College of American Pathologists and Newswise Live present an expert panel discussion Testing, Testing, and More Testing. What’s the status of current COVID-19 testing capacity, what kinds of tests are available, why tests are so crucial as we return to business, sport school and life. 

Who: 

Patrick Godbey, MD, FCAP

President of the College of American Pathologists, Laboratory Director, Southeast Georgia Health System.

Bobbi S. Pritt, MD, FCAP

Director of the Clinical Parasitology Laboratory and Co-Director of Vector-Borne Diseases Lab Services, Mayo Clinic, Rochester, Minnesota, Chair of the CAP’s Microbiology Committee 

Raouf Nahkleh, MD, FCAP

Professor of Pathology Mayo College of Medicine, Consulting Pathologist, Department of Pathology, Mayo Clinic, Jacksonville, Florida, Chair of College of American Pathologists Council on Scientific Affairs,

Emily Volk, MD, FCAP

President-elect of the College of American Pathologists, Senior VP of Clinical Services, University Health System and Assistant Professor of Pathology and Laboratory Medicine, University of Texas Health, Long School of Medicine, San Antonio.

When: May 28, 2PM to 3PM, EDT

Where: Newswise Live event space on Zoom - https://newswiselive.zoom.us/j/7459578068

Registration for media, as well as colleagues from participating Newswise member institutions

This live event will also be recorded and transcribed for use by media and communicators after it is concluded.

 

Thom: Welcome to this Newswise live expert panel. Today’s topic is testing, testing, and more testing. We have partnered with the college of American pathologists to bring this panel here to talk about all topics related to testing. The availability of testing, the different types of testing and even the logistical challenges to doing more largescale and widespread testing.

I’d like to introduce briefly each of our panellists. We have today the president of the college of American pathologists, Dr. Patrick Godbey, he’s the laboratory director for the South East Georgia Health System. We also have Dr. Bobbi Pritt, she's director of the clinical parasitology lab and the co-director of vector-borne diseases lab services at the Mayo Clinic. She's also chair of the CAP’s microbiology committee. We have Dr. Emily Volk. Dr. Volk is president-elect of the college of American pathologists. She's also a senior VP of clinical services at the University Health System and she's an assistant professor of pathology and laboratory medicine at University of Texas Health, the Long School of Medicine in San Antonio.

Last but not least we have with us Dr. Raouf Nakhleh. Dr. Nakhleh is a professor of pathology at Mayo College of Medicine and he's also a consulting pathologist for the department of pathology at Mayo Clinic in Jacksonville Florida. He’s currently chair of the College of American Pathologists council on scientific affairs. Thank you very much to all of the panelists for joining and I want to give a couple of quick instructions for media. Please identify yourself by name and media outlet. If you hover over your own window in the upper corner, there's a little three-dot menu where you can click on the rename option there and if you can indicate your first name, last name and media outlet, that will help us to identify you as we take questions.

We’re not starting off with any presentations, I have a few questions prepared for the panelists and we want to get questions directly from you in the media. So please do ask those questions, you can chat them to us. We will invite you to ask the question yourself if you'd like to do that, if, for any reason that's not okay, I can ask them for you.

I do want to go ahead and get started right away with a couple of questions for Dr. Godbey and Dr. Godbey generally talking about the role that pathologists play in doing lab work, in testing and screening for the coronavirus in this current pandemic. What can you tell us Dr. Godbey is the most vital aspect of testing that you as a pathologist and a lab director feel needs to be improved at this stage of the pandemic? 

Dr. Godbey: The thing that needs to be improved most is the availability of testing, particularly the availability of local testing. There is a recent good study done by the College of American pathologists which showed that 79% of laboratories that provide testing, can’t get enough reagents, they can't get enough transport media, they can't get enough of the swabs necessary to sample for the test. They have excess capacity as far as the platforms, the machines that it takes to run the test. They have excess capacity as far as the medical laboratory scientists and they certainly have excess capacity in the pathologists who are the physicians who sub-specialize in laboratory medicine diagnosis and treatment advisory. Pathologists are the ones who are responsible for the testing for Covid-19. That’s the basis of all further treatment. So, what I would like and before we can even talk about the extent of the pandemic, how many in the population are infected is the availability of accurate testing, and pathologists are responsible for the accuracy of the testing, from those labs. 

Thom: Great thank you, Dr. Godbey. There has been recent news coming out just in the last few days about the antibody test and the serology, so I want to go ahead and take the next question to Dr. Nakhleh, who can tell us a little bit about what serology testing is and why it’s been useful to research this in the fight against COVID and what can you say about the report from the CDC that current antibody testing may be wrong up to half the time?

