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Coronavirus Test Kits Sent to States Are Flawed, C.D.C. Says

Some tests distributed by the agency deliver “inconclusive” readings. The C.D.C. will need to ship new ingredients, further delaying results.

A medical staff member working with test systems for the diagnosis of coronavirus, at the Krasnodar Center for Hygiene and Epidemiology microbiology lab in Russia.Credit...Associated Press

Some of the coronavirus testing kits sent to state laboratories around the country have flaws and do not work properly, the Centers for Disease Control and Prevention said on Wednesday.

The kits were meant to enable states to conduct their own testing and have results faster than they would by shipping samples to the C.D.C. in Atlanta. But the failure of the kits meant that states that encountered problems with the test should not use it, and would still have to depend on the C.D.C.’s central lab, which could cause several days’ delay in getting results.

“Obviously, a state wouldn’t want to be doing this test and using it to make clinical decisions if it isn’t working as well, as perfectly, at the state as it is at C.D.C.,” Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, said at a news conference on Wednesday.

The C.D.C. recommends testing for people who have symptoms like fever, cough or shortness of breath, and who, within the past 14 days, have traveled to China or have been in close contact with someone who is infected with the coronavirus. Doctors with patients in that category are supposed to consult their state health department about whether the individuals should be tested for the virus.

The C.D.C. announced late Wednesday that another evacuee quarantined at a military base in California had tested positive for coronavirus. The latest individual who was diagnosed among the evacuees from Wuhan, the epicenter of the outbreak, brings the total of confirmed cases to 14 in the United States. A previous case was diagnosed at the Miramar base in San Diego on Sunday.

The first and second patients arrived on different planes and were housed in separate facilities at Miramar, according to the C.D.C. Dr. Chris Braden, an expert on the site, said in a statement that “At this time there is no indication of person-to-person spread of this virus at the quarantine facility, but C.D.C. will carry out a thorough contact investigation as part of its current response strategy to detect and contain any cases of infection with this virus.”

The C.D.C. announced last week that it had begun shipping about 200 kits to laboratories in the United States and roughly 200 more to labs in more than 30 other countries. Each kit can test about 700 to 800 specimens from patients, the agency said.

Kits were shipped to every state, but officials did not say how many of the kits were faulty.

At a news conference on Wednesday morning, Dr. Messonnier said that test kits had been shipped to more than 30 other countries, but later in the day said that she was mistaken, and that the international shipments had been held back because of the flaw.

Before the kits were shipped to the states, Dr. Messonnier had emphasized repeatedly at news conferences that the kits would not go out until the C.D.C. was sure they were as accurate as possible.

Dr. Jeanne Marrazzo, director of the infectious diseases division at the University of Alabama at Birmingham, said accurate diagnostic tests were invaluable.

“The test is the only way you can definitely know you have the infection,” Dr. Marrazzo said. “You absolutely need it for case counting. It allows you to know who’s infected. You can treat those people, if a treatment is available, and you can isolate them.”

Doctors in China said there was an urgent need for a simpler, quicker diagnostic test, officials from the World Health Organization said during a news briefing on Wednesday.

On trial runs in some states, the C.D.C. kits produced results that were “inconclusive,” Dr. Messonnier said. The tests did not involve samples from potential patients, but were part of the routine quality-control procedures that labs followed before using a test to make real diagnoses.

“Things may not always go as smoothly as we may like,” Dr. Messonnier said.

The problem appeared to come from one ingredient involved in the test, Dr. Messonnier said, adding that the C.D.C. would make a new supply of that ingredient to send to all of the laboratories. Officials did not say when the ingredient would be shipped, but said the process was being expedited and the material would be made available as soon as possible.

States that did not have trouble with the kits could keep using them, Kristen Nordlund, a spokeswoman for the C.D.C., said, adding that those states would still receive the newly made ingredient from the agency.

The flawed test kits are a separate issue from the mislabeled samples in San Diego that had led officials to discharge a woman, who was sick from the coronavirus, from a hospital.

More than 1,380 people have died, nearly all of them in China, where there are more than 55,000 confirmed cases.

The C.D.C. does not recommend testing for people who may have been exposed to the virus but have no symptoms. Even if they are infected, if they are still in the incubation period, there may not be enough virus in their bodies for the test to detect.

The inability to detect very early infections is one reason for keeping planeloads of people from Wuhan in quarantine instead of just testing them and letting them go if the results are negative. A person could test negative and still be infected.

For the same reason, health authorities say there is no benefit to testing symptom-free people on cruise ships.

