UNIDENTIFIED PERSON #1, BYLINE: This is PLANET MONEY from NPR.
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KAREN DUFFIN, HOST:
Hello and welcome to PLANET MONEY. I am Karen Duffin. And today on the show, we are going to take you inside the pandemic testing system to try to understand what are these coronavirus tests that we've all been hearing so much about. How do they work? Who even makes them? And most importantly, why is it taking so long? But first, we want to just answer the question, what is it like to take one of these tests? And to answer that, we are going to take you to a parking garage in Seattle with Jon Hamilton, who is a science reporter at NPR.
JON HAMILTON, BYLINE: You know, it's one of these multilevel concrete parking garages, the kind you see outside of most hospitals, and they had actually set up a testing station in the ground floor.
DUFFIN: A University of Washington hospital setup their own drive-through coronavirus testing. You may have heard of this by now.
UNIDENTIFIED PERSON #2: I'm going to have you pull up. And I want you...
HAMILTON: So you pull in...
UNIDENTIFIED PERSON #2: Don't get out of your car. Stay in your car at all...
HAMILTON: ...Roll down the window. Nobody ever gets out of their car. They pull up to the next place, which is in front of these three medical tents. And then the second nurse...
JEFF: My name's Jeff. I'm the employee...
HAMILTON: ...Goes up to the window...
JEFF: We're going to be doing your swabs today.
HAMILTON: ...Through the open window has people kind of lean back and make their nostrils available.
JEFF: OK, I'm just going to have you lean your head back just a little bit.
HAMILTON: Then takes a swab. This is not just a regular nasal swab; this is what is known as a nasopharyngeal swab. It's like, it goes up your nose and then, like, most of the way back to your throat.
DUFFIN: People who've had this test say that it feels like that swab is actually touching your brain.
HAMILTON: It's a little invasive (laughter).
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JEFF: OK, one down.
HAMILTON: But they take one swab from each nostril, package it up in this plastic tube.
JEFF: ...As well as COVID-19.
UNIDENTIFIED PERSON #3: OK.
JEFF: We'll get you back results as soon as possible, OK?
UNIDENTIFIED PERSON #3: OK. Sounds good.
HAMILTON: These folks had figured out a very practical and - done it very quickly, a way to test a whole bunch of people and to do it with professionals who really know what they're doing. So I took a lot of hope from that.
DUFFIN: But that is just the first step in the test. And, you know, when we say the word test, here is what that actually means. It's three things, really. There is, No. 1, equipment - things like swabs and test tubes. No. 2 - there are special chemicals that, like, hunt for the virus. And No. 3 - there is a machine that you actually run the test on. And to know whether or not someone has the virus, all of those three things have to work together.
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DUFFIN: Today on the show, we are going to introduce you to the people who tried to make this test, who can help us understand why the test took so long to get to all of our local garages.
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DUFFIN: You've probably heard of the CDC, the FDA, the National Security Council. These are all government organizations that get activated in a public health emergency. But there's also a group that you may not have heard of that are, like, first responders for outbreaks like this - public health labs. While our doctors monitor me and you, public health labs monitor us, the health of the collective that we are all now so much more aware of.
KELLY WROBLEWSKI: We always say that sort of clinical and commercial laboratories do testing to inform the care of patients, where public health laboratories do testing to inform the care of population.
DUFFIN: Kelly Wroblewski is the director of infectious disease programs at the Association of Public Health Laboratories, or APHL. Firefighters have hoses, EMTs have tourniquets, and public health labs have tests so they can test the population and know how to treat it. Every state has at least one public health lab; some cities do, too.
These labs are like public health threat detectives. They're constantly scanning every corner for biological and chemical threats. Remember when E. coli was spreading in lettuce? Public health labs tested lettuce to help inform the recall. They also monitor for STD outbreaks and influenza outbreaks, in part so they can do things like help develop the yearly flu vaccines. Most days, Kelly's job is a lot like most of our jobs.
WROBLEWSKI: Yeah. So I certainly send a lot of emails. We're on a lot of conference calls. But, I mean, it is a pretty steady kind of job.
DUFFIN: That all changed last December. On December 31, New Year's Eve, a health official in China contacted the World Health Organization to say, hey, we have spotted a new strain of virus here, and we think that this one might be very bad. Before most of us knew the word coronavirus, back when we were obliviously going to concerts, innocently riding subways, hugging with abandon, Kelly was worried. That's what public health labs do; they worry in advance.
But for 11 days, there wasn't a whole lot that anyone could do because to make a test to detect this virus, you have to know exactly what the virus looks like. You have to have access to the virus. But at that point, the virus had only been spotted in China, so the world had to wait while China mapped the genome.