Dr. Nakhleh: Thank you for the question. I’ll be happy to answer this. Basically, serologic testing is the identification of antibodies in people’s serum and what it does is it recognizes that the individual is developing immunity to Covid-19. Now, there are some things that are important to understand. Why do we do this? Well, the reason we do this is number one – if you were infected and you’ve gotten over the illness, we want to see if you have immunity so the illness won’t affect you again. That's one reason. Another reason we do this testing is to potentially use the individual’s plasma to treat other patients with active infections. The other, the last point I want to make about having antibodies is that this is one of the mechanisms that’s used to check the response to a potential vaccine. So, all these companies are coming up with vaccines, how will they know if that vaccine is effective? Well, they’ll look for the antibody response or immunological response in that individual to see if that vaccine is working. 

Thom: Thank you for that explanation Dr. Nakhleh, we’ll come back to you more about serology and antibody testing, I want to go next to Dr. Pritt who can tell us a little bit more about what the current model of testing is with what's known as the PCR, I'm sure that’s a term most people are familiar with. What's your assessment of the accuracy of these PCR tests and what do you make of continued reporting about lots of false negatives adding to the mystery and uncertainty about how to approach this pandemic?

Dr. Pritt: Sure, well that’s a great question. Let’s just take a step back and talk about what PCR is – it’s actually a test that is done to detect the virus itself, most specifically the virus’s genetic material called RNA and PCR in similar tests can detect the virus’s RNA and that would, therefore, indicate that the patient is either infected at that time point or had recently been infected. Unfortunately, there are a lot of variables that are at play when you talk about how good our tests are for the viral RNA and it starts with collecting the best sample as possible. So, the quality of the specimen that is obtained initially, usually done by collecting a nasopharyngeal swab is key. The nasopharyngeal swab is a bit invasive, it goes all the way back into your nose, most people don’t describe it as a pleasant experience, but it is the best specimen that we have to this day but you can collect other specimens that are easier to collect, such as a swab from the inside of your nose or from your throat. People are even looking at saliva. Those are all acceptable alternatives in the eye of the FDA but it’s important to note that they don’t provide as much viral material and you’re therefore more likely to get false-negative results. So just starting with the type of specimen you have can make a huge difference. Then there is some variability amongst the tests you use. Not all tests are as sensitive as other tests and by that, I mean not all tests are capable of detecting positive results when the patient is truly positive. They may not be as good at detecting that viral genetic material as other tests. So, those are the two main components that go into the virus detection and the third main component is the time point and disease. So, we know early on in disease the viral genetic material is mostly in the upper respiratory specimen. The nose, the upper respiratory tract, but as the patient progresses through their illness, the virus may move to the lower respiratory tract, the lungs and therefore sputum might be a better source. So, it’s the adequacy of collection, it’s the type of specimen collected, the time point of illness and then the test itself that’s used for testing. All of those play into the role of whether you're going to get false negatives or not. 

Thom: Thank you very much for that explanation Dr. Pritt and we’re going to ask the panelists further about the accuracy and proficiency testing to screen for these lab results and make sure that they're as accurate as possible. So, any of the media who are here, some of those questions are the kinds of questions that Dr. Nakhleh and Dr. Pritt can answer. I want to go and introduce also Dr. Volk really quick and Dr. Volk I want to ask you, we’ve talked a little bit about what your colleagues feel is important to know about the current state of testing. What are your thoughts about who should get tested and in particular as more and more states try to reopen their economies; workers try to go back to businesses and be in contact with customers. Should workers in high risk and high contact jobs be tested and potentially be tested repeatedly.

Dr. Volk: Thank you so much for the question and thanks for having us here today. Ideally, we would all have an opportunity to be tested each morning before we walked out the door. But of course, resources limit our ability to provide that testing for every single person. So, there are businesses who are pursuing testing individuals every morning, there are also businesses who are just testing workers for the presence of symptoms or history of contact with someone who has been diagnosed with Covid-19. All of these methods are potentially reasonable for understanding how many folks are coming into the business with asymptomatic Covid-19, which is a big concern for everyone in the community. Certainly, it’s a concern for me and my family. So, if a business has access to testing that is accurate and gives them reliable information that they can use to identify their workers who might have asymptomatic Covid-19 – great. The problem again to Dr. Godbey’s earlier point is access to enough tests. So, I don’t think realistically we’re going to be able to see any time in the next couple of months widespread testing of every employee and every large business each day when they come into the office or into the factory for work.

Thom: Okay, thank you Dr. Volk, if any of the media participants have any questions, please do chat those to us. 

Dr. Volk the idea of conducting this kind of testing and the logistics involved in that, something you have some experience with doing testing at your health system and changes and protocols that you’ve had put in place there. What are some of the logistical challenges to being able to conduct those largescale tests and what should people understand about how institutions can set up something like a drive through testing. Are these kind of challenges being solved or they linger?

