Are We Getting COVID Testing All Wrong?

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S1: Hello. I just wanted to say hi to our new listeners, it is very nice to have you here. We are happy you’ve joined us. And if you like what you hear. Subscribe. Rate us. Recommend us to your friends. All of those things, they help other people find us and listen. OK, here’s the show. On Wednesday, the day I recorded the show, I was awake at four a.m. I sat in bed listening to my toddler sniffle pathetically on the baby monitor. He would sneeze and then kind of whine and rearrange himself and go back to sleep. My husband was out of town and I sat in the dark running through my options. I needed to work, which meant I needed childcare, which meant I needed to get my kid a Covid test. My baby’s 14 months old. He touches everything. So the odds were very good that it was just a cold. But we share child care with another family. And on the off chance he was positive, I couldn’t put everyone else at risk in this scenario. Whether it’s your kid, your roommate or you is exactly the kind of thing the doctor and epidemiologist Michael Mina is obsessed with.

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S2: Imagine if within moments of noticing that your toddler was had, a runny nose had some symptoms that could be Covid, you could just reach into your cupboard and in five minutes have performed a Covid test without having to get in the car, bringing him around to potentially infect other people.

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S1: I ended up bundling my kid into a stroller, going to two different urgent care, finding one that could take us and thankfully getting a negative rapid test result, one that allowed me to actually do this interview.

S2: And now just scale that idea up to the many hundreds of millions of people who are kind of going through the same thing on a daily basis.

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S1: Minow wants anyone in this situation to have a quick, easy testing option without even leaving the house.

S2: We just have thus far truly neglected to use some of the most powerful tools for for no real, particularly good reason. Just we just haven’t focused on them because we’ve had a singular focus for the most part in this country, and that’s been vaccines. But vaccines aren’t going to help you understand if your toddler has Covid and could be infecting you or other people around you.

S1: Mina, who teaches at the Harvard T.H. Chan School of Public Health, has been preaching the gospel of cheap, rapid antigen tests for 18 months. First, he was a lonely voice. Now he’s part of a growing chorus saying that we as a country are ignoring an easy tool to help us control infections.

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S2: You know, it’s just so, so hard to be in this position and recognize and see so clearly that, of course, this wave of Delta was going to happen. I mean, we were writing about it last year that that that this was almost an inevitability. And yet we didn’t prepare. And I would argue that we’re still not preparing for what’s potentially to come next year.

S1: Today on the show, Mina argues that for less than a dollar, we could break the chain of transmission. So what’s stopping us? I’m Lizzie O’Leary and you’re listening to what next? TBD a show about technology, power and how the future will be determined. Stick with us. I want to start by kind of breaking down the universe of Covid testing that exists in the U.S. right now. You can get a PCR test, which is a molecular test or a rapid antigen test. And I think the common understanding is that a PCR is slower but more accurate. Is that the correct understanding?

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S2: It’s not. And the reason is it’s because accuracy is entirely dependent on what your objective is. And the conversation has been 100 percent dominated by physicians and clinical laboratory directors who are completely focused on medical diagnostics and in the medical diagnostic. You’re not asking, how are we going to stop spread across the community? You’re asking, does my patient have any evidence that they currently have Covid or did in the recent past? Right. And so they want a test that’s going to be just like a forensics detective wants to get to detect even small molecules of of hair at a crime scene or blood at a crime scene, and they actually use PCR to do that. But if our goal is instead to identify people who currently are transmitting the virus to other people, then actually the rapid test is much more accurate. It’s very, very sensitive to detect viral loads that are infectious because that you don’t spread the virus when you have one molecule of virus in you. You spread the virus when you have a million or a billion or a trillion. And the important thing is there specific meaning they are only going to turn positive when you’re actually actively transmitting the virus. We have to ask what the goal is and if the goal is to detect infectious people, then a rapid test is actually much more accurate, not less.

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S1: Why are we so all into two PCR tests then?

S2: Primarily because of testing and especially in this country from a legal perspective, we have so devalued and under funded public health that we literally don’t have. A regulatory framework or laws to even ask the question, what is a public health test? You know, there’s no definition of a public health test. And because of that, the only lens we have in this country is a medical diagnostic test. And again, as a physician, if I have a patient, come to me and say, Doc, I don’t feel, well, sure, I want to use the most sensitive test I can get, but it’s just such a different question. Then is the patient sitting in front of me infectious? And I think the only reason we’re so infatuated with it is just the it’s a founder effect. It was the first tool that got started for Covid, and that’s really what underlies so much of the mis messaging and mismanagement of this pandemic, really.

