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

Feb 12, 2020 · 66 comments
Wilmington EDTsion (Wilmington NC/Vermilion OH)
Of course masks help. Anyone, doctor or not, that says they are of no help is not being helpful. Being helpful would be to give detailed instructions on how best to wear and remove a mask to make them as helpful as possible. Doctors and nurses wear them in surgical settings for a reason. My healthcare providers office has them freely available at their sign in window and urges any one with a cough to war them. This was before the Corona virus scare. I sense the real issue some downplay them is they know there are not enough to go around. At least until production is ramped up. But, yes, they help. So does hand washing and alcohol sanitizers and wipes. And tried and true household sanitizers that have been around for decades. Not touching one face. They all help and reduce the chance of infection. Nothing is perfect. Situations vary. But all of these measures help! I am not impressed with the guidance we are getting directly as a nation from our CDC. They need to step up their game on prevention. Also, a quick and effective and reliable test. And, fast tracking an immunization. Peoples lives depend on it. We need a modern day Dr. Salk. And, if and when it subsides, we must continue to improve immunity and testing. It’s not if it or a variant will be back. Simply when.....and perhaps a more virulent version. Drug companies should take every stupid cent they spend on TV ads to consumers for drugs and immediately put them to use funding their role in all of this.
Bos (Boston)
this is more panic than pandemic
BCD (Pennsylvania)
See my previous post, but here's more.  The kits were delivered to our state health department last week, on a Saturday no less.  Several state labs, including ours, were able to immediately run the Verification Panel (see below) and share results with the CDC.  At 2:08 PM on Sunday, I received a nationwide email alerting labs to the defective component of the kit. This was discovered through a process called verification.  The test, RT-PCR in this case, is performed three times by three different analysts (I was one). This particular verification consisted of 10 samples: three negative, three medium positive, three strong positive, and one control sample.  Each sample and control were then tested for the presence or absence of N1, N2, and N3, which are RNA sequences specific to COVID-19.  The test performed admirably, accurately detecting all six positives (mediums were medium, strongs were strong), with no detection in the three negative samples.  The issue is that the one control sample exhibited background noise where there should be none, thus nullifying all results. In it's current state, I'd trust the kit the diagnose me as COVID-19 negative or positive, but the rigors of medical testing don't allow cutting such corners.  However, if we were all rapidly turning into flesh-eating zombies, then I'm betting that exception might be made :)
Vashti (ATL)
@BCD Thank you for explaining and communicating to everyone. You seem to care about the people enough to give us an important explanation, clearing away a lot of confusion and fear. I'm grateful for your contribution - you stay safe and keep up the good work!
A Cynic (None of your business)
These are the people whose competence we rely on to stop this disease from spreading. We are doomed!
Paul F (Canada)
Hmmmm ... a few hundred coronavirus cases/quarantines and already having problems? And all this time telling (even demanding) China what and how to deal with said virus?
Tom Fitzgerald (Studio City)
When recently arrived U.S. citizens from China are not quarantined separately from existing travelers already here a few days, doesn’t that reset everyone’s clock to 0? Why was a South Korean flight with 5 whales (big gamblers) who had been to China within the 14 day window redirected to LAX, checked (no symptoms), and allowed to fly to Las Vegas instead of having the whole plane quarantined for 14 days? Why are some online newspapers not freely disseminating COVID-19 news? Public awareness is paramount during an epidemic. The CDC needs to hire some professional reporters so it can better disseminate knowledge to the public. If masks are only partially effective, wouldn’t the American public still be better off with masks than without them? What good does it do to turn off the water faucet with a paper towel and not also have one for the door handle? Instead of just free lunches for our school children, shouldn’t we teach our children to wear masks when they are sick and praise them for being so thoughtful and considerate of others? (can’t we have them go to class online with their teacher instead?) Why aren’t we supporting (to the hilt) those quarantined citizens who are our foot soldiers in this battle against the enemy since the federal government is falling short of making their 14 day quarantine comfortable? Let’s start a go-fund me for these brave and rightly terrified U.S. citizens! For that matter, a go-fund me for CDC as well. Any 14 day emergency CoVid-19 kits?