Dr. Volk: So, it has been a real privilege to partner with my colleagues at the University Health system, the San Antonio fire department and the South Texas regional authority council stack to deliver drive through testing to their community in their county Texas. Some of the challenges about getting that testing accomplished have been – first of all to Dr. Pritt’s earlier point, making sure that we collect the specimen in a safe and complete fashion. So, we needed to find a place where we could have folks drive through that was protected from the weather. We had to make sure that we had appropriate personal protective equipment for our medical or trained staff to collect the specimen. To include masks and gowns and face shields and gloves. We had to make sure that we had enough swabs available and enough of the liquid that goes into the test tube that we put the swab in to make sure that the sample is kept alive. If there is a virus, we want to keep that virus viable until we can bring it back to the lab to test it. So then we have to get the patients enrolled into our database to make sure that once we get those results that we deliver those results to the correct person, so the whole issue of positive patient identification – because you can do a test, do a great test, but if you do it and deliver the information to the wrong person it doesn't help anybody. Right. So, we have to get those details correct. So, its registration personnel, its nursing personnel, its medical assistance and then there is all of the delivery component – how do you get that collected test from the site of collection to the lab where you're going to have your analysis done? Once that analysis is done, then how do you deliver those results back to the patient? We also need a physician by the way – to write an order for a test. We still want physicians to participate in the test ordering, because without a physician’s input on how that test is interpreted could be impacted greatly. So, in order to deliver a meaningful result, we also need a volunteer physician to help order those tests and then deliver the information about those tests to our community who is being tested. So, it is a huge logistical challenge – what I've been very impressed with is the public-private partnerships that have developed certainly here in South Texas and what I've read about around the country to overcome these logistical challenges on behalf of the community.

Thom: Thank you Dr. Volk – Dr. Godbey we have just heard Dr. Volk describe a lot of really complex logistical issues for setting up testing sites. What are your thoughts about leadership that’s needed from public health departments, state and local agencies, to coordinate with these kind of issues across the bigger picture? There's been a lot of news coverage about states competing with each other for resources for example. What can be done for leadership that looks at that bigger picture?

Dr. Godbey: Several things and that’s a very good question, that’s a very timely question. First of all – the involvement of leaders at every step of the way is imperative. In the laboratory, involvement with the laboratory director, the pathologist that’s in charge of making sure the test is done correctly and report it correctly. Our physician colleagues who have to be involved as Dr. Volk just talked about – obtaining the test. Identifying the patient. Making sure that the test is sampled correctly. The industry needs to be involved and delivering the needed supplies to the physicians, to the pathologists, to the laboratories performing the test and then to those who need to report the results. So, it needs to be a partnership between physicians, healthcare workers in general, industry and in the end with this large an effort – government resources need to be brought in to play. Both for coordination of effort and also to reach out further to the population, to say come in, this is what we need to do.

Thom: Thank you, we have a question from Barbara Fraser, she's a freelancer based in Lima, Peru – Barbara I think your question will be best directed to Dr. Nakhleh but feel free to go ahead and ask your question.

Barbara Fraser: Thank you, I wasn’t sure if it would go to Dr. Nakhleh or Dr. Pritt. I am based in Lima, Peru and there has been an issue here about – there have difficulty in getting PCR tests. So, they’ve been doing their case tracking using a combination of PCR and antibody tests and the ratio is approximately one PCR test to 7 antibody tests. I understand this is the same issue that came up with the CDC case tracking not too long ago and I know that – I understand that the two shouldn’t be mixed. That when you combine them you get an erroneous case count, but what I'm trying to understand is, is that the case count that they're getting likely to be too low, too high or is there no way of knowing? And the second part of the question is – given that for countries that are having a hard time getting a PCR test, what's the best way for them to do surveillance as they start to reopen their economies. What should they be targeting, what should they be looking for, what kinds of signal should they be targeting? Particular groups or looking at geographic areas and what kind of signals should they look for that might indicate that they need to impose quarantine again. Thank you.

Thom: So, Dr. Pritt or Dr. Nakhleh, either of you want to address that one.

Dr. Nakhleh: I can start and we’ll see if Dr. Pritt could add to it. For one adding the two tests, the PCR test with antibody tests gives you really an odd mix of information. The PCR test tells you about active infection, so those would be more accurate in telling you how many people have been infected. The antibody serologic tests they're looking backwards to see if you have had an infection recently or in some time in the past. So, it doesn't tell you anything about active infection and it certainly doesn't tell you that that individual should be quarantined, because if you have those antibodies and you're over that infection, you're not infectious at that point. So, mixing those two tests is really not advisable. 