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S1: OK, so let’s say you Michael Mina, you are like the Covid boss of everything, you’re the Covid czar. You have carte blanche. What is a day in the life look like if your kid’s got a runny nose?

S2: Covid is an information problem. This pandemic is an information problem. And by that, I mean, the only reason we quarantine, we keep people home from school. We do any of this stuff is because we don’t know if they’re infected with Covid. And so what I would say is if my kid had a runny nose today and I thought, Oh, maybe they were exposed at school yesterday or a couple of days ago, I would want to and I do. I would go and pull out a rapid test, and I happen to have lots of rapid tests at my house and I would use it. And in 15 minutes from start to finish, I would have an answer. And I would feel good about saying, OK, you have runny nose, but you know it’s OK for us to go to family dinner tonight. It’s OK for you to go to school. It is OK for you to be out in the world as far as Covid is concerned. And so it’s so simple. It’s literally 30 seconds of hands on time. Pull the test out of the cupboard and use it.

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S1: So what does it look like at scale, if you know, a school system worth of parents is using rapid tests or a workplace or a county?

S2: So one of the most simple examples of how these tests can be used at scale is this test to stay program. I’m really tired of seeing schools closed down. It’s sad, you know, kids have been out of school for so long and we quarantine whole classrooms of people when one person turns positive in the classroom. But why? We have to ask, why do we quarantine a whole classroom? We quarantine them because of the information problem, because we don’t know which of any of them got infected. So instead of quarantining a whole classroom of students for 10 days because one person was positive, you just test each of those students every day for the next seven days and each morning you test at home. And if they’re negative, they can go to school and if they’re positive, they don’t. That’s one example. Another example is if businesses want to be back in session and not worry about outbreaks, you do enough testing to monitor for any outbreaks that might be emerging. You can say, OK, we’ve seen three cases in our office building this week. So what we are going to ask you all to do is to test yourself every morning before you come to work for the next seven days. And that’s enough to completely squash the outbreak very quickly.

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S1: What Mina envisions is essentially thinking about Covid differently, focusing on infectiousness, not detection. To him, that’s the beauty of home testing. But it’s complicated when I think about the information question, right and what this might look like at scale. I wonder a couple of things like, let’s say, then I have the ability to do that. My neighbor has the ability to do that and my kid tests positive. Doesn’t me doing that at home, not give public health authorities a clear picture of what’s going on because my kid didn’t get tested at the doctor and maybe I don’t tell anyone. How do people then have an accurate sense of positivity rates and community spread?

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S2: If we’re talking about public health first and foremost, like I would, I would forgo having the data if it meant that if it meant that the outbreaks disappear, like that’s our number one goal is to not have people get infected. But these rapid tests do not have to be done without any reporting. So right now, there’s one company in the country who does this, maybe in the world. I’m not sure. And it’s Imad. Imad actually worked with the CDC to actually allow you to take a rapid test at home, but with a proctor who’s actually watching you do it over the over your phone or over your computer. So they just watch you swipe your nose. If you’re an adult, they ask you to see your IDs so that they can actually give you a real laboratory report and they report out to the public health officials in all 50 states. So Imette has become a massively important service and model for how you can take these home tests and get have your cake and eat it too. You can have a test from the comfort of your kitchen table and you can get a real lab report, which might allow your kid to go to school or you to go to work because it’s actually a verified laboratory report.

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S1: I want to look at what is going on in the U.K., where something sort of similar has has been put into place. Tell me a little bit about what the United Kingdom’s been doing,

S2: so they have generally done what I think of as like one half of what I would like to see that started in Liverpool and now it’s nationwide. They are actually enabling anyone who wants a test to get seven free tests every day if they want. So you can just call up, you can go down the road, you can ordered online, call the phone number and you’ll have seven tests delivered to your doorstep. What they’re not necessarily doing is that second piece of like, how do you really track them? They’re they’re taking the approach that, OK, maybe if you have enough people using them, we just want to give people empowerment tools to enable them to control their little slice of the pandemic.