Girish Kotwal (Louisville, KY)
There are are a lot of unknowns about testing for a viral infection and at imes testing needs to be repeated at different times. For instance if I am infected today and you test me tomorrow then I could test negative if the level of exposure is minute and the result will be inconclusive or false negative. Now if I am tested a week after exposure and virus has multiplied sufficiently to be detected then I could be true positive. If there are signs and symptoms of COVID-19 then the tests could be positive assuming that other possibilities are tested and ruled out. I developed a specific and sensitive assay for Hepatitis C virus (HCV) when the entire RNA sequence was known, before that HCV was called parenterally transmitted Non A and non B hepatitis (NANB hepatitis) . What that meant was Hepatis A virus infection was ruled out and so was hepatitis B virus and if the virus was transmitted not by the oral route, it was NANB hepatitis. Shipping new ingredients can certainly make tests reliable if they are shipped appropriately and stored appropriately by the testing labs. Someone with experience needs to do preparation of tests and the testing. One cannot acquire experience and expertise in haste. Panic and rumors are not going to enable the eradication of deadly, highly contagious sturdy COVID-19 but careful testing in biosafety lab, optimal quarantine of exposed persons, proper handwashing, wearing double gloves, gowns and appropriate masks would knock down the spread.
Bob (Minn)
Why hasn’t the CDC been able to collaborate with the Chinese government?
Denise Grady (New York Times)
@Bob The C.D.C. cannot go into China without an invitation, and China has not invited them, even though the C.D.C. has been offering to help for quite a while.
CITIZEN (USA)
When the virus was first known, Chinese authorities did not want the news to spread. Information was suppressed. A doctor who was not allowed to speak to others, has died, himself a victim to the coronavirus. Is China equipped to meet this new threat? Can we rely on the information the country is sending to the outside world? China is linked and connected with almost the whole world. With the largest population in the world, the biggest challenge for the country is having to face a major epidemic like this coronavirus. China should capitalize on the lessons and experience from this problem, to seek solutions and be prepared for the future. For that matter, it applies to us here at home, and all countries around the world as well.
Aaron (New York)
The problem with the new corona virus vs flu is that most people have at least some immunity, from previous years exposure if not vaccination. No one has immunity to the corona virus, and therefore it can spread explosively, as it is doing in China. Even one undetected case going to a hospital without having any suspicious travel history or contact with a known case could trigger a massive explosion of cases. All it would take is to have the person kept in the ER for a couple of hours, infecting half of the treatment staff.
Jay Tone (New York, NY)
I spoke with a medical doctor today about the corona virus and based on what I was told today I'm not really concerned at all. Especially here in the US. I rather not have to experience it but I'm more focused on the sales that will come as a result of companies needing to meet or exceed Wall St earning expectations. Best of luck everyone - stay safe.
Machiavelli (Firenze)
These test kits & chemicals come from China correct? Let’s try Made in U.S.A. Ok.
Student (NYC)
Surely you jest. You think China has such a surplus of testing supplies that they are sending us some? I think we *are* dealing with “Made in the USA” here.
SridharC (New York)
I often read comments about what is the big deal when flu kills a lot more people in the US. I hope with this we understand the particular difficulty we are all facing with emerging new infections. They are tough to detect, difficult to control and treat. The best strategy has been to be hyper vigilant and avoid doing things that could cause such zoonotic outbreaks. There are many more deadly organisms lurking in deep jungles and caves. You wonder with wanton destruction of forests in Brazil what disease might emerge! And the discriminate use of antibiotics in farms must be leading to antibiotic resistant organisms. With climate changing we will unearth viruses which must have been dormant in many glaciers. Folks we are in for very challenging times ahead. Reminds me of this famous definition of humans " Humans belong to the group of conscious beings that are carbon-based, solar system- dependent, limited in knowledge, prone to error and mortal."
kj (nyc)
@SridharC You do not need to go to jungles to find zoonotic risks; have you ever been to a puppy mill or feedlot?
sandy (PA)
This is the CDC under the Trump administration. Sad and scary...
A Reader (STL)
Was this related to the false negative in San Diego? Is that how they found out?
Denise Grady (New York Times)
@A Reader This issue with the test kits was not related to what happened in San Diego. In that case, there was not a false negative. Because of a mix-up in labeling specimens from patients, officials thought that a patient had tested negative for the virus. After releasing her from the hospital, they discovered the labeling mistake and realized that her specimen had in fact not been tested at all. It was then tested, and came back positive.
BlueBird (SF)
“But the flaw was actually discovered, C.D.C. officials said, before the kits had been shipped overseas. Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, had said during a news briefing Wednesday morning that the international shipments had been sent, but later in the afternoon said she was mistaken and the test kits had not been distributed to other countries.” Not at all reassuring. This would not have happened under the Obama administration.