As far as how you approach testing, I think you have to look at the high-risk population – it’s no secret that people residing in sort of senior care type facilities have been infected heavily, those institutions should be focused on. Anywhere you have crowds and people just being really close together, where they have no choice of not being close together, any place where people don’t have good air circulation, I think those should be prioritized. As far as a strategy for the general population, I think that is yet to be determined and it’s really – I want to answer a question you asked earlier about the CDC report which I think plays into why there's difficulty in serological testing. Part of the problem is even if you have good tests, if the prevalence of the infection is low, your accuracy really drops. If the prevalence is very high then the accuracy gets better and that’s why it can be false, you get the wrong results in up to 50% of the cases. I’ll turn this over to Dr. Pritt – see if she has anything to add.

Dr. Pritt: Yeah Dr. Nakhleh did an excellent job answering, I’ll just add in your first part of your question you said – by using the two tests together, they're giving us different pieces of information would that result in over-reporting, under-reporting, or dismissed reporting? It could potentially result in over-reporting if the numbers continue to be added together over time. The reason being that when you're sick you get tested, you get a PCR result, you're positive – oaky, so that gets counted as one positive. Well, if that same person gets tested two weeks later by an antibody test, by that point the antibody test would be positive. So, each person if they're tested twice by these different tests over a period of time could end up with two positive results. So that could end up in over-reporting. Of course, if you're just doing a single time point, then your testing and detecting a mix of people, it would be difficult to interpret the data because some you're testing by PCR and you're indicating they're infected right now and the serology is telling you they were infected in the past. So, it’s difficult to make public health decisions based just on a single time point like that.

Now your second part of the question is a bit more challenging, what to do in a resource-limited setting or in a setting where you just can’t get a hold of PCR supplies or PCR supplies to any extent and as Dr. Nakhleh said, I think at that point you really have to do a rescind approach where you use your limited resources to the best ability possible. You would use them for your high-risk populations, for example, your elder care, your healthcare workers that are on the front line, seeing patients with potential Covid-19. Your symptomatic patients, but if you're also using testing to try to just determine how many people in your population are infected, you probably can't test your entire population, but you could at least do a subset, you could do random sampling and that would give you an overall idea of how many people in your population are infected, even if you can't test everyone. So those are the types of hard decisions that governments, national and local healthcare facilities are trying to make right now, is how do they use their precious resources so that they could actually test the people who need to get tested and they're getting results they could actually act on. 

So, it’s rather complicated as you can imagine.

Thom: Thank you Dr. Pritt – we’ll go next to Deb Wood from Nurse Zone with her question – Debb are you able to get on audio? I'm not sure if you're connected or not. I don’t hear Debb and I don’t have an unmute option on her, so I will go ahead and ask her question for her, she’d like to ask with all the challenges of testing is it realistic for hospitals to test all patients undergoing surgery or other procedures? I’ve talked a little bit about this before this with Dr. Godbey and Dr. Volk, so comments from either of you on that question for Debb. Dr. Volk?

Dr. Volk: Yeah sure, I'm happy to comment on this. I can tell you that in our health system we are testing all patients coming in for elective procedures and we are ramping up to testing all patients admitted into the hospital. So, we now have the capacity to do that kind of testing. I will say though, two months ago we did not have that kind of capacity.

Thom: So, it’s something that's been able to be accomplished in those two months, so that would count as realistic in my book for Debb. Dr. Godbey what else do you have to say about Debb’s question?

Dr. Godbey: I agree with Dr. Volk. I think that we do have the capacity to test all pre-op patients now, and we did not have that capacity six weeks ago, but we do now. And that’s some interesting data, because these patients are asymptomatic and as we increase the number of tests that we performed and we know these tests are done in an accredited lab, with proficiency testing performed, and so we can reasonably expect the test to be accurate. It would be interesting to see what percentage of asymptomatic patients are positive.

Dr. Volk: I’d like to add to that if that’s all right. We have looked at those numbers in our health system over the last month that we have begun testing asymptomatic patients coming in for elective procedures and what we’re seeing in – again San Antonio, Texas is less than 1% of our patients coming in for testing prior to having an elective procedure. So, these folks are all asymptomatic, less than 1% of those folks are positive for Covid-19 using the most accurate gold standard test, the PCR test in an accredited laboratory where we do proficiency testing.

Dr. Godbey: That’s interesting because that’s exactly what we are seeing. We are at significantly less than 1%, in fact we’re at less than 0.5%, performed in an accredited lab using proper proficiency testing and the test performed by excellent laboratory medicine specialists.

Thom: Help our listeners to interpret that a little bit. Is that potentially an indication of the overall exposure of a population or does that tell us something else about the rate of asymptomatic cases? What do we make of that number? Dr. Volk or Dr. Godbey any thoughts?

