UNC Health experts discuss need for COVID-19 testing
UNC Health experts discuss whether or not asymptomatic patients should be tested for the coronavirus and talk about how testing will need to change during the flu season.
my I like the Wolverines or this kind of a weird thing. You should have left the chops. I've done that before. Just It's funny. We will wait just another minute or so and then we'll get going. Yeah. Um, and folks, for I think I've already done it for everybody. But for media, there are If you need to record directly from here, let me know. I think I've all I've done allowed records for everybody. But if you have, if I haven't just let me know on the chat function, and I'll do that for you. Mhm. Let's see. All right. Well, it's 10 01 We may have a joining us as we go along, so let's get going. Mhm. Right. Here we go. All right. Well, thank you, everybody, for joining us. This is another media briefing from U. N C Health. Um, today we're going, the subject will be testing testing for co vid 19. A process with just changed a lot since going back to march up through now and will continue to change. Aziz, we progress through this. Um, our expert today will be taking questions on covert 19 testing. Um, how it's evolved since March, whether patients who are asymptomatic should be tested capacity and various topics. So please let us know if you have questions you can directly yourself. Or you can send them to us through action in provide both a video file and an audio file for your You get posted within 30 minutes of the meeting closing out. So at this time, I will hand it over to my colleague Alan Wolfe, who will introduce our expert today. Alan, Good morning. Thanks, Phil. Good morning, everybody. Thanks for joining us. Our our expert guest today is Dr Melissa Miller. She is a professor of pathology and laboratory medicine at the University of North Carolina Chapel Hill School of Medicine. She is also the director of the Clinical Microbiology and Molecular Microbiology Laboratories for You and See Health. She received her PhD in molecular biology from Princeton and a fellowship in medical and public health microbiology at U. N. C. After Miller's research, interests include the development of accurate and cost effective molecular tests for viral infections and the assessment of patient and healthcare outcomes. Associate ID with the implementation of new molecular technologies. Dr. Miller, would you like to make a few opening remarks and then we will open it up for questions. Thank you all for joining us today, as you all are keenly aware of. As M I testing has been at the forefront of this pandemic. How can we get more test? Who should we be testing? What types of test should we be using? And that discussion, um even continues today over six months now into the pandemic here in North Carolina. So I'll just take you back a little bit to remind you it's always good to look back at where we came from. So we started our first coated test here on March 16th. Seems like about a decade ago a this point and that was our own test that we developed following a W h O Protocol that we received FDA emergency use authorization to use for patient care. We still have that test available, although due to the throughput, we tend to use more of the commercial based FDA anyway, tests now to have more tests per day that we're able to put out. So when we started, we could do a maximum of between 122 300 a day using our test alone very quickly, we built capacity about 2 to 3 weeks. After that, we had some commercial tests that we brought in house, which brought us up into the 300 or 500 range. So today it's very exciting. I can tell you we have the capacity to do 2500 tests per day with the capacity that we built here at the medical center. We're still testing for all of our affiliate hospitals, a swell. Many of them have, um, rapid tests that are available at their institutions so that they can get those quick results for patients that might be admitted and symptomatic, or and the emergency department and symptomatic but asymptomatic patients and patients who can wait a little bit longer for their test. Those would be sent here to the medical center. We also support our respiratory diagnostic center here in Chapel Hill and do all of the testing, um, of those that are being seen at that site. Some of our other respiratory diagnostic centers do use some of the commercial based laboratories for the testing, so we continue to ramp up capacity for co vid were able to support some of the state efforts by doing this. Um, and we're not testing 2500 day, so we have capacity to test more, and I think that becomes very important as now we head into flu season. So you've heard these two when epidemics, twin mimics or whatever they're being called or flu did. A number of different names have been used, and it has caused a lot of concern, I think, for for us in the laboratory for providers and probably some for the community as well. How do you manage a respiratory virus pandemic in the middle of another respiratory virus potential epidemic? And