Jo Powell (Georgia)
@bluebird So you say. As if the Obama Admiration was flawless. Think again!!!
Mr. Dave (Mass)
Bumbling self-righteous, turf protective experts here in the states are nowhere near prepared for something like this. I'm developing a great respect for the way the Chinese have been managing this mess at ground zero. Especially the individual selfless attitudes of the both the healthcare workers and those affected. We are certainly capable as I've great faith in the good old USA, but we're going to need to get real PDQ if this thing busts open. We are not near ready for that and shouldn't have to play catch up if and when it does. Unfortunately, we will be from what I've seen so far. I hope were not too proud to ask for advice from the Chinese people before bad days ahea.
Bob Richards (USA)
@Mr. Dave Which of the many possible reasons do you most respect China for their handling of this? (1) For squelching early concerns that medical personnel voiced when they noticed the problem and detaining one such doctor (who has since died of the virus) for hours at a police station until he publicly apologized for pointing out the problem? (2) For refusing to acknowledge the scope of the problem for weeks (and likely to this day)? (3) For refusing to accept help from foreign countries or even respond to offers to help? (A few days ago they finally accepted help, so obviously they need it). (4) For Xi hiding away and, until recently, trying to avoid being associated with the handling of the outbreak? (5) Or, for something else? The way the Chinese government has handled this is far from admirable. On the other hand, what "turf protection" on this matter do you have evidence of here in the US?
kj (nyc)
@Bob Richards He probably meant the Chinese healthcare workers, not the government.
Covert (Houston tx)
Well, fortunately our leaders are busy making excuses for a convicted felon, rather than prioritizing the health and safety of three American people. . . .
Jona (Rochester, NY)
I want to say just send them to the red states, but I won’t :/
Why not (A town of Georgia)
This test must be a quantitative PCR, not difficult for a qualified professional.
BCD (Pennsylvania)
I didn't read the article because I've actually used the kit. Here's the long and short of it: the test is designed to detect 3 specific RNA sequences that are specific to COVID-19. These markers are N1, N2, and N3. There has been observed background noise (i.e., weak detection) in the internal control for N3. There should not be any N3 detection in this control sample. When there is, then the test is resulted as inconclusive. However, the test is still capable of detecting (or not detecting) the presence of COVID-19 RNA in human patient samples. I say great work on such sort notice. A little embarrassing perhaps, but I know many people at the CDC and they don't care what you think, but only about getting it right. Because right matters. https://www.cdc.gov/coronavirus/2019-ncov/downloads/rt-pcr-panel-for-detection-instructions.pdf
Clarice (New York City)
@BCD Helpful! A brilliant doctor once explained to me a similar issue with the vagueries of the lyme disease test.
AGoldstein (Pdx)
@BCD - In 1985, shortly after national blood supply started being tested for HIV contamination, the country needed a confirmatory test. The CDC provided a one week, on site crash course for laboratorians to learn not only how to perform the complex Western Blot assay, the confirmatory test for positive HIV screening test results, but how to manufacture it as well. They did a superb job including follow up support. As far as I am concerned, for real world test development and training, they are among the very best in the world but they need adequate funding.
Bob (Minn)
Thank you. Makes sense.
DGH (Houston)
One can’t help but think that perhaps Trump’s 80% defunding of the CDC Epidemic programs had something to do with this.
T. Rivers (Seattle)
I’m certain that everyone piling on the CDC probably has an advanced degree, decades of experience in molecular diagnostics, and has built their own test suite in their garage lab. Science is hard. Be grateful we have good scientists that are willing to work for the peanuts we throw at them, and for enduring the disdain of expertise from our worthless and pointless political elites.
Joseph (Missouri)
This is just another prime example of what I have foreseen. I think it's disgusting how on The White House's official's website there was not one mention about the Corona Virus until the end of January. Wasn't China officials in the White House on Jan 15, signing and smiling and gloating about securing a Trade Deal? When news was already trending a week before about the virus becoming a potential pandemic. yet not once was any mention of the disease or issue on the News Feed on the offical website until Trump was asked by a reporter. The actions by the CDC, combined with the lack of concern and lack of information coming out from the actual US victims is quite disturbing. This needs to be addressed because a 1100 deaths, and the rising level of infections daily. People really need to be made aware about this.