Because there is an unknown window of time between when a person becomes infected and when the test can find the virus, health officials have determined that a quarantine of two weeks — believed to be the incubation period of the illness — is the best way to make sure that people who may be infected do not transmit the virus to others.

Tests for other infectious diseases can also fail to detect some cases. A panel of tests used to screen for respiratory viruses when pneumonia is suspected can give negative results even if a patient is infected, Dr. Marrazzo said. So can rapid tests for flu and strep throat. Blood tests for H.I.V. can miss the diagnosis in people who were recently infected.

“There is no perfect test for pretty much any infectious disease I can think of,” Dr. Marrazzo said.

The Daily Poster

Listen to ‘The Daily’: Fear, Fury and the Coronavirus

China’s Communist rulers are not just fighting an epidemic. They are also struggling to contain an upwelling of public anger about their own failure to stem the outbreak.
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0:00/25:16
-25:16

transcript

Listen to ‘The Daily’: Fear, Fury and the Coronavirus

Hosted by Michael Barbaro; produced by Lynsea Garrison, Michael Simon Johnson, Daniel Guillemette, Alexandra Leigh Young and Neena Pathak, with help from Sydney Harper, Hans Buetow and Mike Benoist; and edited by M.J. Davis Lin

China’s Communist rulers are not just fighting an epidemic. They are also struggling to contain an upwelling of public anger about their own failure to stem the outbreak.

gps voice

[SPEAKING MANDARIN]

amy qin

I’ll say a few things. So it’s a rainy day. Very, very gloomy, rainy day. And it’s a little loud because we have to keep the windows open, because that’s the recommendation in these situations. You have to keep everything ventilated.

[music]

amy qin

Two weeks ago, our researcher Elsie and I went down to Wuhan, which is this major city in the center of China that has been the epicenter of the recent coronavirus outbreak. By then, it had been under lockdown for about a week. And we were really curious to see how people were faring and what was going on, especially at the hospitals there. We took the train from Beijing to Wuhan. And we got off, and what we saw was totally crazy. I mean, we’d never seen anything like it. This is a city of 11 million that had come to a complete standstill. It felt like being in a parallel reality.

To see those streets completely empty was really striking. It was eerie to hear the silence. And the only time we heard anything was the occasional barking of a dog or an ambulance passing by. We were walking around this hospital and we walked into the courtyard in front of the outpatient department. And that’s where we came upon this very jarring scene. You had 30 or so patients that were all kind of sitting quietly in the courtyard, all hooked up to IV drips that were hanging from tree branches or in their cars.

interposing voices

[SPEAKING MANDARIN]

amy qin

We meet this mother and her two children who are all hooked up to IVs. The mother’s name is Yang Ling.

yang ling

[SPEAKING MANDARIN]

amy qin

They tell me that they are actually a family of six. There’s Yang Ling. There is her husband, her husband’s parents and then their son and their daughter. And they have all been staying together. And she tells us that their grandmother got sick first and one by one, each of them has gotten infected by the coronavirus. And now, her husband is the only one that doesn’t have coronavirus.

yang ling

[SPEAKING MANDARIN]

amy qin

And then they tell me that just one week after the grandmother started showing symptoms, their grandfather died.

yang ling

[SPEAKING MANDARIN]

amy qin

She tells us that after the grandfather dies, the funeral home comes to take the body away —

yang ling

[SPEAKING MANDARIN]

amy qin

— and he is cremated immediately. And she says that —

yang ling

[SPEAKING MANDARIN]

amy qin

— he was taken away just like a dead dog or a dead pig.

yang ling

[SPEAKING MANDARIN]

amy qin

As she’s talking, her voice is starting to carry across the courtyard outside this hospital. And other people are starting to listen in and crowd around us, and she’s starting to get more and more upset. She was so palpably angry that at one point —

yang ling

[SPEAKING MANDARIN]

amy qin

— the mother was waving her arms around in frustration and almost ripped the IV needle out of her hand.

yang ling

[SPEAKING MANDARIN]

amy qin

I’ve been covering China for seven years. And I’ve heard people express frustrations with the government before, but really only in private. This was one of the few times that I’ve heard such raw anger toward the government publicly.

yang ling

[SPEAKING MANDARIN]

amy qin

And she basically says, is this really my country or is this some kind of [EXPLETIVE] up country — a country that doesn’t take care of anything?

yang ling

[SPEAKING MANDARIN].

amy qin

And then she says, what kind of government is this? And after hearing that, that made me think that something was happening that was bigger than just an outbreak of a virus.

michael barbaro

From The New York Times, I’m Michael Barbaro. This is “The Daily.” Today: Inside China, what began as a story of fear over the coronavirus has now become the story of fury over the government’s handling of the crisis.