I'm speaking of fluent in terms of that second virus, we can talk a bit about that. We're working on algorithms now how to co tests both flu and covet and maybe even other respiratory viruses. Who needs what test? How do we build, um, duplicity or even, you know, three or four tests for these different algorithms? So as we continue tohave supply chain problems, we can switch from one test to another test without interrupting patient care. So that's a lot of behind the scenes action that I think is not readily apparent to most of the community. That will be very important, as we now are heading into kind of our traditional respiratory season now, so I'll stop there, And that's kind of where we are. And we can talk about anything related to testing that you'd like to ask. Yes. Members of the media, please, If you've got a question right now, jump right in and ask. Um no need to raise your hand or anything. Jump right in. Dr. Miller. Let me ask one question. Um, you and I talked earlier in the week about a milestone that your lab reached just recently. You talk a little bit about that? Yes. I can't believe I didn't think to mention that. So thank you for prompting me. So about two weeks ago, we had our 100,000 cov test reported here at the medical center. Um, and to give you a nice idea of scale, I looked at all of the molecular microbiology testing. So every test that we do, including for other infectious diseases before co vid and then a similar six month period, we did less than 50,000. So we've done twice as many tests is overall that we did the six months prior, plus all of our other regular work. So it's really quite phenomenal what laboratories have accomplished during this time. You know, we're often behind the scenes and nobody really knows what happens after their specimen is collected, and it goes to the lab to be able to build this capacity and to reach that milestone in terms of numbers of tests, we've had Thio, um, not only by instruments we've had to hire new employees, get them all train, find space for all of the testing that's being done. So it's really been quite a massive effort to get to where we are today. Excellent talk. Talk to us just a little bit about as we head into flu season. What? What are your sort of top concerns? Um, you know, is it is it the supply chain? Is it capacity? Is it just being ableto sort out? Who has flu has covert who has something else? All of the above. This is what keeps me up at night right now is thinking about what this looks like in the middle of a flu season and and we don't know how much blue we're going to see. Certainly in the Southern Hemisphere, which we often look at, what happens, um, in their respiratory season to predict what might happen here. There was not a lot of flu. And in the Southern Hemisphere, um, that being said, some of the restrictions are very different here and maybe less strict than they are in places in the Southern Hemisphere. So we we very well may see more for blue than they saw him. We have to be prepared as if that's going to happen, no matter what happens. So, first of all, everybody get your flu shots. That will help. I have my appointment for mine next week. So, um, the supply chain continues to be a major issue. Um, not just for cova testing, but for all laboratory testing, particularly as it relates to the microbiology lab. So even doing our traditional cultures, like for a urinary tract infection or a surgical wound culture. We've had problems getting supplies to be able to do those cultures, how we normally do other issues that we've had, or just basic disposables in the lab. There's been shortages of certain plastics that are used in these disposables, and that effects a lot of areas of the lab. So we're constant every day. It's a new fire we're having Thio, um, you know, this lab is, you know, one of our affiliates labs or out of this Can they send it here? Can we send there this big shell game to keep laboratory testing to the standards that we want to keep it on? But it really is sometimes just in time shipments that we're getting. So that is a very serious concern going into the flu season. Will we have the test that we need, um, to do both flu testing and other respiratory testing as well as Kobe testings to making sure we prioritized patients appropriately? So the medical center has a testing workgroup that has worked on these priorities. And who gets a flu plus cova test? Who gets a full respiratory panel plus a cova test and who just needs a covert tests? So anyone who is symptomatic will minimal a be tested for flu and covet clinically, you can't distinguish them. Your symptomatic. You need a test. There's no reason to Onley test for Covic or only test for flu, so those will be combined into one test. Um, in terms of asymptomatic patients, we don't test asymptomatic patients for flu and other respiratory virus like we have for co vid and the pandemic. So we have we know we have asymptomatic persons that are infected with SARS. Kobe to that, we need to be able to detect in order to interrupt that transmission