Skip to Main Content

The discovery that a California woman was likely infected with the novel coronavirus by a previously unrecognized case in her community is proof of an enormous problem the country is facing at the moment, according to public health experts. It’s clear that the virus is spreading undetected in the United States — but how broadly it’s spreading is an utter mystery.

Before Thursday, a perfect storm of problems in the Centers for Disease Control and Prevention’s development of test kits — and the agency’s reluctance to expand its recommendation of who should be tested given the limited availability of kits — meant very little testing has been done in the country. As of Wednesday, the CDC said that 445 people had been tested — a fraction of the number of tests that other countries have run.

The new case in California makes it clear the virus is spreading undetected in at least one area of one state. The woman is not believed to have traveled outside the country and had no contact with a known case. As her condition worsened — she is on a ventilator — health officials in California asked the CDC to test her for the virus. Because she had not been to China and had not been a contact of a known case, the agency said no.

advertisement

Eventually, more than 10 days after she went into hospital, the CDC agreed she could be tested. Dozens of health workers who may have come into contact with her at NorthBay VacaValley Hospital, in Vacaville, Calif., are now being monitored.

Support STAT: STAT is offering coverage of the coronavirus for free. Please consider a subscription to support our journalism. Start free trial today.

California Gov. Gavin Newsom was critical of the testing debacle in a press conference on Thursday. His state has only 200 kits to test for the new coronavirus, he said.

advertisement

“Testing protocols have been a point of frustration for many of us,” Newsom said. He added that, based on conversations with the CDC, states have been informed new protocols are coming and they have been promised an “exponentially” increased capacity to test.

Indeed, on Thursday the CDC announced a new testing protocol that will greatly expand the number of people who should be tested.

Requests for comment from the CDC on Thursday went unanswered. The New York Times reported that the Trump administration has ordered that all statements on the coronavirus be funneled through the office of Vice President Mike Pence, who was named to head the administration’s coronavirus response on Wednesday by President Trump.

Experts said it has been long past time to broaden the testing protocol beyond people who traveled to China. Outbreaks are gathering speed in Italy, Iran, and South Korea, and dozens of other countries are reporting cases.

On Thursday afternoon the agency did just that in new guidelines for the medical community on who to test for Covid-19, the disease caused by the virus. People with symptoms compatible with Covid-19 and who have recently traveled to China, Iran, Italy, Japan, or South Korea should be tested for the virus, the new guidance says.

The CDC’s own advice to travelers warns Americans not to travel to South Korea because of the coronavirus risk and urges people with medical conditions to avoid traveling to Italy, Iran, and Japan at this time.

“It is accurate to say that we have recognized 60 cases in the U.S. from returning travelers and one now unexplained by travel in California. But it’s not accurate to say that we have 60 cases,” said Tom Inglesby, director of the Center for Health Security at Johns Hopkins School of Public Health. “We don’t know how many cases we have. We can’t estimate that until we’ve done clinical testing and surveillance testing.”

The new guidance also frees up hospitals to test patients with ARDS — acute respiratory distress syndrome — for which there isn’t a diagnosed cause to see if they are infected with the new virus, a move Inglesby had also called for.

The CDC developed and sent test kits to state and local labs in early February. Even then, those labs were clamoring for the ability to test and questioning why it was taking so long to develop assays for the new coronavirus.

Because the federal government declared the coronavirus outbreak an emergency, state and local laboratories are prohibited from using tests developed in-house. They could only use tests that had received an emergency use authorization from the Food and Drug Administration. In this context, that means the CDC test.

When laboratories start to use a new CDC-designed test, they have to first assess their own ability to run the tests accurately, and report back to the CDC if they are having problem getting the tests to work in their hands. It quickly became apparent that a lot of the state and local laboratories were having trouble with one part of the test, Health and Human Services Secretary Alex Azar told the House Ways and Means Committee on Thursday, adding that the CDC “probably, in retrospect, maybe over-engineered [the test] a bit.”

The CDC told the few states that weren’t having a problem to continue testing and pulled back the kits from the others, which meant that any time those states had a patient who needed to be tested, they had to send the sample to the CDC.

The organization that represents state and local labs — the Association of Public Health Laboratories — was so concerned that on Monday it asked the FDA in a letter if local labs could begin to use in-house tests, executive director Scott Becker said.

“That’s really what led us to reach out to the FDA in really a very public way saying: ‘What else can we do? Because we’re hamstrung here. We’re between a rock and a hard place,’” he told STAT.