WROBLEWSKI: That's basically the genetic fingerprint of the virus.
DUFFIN: Finally, on January 11, China posted that genetic fingerprint, and the race to create a test began in earnest around the world so that everyone else could find out, has this virus crossed the border into our country, too? Germany created a test within days. The World Health Organization picked up that test and started distributing that one. And the United States created its own test.
WROBLEWSKI: CDC scientists start to develop a test based on the sequence. So you sort of reverse engineer and then develop an assay from there.
DUFFIN: An assay - A-S-S-A-Y. Assays are essentially chemicals that cling only to one specific virus - if the test works right, that is. And this particular new virus lives in RNA strands. So this assay wanders through a person's RNA looking for a match, and if the assay does meet its viral match, it clings to it and, like, waves at the scientist, like, hey, I found it; that virus, it's here.
WROBLEWSKI: Using that information, scientists at CDC and around the world were able to develop tests to detect the virus.
DUFFIN: And it's at this point, now that the CDC has developed the chemicals for this test, that Kelly's team, this network of public health labs, really starts to suit up. What needs to happen next is that the CDC's assay, those coronavirus-hunting chemicals, get sent to the public health labs so those labs can, like, test drive the test, make sure that the test works, so that then tests can be widely used on actual patients. Kelly set up an emergency operations center to help coordinate the work of public health labs across America.
The CDC detected the first case of the virus in the United States on January 18. And so, you know, at that point, Kelly's labs are like, cool, send us the test. A week passes, then 10 days passed, and you have these public health labs around the country waiting - I can imagine refreshing the FedEx website because in those 10 days, as they waited, the only way to makeshift test the increasing number of patients around the country was to take a swab, like they did in that parking garage in Seattle, and mail that swab to the CDC in Atlanta. In those 10 days, only the CDC could conduct tests.
But while the labs are waiting for the test, Kelly is starting to work the phones.
WROBLEWSKI: Normally, what would happen is the - we would start to have phone calls at the laboratories.
DUFFIN: Like, the test is coming; are you ready? Because the CDC provides the chemicals, but this is a BYO equipment kind of situation. The labs have to have equipment to run the test. So she's calling labs and running down the supply list.
WROBLEWSKI: Make sure they have the extraction platform.
DUFFIN: Do you have the right swabs?
WROBLEWSKI: There's the different chemicals that they need.
DUFFIN: Test tubes, information systems. Like, are you stocked? Because a tidal wave is coming.
WROBLEWSKI: And so while CDC is working on developing the test, the public health labs are preparing all of those things in the background.
DUFFIN: Finally, on January 28, the CDC publishes the protocol for their test, which is essentially a recipe. Like, you need our CDC assay, those chemicals, and this kind of equipment to make the test work. So yay - America finally has a test. But before it can be actually used on the many patients who are now clamoring for this test, the FDA first has to sign off on it. And, you know, that's what the FDA does every day; they approve all medicine and medical equipment to verify it does what it says it does. Even the CDC has to get approval from the FDA.
And FDA approval often takes months, if not years. And that slowness is by design. The public health system was created to stop people from just, like, willy-nilly making medicine that might actually kill you instead of heal you or, like, marketing cocaine as a great diet supplement. The public health system is designed to check and triple-check.
But in a crisis, we don't need perfection. We don't just need quality; we also need speed. So in an emergency like this, the FDA does have a route to fast-track their approvals. It's a special bureaucratic magic wand called an emergency use authorization, and they use that here. A week after the CDC submits its test for approval, the FDA waves that wand and clears the test for use with patients.
And then one more thing has to happen to get this test in shape for patients - the labs have to test drive the test to make sure that the CDC's recipe works in their specific state and local labs, on their equipment. So the public health labs get the CDC test, and their work begins.
WROBLEWSKI: So very shortly, the day after the tests started to be delivered, we at APHL and CDC started to receive calls and emails from a few laboratories that had come in on a Saturday and - just not everything was where it should be.
DUFFIN: The test that they had been waiting for, once they finally get it, they realize that it's not working the way that it's supposed to be - in some of the labs, at least, not all of them, but a lot of them.
WROBLEWSKI: We sort of continue to monitor the situation through the weekend. By early in the week, it becomes clear that this isn't a problem in a single laboratory. So it is probably a problem with the test.
DUFFIN: And is this normal? Does this happen or is this unusual?
WROBLEWSKI: It's not usual, but it does happen. And it was just very unfortunate timing that it happened as we were preparing for, you know, the coronavirus to come to the U.S.
DUFFIN: The United States was already several weeks behind other countries in testing. Now, with this glitchy test, it will be even more time before testing can start in full.