chain. So that will continue. And that will be a covert only test. So I feel best about that supply chain because we've had some time to build up to of the capacity we have. But we're reliant on ah, lot of commercial manufacturers for these combination tests of flu. Um, and cove it. And so, as I mentioned before, we have several platforms already in the laboratory that can do these types of tests. Um, and we're acquiring two additional different manufacturers tests to bring into the lab. So we have that as as backup, So certainly, ah, huge concern from a supply chain. But I think where, as prepared as we can be going into this very early on, one that I know, one of the supply chain challenges you had with swabs because they happen to be source out of Italy, which was just being pounded in time. Um, how did you deal with that? No, knowing that the longer swabs that folks were having to use What did you do to Yeah, swabs were a major crisis early on again, it seems like a very long time ago. You may be able to see on my back table where I have a bucket of swabs back there. Those air, all swabs that different swabs from different manufacturers from different countries that we got in that I actually tried on myself to see, um, how the comfort level waas. We tried them in our essays to make sure they recover the viral RNA, and they didn't inhibit the test. So, um, really, how we got through that is by diversifying, looking at all the different places that we could get swabs looking outside of kind of our normal manufacturers of these swabs and even the types of swabs that were getting on den, validating them also, Every time we get like a new transport, media or new swap type, we have to make sure they work in all of our tests. And so now we have to do that not only with all the covert tests, but all the flu and respiratory virus tests as well. And so that has definitely kept us busy. We even looked outside of the box and your traditional swab into three D printed swabs Thes, can you know, be printed in a day? They would FedEx them to us way want this part shorter. We want this part longer. We want the great point here, and they could print them again and send us examples overnight to really optimize that. And so that was always our plan B. If we couldn't get the traditional softer swabs that we used for the names of your NGO collections, that we would switch to three D printed swabs that can be produced at higher quantities on demand. So that was definitely a learning curve and something that I think was important to experience. And we don't no, for sure yet what the volume is going to be, um, you know, in North Carolina, you know, I really hate to even say it out loud, but our positivity rates have been decreasing, you know, slowly but steadily decreasing over time. We still have around a 5% positivity rate for the state with Cem Cem, lower ones bond, some of our local counties, um, Durham and Orange County, for example, below 5%. Now, what that looks like in a flu season may be very different. And we may see volumes greater than we even saw kind of in our peak covert testing, which was around July, shortly after July 4th. We had our peak covert testing. So, um, it may come up again, but, you know, we have sourced, um, thousands and thousands of swabs, um, that we have available and even we packaged our own kits. So usually they come in a kit with the swab and the transport media where we couldn't get them as kit. So we bought everything separately, even made some of our own transport media. And we had volunteers come in people from all areas of the hospital. Some folks who had were on leave and couldn't, you know, run their clinics and physical therapists, all sorts of people in the lab that we're sitting and making these swap kits that we still have available. So do we have any questions from media. So just ask away. I can't believe there no testing questions. Well, we've got media online, so they're in there and we're broadcasting on the bureau's website. Quick questions. So, you know, if you're driving around now at various, um, drugstores, you'll see you may see signs that say, free testing or testing here. If someone is not symptomatic on, they just want to know, Is that a good option for or where should folks go? You know, some some of those will test a symptomatic persons, you know. And sometimes, you know, people are required to travel for a variety of reasons, and you have tow have that proof of a covert tests for some travel now. And I do know they will accommodate those that some of those drive through clinics. I think, um, you know, I think an important thing about testing is the test don't necessarily perform the same and symptomatic patients as a symptomatic patients. And, um, so the test that we use in the hospital lab are highly sensitive and highly specific. So that's why they're not a 15 minute test, right? So I think our our median turnaround time right now is about 11 hours, but everything is resulted within 24 hours. Still, um, and it's because it's more of a complex test to get that higher act to