treat the potential of (lucrative, sweeping) health data responsibly. Critics are a little less sure about that rose-colored-glasses view of an industry mired in data-privacy scandals.

Politico: Trump’s Next Health Care Move: Giving Silicon Valley Your Medical Data


Covered California enrollment numbers gave health law supporters something to be smug about this week: Thanks to a state-level individual mandate and more subsidies, the marketplace saw a 41% jump in new sign-ups. Covered California officials were pretty much, like, “See what can be done when you support this model?”

Sacramento Bee: Covered California Health Insurance Sign-Ups Rise in 2020

Speaking of California, Gov. Gavin Newsom made a big statement by devoting the entirety of his State of the State address to the homelessness crisis. “Let’s call it what it is. It’s a disgrace,” he said. A main focus for Newsom was the intersection of mental health and homelessness, and what the state can be doing to better help those who need it.

Los Angeles Times: California Homelessness Crisis ‘A Disgrace,’ Newsom Says in State of the State


In the miscellaneous file for the week:

— Pharma used to rule the roost on Capitol Hill. But those days are looking more and more like a thing of the past. The WSJ dissects the once-ironclad relationship between the industry and Republicans, and what went wrong for the drugmakers.

The Wall Street Journal: How the Drug Lobby Lost Its Mojo in Washington

— These days we’re used to courts demanding scientific evidence, to jurors being presented with experts in the field when having to make a decision about the medical ramifications of something like a pesticide or other chemical. But that wasn’t always the case. Undark looks back on when that changed, and the family that’s cited so often in court cases their name has become a verb.

Undark: For Science in the Courts, the Daubert Name Looms Large

— Ever wonder why things are priced to the 99 cents? That’s because of the way people perceive numbers and the greater likelihood you’ll buy something priced at $4.99 versus $5.00. When it comes to pennies, that might seem inconsequential. But it turns out the same kind of thinking can be applied to age — and, thus, decisions about where the cutoff should be on procedures like open-heart surgery.

Stat: How Psychology of a $4.99 Price Tag May Affect Doctors’ Decisions

— Everyone went into the opioid lawsuits with high hopes, buzzing about the possibility of the reckoning (and settlement) being akin to that of Big Tobacco’s in the 1990s. But the reality is likely to be a letdown.

The New York Times: Payout From a National Opioids Settlement Won’t Be As Big As Hoped


And that’s it from me! Have a great weekend.

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