Beijing correspondent Amy Qin on what she saw in Wuhan. It’s Thursday, February 13.

Amy, what is it about this moment that you think is making people like the Zhang family feel free to speak out about their anger and to pretty explicitly criticize the Chinese government?

amy qin

So for the Zhang family, this is for them a matter of life or death. And it was a common feeling I heard throughout the city. But there’s another added frustration boiling across the rest of the country about how the government is handling this crisis. And for them, it’s really been captured in the story of this doctor named Dr. Li Wenliang.

michael barbaro

And who is this doctor?

amy qin

So Li Wenliang is an eye doctor at a hospital in Wuhan. And he had heard about this virus back in December that was going around the hospitals in the city. And so he went on WeChat, which is this big social messaging platform, and sent in a private messaging group with some of his med school classmates a text message basically warning them to protect themselves. And a few days later after he sent that message, he was actually called in by the police in Wuhan. They brought him into the police station and they made him sign a statement saying that he was spreading false and illegal information — basically, that he was spreading rumors.

archived recording

Authorities say it is untrue and eight people were detained for spreading fake news online and no medical staff had been infected.

amy qin

But of course, it wasn’t a rumor.

archived recording

Chinese health authorities are still working to identify the virus behind a pneumonia outbreak in the central city of Wuhan.

amy qin

By the time Dr. Li was brought into the police station, 41 people had the coronavirus. And from there, it just spread.

archived recording 1

A SARS-like virus, which has infected hundreds in China, has now reached the United States.

archived recording 2

Now China has announced the first death from an outbreak of pneumonia caused by an unidentified virus.

archived recording 3

121 people are under medical observation in Wuhan. Rumors on social media alleged that the outbreak in Wuhan could be linked to SARS.

archived recording 4

The World Health Organization says it’s a new type of coronavirus.

michael barbaro

And Amy, at this point, what is happening to Dr. Li?

amy qin

So after Dr. Li gets taken into the police station and forced to sign this statement, he was actually treating a patient for glaucoma. And she wasn’t showing any symptoms at the time, but he ended up contracting the virus from her.

michael barbaro

Wow.

amy qin

And from his sickbed, he starts to speak out again.

archived recording

In a matter of days, Dr. Li Wenliang went from treating patients to becoming one.

amy qin

He gives some interviews to Chinese media and he starts to become this public figure.

archived recording

Struggling to communicate, Li spoke with CNN briefly by phone. You can hear the hospital machines pulsing in the background.

amy qin

He becomes known as a whistleblower —

archived recording

Whistleblowers silenced by police. Calls for Li and the others to be vindicated grew online.

amy qin

— that the government didn’t act fast enough on information that they were given, and that they had missed this critical window of opportunity to get the outbreak under control.

archived recording

China’s Supreme Court even weighed in, adding quote, “It might have been a fortunate thing if the public had listened to this rumor at the time.” But for many —

michael barbaro

So he’s becoming a kind of spokesperson for a lot of frustrations.

amy qin

Exactly.

archived recording (li wenliang)

[INAUDIBLE] [COUGHING]

amy qin

And so at this point, it just feels like there is no light at the end of the tunnel.

archived recording 1

Now, the death toll in the outbreak of a new coronavirus in China has jumped to 17.

archived recording 2

Hundreds of people have been diagnosed with a deadly virus known as the 2019 novel coronavirus.

archived recording 3

Overall, there are now more than 31,500 confirmed cases worldwide.

amy qin

More and more people are getting sick. We’re seeing the numbers just surge every day —

archived recording 4

600 deaths.

amy qin

— people who are confirmed cases of the coronavirus, people who are dying of the coronavirus.

archived recording 5

Has jumped to more than 700.

amy qin

Everything felt so uncertain.

archived recording 6

Officials are imposing restrictions on travel out of Wuhan, China.

archived recording 7

And 13 cities in lockdown this morning.

archived recording 8

Near-empty shelves line supermarkets.

archived recording 9

A need for masks and protective suits.

archived recording 10

China’s health minister, Ma Xiaowei, has said that he expects infections to continue to rise. And of course, that has everyone here in the country even more nervous.

archived recording 11

The citizens are actually freaking out.

archived recording 12

China right now is being massively rocked by anger.

archived recording 13

And the State Department has said it is chartering a flight to evacuate Americans out of Wuhan. Justin, though, will not be on that —

amy qin

So foreign governments started pulling their citizens out of Wuhan, and that’s when I got the call.