Becker said state and local labs have now been told that those that can run all three parts of the test should do so; those that can’t get the third part to work properly can now drop that part. Meanwhile, a next-generation test is being readied.

“I expect it to go very quickly in the next few days,” Becker said. “I really feel like yesterday” — Wednesday — “was a pivotal point and there’s some positive movement.”

Having more laboratories able to test will only solve part of the problem, however. Giving doctors and hospitals more leeway to test more patients who look like they might have Covid-19, regardless of whether they’ve traveled or not, will help further define the level of transmission in this country, experts said.

Inglesby called for a surveillance effort — designating certain hospitals or cities to test more broadly for the virus to try to assess whether there is undetected spread.

The CDC said several weeks ago such a program would be launched in six cities. But the testing problems have delayed the rollout.

Megan Thielking contributed reporting.

  • I read in an article a few days ago that there is a lung test that can detect coronavirus it was an MRI or another test that scans the lungs and will show similar findings of the lungs of SARS.. it was described as white shiny patches on the the lungs of people who are infected with the coronavirus. I’m not sure how accurate it would be in detecting cases that are very new, but I would think that any test is better than no test. Also, whether a test is able to be done or not, if any person who is possibly infected, they should be put in quarantine regardless.. better safe than sorry is definitely the way we should be dealing with this at this point considering the obnoxiously large amount of mistakes that have been made so far.. it’s like we’re consistently 3 or 4 steps behind when we should be taking so many more steps to containing and stopping the spread that’s all over the country and there are travel restrictions to certain countries and from certain countries?? I’m not the expert here but I would think that stopping all flights for 2 or 3 weeks would be the best option, but they insist on risking more spread to avoid losing money by cancelling all flights for a couple weeks but I see that being another disaster caused by the “experts” not thinking long term.. the amount of people that are going to be infected in the next 2 weeks bc they were allowed to travel makes no sense… it’s been the repeat occurrence for 2 months now.. God help us

  • cases in CA, OR and WA without any known contact with affected person – anyway this thing is traveling in wind currents across China, Japan, s. Korea and hitting Pacific NW?

    • This is what I asked too.
      In China the spread was severe faster in southern states than eastern that was weird because the eastern/northern than Hubei counties were more populated, more big cities, more highways and airplanes. ( North/South winds until February)
      Then we have Eastern province of China/ North Korea( a mystery) and then South Korea. ( North/South Winds too)

      Now we have North Italy, and as the winds come from Northwest and they go North above the lake in a circle.
      If this is wind-spread ( I asked about this earlier and it seems that is possible) then France must have an issue similar to Italy already in terms of infections and now Switzerland/Germany will have the same issue.
      Also, after Iran, the infections go west as in Iran Qom, the winds come from East and go west. So Middle east/Greece seem to picking up too.

      The question is if it is Wind spread what does it mean and how we get protected?

      Noone talks about the wind patterns yet but I am sure that their models show the same that my model shows.

  • It is time for testing anyone with symptoms for CoVid. Since containment and testing based on first infections doesn’t seem to be working elsewhere in the world. There is a possibility – slight – that it is wind-spread. My model gives me indication on this. If this is true then Germany first and South France will start having many more infections in the next few days.
    In this case, the epicenters may be the reason for the spreading of infections with the wind.
    I wrote before that this is far-fetched but the way that the virus spreads around the globe until now supports this theory.

    I am sure that CDC with the surveillance testing can identify potential epicenters and sets lockdowns immediately. At 40-50 infections max.

    I hope that they can see that the situation requires pre-action, rather than re-action by now.

    After all, the markets woke up, so let’s start the drums for the universal good.

  • Timing is wrong. She contracted illness long before Diamond Princess passengers showed up. There was the original, botched, Wuhan evacuation to Travis, but her virus doesn’t seem to be a phylogenetic match. It’s most closely related to a Wuhan patient in Thailand on January 7. She likely got it from someone unknown.

  • The fact does remain that Influenza is far worse than Covid-19 with 400,000 deaths per season, 29 million infections in the US, 230,000 hospitalizations. H1n1 has had 100 million infections since inception in 2009 and has never been contained. I am more concerned that we’re giving more press to hysteria than science. Covid-19 is not the Black Plague, Not Spanish Flu, and not even Influenza. It is one virus of many, most of which have no cure or containment. More concerning is that SARs, a cousin of Covid-19, spreads by roaches and humans, among other means, remains on surfaces, presumably the usual tables and counters, but also fur of pets, rodents, bodies of insects and bird feathers and beaks. The fact seems to be that Covid-19 is mild. Period. But, for whatever nonsensical reason, the media is pretending it is apocalyptic. It is not. Let’s focus on real viruses and stop playing games with Covid-19.