S1: Yeah, I mean, there was a national audit in the U.K. that showed that, you know, almost 700 million tests have been sent out and the results of only about 14 percent were reported. So they seem to be missing that surveillance part of the equation. But the other thing is they’re talking about winding this thing down. There’s some fear that maybe, you know, having rapid tests be plentiful and available is actually cutting into to vaccination rates, which seems also to be a sort of complicating part of this picture.

S2: It it can be, I mean, the US at this point. I think we have to be very honest with recognizing that the vaccine is not stopping transmission. Period. You know, it’s just not. And once we’re honest about that peace, then we can start thinking critically about, okay, what are the right approaches to take? And we have to be really clear that these are two different things. One is to stop you from going to the hospital and one is to keep your workplace open so you don’t have outbreaks.

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S1: When we come back using a rapid test sounds easy, getting it approved is another story. You’re listening to what next? TBD, I’m Lizzie O’Leary and I’m talking with Harvard epidemiologist Michael Mina Mina has spent the last year and a half trying to get the U.S. to adopt widespread rapid antigen testing as a way to control Covid. But those tests have to be authorized by the Food and Drug Administration. Currently, only a handful of home antigen tests have emergency use authorization.

S2: The entire bottleneck for the United States is the authorization of the tests. We have very few tests available to us in the United States. If you go to Germany, they have almost 70 different manufacturers producing tests. That’s created market competition that’s driven costs to the actual tests down in the UK, they have partnered with companies that can scale to massive numbers in the US. We essentially have taken a very small handful of companies, none of which are scaling particularly large numbers, and that was it. So the real problem in the United States is that we have failed to authorize enough of these tests, not because the tests don’t work, but it’s simply because of how we define these tests.

S1: The FDA defines the tests as medical devices. They want rapid antigen tests to show sensitivity comparable to PCR tests. Only a handful of companies meet that requirement and could get emergency use authorization that EUA for their tests. Other companies have the technology, but not the authorization.

S2: Essentially, the FDA said, OK, well, now we have some companies, we’re going to raise the bar even more so it’s just become harder. And I talk a lot to all these companies and all of them say, we just don’t understand, you know, Michael like, can you help us? It just feels like the FDA is like changing the goalposts on us, said every time somebody said to me yesterday, it feels like The Hunger Games, where the moment you’re about to succeed, the moment you’re about to get your EUA, a new gauntlet is thrown into the picture. And that’s kind of what’s happened for almost a year now for these companies.

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S1: There’s a push and you’re one of the people who has talked about this to reclassify these tests as a public health tool and not a medical device. What would that take?

S2: So I started saying that because I’ve I’ve tried for a year to over a year to get these, to get the FDA to evaluate this differently than a medical device. It’s been essentially an immutable wall. And so what that would take is for, I think, an executive action from the president and what the executive action would state is that the tools used for public health testing during this public health emergency are designated as public health tools. And if that happens, then the FDA does not evaluate public health tools. So if the president can come out and say this and I think it’s an extraordinarily reasonable thing to say, it’s how the UK does it. It’s how many countries do it, then the the onus can move over to the CDC to evaluate these tests. So the number one thing would be as part of this process, the CDC could say, OK, as a public health agency, we are going to recognize our peer trusted public health agencies like the UK and Germany and any tests that they have had good experience with with millions and millions of the tests that they’ve done. We will automatically give a certification for our use in the United States. So overnight there are companies. Some of the largest companies in the world have told me directly that if that happened, they could start tripling the United States access to rapid tests overnight.

S1: The Biden administration recently rolled out a new Covid plan, which emphasizes more than just vaccination. It includes ramping up production of antigen tests and buying 280 million of them for community testing centers, nursing homes and jails. Plus, they’ve pushed big retailers like Wal-Mart and Kroger to offer antigen tests at cost.

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S2: They want to be very supportive of the plan because I think the most important piece of the plan as far as testing goes, is that we now have the president of the United States re upping his initial emphasis on recognizing the power of these tools. The actual number of tests that are going to be purchased is not going to make much of a difference. Two hundred and eighty million to sounds like a lot of tests, but when you have 330 million people in a country that’s less than one test per person and the benefit of testing, whether it’s PCR or rapid testing, is frequency of the test. If you’re not doing a test frequently, you have no idea if you’re asymptomatically spreading. So we’re about to see a testing crisis because of the Covid 19 action plan. The test or vaccinate, vaccinate or test part of it is going to massively drive demand for tests, right?

S1: That just pushes people toward testing.