So it was late last week, and I had been on the phone all day with my editors. And I get a final call saying you need to go to the airport. There was one flight left that was being arranged by the U.S. State Department to go back to the U.S., so I start scrambling. I leave all my masks, my disinfectant wipes, my hazmat suit, my gloves with my colleagues. And then it’s about a 40-minute drive to the airport.

amy qin

O.K. So I am at the airport in Wuhan now. And it’s been a crazy, hectic day. I think that the next few weeks in quarantine on a military base will bring its own interesting moments.

michael barbaro

And what is the scene at the airport?

amy qin

The scene at the airport was a little bit frenzied. I mean, at this point, these are really some of the last flights out for these countries who are evacuating their citizens, so it wasn’t just the Americans. There were also the Canadians, the Japanese. And we didn’t even know at that point where they were taking us to. So I’m in the airport lobby and I’m waiting for my flight. And then my phone starts to buzz, and I’m seeing all these messages come through. And I look at them, and then I see that Dr. Li has just died.

And I could sense that this was going to be a big moment, because I had started overhearing people talking about it in the airport terminal. But then I just had to leave. I had to get on the flight.

michael barbaro

We’ll be right back.

So Amy, Dr. Li has died from the very virus that he alerted the government to, and you’re on a plane back to the U.S. from Wuhan. So what happens once you land?

amy qin

So once I land, I find that I am at the Miramar Marine base in San Diego, California. I’m carted off to quarantine, and then I turn on my phone and I start going through my messages. And I see this huge upswelling of outrage over Dr. Li’s death. People from every stripe of the political or social spectrum in China — so you have people who are business people, who are blue-collar workers, artists, lawyers — they’re all posting about Dr. Li’s death. And I’ve never seen people come together like this before — and people were so upset about his death.

michael barbaro

And what are they saying?

amy qin

A lot of people were posting candle emojis and other kinds of remembrances for Dr. Li. They were posting photos of him. He had taken a selfie of himself wearing a surgical mask and someone had recreated that image to replace the surgical mask with barbed wire to kind of indicate that he had been muzzled. Some people were posting the anthem from “Les Mis,” “Do you hear the people sing? Singing a song of angry men?”

michael barbaro

Wow.

amy qin

We actually saw the hashtag “I want freedom of speech” trending for five hours, which of course, it was quickly censored. And we saw petitions going up by Chinese academics calling for freedom of speech. And we even saw a local government social media account posting a portrait of Dr. Li, along with the lines, “Heroes don’t fall from the sky. They’re just ordinary people who step forward.”

michael barbaro

Wow.

amy qin

So the reaction is really remarkable. I mean, even the hospital where Dr. Li died posted an official notice of his death. And that had three million reactions and 300,000 comments. And so it was so clear that this was something that had really tapped into the frustration that was happening.

michael barbaro

And what do you make of those reactions? Because it feels like it no longer is really just about this virus and the way that it was handled?

amy qin

Yeah so at this point, it is clear that this is becoming so much bigger than just the virus. This is really about the government and this social contract that the people have had with the government, where they agree to keep silent as long as the government provides for their prosperity and health. It operates under this principle of stability at all costs.

michael barbaro

Right. And in their effort to create stability, in fact, they did the opposite.

amy qin

Yeah. I mean, I think that there’s this realization definitely that there is something wrong with the system. And I don’t think that it means that people are going out in the streets and calling for a revolution. But the fact that people are calling for freedom of speech, I mean, that’s really what this brought out. People in China are already used to a pretty high level of censorship, but when it comes to censoring a warning about public health, that goes too far. And the reaction is so overwhelming that the government quickly realizes that they need to do something. And that’s when we see China’s leader Xi Jinping come forward out of the shadows and try to take control of the situation

archived recording (xi jinping)

[SPEAKING CHINESE] [LAUGHTER]

amy qin

He comes out and makes an appearance in Beijing.

archived recording (xi jinping)

[SPEAKING CHINESE]

amy qin

He visits a community center and a hospital. He gets his temperature taken. He talks with local residents.

archived recording (xi jinping)

[SPEAKING CHINESE]

amy qin

And he does a video conference with doctors in Wuhan.

archived recording (xi jinping)

[SPEAKING CHINESE] [APPLAUSE]

amy qin

So by this point, the government has sent the nation’s top anti-corruption agency to go down to Wuhan and investigate Dr. Li’s death. And state media is calling Dr. Li a hero.

michael barbaro

This feels like a real shift for a government that originally reprimanded Dr. Li and is now sending a team to investigate why he was muzzled. It feels like a concession.