Dr. Volk: Sure, that tells me and it tells our other leaders in the community that we have a relatively low prevalence among asymptomatic persons. That doesn't say anything about what we need to be doing as far as keeping our community safe. We need to continue to socially or safe distance – we’re calling it safe distancing now in San Antonia. We need to continue doing great hand hygiene and we need to continue to wear face mask wherever possible. Even when we can find ourselves spaced out beyond 6 feet. So, we’re really working hard in San Antonio and especially our hospital to make sure that we’re honoring all of those non-pharmaceutical interventions.

Thom: Dr. Godbey what do you make of that 1% asymptomatic rate among patients coming in for elective surgery?

Dr. Godbey: Remember the PCR test is that point in time. You test the patient and at that point in time you find it or you don’t find it. What it says to me and I agree with Dr. Volk – it says that this point in time in the asymptomatic population in South East Georgia, only about 0.5% of less percentage of people walking around at that moment positive for Covid-19. You cannot extrapolate from that and is dangerous to extrapolate that. We need to stop wearing masks, we need to stop social distancing, we need to stop doing those things. That’s not – if anything it says that we’re doing the right thing. We’re limiting that, but other than saying that we have a very low rate, I don’t think that it would be good medicine to go out and say everything fine. Go back to the norm.

Thom: Okay thanks for that clarification. I’d like to ask Dr. Nakhleh, would you consider any test to be full-proof and what does it mean and why is it important to get a test right and talking about these things, like the proficiency testing.

Dr. Nakhleh: thank you for the question. Let me back up and actually address what proficiency testing and accreditation is so that everyone understands what we mean when we use these terms. Accreditation is mandated by the government for having a laboratory that does high complexity testing and so accreditation is essentially having a system in which you follow some mandates so that you're collecting specimens appropriately, you're running the test appropriately, there's a whole design of quality systems that must be adopted, that's what it means to be accredited. That means you’re doing it the right way. Now proficiency testing is another layer of quality that’s added on top of that. In other countries, they call it external quality assessment. So what it is is that specimens that have low quantities of known virus are sent to that laboratory and those specimens are tested in that laboratory and then, of course, they don’t know the result but they send it back to us and at the same time they also gather information about how the testing is done, what methods are used, what platforms are used. So, all that information across hundreds of laboratories and probably thousands of laboratories is accumulated and then we could compare laboratory to laboratory and method to method as to what is really well and what needs to be improved, and that really is our goal, is to constantly improve testing. Nothing is 100%. You are limited by – let me restate that. Most testings are pretty complex. There's the logistics of actually doing the test and making sure that the specimen is viable when you get to test it, but on top of that you have to actually mechanically, physically do the correct test, and we’re dealing with molecules which are super tiny, so we have to make sure that all the conditions are appropriate. So, nothing is 100% but we constantly have the monitoring systems in place so that we can improve continuously. And laboratories that follow both systems, they are constantly on the lookout for variations in the testing. Part of what we do is to constantly look to make sure that a test is performed as its intended. We do that before we- when we establish a test for the first time. Many people – over the past two months they’ve been establishing Covid-19 testing so they bring in all their equipment, but still, that laboratory has to establish that it's performing as intended and that result is as accurate as can be. But proficiency testing is a layer on top of that where you compare yourself to the world essentially and you find out if you're as good as your neighbors. So that’s it in a nutshell.

Thom: We have a question in the chat from Debbie Savage and she’d like to ask about Abbot pharmaceuticals rapid result test, has this been subjected to proficiency testing and is it bond to be accurate and if it’s not what may be the problem with it and she indicates that she's heard that these tests have been used a lot in Chicago area.

Dr. Nakhleh: Well the problem is we have a brand-new disease and so a lot of things get crushed out to test for the virus. Proficiency testing is not something we do in an instant, it takes a little bit of time. Actually, we sent out our first wave of proficiency testing for Covid-19 earlier this month. Now it takes a while to kind of gather all that information and actually go through it and test it. So, I don’t have real data at this point, but we will soon and we will have data to compare the different platforms. It’s a process that's ongoing. Unfortunately, science takes time and I can't really talk specifically about any one instrument. I think Dr. Pritt probably has more experience with those platforms and maybe she can add something.

Dr. Pritt: Yeah sure thanks Dr. Nakhleh. Yeah, the Abbot does have their rapid test, the ID now which can deliver a result in as few as 5 minutes or a negative result in about 13 to 15 minutes. There is some concern that it might not be as sensitive as some other tests that are on the market, and by sensitive I mean it may not be able to detect positive results as well as some of the other tests, but as Dr. Nakhleh mentioned, its early on and we’re still learning a lot of this virus and the best test to perform to detect this virus and I think as we get our results back from proficiency testing and we experience with these different types of tests, we’ll have a better idea of which ones have the best performance and then laboratories will probably start shifting to those. At this point now, I think it’s probably too early to say that one test is clearly superior to another, but as Dr. Nakhleh said, there's no test that’s perfect and some tests maybe a little better in some areas than others. 

