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CDC Update: Failed Roll-out of Diagnostic Due to Faulty Reagent; Sample Prioritization Mishap Delayed COVID-19 Diagnosis

The U.S. Centers for Disease Control and Prevention hosted its most recent 2019 novel coronavirus response update call on February 12. Dr. Nancy Messonnier, Director of CDC’s National Center for Immunization and Respiratory Diseases, conducted the briefing. A selection of her statements and answers to reporter questions are included below. The full transcript is available here.

State Health Labs Identify Problems with Some CDC Diagnostic Kit Reagents

“Now I’d also like to update you on our diagnostic test kits.  As you know, this is a dynamic, rapidly evolving situation, and our response continues to be based on the latest science.  We continue to be flexible to meet the public health challenges that the virus presents, and clearly a success is the CDC rapid development of a diagnostic and rapid deployments to the states, which was clearly important to try to bring the testing closer to patients to avoid delays that have been inherent in sending samples to CDC.” 

“When the state receives these test kits, their procedure is to do quality control themselves in their own laboratories. Again, that is part of the normal procedures, but in doing it, some of the states identified some inconclusive laboratory results. We are working closely with them to correct the issues and as we’ve said all along, speed is important, but equally or more important in this situation is making sure that the laboratory results are correct. During a response like this, we know things may not always go as smoothly as we would like. We have multiple levels of quality control to detect issues just like this one. We’re looking into all of these issues to understand what went wrong, and to prevent these same things from happening in the future.”

“I would say is that of course we hoped that everything would go smoothly as we rushed through this, you know. We moved quickly, that’s appropriate under these circumstances but it’s equally appropriate to do quality control which is what we do, and where these — where this issue was caught, it is part of the normal procedures. Of course, I hoped that this week every state — and every state did receive a kit — every state would be up and running. How long is it going to take? I can’t tell you that for sure because I understand that not every state has completed their verification yet. And it won’t be until we have results from every state that we know which states can continue and which states we need to — we need to get new reagents to. We’re working closely with FDA. Again, we do expect this week that some states may move forward. Other states may need to get additional reagents from CDC, and I don’t have an estimate yet from our laboratory staff as to how long that takes, and when we do, we will definitely be, first, letting the states know and then letting you all know.”

“In terms of the test problems, it gets a little weedy, but I can give you a little more detail.  When a state gets the test kits, they have to verify that it works the same in their lab that it worked at CDC.  And when some states were doing this, we received feedback that they weren’t — that it wasn’t working as expected, specifically some public health labs at states were getting inconclusive results and what that means is that test results were not coming back as false positive or false negatives, but they were being read as inconclusive.  Now, these were not tests being run on actual clinical specimens from potential patients.  These were part of the verification process, and because of that we are — when we evaluated what the issue is, we think that there might be an issue with one of the three assays and we think that maybe one of the reagents wasn’t performing consistently, so it’s a long story to say that we think that the issue at the states can be explained by one reagent that isn’t performing as it should consistently and that’s why we are re-manufacturing that reagent, 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 CDC, so this is part of a normal process and procedure and redoing the manufacturing is the next step.”

“…all clinical specimens are still being sent to CDC for validation. I think you would expect nothing less from us as obviously the results of this test are so meaningful, and we’ll continue to provide that backstopping frankly even after states are up and running. I would ask that you — that the right language wouldn’t be a problem with the states. It’s a collective problem, so I don’t want this to be seen as something that the states are doing incorrectly. That is certainly not the situation here. This is really part of a normal process and procedure, and, you know, we have the quality control set up specifically to allow us to identify these kinds of problems.”

Evacuee to Miramar Confirmed COVID-19 Positive After Mix-up on Test Delayed Diagnosis

“Since we briefed you last, there has been one new confirmed novel coronavirus infection detected in the United States. The new confirmed infection is an individual who returned from Wuhan and was quarantined at Marine Corps Air Station Miramar. This individual was on one of the last Department of State flights out of Wuhan, the epicenter of the outbreak in China.  Given the spread of the virus in Wuhan, it is not surprising to see a positive case among people who recently returned from there. That is in fact the reason they are being quarantined.  Currently the person has mild illness but is hospitalized. This brings the total number of confirmed positives in the United States to 13.”

“I want to clarify some of the reports that have been circulating about this case. Last Thursday when one of the planes from Wuhan landed at Miramar, a few people were sick and transported to local hospitals for further evaluation. These people were placed in isolation and samples were taken for testing. When running laboratory diagnostics for any disease, anywhere in the world, the ability to match the individual to the specimen is key, and is part of the normal procedures put in place to ensure that that matching is done correctly.  But in this situation with this patient, it didn’t work correctly, and the patient was misidentified initially as negative. The issue was identified within 24 hours. The CDC tested the sample, the positive result was conveyed quickly to the local public health and CDC teams. The mishap was unfortunate, but we have corrected this from happening again in the future by adding additional quality control. And it’s really important to emphasize that during this time appropriate infection control precautions were taken around everyone, including around this patient who, again, is doing well.”

“You know, as you can imagine, at CDC, there are a large number of specimens being processed, coming in and out, and it’s important that they be identified appropriately so that they’re prioritized. Because of the way that sample was identified, it wasn’t run in that first run. Therefore, it was when the second run was done that we found that it was positive, so it isn’t that somebody else was identified as positive. The sample wasn’t initially run.”

Travel Screening, Quarantine and Self-Isolation Protocols

“Since the airport screening began in mid-January, CDC and its partners have screened more than 30,000 passengers from China. With the temporary restrictions on travel, we are seeing fewer and fewer travelers from China, especially from Hubei province. Passengers are being funneled through 11 airports, most of these people are coming from parts of mainland China outside of Hubei, show no symptoms and have not been assessed as high risk. Those who passed the screening continue on to their final destination where they self-monitor their health for 14 days in cooperation with their state and local health departments.”

