VeiligHealth Insights to Actions – 2 Dec 2020

 

Our weekly question and answer session with Fred Goldstein, Dr. Luis Saldana, and Nick van Terheyden, MD on our COVID Insights to Action Discussion webinar that takes place live every Wednesday at 4pm ET
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Transcript

Nick van Terheyden 

Hi, this is Nick van Terheyden. I’m one of the advisors here at veining insights, holding the webinar for question and answer sessions. And welcome to all of you that are joining us. Currently, I’m here with my colleague, Dr. Luis Saldana. Unfortunately, this week, Fred has not been able to join us. But we will still continue to run through the regular exchange. And this week, we’re focusing on testing and discussing the various tests that are available, and how people can organize and go through the testing process. So to kick us off, Luis, if you could, perhaps you can explain in simple terms, the various types of testing, and what all of that means. I think, you know, we’re all sort of struggling with the terminology, the various types of testing accuracy and so forth. So maybe you could set the groundwork and start the conversation by describing the basic tests that we have.

 

Luis Saldana 

Yeah, yeah. Thanks, Nick. Yeah, I think, yeah, I guess it gives a good overview to talk about first that the virus itself, that’s what we’re measuring is some of the products around the virus as we do the testing. And so the most commonly done test or test, most people are seen as what’s called the molecular test, or the PCR test, which actually measures or looks for pieces of the virus itself, pieces of the RNA of the virus. And so that that is probably the most commonly done test. You, you know, now is kind of the earliest that we saw, there’s a second type of test that we’re starting to see more and more of, which is a antigen test, which measures another component of, of the virus and, and it, there’s different things about this virus, about this, these type of tests that they’re often done, you’re often now seen quick test results, the test results for this are typically faster than for the PCR test, though you are seen some more rapid PCR test, depending on on kind of the testing infrastructure and things. But what you’re what you’re essentially looking for, is, is a piece of the virus itself with with this test, and, and so the two don’t always line up as to when they’re positive or not. And this often leads to some of the confusion around false positives and negatives, which is the which which did you know it was this a false positive or false negative test? And, you know, I think it’s, it’s a little challenging and, and you almost have to look at testing a little bit differently. I think for COVID. In that was false positive and negative is still a relevant thing. First of all, the PCR is considered the gold standard for diagnosis. If you if you get sick, and you go to the hospital, they’re going to do a PCR test. That’s, that’s considered the diagnostic gold standard. But we’re seeing the antigen test being used for screening or surveillance testing, which is intended because because of the uniqueness of this virus, and the asymptomatic nature, often of the virus, you’re often testing asymptomatic either contacts are just asymptomatic people have may be working in higher risk areas, such as essential workers. And so that leads to kind of the suggestion that you can do this mass testing, which will be repeated over and over again, potentially. So you’d be screening essential workers, you know, successively, which often would address any kind of major concerns around around the sensitivity and specificity relative to the rt PCR, which is kind of a big question. It’s, it’s they’re looking at the the sensitivity and specificity, specificity relative to the rt PCR.

 

Nick van Terheyden 

Can I just interrupt for a second racers for the folks that are joined, so that you understand what’s going on? Please feel free to ask questions in the q&a or in the chat box, we’ll be monitoring that. We were just talking about the various testing modalities. Luis was talking about the various types of tests and how they applied. I’ve promoted you all to panelists, that if you want to ask questions, visually, you can switch on your video, you’re currently muted, but we’re going to talk about this. And we’ll steal questions as we see them coming up. Sorry to interrupt. No, not

 

Luis Saldana 

not, not at all. Yeah, I’d say definitely supposed to be a conversation, I’ll just cover the last kind of type of tests before we kind of lead into the discussions because lots of questions come up around testing strategies. But the third type of test is the antibody test, which measures the result of the infection antibodies are formed as a result of the infection. So those won’t be picked up in it necessarily an acute infection. They’re not used for the acute infection, but used to detect the fact if you’ve had an infection. So that’s the answer, you know, the question you’re trying to answer there, has this person been affected? And I think it’s important in all the testing, as we get into conversation is what what question are we trying to answer here? And I think that kind of leads you to, to different testing strategy. So I’ll leave it at that. Open it up.