Dr. Nakhleh: If I could add one more point, manufacturers also pay attention to this proficiency testing and they approve their instruments based on this type of analysis. So, it’s an ongoing process with everybody involved.

Thom: Dr. Godbey, you have something you'd like to add?

Dr. Godbey: I do. I think it should be remembered that a proficiency test is a test. The lab receives an unknown, performs the assay on that just as if it was a patient sample. Sends it back to the person or the organization that provided the test and you're graded. So, in addition to comparing yourself with all other labs, you are told yes, you're doing a good job, you’ve got this one right. So, it’s another way to make sure that your lab is doing a good job. 

Thom: Great thank you. We also have a question from Charlotte Libov. I’d love to turn it over to Charlotte to ask her question herself. Charlotte your audio is live, go ahead.

Charlotte Libov: Thanks. Given all the concern about the accuracy of antibody testing including the CDC’s statement the other day that the results could be wrong 50% of the time, I know that people in my community and I assume others are still under the impression that if they get a test and its positive that this is going to afford them some degree of immunity. What would you say to them?

Dr. Volk: I’d love to take that question. That is such a great question and I'm getting that question from my neighbors and we’re talking a lot about it at the hospital. I think there is a desire to have a badge of immunity right, to have the so-called certificate of immunity that says hey, I'm good to go. I don’t have to wear a mask. I don’t have to wash my hands like I have an obsessive-compulsive disorder. I don’t have to worry about social distancing. I can go hug grandma right – I mean that’s what we’re all looking for, we want relief and we want assurance. Unfortunately, as Dr. Nakhleh said, science takes time, medicine takes time and this is a really brand new disease and we’re still understanding what it means to have antibodies and what level of immunity if there's any immunity at all, one is afforded when you have antibodies identified in your blood. And so, I think we’re understanding how to more accurately test for antibodies and again the proficiency testing that the CAP provides will help with that and I think we’re learning more and more about what kind of protection do these antibodies provide an individual when they have them. Right now, I would tell – and I do tell my colleagues and my neighbors and my family. It doesn't matter if you have a positive antibody test or not. You need to do the social safe distancing. You need to wash your hands and you need to wear a mask out in public. That's what we need to continue to do to keep our communities safe until there's a vaccine or we understand this disease a little bit better.

Thom: Thank you Dr. Volk. Dr. Godbey, I’d like to ask you to tell us a little bit more about who should get tested and we’ve all seen stories in the news repeatedly over the last couple of months of people having difficulties getting tested. If you're able to give us some scenarios, some examples of cases where people are able to get tested or their physicians would agree with ordering the test, and also maybe some cases of people who don’t need to get tested but may have the opportunity to later.

Dr. Godbey: Surely. Well first of all let’s take one step back and say that there is not enough testing, not enough availability of tests now. And the first thing we need to do is increase the availability of testing, particularly at the local level. Therefore, these decisions, if this occurs, these decisions become much easier. Does this person need a test? Does this person get a test? The first step in that is making testing accurate, reliable testing available to as many people as we can. The healthcare workers and people who come in contact particularly with immune-compromised patients and other patients need to be tested. They need to have that available. At-risk populations Dr. Nakhleh referred earlier need to be tested. It’s interesting – my daughter and I have this debate almost daily. My daughter is also a pathologist and is a transfusion medicine specialist and responsible for providing the convalescent plasma in her institution. So, your question is debated at several different levels by several different people, but the answer is – more testing so that more people can have access and be tested without rationing. Then, the local physician, local public health department needs to assist in that determination. Who gets tested? But I can't overemphasize the need for added testing capacity in local hands and local institutions, because that makes all these questions go away.

Dr. Volk: I’d love to also respond to this question if you don’t mind – 

Thom: Yeah please I wanted to open it up to the other panelists as well. Go ahead Dr. Volk.

Dr. Volk: Thank you. You know one of the things that pathologists do especially in a pandemic like this is we help make the enemy visible right – and that’s why we all want testing to be expanded, to be readily available locally and again ideally everyone would get tested every day. We’re probably never going to get to a point where we have that kind of availability or resources to do exactly that. We have seen a progression since the pandemic began were back in early March, it was difficult to get a test even from the local health department because there were restrictions on who was eligible to get a test and again, this was because of the limitations in supply and there was a need to control the demand. So initially we were only allowed to test patients who had symptoms and positive travel history. The symptoms that became more known to be associated with COVID beyond just the cough and the fever we learned as the disease revealed itself to medicine that there were other symptoms that could be associated with COVID-19, including GI symptoms, nausea, vomiting and so forth. So, we needed to broaden the group of patients who were considered symptomatic. As the tests have become more locally available and the turnaround time has become better, the limitations on the previous testing such as travel history and a very limited set of symptoms has been changed. So, I agree with Dr. Godbey, the more we can get testing in local communities, with good turnaround times, with less than 24-hour turnaround times, the better it will be for the local communities to manage this pandemic. 

