Where Are All the Tests?

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S1: About 10 days ago, I woke up with a headache and a cough. I was weak and my chest felt tight, like I couldn’t quite get a full breath.

S2: I took my temperature and it was ninety nine point five. Not quite a fever, but higher than normal and wondered, of course, if I had covered 19. For a little background here, I’m six months pregnant and I also have an autoimmune disease.

S3: So while I’m not as high risk as some people, seniors, people with more serious pre-existing conditions, I am at a higher risk than most people. The day before I’d been at my obstetrician’s office, I didn’t feel sick then, but I was worried that maybe I’d exposed her and her staff when I talked to her on the phone. She wanted me to get tested, but it was impossible in her hospital system.

S4: So I called my internist. All of this, I should note, was before New York tightened its guidance to only test hospitalized patients. So given my risk factors, my internist asked me to come in right away when I got there. I was ushered into a side entrance, wearing a mask and sent straight into a back room that they were disinfecting every hour.

S2: My doctor wore a mask, gloves, eye protection and a gown as he swabbed my nose for both flu and covered 19. They really stick that swab up there. By the way. My test was sent off to a big commercial lab run by quest-, and then I waited.

S5: That same week, I had a family member in their 70s get sick first they got a drive thru test in Maryland.

S2: Then they ended up in the hospital in Washington, D.C. and got another one. Both of their tests came back thankfully negative in 18 hours. My test, on the other hand, took seven days. I’m negative. It tested positive for flu and I’m OK. But since then, I haven’t been able to stop thinking about why we had such different testing experiences and why so many people are having trouble getting tested in the first place. And as time goes by and more people get sick, many more people are going to have questions about testing, not just about why their own test is taking so longer, why their loved ones can’t get tested, but about why the entire testing system is so fragmented and inconsistent in the first place.

S4: So I called up Robert Baird.

S6: You know, you miserliness to Robert since it’s on my byline. Everyone calls me Bobby. But if people want to look.

S4: Actually, we did a video conference where we both tried to escape the sounds of children and spouses and dogs.

S6: My dog is gnawing in the background, but, you know, he’ll be content until he decides he wants go outside. He might get me a bath, but we’re good for now.

S3: Robert has spent the last few months reporting and writing about covert testing for The New Yorker. So today on the show, he’s going to explain why testing for the novel coronavirus has been such a complicated mess in America and why that’s not likely to change anytime soon.

S5: 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. Stay with us.

S1: To understand the state of Cauvin testing now and why it’s so complicated, we have to go back to the beginning of the year to January, the very beginning, things seem to be working OK.

S6: On January 10th, a group of Chinese scientists posted the RNA genome to a Web site, and that allowed scientists around the world to start building out these diagnostic tests. And they did. A team in Germany was able to get a test up and running very quickly. They’re able to publish it within less than two weeks. The CDC had its own tests working in about the same time. So end of January, things are looking good. We’ve got working tests. We have more than one working test. But what happens is then in this country, we shift into the second phase, which is where we’re going to start sending test kits out to these public health laboratories. These are the state labs. These are the large local labs like New York City’s, a few county labs. The CDC puts together the test kits, as they always do. They send these out to labs around the country when the labs receive these test kits. The first thing they do is a process called verification. And this is simply they run the test against some known samples to make sure the test works the same way that it worked in Georgia.

S1: Georgia is where the CDC is. By the way, and what state and local labs found when they ran these tests is that they weren’t working. So they started looking for ways to create and deploy tests themselves. But there was a catch.

S7: I have today declared that the Corona virus presents a public health emergency in the United States.

S3: Alex Azar, the secretary of health and Human Services, had declared a public health emergency.

S7: The United States government will implement temporary measures to increase our abilities to detect and contain the Corona virus proactively and aggressively.

S1: That meant all tests had to get FDA approval. What’s called an emergency use authorization or U.A.. And the only tests with that a Yueh were the CDC ones that didn’t work.

S6: The reason for this policy, as someone explained to me, is when you get into a crisis in an emergency situation, you don’t want people all over the country saying, hey, I’ve got a test. You should use mine. Hey, you’ve got one. I got mine. And the first airway that’s granted is granted by the FDA to the CDC on February 4th. So from February 4th on, the only test for kohver 19 is the CDC test.

S8: One of the big problems that we have is that nothing else came on line until February 26 to ameliorate that problem. So from February 4th until February 26, the only test people can use is the CDC test.