“We’re asking these people to limit their activities and stay home during that 14-day period. Our goal is to be as least restrictive as possible while ensuring the safety and health of all Americans. Since starting our travel restrictions and funneling through airports, we have not detected any cases among returning travelers from China. Most of the U.S. cases were found before the travel restrictions were put in place among travelers who returned from Wuhan and later sought medical care for their illnesses. These cases were picked up by astute clinicians and reported to CDC. We are continually reassessing our recommendations around quarantine and self-monitoring and will continue to work with state and local public health departments to refine and improve this process. Most of the diseases in China, however, we can and should be prepared for this new virus to gain a foothold in the U.S. The goal of the measures we have taken to date are to slow the introduction and impact of this disease in the United States but at some point, we are likely to see community spread in the U.S. or other countries and this will trigger a change in our response strategy”

PPE Shortages, Guidance on Wearing Masks in Public

“We understand the importance of providing guidance that health care facilities can implement given the availability of personal protective equipment or PPE supplies. CDC talks regularly with health care industry partners as well as PPE manufacturers and distributors to assess availability of PPE.  At this time, some partners are reporting higher than usual demand for select N95 respirators and face masks. CDC does not currently recommend the use of face masks for the general public. This virus is not spreading in the community. If you are sick or a patient under investigation and not hospitalized, CDC recommends wearing a face mask when around other people and before entering a health care provider’s office, but when you are alone, in your home, you do not need to wear a mask.”

“People who are in close contact with someone with novel coronavirus, for example, household contacts and care givers of people with known or suspected 2019, I’m sorry, nCoV 2019, we should wear a face mask if they are in the same room as the patient and that patient is not able to wear a face mask. Health care personnel should wear PPE including respirators when caring for confirmed or possible nCoV patients because they’re in direct contact with those patients which increases their risk of exposure.  We will continue to work with our public health partners around the clock to address this public health threat.”

Will the Virus Weaken or Die Out with Warmer Weather?

“So, I think I would caution over-interpreting that hypothesis. I think what folks are saying, which I think is a valid point is that most viral respiratory diseases are seasonal, and we’ll use as an example influenza.  Influenza has a season. It can alter a little bit but it’s generally, we know what time of year is going to be the peak of influenza and in general, as we head towards spring and summer, we expect the cases of influenza in the United States to fall off. That’s true for other viral respiratory diseases also that have a winter season. So, if this behaves similarly, it may be that as we head towards summer and, I guess, spring and summer, the cases would go down, but this is a new disease. We haven’t even been through six weeks of it, much less a year, and so I certainly would, I mean, I’m happy to hope that it goes down as the weather warms up, but I think it’s premature to assume that, and we’re certainly not using that to sit back and expect it to go away. The aggressive actions were taken or we’re taking are because we don’t think we can count on that since again, we haven’t been through even a single year with this pathogen.”

On the Status of a Serological Test

“…Clearly a serological test is important in the United States we want to be able to look to see if people zero converted but especially hopefully we’ll be able to help the Chinese look.  That test would be really helpful to be able to understand the spectrum of illness that is are there people who are either asymptomatic or mildly symptomatic that have serological evidence of being exposed to pathogens. We have the beginnings of the serological tests, because we now have patients in the United States, we’re able to collect additional specimens but we have to collect them over time so that we can have the appropriate timing of specimens to make sure that we understand what the immune response looks like.  Once we complete the gathering of those specimens from the patients we’ll be able to pretty rapidly, I would say within a couple of weeks, three weeks, four weeks, be able to have a test available but right now, we’re still in the range of testing of gathering the appropriate specimens from the patients in the U.S.”

On the Drop of Case Counts in China and Access to Epidemiological Data

“So, the Chinese cases dropping down, I’m going to be optimistic that that is a sign that their aggressive efforts have been effective, but I really do think it’s too soon to say that for sure, not having hands on the data ourselves. There is a WHO advanced team in China now, and I’m hopeful that they will have access to the data themselves and be able to validate those findings.  It would certainly be reassuring if we were now seeing at least a slowdown of this outbreak in China.”

“There has been a lot more data coming out of China in the recent weeks, compared to perhaps from the very beginning, and there have been meetings, for example, hosted by W.H.O.  where Chinese authorities have presented their data.  As an epidemiologist seeing a graph that somebody else produced is never as good as touching the data yourself.  Being able to look at it yourself and being able to ask the questions and run the data directly, so having that distance from the actual ongoing investigation in China or anywhere is never the best way for us to be able to be completely confident that we understand the situation.”

“That is the — part of the reason that we want to have folks on the ground. I’m working specifically on this investigation, the other is that I would say that CDC scientists are certainly some of the best in the world and our scientists have a lot to offer in terms of looking at what’s going on right now in terms of the analysis. We also find that when you’re in the midst of doing an investigation yourself, sometimes it’s hard to step back and folks coming from outside who haven’t been so enmeshed in the day-to-day sometimes can pick up things you didn’t think of or have a different perspective. That’s the other reason that it would be helpful to have a broader set of folks being able to look at the data itself.”

Will the CDC Support the WHO Team in China?

“The advance team is three WHO staff. They’re staff that are well known to us. They have a lot of experience. They are being articulated as an advance team, and I heard a report from them this morning.  They’re getting access to data, and doing the things you would expect them to do and as you all know, CDC stands ready to send staff to the affected areas in China to work on this investigation and as soon as we’re given the invitation, we are happy to do that, but we haven’t been invited yet.” 

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