Thom: Thank you, Dr. Pritt I want to ask you your thoughts about this as well, it’s something that we discussed beforehand and in particular any thoughts about how policymakers ought to show leadership or give guidance about this question.

Dr. Pritt: Well I think that it’s definitely a team effort and so policymakers really, I’d love to see them reaching out to pathologists and pathologists reaching out to policymakers to help shake these guidelines. We need to have folks from pathology on the table as well as people from the community and the public health labs. And I agree with all the other statements that have been made so far.

Thom: Thank you, and Dr. Nakhleh anything you want to add to that?

Dr. Nakhleh: Yeah, I do, there's a couple of things. I think I agree with Dr. Volk about how symptoms have changed. I've had a personal experience in which I know someone that presented without respiratory symptoms but they were in the hospital for a week before they were tested and it turned out that that was the problem. Covid-19. The other aspect that I think communities have to think about and it’s not such a problem now that most things have shut down and people are not traveling, but travel – remember, travel is what exploited this problem and so as we try to open up we have to realize that travel is part of the equation. If I'm only at home with my wife and I come to my office and go home, very minimum interaction with the world other than what I have. But if I start going to Chicago and going to New York and going to LA – you have to figure that out. You have to figure out how do you test so that you can pick up asymptomatic people as they travel. Now, the promise down the road is that we get a vaccine and all this becomes moot – we hope. 

Thom: Could travel be another scenario where someone goes to their physician and says – hey look I have to take this trip, maybe I should get tested before I go, maybe I should get tested after I come back. We may not be at the point that people can do that today, but is that something that you might like to see included in the mix?

Dr. Nakhleh: I think you have to think about those vents, particularly if you're going to a big meeting or you're going to meet a crowd that you haven’t seen in quite a while and the prevalence in New York is much higher than it is in Jacksonville where I reside. I think you have to start thinking about those things. You do want local control and so long as we’re isolated, that works. For example, New Zealand claim that all the cases have been eradicated from New Zealand. Well, wait for that first flight going in. what's going to happen then. And so, you have to again start doing the testing and tracing and those kinds of things so that you minimize the potential for infection.

Thom: We have another question from Charlotte, go ahead Charlotte.

Charlotte Libov: thanks. Since diagnostic testing is only a moment in time, in my community for example which is the city of Miami Beach, they're putting an extra standard and that would recommend that restaurant workers get tested monthly. Is this going to tell you anything? I mean is it useful at all?

Dr. Nakhleh: I’ll try that. It probably is useful in picking up some cases. I don’t know if that frequency is the appropriate frequency. I mean essentially what you're doing is sampling the population and you're sampling a population that comes frequently in contact with other individuals and probably travelers and so it will add some help, but it’s not a guarantee that everything is going to be fine. It’s something that the localities have to decide and basically it is trial and error. You're going to have to try it for a while, see what happens, see what kind of pick up you're getting and how it is helping you manage the control of the disease. And as I said, as things change then we’ll have the appropriate – then they may not be helpful down the road but – 

Thom: Any of our other panelists want to comment on this question?

Dr. Volk: Yeah, I would – go ahead Dr. Pritt.

Dr. Pritt: Well I was probably going to say the same thing that Dr. Volk was going to say. I was going to go back to a previous statement by Dr. Volk that we need to continue our safe practices, safe distancing, masking, hand washing and so if you test monthly, sure that’s helpful but that doesn't mean that you can give up these other things. It still has to be one tool in our toolbox from protecting us for Covid-19 and testing once a month will tell you that time period that on the day of that test that person is not infected but if they're not exhibiting and adhering to all the safe practices, then for the next months – well that whole entire month they could be potentially at risk. So, you have to do all of these things at once and as Dr. Nakhleh mentioned I'm not sure that monthly testing is the right time frame, but as long as you're doing all those other aspects that’s probably just another reassurance that you have. That you're going to keep your folks safe. 

Thom: Dr. Volk was Dr. Pritt correct that that’s what you were going to say. 

Dr. Volk: She was, she was absolutely but just to add to that, my hope is that any business, certainly a restaurant with a lot of exposure to the community would continue to mandate that their employees followed good hand hygiene practices, that they wore masks appropriately, that they did follow social distancing as much as they could and do their jobs and the testing once a month would not relax the safe non-pharmaceutical interventions. We know that they're so important in keeping the community safe.