S9: And that test is not working. Wow.

S10: So what were the consequences of this period of time in February?

S8: The consequences are what we’re seeing now. We just have massive prevalence in New York City and certainly in Washington state. And I think we’re going to see it in other places soon.

S3: By now, the federal government knew that they had fallen way behind on testing.

S1: So in February, they started making changes. The CDC pinpointed the issue with their original test kits as a problem with one of the reagents chemical needed in the testing process. So they instructed public health labs around the country to discard it. That worked for some labs, but not all of them.

S6: It did not work for New York State, New York City. They were having problems, two of the reagents. So they still were not able to test. But very quickly, New York State put together an EPA application and within 24 hours, the FDA approved it. So now New York state is up and running. Right. Another thing the FDA said was they said, OK, New York State, you are very good at regulating other laboratories in New York State. Has its whole infrastructure in place to supervise labs within the state. If you want to authorize other labs in the state run tests. We’re going to outsource that to you and you can do it. So that also helped because it meant that New York state can now say, OK, we know this lab in New Rochelle or we know this lab in Brooklyn or whatever, we can get them up and running as well. After they made that authorization to New York State to regulate other labs, there was a presidential memorandum that Trump signed on March 13th where he basically said, we want to do this for all the other states as well. We want to let public health labs in every state regulate the labs in their own jurisdictions. Essentially, the problem here is that most states are not set up the way that New York is. New York State’s laboratories called Wadsworth Laboratory. It’s recognized as a world renowned institution. Someone described it to me as like a combination between the CDC, the NIH and the FDA. They do this stuff all the time. Most other states don’t have that. And so I spoke to a number of lab directors who said this news that the presidential memorandum came into their e-mail inboxes and some of them thought it was a hoax.

S8: Really? Yeah. The FDA sent out an infographic to the state directors and it said something like states are now in charge of testing. And these lab directors said, wait, what?

S9: You’ve got to be kidding me. There’s no way.

S10: Is the federal government passing the buck?

S3: Or are they making it so that states can be more nimble in a time of crisis?

S8: I think it depends on who you are. I mean, I think they’re doing both right. FDA very much said, look, we’re just trying to be nimble. We’re trying to be flexible. The states don’t have to do this if they don’t want to. It’s completely up to them. Lab directors, of course, see a little bit differently. And one of them said she felt like this is the FDA essentially throwing in the towel and saying it’s up to you guys to take care of this.

S3: Even with the changed regulatory landscape, that doesn’t solve the other underlying issue, which is that the shortage of components and supplies for testing, though, right?

S6: That’s right. The initial roadblocks were these faulty tests from the CDC. The kind of second set of roadblocks for regulatory. How do you fill in the gap left by the faulty CDC tests? But now we’re recognizing it as we’re trying to test at scale. We just have these massive supply chain shortages of components needed for the tests.

S1: I want to back up and go through some basics here. On a really fundamental level. We refer to the test. A test? What is this thing?

S6: Okay. So there’s a very good question. The test is basically a way to figure out if somebody has Corona virus in their blood. Right. And what we’re trying to do is we’re trying to figure out if we can detect pieces of viral RNA. And it’s essentially a recipe. There’s all these different components of this test you’re putting together. And one of the lab that director said, imagine that you’re baking cookies and you have enough supplies for a couple of dozen cookies. And then one day somebody says, hey, we’re having a party. Tomorrow, we need 500 cookies. So you look in your pantry, you might say, OK, I got enough flour, I got enough sugar, I don’t have enough eggs. You so send somebody out to go get some eggs. Great. Now you have eggs. You start baking cookies. But now all of a sudden you’re out of sugar. Right. So then you go get some more sugar. But now we’re out of flour. Now we’re out of chocolate chips. That’s the problem they’re running into. It’s not one particular item that constitutes the test. It’s all of these different pieces. And of course, everybody needs them at once. Not just in New York State. Not just in the United States, but around the world. So everybody’s kind of fighting for these same components.

S4: We’ve heard a lot and they’ve been a lot of news stories about the shortages in hospital equipment, ventilators and and also personal protective equipment for health care workers. I don’t feel like we have heard as much about the shortage of testing supplies. Is that just because it’s harder to understand or is there a reason behind that?