S2: Exactly. And so we’re about to see a crisis because we don’t actually have an increased scale. He did talk about invoking the Defense Production Act, but actually, that’s not the problem. The companies that we do have is evaluated and authorized in the US are pretty much at their maximum of scaling anyway. We’re going to see a problem where where we’re going to continue having empty shelves of rapid tests. It’s going to push employers and we’re seeing it already. Schools are, you know, trying to figure out how the heck are we testing our students? Businesses have gotten so many calls from Fortune 500 companies, Fortune 20 companies, you know, trying to ask me, you know, Dr. Mina, what? What can we do? We have 8000 12000 employees who aren’t vaccinated and don’t want to be vaccinated. How do we get tests? And so it’s really going to drive the demand for testing, which is going to further deplete any rapid tests that do exist. And then it’s going to push it all to the PCR Labs and very quickly, the delays in PCR are going to go from, you know, one or two days, which I would say is already too much to stop transmission to five days again. And then you have a useless public health tool. I do think that this idea that the president can take executive action to create this as a public health designation and increase the influx of tests, the billions of tests that exist around the world to have America get to have a slice of those will will massively allow us to scale up. And if that doesn’t happen, frankly, we’ll have a crisis on our hands.

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S1: You know, the other component here is, of course, cost. Right now, if I try to go buy some rapid tests at my drugstore, I mean a they’re sold out, but but b they’re like 20 bucks. And you know what, like, I can do that a little bit. But if you’re asking families across America to be stocking their shelves with test, this adds up really quickly. Do you see any movement on the price aspect?

S2: Well, the price is coming down to market competition. At the end of the day, we are a we can either really increase market competition, which would require us to authorize more tests or certify them through the CDC. And that can drive the cost way down because these tests cost like 80 cents to make. And that’s why we’re seeing one dollar test throughout Germany because they have 60 somewhat different manufacturers authorized. The other thing that the federal government can easily do is subsidize the tests so that they’re free or a dollar for every American, you know, ideally free. And the reality is it would be such a drop in the bucket compared to the trillions that we’re spending. So people say I would be expensive, you know, two billion here, two billion there. Are we forgetting that we’ve spent 10000 billion already on this virus? So like ten thousand billion dollars, it’s you know, it’s it shouldn’t be a drop in the bucket to say, OK, we’re putting $100 billion or whatever into subsidizing this. Every American can have a free test every couple of days, so the prices should come down, in my opinion, and it should be part of these packages.

S1: You have been beating the drum for 18 months, and suddenly I feel like your name is everywhere. Do you feel different? Do you feel like you’re making some sort of progress?

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S2: I’ve been cautious, so I felt like I was making progress last summer. My name was everywhere last summer for this exact same conversation we’re having. And then we got into the fall and it didn’t make progress, but I do think we were. Last summer, we were in a position where everyone was so focused thinking that the vaccine was going to be the silver bullet. And now we have to come to grips with realizing the vaccine is not the silver bullet that the next variant might be right around the corner. Last year, I felt like it was me on a mountaintop screaming into an abyss, and people were like, Who the heck is that crazy guy? And what they’re actually talking about and what’s changing is now that people are seeing this and feeling it, they’re actually getting frustrated. Now the public is frustrated that they go to CVS and they see empty shelves. And I think that this is placing political pressure on the president and on the decision makers and on the FDA to say, how do we change the system? Something’s not right. Why are we so behind our peers? How do we get America up to speed? And I’m sick of our government and academics saying certain segments of our population are the problem. We always have to remember that the virus is the problem. The only solution we have for a public health problem like this is the public, and these are the exact kinds of tools that allow the public to feel empowered to take control of their slice. And if enough of the public does do that, then the slices add up and we’re taking care of the whole pandemic.

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S1: Michael Mina, thank you very much.

S2: Oh, absolutely.

S1: Michael Mina is an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health. And that is it for us today. TBD is produced by Ethan Brooks. We are edited by Torrey Marsh and Alison Benedict. Alicia Montgomery is the executive producer for Slate Podcasts. TBD is part of the larger What Next family? And we’re also part of Future Tense, a partnership of Slate, Arizona State University and New America. And I want to recommend you take some time to listen to Wednesday’s episode of What Next, which helps explain why thousands of Haitian migrants, many with little kids, are stuck at a U.S. border city in Texas. What next will be back next week? I’m Lizzie O’Leary, thanks for listening.