Thom: Dr. Godbey, we talked a little bit throughout today's panel about the role of pathologists in advising on policy, making sure that the right kinds of tests are used, that the labs doing them are doing it correctly. A lot of these things happened behind the scenes of where most members of the public interact with healthcare and yet what pathologists do is so integrated with so many different steps of all that, what would you like for people to understand better about pathologists role and especially how the correct diagnosis and sometimes even information about the right treatment course come out of the labs and the pathologists' recommendations. What would you like people to understand better about that, about what's going on with lab tests and those results?

Dr. Godbey: First of all, labs are directed, have the responsibility for the labs fall in the hands of the pathologists. The vast majority of diagnoses now come from the lab. And more and more treatment decisions are based on lab work. Laboratories no longer just come out and say you have cancer or you don’t have cancer. Now laboratories come out and say – you have cancer and here is the best way to treat this based on these laboratory tests. Many malignancies – again, not just diagnosis but treatment decisions, treatment avenues are now made because of lab work, which means that the lab is more important in healthcare than it ever was before. It’s more important from diagnostics, it’s also more important for treatment decisions. That bad data is worse than no data at all. So, the quality of the lab is extremely important and it has never been more important and that trend will continue. The lab can now offer decision-making ability and capacity that it’s never had before and the responsibility for that lab and for the quality of the lab work that comes out of it, falls on the shoulders of the pathologist. The pathologist and the college of American Pathology, it interacts with the FDA, it interacts with the administration, it interacts with the senate offices, with congressional offices all the time, and so the College of American Pathologists has input and at least it asks about some of those things. So, our opinion has never been more important and our avenues of communication are opening up.

Thom: Thank you Dr. Godbey. Dr.Volk, you talked a lot about watching the early logistical challenges of testing and what progress is been able to be made in the last two months, and all of that is very promising for what further improvements might be able to be made which you commented about as well. what would you advise the public to be on the lookout for? To understand when they might have access to more widespread testing and how soon you think that can be accomplished in more parts of the country.

Dr. Volk: Thank you for the question. Before I answer that question I would like to also point out, add on to what Dr. Godbey was saying about the essential role of pathologists in diagnostic medicine and that is – we’re also responsible for all of the other diagnostic tests that are being performed on patients who do have Covid-19 and who are in the ICU’s and we’re making sure through the CAP proficiency testing programs and the good work of these physicians every day that those tests are also accurate, reliable and trustworthy. So, all of those things are parts of the puzzle that keep the community safe through this pandemic. 

With regards to what the public needs to look out for, I would recommend that folks work with their physicians if they're interested in getting testing – whether or not they're symptomatic or asymptomatic and I would encourage folks to get more information if they're going to pop up testing site that is not sponsored by their local health department or a local known health system. We have seen there are some folks who are taking advantage of this crisis and looking to make a buck and not necessarily promoting what I would say quality testing. So, I would encourage folks to work with their doctors when they're interested in testing.

Thom: Very helpful and a bit of caution about possibly not credible testing sites that may pop up in your community. Thank you for that. If any of the media have any questions for our panelists, we’re about at an hour and we’re going to wrap up here shortly but I want to give time for any last-minute questions from any of our media participants and I want to also ask Dr. Volk if you can tell us about a recent CAP lab survey about testing and what some of the results are with that, any conclusions and how reporters might find out more information about that if they're interested?

Dr. Volk: Well we can certainly make the information about the survey available to you, provide a summary – we can absolutely take care of that. The CAP accredits over 7000 laboratories and we know that in our recent survey that we had over 1800 laboratories that were doing the molecular or PCR assay for the virus and then there were about 420 or so laboratories bringing up the antibody testing. So, we know among CAP-accredited laboratories there are more labs doing PCR testing than there are antibody testing. We also know as Dr. Godbey said earlier that laboratories are still struggling to get enough reagents and enough supplies and so we do look to public and private partners to clear up those supply chain issues.

Thom: Great, thank you Dr. Volk. If we don't have any other questions from the media, we will go ahead and wrap things up. Just to remind you media attendees we will have a video and transcript available of today’s event. If you're registered, you’ll automatically be on the email to get those when they're available. And if you're not registered for the event, send us an email to [email protected] and we’ll make sure to get you on the list for that. You're welcome to use any quotes from the panelists in today’s call as well as follow up with them and ask further questions.

The main contact that can help you connect with all of these experts is Catherine Dolf, Catherine if you wouldn’t mind chatting your email in the chat so that all the media in our call today can have access to that information and that contact information will also be available in the link that we send around to you media registrants with the video and the transcript.

I believe its cdolf@cap – I’ll type that into the chat for all of you. With that, we’ll draw to a close. I want to thank Dr. Godbey, Dr. Nakhleh, Dr. Pritt, and Dr. Volk and the College of American Pathologists for working together with us to present today's panel.

Yes, its [email protected] – Mary Catherine posted that for everyone. So, media please do take note of that email address. Thank you all very much, stay safe, stay healthy and Good luck.