 

Nick van Terheyden 

So I’m going to try and break it down into two two basic tests. concept. One is Do you have it? And the other is have you had it? Do you have it comes in the two forms that Louise talked about this molecular test? I always find this confusing. Why do they call it the molecular test, but that’s essentially the PCR or the polymerase chain reaction process that has a long background in essentially amplifying pieces of the virus. And then we detect those. And then, as Luis talked about the antigen test, which is looking for the little spikes that everybody sees, and then the other test, which answers the question as to whether you’ve had it or not, is related to the antibody production in an individual’s body. So if your body produces antibodies to the virus, then we deem that to be an indicator potentially of you having had the disease. We don’t know as much about that at this point. I’m gonna pause for a second. Douglas, you’ve raised your hand and I’ll ask you, if you’d like to ask a question.

 

 

Yes, my name is Doug SEALAB. I’m CEO of UBI. Medical. Our company holds two Nobel prizes in medicine. The first was for the cure of lupus. The second was was for the cure of viral bacterial, pneumococcal, and fungal infections. And I’m working with a company that has developed a very effective 100% success rate COVID. It’s an oral solution. It’s called a nutraceutical. And the actual name brand is called electro side. And it is worked in 36,000 cases so far, even for those people who have been innovated. And I think this is something that, you know, with your guys credential, it is something that you should know about. Um, my technology, of course, is UBI. And I don’t know if you’re familiar with that, but the President spoke about it on TV. I’m looking at the oral solution, because it’s something that’s a lot easier. The clinics that we have around the country are extremely busy. And this is much less expensive and can be taken in the comfort of someone’s home. And I think that it’s important to let people know that this is out there.

 

Nick van Terheyden 

So I I appreciate the insights. But for the purposes of this webinar, we’re really trying to answer questions for people that are joining. I’m obviously this is an interesting technology, something that we can take offline. But we’d really like to focus on questions from people focused around testing around the COVID virus rather than talking about a specific product. While that’s interesting, you know, for the benefit of everybody that’s on the webinar, I’d like to sort of keep it more general than that, if that’s possible.

 

 

Okay. If there’s any way that I could get your email addresses to forward that information to you, I think that would be a good idea. So you could see all the research and clinical analytics, and all the support documentation,

 

Nick van Terheyden 

I absolutely will make sure In fact, our emails and contact information is available throughout. So thank you. Let me go back to the the testing. So we talked about the various test availability Luis, or the types of tests. So do I have it? And you touched a little bit on the rapid testing? Tell us a little bit about that, if you would, and how that relates to our ability to detect? Why does it take so long? What are the problems with that? What what are your thoughts around the speed of testing? Yeah, that

 

Luis Saldana 

has been one of the major issues with the testing one as we have not scaled up and testing enough in the United States. Because, and the reason why I’d say that is because of the asymptomatic nature of this or, or the fact that people are infectious before they’re symptomatic often, and that’s a that’s a big concern. So weigh in, so you lose time with infectiousness, when there’s a delay in the turnaround time, the quicker you can get the turnaround time, will the speed often makes up for the lack of the set the sensitivity, or specificity and things and so that speed can help you make make decisions, you know, decisions, on on on patients that you’re monitoring, again, like health care workers, or front, you know, frontline or essential workers. And actually, it’s been used in places like Liverpool and Slovakia, scaling these tests up at a very high level, to where you’re, you’re testing everything, essentially testing everybody at a rate on a regular basis. So that you identify the people that may be infected, take them out of a population, and and isolate them so that the infection is not spread the infections slows down and spreads. And that’s been used very, very effectively, in those places. And I think there was an article by Dr. Michael Mena, and in Time Magazine, which is very good for even lay people to read through that. And I’d suggest that on, on on kind of getting out of this crisis by Christmas, I think has something something like that is the title. So So these tests can be quite useful for for that. But the concern about turnaround is you lose time on contact, tracing all the issues, you’ve already been infectious, when when your result comes back to the May Two hours later.