S11: I think it’s partly because it’s still new. You know, I think once we got through this initial hurdle of the test kits and the test kit sort of debacle, the word from the president on down was like, OK, we’ve got this solved. We’ve got it going. Let’s get it rolling. And, you know, in speaking to people for the last four or five days, they said, no, we had this whole other wave of issues that we have to deal with.

S3: To understand this new wave of testing issues. It’s helpful to look at New York. While the state is currently running more than a quarter of the tests being done nationwide, its labs are being pushed to the limit. Robert told me a story about New York City’s public health lab that shows just how desperate the situation is after the CDC fixed its problem and sent out new kits. Demand at the city’s lab was so high that it was on the verge of running out after only nine days.

S6: So the day before they were going to run out, they got to the last two of something called an extraction kit. An extraction kit is basically the part of the test that allows them to draw the viral RNA out of the sample. So, you know, you basically stick this swab up on your nose, take it to the lab, and then they have to run this process to get the viral RNA out of that specimen. The CDC uses a certain kind of extraction kit. And nine days after the lab first started testing the lab down to its last two of these extraction kits. And just by chance, the New York state lab in Albany had started setting up a different protocol, a different testing protocol, and it allowed them to use a different sort of extraction kit. And so they sent up a car up to Albany. They picked up the new extraction kit that they needed. They brought it back in. The next morning, the New York City lab opened its last extraction kit and started using that. And then as soon as they ran out of it, they were able to switch over to the el-Banna test.

S1: Is New York’s lab an outlier or is this happening across the country?

S6: Now, this is happening all over the country. It’s happening in big states and small states, in red states and blue states in 10 states, in very sparsely populated states. And sort of frighteningly, it’s also happening at the commercial laboratories. So, you know, it’s one thing to say, OK, well, the public health labs are running out of supplies. They don’t have enough reagents. A big shortage of these swabs that you actually use to collect the specimens. But I spoke to the president of the organization that represents a lot of the big commercial labs. And she said that they’re seeing these shortages as well. So they’ve been a huge part of helping us to ramp up our testing capacity in this country. But they are also facing these drastic shortages.

S4: I was struck when I talked to my own doctor about what was happening. He said he had sent samples from two family members to the same commercial lab and they would come back at wildly different times based purely on lab backup.

S6: Yeah. And you know what? One of the messages that the president of that organization, the trade organization for these big labs said is we need help prioritizing lab samples. We need the CDC or someone to tell us what should we do? Because from their perspective, they just get in samples every day. They just come in the front door. You know, they have a number barcode attached to them, whatever it is. And they run the tests and they said, we want to help hospitals. We want to help doctors prioritize who really needs these tests. But we need somebody to do that for us. We can’t be the organization responsible for that because we just don’t have that information.

S4: There’s also this weird relationship between the shortage of testing kits and the shortage of other equipment to hack. How does the kind of desire to test and and the influx of demand for testing strain the supply of other medical equipment?

S11: That’s a great question. Yeah. So this is one of the big reasons why New York City, for instance, is encouraging, in fact, urging people not to just go into their doctor’s office to seek out a test if you are sick and even if you’re not sick when you go in to get tested for Kove at 19, your nurse or your doctor is going to have to wear personal protective equipment to see you. You have to wear a mask. They may have to wear a face shield, other things like that. Once they do that, that’s one mask or one face shield that they won’t be able to use down the road. The shortage of personal protective equipment are even more dire than the shortages of tests. At this point. And so if doctors and nurses and other health care workers are using this PPE when they’re seeing people who are relatively well. And I stress relatively because this is a nasty disease. I mean, people who have it, the people who are called mild or moderate are really quite sick. But people who are mild and moderate, going to their doctor requires then the doctor or the nurse to use this PPE. And these are there are critical shortages of that as well.

S4: We’ve also heard some noise about mail testing. It was something Deborah Bourke’s from the president’s task force talked about in one of the White House press conferences. Where does that stand?

S6: Last week, a number of companies announced that they were going to do at home testing kits for Koven, 19. So you would get a swab, stick it up your nose. You put it in the viral transport media, you send it to the lab, they process it at one of the labs. It’s been approved by the FDA. So, Dr. Brooks, as you mentioned the other night, said that self swabbing would soon be an option. She said that on Monday night at the press conference. On Tuesday, I got in touch with the FDA just to see what was gonna come of that. And they pointed me back to their guidance that said that this was still not allowed.