receive. And so it stands to reason. You know, if you go towards a test, that might be 15 minutes that some of these sites that and some of the sites are sending them for these highly sensitive and specific tests. But others might be using rapid an agent testing or even a rapid molecular point of care device on. We know that these myths about 1/5 fifth of the symptomatic patients, so 20%. What we don't know is how well these perform in an asymptomatic, um, population. So the worried well as we like to call them, you know, if you have no reason to suspect you have cove it, you've not been, um, notified that you have a contact that has tested positive for cove it. I really don't think those persons need to be tested, because at some point it's going to maps are capability to offer services, and we need to make sure we still have the testing available for those who are at greatest risk who are symptomatic or who are contacts of those who have tested positive and again, there's a risk of a false negative results. So even if you're worried and you get a test in your negative, that doesn't necessarily mean you're absolutely negative. So, for example, if you have a contact who's covered positive, you have no symptoms. You go and you're tested negative. You still have upto 14 days after, um, that exposure to potentially develop symptoms or to potentially become infected and have a positive test. So it's really just, you know, that point in time you're getting a result. Um, it doesn't. It's not like a negative past. It is what I call it. It doesn't mean Okay, I'm I'm good for the next. However many days we don't know those data, I will say, you know, related to this. There's been some confusion on the CDC website lately, and I'll focus on the one regarding testing contacts testing asymptomatic person. So ah, couple of weeks ago, the CDC website was, um, updated really wasn't announced, and it wasn't clear why it was updated. That said, they don't recommend testing asymptomatic people, even those who have been context of known covert positive patients. And there is a lot of, um, I'll cry from both laboratory ins, infectious disease physicians. Many of our societies wrote, wrote letters and spoke out about this because we definitely believe, um, there is purpose and testing asymptomatic persons and especially those who have been contacts of positive. So, um, and you may be aware that just earlier this week, I believe the CDC website was updated again to now say, um, yes, contacts and exposure should be tested, even if asymptomatic. So, unfortunately, that caused a bit of confusion around this. But our policy here in the medical center in terms of meeting criteria to be tested did not change during that time. We certainly were still doing contact tracing Great recall early on that your your lab developed passed a test. Did you talk about how that how that came about? I mean, or sort of what the process is? Uh, you get I assume some assistance from the CDC and they provide No, there was a deceased us involved on this. You know, we have experience with this, and I was actually a medical microbiology fellow during the first stars. Andi. That was my first experience developing a test for a potential pandemic. And, you know, and and you know, this is you know, that was you know, I hate to say it's, you know, 18 years ago or so now, but things have changed a lot in that time. But the same basic premise applies today is that there's not a commercial test, right. There is a virus that has been sequenced. The sequence is publicly available. So as long as, um, the genome of the virus is publicly available, we can design a test to detect. In this case, it's RNA. It's genetic sequence. So, um, you know, we've done it with the first stars, and we did it with Zika. We did it with pandemic flu. We did it with the Middle Eastern respiratory virus coronavirus. A swell eso we were already kind of watching towards the end of 2019 early, 2020. Um, what was going on with this novel coronavirus? And you know you know that point in which you decide? Okay, we need to develop a test. It's not clear cut exactly what that is. But once we realized that, um it was at least going to be an epidemic, not knowing it was a and, um, it quite yet we thought, Well, it be better to develop a test and never use it. And it just sits in the freezer. Um, than Thio arrive on our shores in the U. S. And then we're not ready. Right? So we started that process, our medical microbiology fellow, then Cecilia Thompson worked on that on Developed that again because there were no commercial test available. So that's why we had to do that. What's changed in kind of those intervening years is the requirement of the FDA to register the test with them and to get emergency used authorization, um, for the test. And that definitely delayed implementation of the test about 2 to 4 weeks. We were delayed, um, and offering our tests because of this, um, FDA requirement, Um, that, you know, we still have this authorization. And in fact, just in the last couple of weeks, every lab that has their own