 

Nick van Terheyden 

And I think the you know, the additional point to that is that a test is a moment in time. So I’m testing you to determine whether you’re effective at that point in time, you could actually have the disease, even with a test that is entirely accurate, 100% accurate, but because of the timing of the test, and you say we don’t detect it not through any fault of the testing modality, but because the virus doesn’t present itself to be detected by any of these tests. And the other thing that I think is really important relative to this is that folks that are struggling with turnaround times as you move into 2448. And longer, the utility of any test diminishes. In fact, if the test takes more than 14 days, I would say it’s next to useless because at that point, if you were under suspicion, you would have just enjoyed the 14 days of quarantine that you were subjected to. And you didn’t get anything additional from the the testing. So one of the key assets that I think you have to think about is the turnaround time. And that’s not just for the test. So some tests are very quick, right? But even the tests that take a period of time in the laboratory have to get to the laboratory in some instances. And that creates a delay so that has to be factored in. Tell us a little bit about the rapid testing and what the options are available to us today, Louise? Yeah, I

 

Luis Saldana 

think that’s that’s one of the things that that we’ve been seeing kind of innovations. And I think the NBA was almost one of the first they you started using technology out of Yale, the saliva direct, where they start testing the, the saliva, the idea of where the source comes from, is, is getting enough concentration, to be sure that you pick up enough of the virus and things and so they’ve gone through different techniques to make it more palatable. I mean, nobody wants to be swapped, say twice a week or something like that. So that that really leads to kind of this the saliva sampling. And there’s some good studies, we’ve seen some studies that have shown that concentration is high enough in the saliva to be useful. And for these cases of screening, and and such, so so I think you’re starting to see that and that’s really the promise. The saliva leads to the promise potentially, of, of these home tests, you’re you’re you’re hearing some talk about home test being approved, and things like that, where you could test yourself before specific situations or test yourself regularly. Let’s say I worked in the ER, so let’s say I’m going or I’m going to my clinic, I test regularly to, again, you’re reducing the the chance you’re reducing the risk that you don’t have an infection by by testing rigor, if you had that home test, you could, you know, do it much like a pregnancy test or something like that. That’s currently done that’s available. Even at ackers, the real concern right now with them, or the ones that are coming out is they looks like they’re going to require a position order, which I think is a huge barrier that I like to see. totally removed from that. And and I do think that with the Biden ministership, coming in, you’re gonna see a real emphasis on on expanding testing, to the kind of things we’re talking about, you know, the kind of scale we’re talking about that has been used elsewhere.

 

Nick van Terheyden 

So when you talk about those instant read tests, I mean, there are a couple at least available now that don’t require laboratory configuration, but they’re not available. Is that what you’re saying?

 

Luis Saldana 

Not Not, not here in the US? I think there’s there’s one that i think that’s that’s been pushed out, I don’t remember the name of technology right now, you may remember, Nick. But there’s lomira, there’s at least a couple that are working in this space. But I’m not sure any of them are yet been been approved. For that use yet, though. It could be almost any time. And I expect that it will, but from what I understand they will require a position order.

 

Nick van Terheyden 

So in the intervening time, as people think about their testing strategy, how do you approach thinking about this? And how should a business Think about this, given the available resources?

 

Luis Saldana 

And I think that really depends, Nick, again, kind of the question triads are, what’s the nature of your business, let’s say we’re talking about business here, we work with college universities, and things as well. But let’s say you’re talking about essential an essential workforce, that may be potentially exposed to infected folks daily, those are folks that should really be tested on a regular basis, you know, to kind of ensure that, that we’re not propagating the virus. So so I think that’s those type of groups, the antigen testing, done on a regular basis, say every two to three, you know, three days, probably every three days, we gain an instant result would would probably be an ideal, you can keep the infection rate way down. And that would help kind of reduce the overall Arnott for the country, even if we, if we did that on a very broad basis, especially for those people that are kind of, you know, at highest risk.

