Weird Medicine: The Podcast - EXTRA: Covid-19 Quick Test to Be Released Soon

Episode Date: March 20, 2020

Jonathan Cohen and Ron Baker from coronachecktest.com discuss the mass rollout of a new quickest for SARS-CoV-2 antibodies that can be done in 10 minutes in the field. Learn more about your ad choices. Visit podcastchoices.com/adchoices

It's weird medicine, the first and still only uncensored medical show and broadcast history and a podcast on Dr. Steve, and this is a special urgent broadcast regarding an anticipated breakthrough in COVID-19 testing. Here's my interview with the folks at 2020 BioResponse. You're listening to Weird Medicine. On the phone, we have Ron. Baker and Jonathan Cohen from 2020 Bio Response, accompanied as soon as to release a COVID-19 antibody quick test for field use. Jonathan is founder and CEO and Ron is National Sales Director. Thank you, gentlemen, for being on the show.

Good to be with you. So people are appropriately concerned about this virus, and one of the major issues has been lack of testing for SARS-COV-2, the virus that causes COVID-19. So your announcement that you were coming out with this test came somewhat as a relief to put it mildly. Tell us something about this test. Sure. So this test, which was developed in China during the height of the incidents in that country, of course, that's the epicenter of the current pandemic,

is basically configured not unlike a home pregnancy test. So this is a technology. It's a very mature technology. known as lateral flow membrane. And it uses antibodies, part of the body's immune system, to detect other antibodies in the blood, namely two of them call it one IGG and one IGM, which are known to be elevated following exposure to the coronavirus. Right. So just for our audience, IGM are antibodies that are developed early in disease. and then IGG are these so-called protective antibodies that develop later.

So I'm assuming with this, since you're testing for both IGG and IGM, that you get separate results for those so that you could tell someone that maybe had a recent or current infection from someone that had a resolved infection. Is that accurate? Yes, yes, that's correct. So we actually right now have agreements with three different suppliers from China. two of the three present the results with in one case it's two bands on the same strip and in the other case there are actually two strips there are some you know some

some would argue that having two separate strips is a better way to go but yes you can see each strip or the value of each the level of each antibody separate and what's the testing procedure. Is this a complicated test for clinicians to do? It actually couldn't be easier. It's a finger stick. The individual is asked to touch a pad at the bottom of the strip. A few drops of buffer are added to dilute the sample and permit wicking. And then in a few minutes you see the control. Hopefully you see there's one stripe, which is the control, that shows that there's no defects in that particular product.

And if there's another strike light that lights up, then that is concern, and there would be some need for some follow-up testing in that case. Okay, very good. Yeah, I'm looking at a picture of the test. It looks just like a urine pregnancy test or a rapid strip screen. Right. So do you have any feeling? it can be done in less than 10 minutes.

Yeah, that's incredible. Do you have any sense for how long it takes for people to develop the IGM antibodies? In other words, once someone's been exposed, how long before your test turns positive? Yeah, I want to point out, we did not develop these tests. Our role is really to source them from the relief. I believe to be the best sources in China. There are many companies, I will point out, to your listeners, that there's a lot of companies, especially in China,

but perhaps outside of China, that are now marketing of very similar products, if not identical. So we, based on decades of experience of our management team in diagnostics, have worked very hard over the past week to source what we believe to be the most reliable manufacturers with the business. best data. And we're going to be implementing our own quality control program as well, both in China and in the United States. We rely on the data from both of the manufacturers, as well as in the general literature. But to answer your question, most of the reports suggest that the

IGM is elevated about four to seven days after initial infection. Okay. So one question I had about this. Okay, so now this thing rolls out on a major scale in the United States. When people have, let's say, a positive IGM test or even an IGG test with this, what's the protocol for follow-up? I'm assuming this qualifies more as a screening test, so we would always want to do something more specific afterward. Or is that true? And then would these things be, these results be reported to some database on the federal government or the WHO to add to the number of positive cases in the United States? Those are excellent questions.