test we were sent a test panel from the FDA. Everybody got all the same reference materials so we can compare test to test to test Um and we did, um, participate in that was requirement of the EU, and all of those data are posted on the FDA website, so you can see how tests compared to each other. So we intend to keep our test that we developed active because, um, it's more like a recipe. Right? So you have, you know, five or six different re agents that you purchase that you put together for this test that we do as opposed to maybe just buying a kit from this company or that company. So that means it's less susceptible to supply chain issues. So we always want to make sure that we have that test available in case we can't get re agents for other tests. So when you were working on that on, do you think saying like you said, Well, it's better to have it not needed. How long did it take from the beginning? When you first decided we're gonna do this, Who you had? No, not you don't have approval or authorization, but do you have a viable test? We had a viable test in about two weeks. Um, around that time, FDA actually came out with guidance. Um that listed what they wanted to see in the e u A. And based upon that, we had to do more work for the EU. A submission to the FDA that took about an additional two weeks. Um, prior to submitting that the FDA, they also, um, in the intervening time again because everybody was We need test. We need test, We need tests. They also change the requirement. Um, they allowed us to go live prior to getting the EU a authorization Azaz long as we were applying for it and working with the FDA in the intervening time. So before you had to submit, get the way before you could even offer testing. So that did help us push up the live date as well. Dr. Miller Couple questions came in from reporter um, should someone get tested for antibodies? It's one question, and the second question was, Should if you could just reiterate and clarify Should people without symptoms get tested? Sure. So the antibody test, um, really has minimal value, not zero value, but minimal value right now, because our prevalence is still very low of disease for North Carolina. So, for example, our positivity rate on our serology test is about 2% eso. Most people that get an antibody test test negative, but we also don't know, although there is evidence to support. If you have antibodies that your quote unquote immune, it appears that, yes, you are, at least for some period of time. You have what are called neutralizing antibodies that actually keep the virus from replicating and causing a Reince affection. We think re infections are very, very rare again, not zero very, very rare. So I think, um, anybody testing can be used and has been used in a few cases of unclear, um, clinical presentation. For example, if somebody's R N a PCR based test is negative, but everything else seems like co vid. We have done antibody testing and some of those patients, which has been helpful for some and not helping for others. So I think the fact that a positive doesn't necessarily give you a license to not distance and not wear a mask you should still do all of those things. Um, it's a really little value where it is very valuable, or patients who have had moved making sure they've developed antibodies whether they had an RNA confirmed case or not, they have antibodies. And they can potentially be, ah, plasma donor, for example, um, to help other patients from a treatment perspective. So that is one way that it is used in terms about the CDC guidelines that change people without symptoms should be tested. But I think among those people we need based upon the test that we have available today, it needs to be prioritized, right? So people who have contacts for exposure and if you're not aware yesterday actually on the North Carolina Department of Health and Human Services released a new app. Um, I'm blanking on with the name of the APP is right now, but you can easily find it on their website on a North Carolina DHHS website. You can download this app and with your Bluetooth what it allows you to do, or people who are reported as a Kobe positive. Um, in that app, it tells you, if you've been in close proximity to that person. And so that's one way that North Carolina is looking at, um, trying to interrupt transmission change. So if you were to get that, you know, you've been in contact with somebody who's covert. Posit that somebody that we would be interested in doing a test on and making sure, um that their contact trace. Um, based on the test we have today, I do not think everybody in the United States population needs to be tested. I know they're advocates for daily at home testing, and maybe we'll get there. I am a bit skeptical that we will get there, but if we get there, there will be, ah, lot of considerations that will have to think about in terms of at home daily testing. Um, those tests are not available, so I think it's, um, a bit of, ah, just a mental exercise to think about that now, with the system we have in place now, we really should focus on those you know who are high risk at transmitting. So, for example, um, employees at a skilled nursing facility that's a very high risk situation. If they happen to be positive, you know, and they're going home and they're in the communities and they have potential contacts outside of that nursing facility. So there are certain pockets of people. Um, that should get tested, even though they're a symptomatic. Um, is that that the app you were talking about for DHS is that called slow Covidien. See? Right. So you can just released yesterday, right? You can find that on the North Carolina Department Health and Human Services N C. The H. H s website that complaint it for you. So we're at 10. 