amy qin

It is. But at the same time, we have to remember that this is also part of the party’s ethos, which is to always try to control the narrative. And for them, the path of least resistance in this situation is to hold Dr. Li up as a hero, but also to do it in a way that coheres with the party narrative.

michael barbaro

Huh.

amy qin

Erasing the parts that might challenge their legitimacy or authority, which is the fact that he was punished by the government for trying to call attention to the fact that there was this virus going around.

michael barbaro

Do you think that the people in China view the government’s response as an attempt to protect them from the virus or to protect the government from the story of a situation that’s out of control?

amy qin

Both. People really believe that the government wants to get this epidemic under control. But at the same time, they know that the government is only going to do this in a way that does not threaten its own hold on power. And that means taking control of the narrative — sending in their own journalists to make sure that only the positive aspects of what they’re doing is being highlighted, and that people who are slipping through the cracks or all the failures of the policy are not being highlighted.

michael barbaro

Amy, I’m curious. Have you been able to speak to the Zhang family since you evacuated, since you took that flight from Wuhan to California?

amy qin

We have. The last time we checked in with them, their situation had changed. The mother and the daughter were both infected with the coronavirus and have finally been able to get into one of the makeshift quarantine centers set up by the government. Bella, the daughter, sent us a video of the center, and it just shows a huge exhibition center with beds crowded tightly together and all these sick patients in these beds.

Meanwhile, Bella’s brother and their grandmother are still at home back in the family apartment sick and unable to get into a hospital. The grandmother is in very serious condition. She can barely get out of bed. And they’re also still living with their father, who is the only family member who hasn’t gotten infected so fae. Though they all think that it will be a matter of time.

michael barbaro

So basically, half the family is being cared for and the other half have been kind of abandoned.

amy qin

Right. And remember, their grandfather had died in their family apartment and was taken to be cremated immediately. And they still don’t even know where his ashes are.

michael barbaro

Is the reality that another death in the family could happen something that they are preparing for?

amy qin

Yes, they’ve been planning for it. They told us that when the grandmother dies, they’re not going to let her go to the crematorium. But actually, the mother said she’s going to drag her body to the local neighborhood committee and just put it there on the front steps to show them how their inaction has devastated their entire family.

michael barbaro

Do you know whether the family knows about Dr. Li’s death, or if they were able to watch that video of Xi Jinping in public addressing the situation?

amy qin

I think if they’ve seen, it’s barely registered. They are so consumed with just trying to survive right now, like so many other people in Wuhan, that they’re just putting their heads down trying to move forward.

michael barbaro

Amy, thank you very much.

amy qin

Thanks, Michael.

michael barbaro

On Thursday, nearly 15,000 new cases of coronavirus were added to the tally of infected people in the Chinese province where Wuhan is located — the largest one-day increase of the epidemic so far. That brings the total number of cases to more than 48,000. At the same time, 242 new deaths were also reported, bringing the total death toll in the province to 1,310. We’ll be right back.

Here’s what else you need to know today. For the second day in a row, President Trump intervened in the prosecution of his longtime friend and adviser, Roger Stone, this time by attacking the judge in the case. On Tuesday, at the president’s urging, the Department of Justice recommended a more lenient prison sentence for Stone, who was convicted of obstructing a congressional investigation into Russian meddling in the 2016 election. That move prompted four federal prosecutors to leave the case in protest. On Wednesday, Trump claimed without evidence in a tweet that the judge who will sentence Stone is biased against the president in what Democratic lawmakers said was a clear attempt to intimidate the judge before she sentences Stone.

archived recording (chuck schumer)

The president ran against the swamp in Washington, a place where the game is rigged by the powerful to benefit them personally. I ask my fellow Americans, what is more swampy, what is more fetid, what is more stinking than the most powerful person in the country literally changing the rules to benefit a crony guilty of breaking the law?

michael barbaro

In response, Senate Minority Leader Chuck Schumer called for an investigation into Trump’s conduct.

archived recording (chuck schumer)

As a result, I have formally requested that the inspector general of the Justice Department investigate this matter immediately.

michael barbaro

That’s it for “The Daily.” I’m Michael Barbaro. See you tomorrow.

Miriam Jordan contributed reporting.

Denise Grady has been a science reporter for The Times since 1998. She wrote “Deadly Invaders,” a book about emerging viruses. More about Denise Grady

A version of this article appears in print on  , Section A, Page 10 of the New York edition with the headline: Test Kits Sent to States Are Flawed, C.D.C. Says, Further Delaying Results. Order Reprints | Today’s Paper | Subscribe

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