    • Hey genius do Health care workers wear hazmat suits to treat flu patients? Do we subject flu patients to mandatory 14 day quarantine? Does China shut down 11 major cities for a seasonal flu?

    • You’re comparing apples and oranges. The case fatality rate of Civid 19 is several times higher than the seasonal flu. (and almost exactly on par with Spanish Flu) Your 400,000 fataoities per year are still only 0.095% of people who get the seasonal flu. Covid spreads easily, and if we don’t develop any game changing treatments in the next 12 months, then it will kill tens of millions. If you don’t believe me, do the math yourself based on 60-70% of the worlds 7.8 billion people projected to be infected with a 2% case fatality rate. (And a 13-20% serious complication rate if you want to see about how many people will be waiting for treatment in hospital.)

    • Unfortunately, your numbers are wrong here.

      There are on average 40,000 deaths from flu per year in US, you have added an important ZERO here! You are missing the point of “proportions” though.
      40000/29 million =0.001 that is 1 in 1000 persons.
      The death rate for coronavirus is predicted anywhere from 2- 5%
      The infections are predicted 60-80%.

      With the lowest predicted numbers based on the cases right now: 210 million infections, 42 million severe, and 4.2 million deaths.
      I can only see an upturn of these numbers, since 2% is the death rate without knowing the outcome of 7500 severe cases at this point.

      Unfortunately, what is unfolding globally, seems to verify predictions, this is if we do not take strict measures.

      Not paying attention to the numbers can lead to huge surprises when the truth knocks the door.

      And Yes, we may need to pause life as we know it, until we have a vaccine, or adequate antiviral.

      Nevertheless, if your nickname means you are also trading, hedge as fast as you can and avoid buying the low …

  • I have NEVER seen a sentence so filled with caveats or qualifiers (in caps below): …Secretary Alex Azar told the House Ways and Means Committee on Thursday, adding that the CDC “PROBABLY, IN RETROSPECT, MAYBE OVER-engineered [the test] A BIT.”
    That doesn’t inspire my confidence.
    Secondly, I like Trump and think he has worked wonders, given the Hounds of Hell have been after him for three years plus. However, his speech last night I thought was not-Trumpian, and certainly not Churchillian. While it is said Churchill, during WW2 gave it straight to the English people, no frills, no caveats…and afterwards he told them how they would win.
    If this thing becomes a global pandemic, it IS like a war. I felt that last night what President Trump said did nothing to allay the concerns of those Americans who have been closely following events and are ALREADY concerned, and likewise did nothing to AWAKEN those Americans who are totally oblivious to any potential danger.

    • He is good in dealing with economy. I think he was concern economic effect if people panic.

      But with this kind of highly contagious virus, it is better to panic that to be complacent. He will have to make a choice, and I sincerely hope he will wake up sooner and stop minimizing the epidemic, otherwise he will end up losing the election if this truly spread in the country.

  • I am going to say, I am in disagreement with Trump that all statement must have approval of Mike Pence before they are release to the public. We are then following China footstep in Wuhan. They have to have leadership approval because they can announce something, meanwhile valuable times are lost. In seems Trump conversation with Xi had bad influence.

    This is like going backward. The CDC has a lot of blunders but at least there statement are informative. It is sad the day they lost there freedom of speech. Trump is making a big mistake on this.

    It is better to panic that to me complacent. Complacent are the people who get caught unaware. Just like the cruise ship passengers, they know there is a dangerous virus going on in Asia but they still went on a cruise.

    It is better to anticipate that to be caught unaware.

  • Helen Branswell’s excellent recounting of the necessity for valid sensitivity and specificity screening of Covid-19 cases to manage the challenges was poignantly covered earlier by Megan Thielking’s alarm raising concern for exposed medical staff under such conditions as now exist.
    UC-Davis and the local county & state public health teams have a well-earned reputation from past successful containments such as an MDRTb “outbreak”
    a decade or so ago in a local penal institution. I witnessed their meticulous focus on detection & care without creating neither panic nor wasteful recriminations of an overworked, understaffed dedicated department. They will rise to the challenge and lead others in responding to these inevitable episodes of contagion that must be contained and handled.

Comments are closed.