S1: I think if you’re a listener listening to this, it’s hard to wrap your head around commercial labs, state health labs, potential startups that might at some point work. How should we be thinking about this giant constellation of potential testing facilities?

S12: So one way to think about it is to imagine the epidemiological curve that we all now see, you know, every 15 minutes of what it looks like when a infection spreads. The idea is essentially in the past has been that our testing capacity would scale with the disease. Right. So you’re kind of keeping pace with it in the earliest days. There’s really not a lot of disease. And if you look at those epidemiological curves, they stay flat for quite a while. It takes a while for them to really get to the steep part in those early flat days of the curve. You can rely on the CDC, you can rely on the public health labs because there’s not a huge disease burden. Once the disease starts to take off, however, you really need these larger scale facilities to come online. And that’s where we are right now. And in fact, the disease has just beaten us. And as one person told me who used to work at the FDA, he said, once you get behind the eight ball on this, you’re kind of lost. It’s hard to catch up because the math on these exponential curves is just relentless.

S1: This leads me to thinking about this moment in time and without being too catastrophic in my phrasing, I guess the idea of whether it’s too late. We discussed what the role of testing could have been a month ago, two months ago versus I guess, what it is now. And can you kind of pass the difference for me? And the stakes of trying to do this correctly right now.

S12: So, you know, one of the lab directors I spoke to said that testing doesn’t help you a lot when you’re at or near the peak of an epidemic. There’s just too many people. And that’s why for New York City, they’re saying we’re not going to test anybody who is not an inpatient. It’s just not going to help us. We need to focus and prioritize on the people who need it most. And for those people, it really does matter. We need to preserve testing capacity for those people. Where testing helps you is two phases of the epidemic. It helps you at the beginning if you can keep up with it, if you can do contact tracing. You can slow it down. You can use isolation and quarantine. But it also will help us at the end. So once we get past the peak of the epidemic here in New York, as we start to think about going back to work, as we start to think about, OK, how can we ease some of these massive and massively invasive restrictions that we’re under now testing is going to play a huge role in that because we’ve got to figure out, OK, for. So are you healthy enough to go back to work? Are you staying healthy? Let’s say that we get to a point where New York City is fairly free of the disease. We’re gonna have to monitor people who come to the city. Right. So this is something that you’re seeing now in Taiwan and South Korea and Hong Kong, some of these places that were able to control the outbreaks. They have to keep a very close watch that it’s not going to now pick up. It’s not like you get through one one cycle and you’re done. Anybody who lands of your airport could be a new vector for the disease. Right. Anybody who walks across the border could be a new vector for the disease. And so you have to be ready to scale that up at a moment’s notice.

S6: Because a new outbreak takes off. You want to jump on that and get the contact tracing going. Get the isolation going. Get the quarantines going.

S4: The president has obviously talked about trying to. Open the economy sooner than many epidemiologists have recommended. It sounds like you’re saying we do not have the kind of testing infrastructure in place that would allow that to happen.

S6: We certainly don’t. And I think the other thing to say is we have not even seen the peak of this epidemic in New York City, let alone the rest of the country, let alone the rest of the country.

S13: I mean, if you look at the numbers coming out of Louisiana, it’s really terrifying. It’s going up very quickly there. I think that we’re about to see a lot more hot spots start to blossom and explode than we have. And so if you get four or five, a dozen states that are in the same place as New York, you can’t talk about reopening the country. But we can start to get ready for that time so we can ramp up these manufacturing needs that we have. We can address the supply chain issues so that we are ready. When New York City says, OK, we’ve got this under control, enough, the peak has passed. Let’s start testing people. Let’s start looking at whether we can get people back to work by doing a rigorous program of testing or not.

S14: Robert Baird, thank you very much. Thanks for having me.

S15: Robert Baird is a freelance writer and editor. You can read a stories uncovered 19 testing in The New Yorker. All right. That’s our show for today. What next? TBD is produced by Ethan Brooks and hosted by me. Lizzie O’Leary. And it’s part of the larger what next family. TBD is also part of Future Tense, a partnership of Slate, Arizona State University and New America. And if you missed, what, next episode on Wednesday, go back and listen. Mary talks to Harvard’s David S. Jones about the history of pandemics. What’s different? What’s the same? This time around, Mary will be back on Monday. Thanks for listening. Talk to you next week.