Bob Richards (USA)
@Joseph You are aware that there has not been a single death from the virus in the US? Those 1,100+ deaths are mostly in China and we are aggressively quarantining those entering the country from China. Do you want the US government to lock down all our cities block by block "just in case" and shut down the economy so you would "feel better". Oh, wait, we should be doing that every flu season yet no prior administration ever thought to do that either. Or better yet, ban motor vehicles which kill about 30,000 people in the US alone each year. Don't confuse drama, panic, and visibly running around like chickens with their head cut off with responsible action. It is possible for large governments to do two or more things at once and its unlikely those focusing on the immediate virus problem were called off of their tasks to work on trade deals. The knowledge of COVID-19 is limited but improving (it would be helpful if China would communicate better on it though). What do you expect the White House to announce hourly? Announcing where to get flu shots would probably be a better way to save lives don't do this every hour. And, how many people who don't consume other information sources are actually going to go to the White House web site/news feed for information? If you need information from a reliable source, try https://www.cdc.gov/coronavirus/2019-ncov/index.html (you know, that agency that is in the Executive Branch).
Carole (Boston)
@Bob Richards “you are aware there has not been a single death in the US?” Go back and track the China numbers, it’s very early days, son. I would hold off celebrating just yet.
Marvin Weiss (San Diego)
In reference to the labeling and communications fiasco in San Diego, the controlling authority (the CDC) made many avoidable errors, and the "no harm, no foul" claims do not mitigate the mistakes. Under-resourced, over-confident, and (apparently) unprepared for the challenge, the CDC must take ownership, apologize to the nation, present a cogent plan for continuous improvement, and do a better job! And, it would be a good idea for Alex Azar (HHS), Robert Redfield (CDC), and Anthony Fauci (NSAID) to address the public. Perhaps they can also explain why the Japanese Health Ministry stated that they can run 1,000 tests daily, and the CDC had a hard time completing 68 over the last weekend (per their website). The lab test kit pick-up is a sign in the right direction.
Alex (New York)
Imagine how many unknowingly infected people by the coronavirus were released because of the broken testing kits and are spreading the virus now. Truly scare times.
Carole (Boston)
Wow, first the CDC mistakenly tells a hospital that a woman’s test was negative when it had not been tested; and then they send out nonworking test kits? I am assuming they are hopelessly understaffed and unprepared. Please, please, CDC employees get your rest, take care of yourselves and proceed slowly and carefully. Take a deep breath! Slow and accurate beats fast and wrong.
Jason (Chicago, IL)
I hope readers realize that one month ago, when the Chinese government first discovered the virus, there were no ready-made test kits. Chinese researchers have to develop a new test, make sure it's reliable, and then mass produce hundreds of thousands of them in short order, distributing them all over China. This fiasco with the CDC in delivering merely 200 kits, when the testing procedure is already well known, reflects poorly on the US's ability to respond to epidemics. We should also keep in mind that there is an ongoing flu epidemic in the US with 22 million cases of the illness in the US, 210,000 hospitalizations and 12,000 deaths. https://www.cnn.com/2020/02/07/health/flu-season-high/index.html
Brant Mittler, MD JD (San Antonio)
Great reporting by Denise Grady - as usual. The CDC has been stonewalling the media. Yesterday the Wall Street Journal reported their failure to respond to messages. I have been trying to report on the Wuhan evacuees in San Antonio for MedPage Today since last Thursday. The CDC media person I was directed to does not answer emails with specific questions about the quarantine/testing process including questions about the accuracy of the test for the virus. The WSJ reported that Japanese officials have questioned whether sputum samples need to be obtained from deep down bronchial passages vs. only from the oral cavity. Also, the CDC refuses to name which San Antonio hospital(s) will be used and how many negative pressure isolation beds there are in San Antonio. At least the CDC appears to be talking to the Times.
BlueBird (SF)
@Brant Mittler, MD JD Sounds eerily like China in the early days of this virus.
Nick (Brooklyn)
We are NOT prepared to deal with the virus here in the States. The CDC has been gutted and we're unable to just lock down an entire city like China did with Wuhan. Can you imagine trying to quarantine NYC? It's not going to happen. God help us when it finally arrives in force here. Trump will find some way to blame somebody else for being ill-prepared I'm sure.