So we're not, you know, we just received a green light from the FDA on Monday, late Monday night with some guidance. They assessed this type of test and believed it to be, based on the low complexity of it, They felt that at least to medical professionals, we were given the green light. So we're not able to recommend a protocol. Those may, you may see, however, other organizations from either the U.S. government or possibly the WHO may recommend particular next steps. But in general, obviously, more information, more accurate information is a good thing, and people can take the steps that they believe they need to take to protect themselves and their families and those around them. Absolutely.

So the U.S. increased its case count by 3,551 cases yesterday. I just checked the WHO sit rep. How much of that is due to increased testing, do you think, rather than necessarily increase in? viral load in the community? Or do you have a feeling for that? Well, for one thing, for one thing, we know that there was a shortage of available test to begin with. So I think the more testing that, the more test options that become available, the more tests, the more reported cases you'll see.

Yeah, I think so too. Let's talk a little bit about the accuracy. What's the sensitivity and specificity of this test? My audience is pretty sophisticated, but we'll go over what those mean. Sure, sure. So, yeah, once again, as reported by the manufacturers, they range at the top level of the sensitivity of 98%. Most of them are reporting those sensitivities to the lowest I've seen is 88% in one case.

So those are good numbers. Just by reference, I was on an industry. only yesterday of leading academic groups and industry groups that are involved in this emergency, and apparently the sensitivity of the swab test, which are the gold standard, the molecular test or PCR test, is only 80%. Oh, my goodness. Probably due to the fact that a lot of the virus, the virus, which mainly infects the lung, may or may not always present in the nasal passageway.

So again, I haven't seen any publications on that, but if true, in any case, it appears at the blood test, blood, you know, being circulatory in nature, may end up identifying disease that could be missed by the swab. And there is a manuscript accepted for publication by a group of leading respiratory professionals in China, including Wuhan, the epicenter, and we're happy to sense that to you. Steve, that suggests that this type of testing approach is optimal because of false negatives inherent with swab testing. Sure. Nasal swab testing. So let me explain what a sensitivity of 98% means. That means that only 2% of people who have the disease would be negative in that sense

or who have antibodies on. It depends on what if they're looking at sensitivity based on. disease or just presence of antibodies, and those two things, you know, could be slightly different, but in general, that means this is a highly, highly sensitive test. And then the specificity on your website is listed as 92 percent, 91 point something percent, which means that only 8 percent of positive individuals will test negative. So, so I, yeah, go ahead. Yeah, that was just, and the realistic thing is that John had mentioned that the swab tests, the PCR-based technologies, you know, being the gold standard, but there is, there's an absolute backup with patients who have been, who have been tested and are awaiting results.

And this is national. Yes. Talk to many people, both on the laboratories, in laboratories, but the State Department of Health, County Department. Department of Health, who all say the same thing that people are now waiting three, four, five days for the results. And that's causing a lot of concern, which makes, you know, tests like we're offering these kits makes it really a godsent to help alleviate this crunch. Yeah, I think this will be very useful in clinical practice and is really, it's a great relief that you all have been able to source this to the United States. When is it going to be released? How many units will you have?

What are we looking at in the near future? Sure. So this is a situation that's literally changing by the hour. since we issued a press release only on Wednesday, just barely, not even 48 hours ago, we've had constant demand, and we have a website, if I may. Absolutely. Corona check. Corona checktest.com, one word, Corona checktest.com.

Where we are taking orders and reservations right now from medical professionals in order for us to sell direct-to-consumer for home use would require an emergency authorization, emergency use authorization from the FDA. We do intend to pursue that in due course. I can't say when. But for now, it's being made available to medical professionals. And we've seen tremendous demand not only off of the portal or the website, but from states. Several states are seeking large amounts. So we're working literally around the clock. We expect the first large shipment to be here about seven days from now. And then hopefully after that, we'll have a more regular supply of that.

So we do not have inventory today, but it is on its way. And we should be able to hopefully be starting to fill some of these orders by this time next week. But we can't guarantee that. Okay. Well, thank you both so much. Do you have anything else to add? No, but thanks for the opportunity for us to speak on it. Yes, thank you both very much. We were talking to Ron Baker and Jonathan Cohen from 2020 BioResponse, a company that's soon to release a COVID-19 antibody quick test for field use. Check out 2020 Biorespons' website at Coronachecktest.com.

Thank you both for being with us today. Thank you. Thank you. All right.