 

Nick van Terheyden 

And, Doug, you have a question. Yeah, I’m

 

Douglas Goldstein 

concerned about this a sense of egg spreading. So if I’m infected with a service, sufficient amount of virus, how how fast Am I transmitting infecting others before I would test positive on any of the tests mean, what is this window of mean, if I get a PCR test? I don’t get the results for two days, but I could still be infected and spreading correct? I mean, how do we, how sensitive are these tests going to be and how can we find the asymptomatic spreaders?

 

Nick van Terheyden 

Louise?

 

Luis Saldana 

Yeah, I think the the real question is at what point in the infection you are when you’re in the incubation phase. The infection that is the infection, the virus is just replicating in your body, you that any test probably will not pick it up, because these tests are kind of meant to find the virus itself, which really won’t kind of manifest or be, be detectable until until the point that there is an infection in your body. That’s what a part of the challenge that we were dealing with with COVID is there is that window, the idea should be Have I been in a high risk situation, if you’ve been in a high risk situation, let’s say, let’s say you’re in a restaurant, or with a no, and you know, there was no low mask, you see, you’re concerned about the ventilation there. He said, Gosh, I’m really concerned and I, you know, I have somebody at home, that’s high risk, then you you might want to go ahead and get get a test, you probably as Nick said, that’s one point in time. So you theoretically would have to wait a couple of days, even from that potential exposure to kind of bypass that incubation pace, the important thing there is masking and and if everybody’s sticking especially to end or masking all the time. You know, especially around vulnerable individuals, but but in any indoor settings, whether you can whether you can distance or not, you should strive to to wear a good mask all the time. And so that should protect me.

 

Douglas Goldstein 

If I’m if I’m in a restaurant that’s at 25% capacity, and and there’s called 20 people 25% capacity, I could probably assume that what 1% 10% of those people would be infected and spreading. I mean, at this point in time where we are with the number of infections, I can assume that if I’m around 10 people, one or two of those are already infected and potentially spreading, right?

 

Nick van Terheyden 

Yeah, in fact, there is some good tools available to apply some statistical probability based on the size of the gathering the current prevalence of the disease, to give you some indication of the likelihood of you know, somebody being positive, just to sort of amplify on Louise’s point, to give people a little bit of context, we have a reasonable understanding of what happens with the disease process. And as you can see from this chart, you know, there’s this period, from day zero through to about day seven, where we see this rising level of the antigen that is detectable. And you can see up to day five, and it can be longer, in fact, people can be asymptomatic, potentially have the virus and could be spreading it. The point at which that becomes detected varies by individual. It also varies a little bit by test and where you take the sample from, although we’ve tended to level that out with both the nasal pharyngeal swabs or the brain ticklers, as they’re sometimes called. And indeed, the saliva test, which is proven to be fairly similar in terms of sensitivity. But certainly in that very early stage, it’s questionable as to whether you’re shedding the virus to be able to spread it in the very early days. And if we can’t pick it up, and particularly with the very sensitive PCR test, then it seems less likely that you have or are spreading the the virus.

 

Douglas Goldstein 

So one of the other things that came up that came up in the other conversation last week was, you mentioned that I might only have to get this vaccine every 18 months, not twice a year every year for the rest of my life, because there’s the Coronavirus protections going to be different. I get an annual flu shot that’s different every year. So I have to get a coronavirus vaccine every year. That’s a little bit different.