Jay Tone (New York, NY)
People from NYC can be compliant and resilient under any situation you throw us in. Did you forget 911 or the major blackout a few years later. While the blackout it wasn't long before it was fixed. 911 was a major challenge. We made it.
Cyberax (Seattle)
This is beyond ridiculous. CDC needs to be held accountable for its failures. Coronavirus presence can be detected by a simple PCR test, these kinds of tests are routinely ran in all major clinics. It doesn't require any special knowledge or materials. But right now clinics can't legally run this test. And all CDC needs is to allow it.
Jay Orchard (Miami Beach)
So some coronavirus testing kits are flawed. The CDC should've realized something was off when it got a great deal on the kits. Turns out they came from Iowa.
Craig H. (California)
Everything is being done in a rush, and there is a tradeoff between risk of not having kits ready in time and risk of kits not being accurate. We'll experience that same kind of tradeoff for many other COVID2019 related items as well, e.g., vaccines. I am very appreciative that the CDC is rolling along.
sh (San diego)
No surprise here. I expected incompetence. The government is never competent. Think how they would manage health care and the degradation caused to health if that was the only option. With the coronavirus test, the CDC is currently the only option. These tests should be performed by a private diagnostic company such as Lab Corp. Then the tests will be far more reliable.
Cyberax (Seattle)
@sh Correction: government is never competent when Republicans are allowed anywhere near it.
thadeus (thadeus)
@sh Yeah. LabCorp will be much more competent using the same flawed kits. If they could get away with it, they would take a patients temperature, ask "how ya' feelin'?" and move on.
Woodrow (Denver)
And things will only improve with CDC budget cuts and reduced contributions WHO contributions?
Robert (Kansas)
The people in charge of communicating crucial information to us use simple words like "kit" that don't tell us the type of sample required, the type of test, the accuracy, the uncertainty, etc. No wonder there is so much confusion.
T. Rivers (Seattle)
Prepackaged experiments — including diagnostic tests — are typically called kits in labs all over the world.
Vashti (ATL)
Hope they have several language translators to instruct that all 320,000 tests or test ingredients world wide are destroyed. Because it would be bad if somebody in some lab somewhere in the world didn't get the message. Sorta like like the High School kids that didn't understand what the CDC meant by self monitoring at home, so they went back to 3 High Schools in Newport News VA after returning from China. I guess they thought that when they were at home that's when they should monitor. CDC deciding that a Lab Tech needs to be present at Quarantine areas to make sure labels are right means this org is not ready to go to China. Going to China was probably motivated by how much more money they could ask for rather than any real contribution. Maybe time for some changes in the CDC.
limbic love (New York, N.Y.)
@Vashti This is another example of why we should not be cutting back on Public Health.
Sean (US)
@Vashti World wide? Its only shipped to US.
Vashti (ATL)
@Vashti Based on other NYT comments from people that used the tests, I wanted to clarify what the "flaw" seems to be. There's background noise making a"Nothing" look a little like a "something" I guess. Problems with the control (negative). All the tests seem to react well when the virus positive samples are tested. What I can't understand is why the CDC didn't explain the "flaw" it better to us. I'm jittery enough as it is. Maybe labs can still use the ones out there, seeing as how they are in short supply. And I don't know who or (WHO) sent the tests outside the US but the Times article says half were distributed outside the US.
AGoldstein (Pdx)
It is extremely challenging to produce a new assay for a new disease and make it work among labs around the world. There are so many variables to control. But the CDC is outstanding. I hope they are adequately funded.
Student (NYC)
So many have criticized China for not eagerly accepting help from the Big Boys at our very own CDC. Between this and the little label mishap, we can now better understand China's reluctance. Maybe it's the Trump cuts, maybe something else, but if you want competence, don't look here. God help us when corona gets here. We are going to look positively stone age compared to Wuhan. And, I am not saying that they are doing such a great job there.
dugggggg (nyc)
@Student when corona gets here?? it's already here.
Julian (Madison, WI)
Can't this just be detected under a microscope? Is it really that difficult to test for?
Chris (Amsterdam)
Exceedingly hard and not feasible for high volume work. It would take 2-3 days for one specimen
Margaret (Maine)
The test uses RT-PCR technology, if you want to look that up to learn more. Well established technique for detection of pathogens, but specific assays have to be developed for each pathogen.
Melanie (Ca)
Only the very largest viruses are visible using light microscopes and COVID-19 isn't large. To get angstrom level feature resolution requires electron microscopy. That is impractical.