30. So, about out of time, I have one question. I was thinking when When you got the question about antibodies. So if someone in this may not be your expertise, but, well, we've got you here, so I ask, um if somebody has shown to have antibodies that maybe they've already been exposed When the vaccine when the vaccine is available, should they still get a vaccine? Yeah. That is definitely not my expertise. I'm sure guidance will be coming out from C. D. C. And Department of Health and Human Services in terms of that, um, I will see my personal opinion. Say, if it was me, I would get the vaccine because we do know there are false positives with serological tests. Um, different. You don't know which Syria logic test? You. You you receive that you were tested with, and so they have different performance characteristics. So unless there ends up being an algorithm or and that's established the clinical trials for the vaccine to indicate you should not get the vaccine, I don't see any reason why you would not. But I'm sure guidance will be coming out about that. Great. Any final questions? Allen. You've got any anybody from the media? Dr. Miller, could I ask you one final question? Um, as we all wait for for unapproved vaccine approved treatments, What do you think? Some of the key things that need to happen on the testing front. Well, that's a good question. You stumped me on the last question on the testing front related to that. I mean, I I think, especially as there are treatment options. If there end up being outpatient treatment options, um, it's going to be very important to get tests done. Rap late. Eso we know if we apply with what we know for influenza, for example, right, Tamiflu really has to be administered within 48 hours of symptoms for it toe have its effect. Um, if there are data to support something similar for stars Kobe to, it's gonna be important toe have people who are symptomatic to get tested very quickly. And those tests have to come back quickly. And so. And that's something that through the pandemic, um, in general, the U. S has struggled with has been the turnaround time of various covert tests we've been able to maintain are less than 24 hour turnaround time. But you know, as and it's related to how many tests are being done, right. So if more people are getting tested, more people are symptomatic. Usually those turnaround times, um, tend to creep up, which we don't want. For example, if there is a treatment available. Um, all right, so one quick question make sure I understood with an increase in flu test, there could also be an increase in Koven test. Is that correct? I'm understanding this correctly. My my point in that waas. If a person is symptomatic with influenza like illness, right, that's what we call it like a fever and a cough. That's the same thing as Cove. It is the same thing as flu. You wouldn't be able to pick one or the other. You know, I want this patient tested for flu. I want this patient tested for Cove. It all symptomatic persons in the middle of a flu season should be tested for both. So the increase in the test would really be due to the increase in symptomatic persons. Right? So we are seeing, you know, for for several months, we saw nothing but cove it from a respiratory virus perspective. We are now starting to see a few other respiratory viruses, mainly a virus culture rhinovirus. Just a common cold virus. A couple other viruses. So? So that does tell me, you know, people are interacting with each other. They're still able to get a cold. You're still able to get a cold. You're still able to get cove it right. So as there's more symptomatic persons, there's going to be the demand for more testing. And it really should always be co testing with flu and cove it again because there is an intervention for flute. Great. Thank you so much. Well, where a 10. 34. So we've kept you longer. Thank you so much for this is a great content. Um, and just to let everybody know the media, we will be posting audio and video files for your use on deal that will be coming out. There will be links to that within 30 minutes or so. So and those air, unedited as always. So you can use those Aziz. You wish, Dr. Miller, Thank you so much for being with us here again today. We really appreciate it. Andi. That will conclude our media briefing for today. Thank you, everybody. Dr. Miller, find it in.