 

Luis Saldana 

We don’t know yet. We don’t know the answer to that yet. My guess is no. And I think I’ve heard Dr. pouchy say it and think so as well. But we can’t say that for sure. I think we have to kind of wait and see. The other thing we do know or at least at this point is with at least with the first two vaccines that are out even if you have had one to say one vaccine or even both, you should continue masking until you know the point is such a point that we are told not to and that probably would be determined by some measure of herd immunity and but you know due to the vaccine

 

Nick van Terheyden 

and I think And if I may, I want to just go back to that chart because it actually amplifies an additional point, a particular bug with me. In the lead up to Thanksgiving, we saw an awful lot of people focusing on rapid tests. And in fact, locally, we saw one of the providers was providing a rapid test. And of course, people wanted that because they wanted to get a decision or some kind of view, instant in time, do I have the virus? Can I go spend Thanksgiving with my family safely? In this particular instance, and here was the the giveaway, this particular test was done by taking blood. And that’s the first alert to tell you that this was the antibody test. So you can see those two lines here, the idg and IGN, which have different profiles in terms of when they present in the bloodstream. And you know, continuing on Louise’s point, what do we know about those levels and what they mean? Well, right now, it’s just research. And it doesn’t tell you much of anything. And it certainly doesn’t tell you whether you’re effective. Whether you’ve really had the disease it may do, we’re not sure about the cross reactivity with other coronaviruses, that could induce some of those antibody responses. So I highlight that point, because not all rapid tests are equal. And the buyer needs to be beware in terms of taking tests that they want a quick response, as you’ve heard from both of us, this is a really important aspect to opening safely. Because if you don’t get information back quickly, then you can’t make any decisions based on that. And it starts to become less useful over time. But importantly, it can get a rapid test of your antibody response, not providing lots of or much of any useful information in the process. For those of you on the line, anybody if you have questions, please feel free to sort of put them in the chat or come out, you know, raise your hand, we’d be happy to take additional questions. Maybe in the closing couple of minutes. Louise, you, you might talk about where you think the testing is going to I mean, we’ve got vaccines or vaccines coming down the pipe, we expect to see them. Does that mean, we’re not going to be testing what’s going to happen with testing in the in the coming weeks and months?

 

Luis Saldana 

Yeah, I do think we’re gonna see, again, higher availability of testing, we already have seen that. around Thanksgiving, as you mentioned, that was kind of the surge in testing. And so the availability will continue to increase. And I do think they said this administration coming in will put a real emphasis on on using those, those rapid tests for you know, frequently in high volume to try and drive down the rate of infection. Also, you’re seeing that already for airlines using this there. for traveling abroad, you’re you’re seeing one, I think I just saw Delta or somebody was required to go to Rome, three tests, you have to have three tests on your trip, trip to Rome. As far as that goes. So I think you’re gonna see a higher emphasis on testing all the way around. So it’s important, I think one thing I’ll say just simple guides, everybody on the call should know, if I have to get a test. Where do I where do I get it, you know, this is all local, but look for your local resources use your county health department is a good resource. And they usually will have sort of places where you can get free testing. Or if you want to pay get, you know, you pay testing, but but you can actually often get free testing through the county allow these I do have some federal subsidies of some of the federal subsidies are ending for some places, but be familiar with it. So when you you know, you either feel like you’ve had a high risk interaction, or are concerned and want to get tested. Look for those resources and be prepared rather than waiting till the time. You really need to get that and know what what resources you have in your community for testing.

 

Nick van Terheyden 

Yeah, I just want to emphasize that the CDC also from a travel standpoint, has also issued guidance now for people traveling. And this is outside of the US, although I think we’ll see an interstate at this point, although it seems to have just spread across the whole of the US but if you travel outside, the CDC guidance suggests that you should be tested before you go, you should be tested in the country when you’re there. And then when you come back, you should isolate and be tested, dude, five days afterwards. So this is going to become a fact of life and I think one of the things I predict is that we’ll see something akin to the idea of pregnancy type stick home testing that will be available and will be carried out daily. The sooner that becomes available, the better I think irrespective of the vaccination because this is all part of a combined strategy. Unfortunately, we’ve run out of time, I just want to thank everybody for joining us today. We hold these sessions every week at the same time. 4pm on a Wednesday, we try and promote people. We’re always welcoming questions, we have existing information, we’ll cover the latest details and emerging news and continue to provide distillation and actionable insights from the latest COVID News. So thanks, everybody, for joining us, Luis. Thanks for joining me today. Goodbye, everybody. Goodbye.



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