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DUFFIN: So it's mid-February, and the public health labs are waiting for the CDC to send their new test. Remember, Germany's test was done within days. The CDC's first test, the glitchy one, that one took a week. But as the labs are waiting for this second test, the new test, a week passes, 10 days pass - still no test.
What's the time between decision to remake it and then they get back out to the public health labs?
WROBLEWSKI: Yeah. It was about two weeks - 2 1/2 weeks before the labs were able to have a new test.
DUFFIN: Within 2 1/2 weeks, the test does finally show up. But in that gap, the public health labs have been doing some contingency planning. With the virus spreading, they don't want to wait because, you know, speed matters in a pandemic. And at this point, only public health labs were allowed to run tests. But, of course, there are a lot more labs in this country. There are also private health labs, labs that are built to scale to do testing en masse.
But at that point, private labs were being kept on the sidelines. The FDA had not yet given private labs emergency waivers to start testing, which left the public health labs to test at a scale that they had never faced before, all alone and at that point still without a working test. So the labs decided to do something that, in their history, they have never done before. Kelly sends a letter to the FDA.
WROBLEWSKI: That basically asked, during this emergency situation, due to the issues with the kit, can public health laboratories go forward and perform their tests?
DUFFIN: Dear FDA, please, please let us make our own tests. Frankly, some of the public health labs had already gone rogue. They'd already started doing their own tests sort of under the radar. And this is something we have all seen lately. As the federal agencies that we normally look to in a moment like this are grappling with this unprecedented situation and not all operating in the way that we need them to, people on the ground are improvising. And it's not just for the reasons that we're all familiar with now, like patients needing tests.
Like, you feel sick, you want a test. Your grandma feels sick, you want her to have a test. For the public health labs, they also want to test populations, like, zoom out and scan the country and see the trends in how this thing is spreading, data that helps public officials as they start to make these huge decisions that we've watched them make over the past week or so.
Population-wide testing helps public officials prescribe more surgical solutions. Like, maybe they don't have to lock down an entire city, but instead maybe just shut down one hotel or just one school - interventions that could still help slow the virus but with less disruption. But on Feb 26, the first case shows up that no one can trace its origins. Nobody knows where it came from, which means the virus has taken root in America. Shortly after this, the FDA shifts gears.
WROBLEWSKI: They issued this new guidance.
DUFFIN: The FDA says certain labs - more advanced labs, the ones that can do more complex science - those public health labs can start developing their own tests. They just have to apply for FDA approval within two weeks.
And this is new for public health labs. You guys have not done this before?
WROBLEWSKI: Yeah. It's new.
DUFFIN: Were people - is that exciting, or is that just frustrating, like, we shouldn't have to do this, or how...
WROBLEWSKI: Well, I think it's exciting. And I think the - ultimately, having more testing available is a new thing. But how is our system going to ensure the quality of the testing and sort of adapt to this new process sort of while we're in the middle of an emergency?
DUFFIN: But at this point, it feels like a risk worth taking. So public health labs begin to ramp up - way up.
WROBLEWSKI: So in those labs, they are working, really, around the clock. They're hiring new staff, and they're really taking some heroic measures to just make sure they get as much testing done as possible.
DUFFIN: But as the labs are toiling away, Kelly says they're also thinking, you know what? We could use some help here.
WROBLEWSKI: And CDC is not a commercial manufacturer, right? They're a...
DUFFIN: Right, right.
WROBLEWSKI: ...Government agency. So I think right now what we're eagerly awaiting is for the large-scale commercial diagnostic manufacturers, for those people that make your cholesterol tests and your flu tests - we would expect them to have testing - tests available to sell to laboratories in hospitals and commercial laboratories.
DUFFIN: And as I've spoken with public health leaders, several of them have told me that bringing in the private sector more and faster probably would have really helped.
Do you know why it took them so long to do that?
WROBLEWSKI: I don't.
DUFFIN: OK. Well, I am talking to them this afternoon. I will ask.
WROBLEWSKI: Great (laughter).
DUFFIN: The FDA was not able to get on the phone that day, understandably. They have a lot going on right now. But in just the last few days, the FDA did finally give some private businesses their first emergency waiver. And to be fair, you know, some of those companies were not even ready to apply for an emergency use authorization until late February, and once they did apply, some of them told me that the FDA granted the authorization within days, not the many months this kind of thing can usually take. But these first emergency waivers for private companies, they were issued just last Friday, March 13 - two weeks after the public health labs had started making their own tests. So not until two and a half months after the virus was first spotted did the capitalism capital of the world let the private sector do what they do best - make stuff for the masses.
And for comparison, the United States and South Korea each detected the virus on the same day in January, but South Korea allowed private health care companies to start making tests by the end of January. And as of this recording, South Korea has now tested close to 300,000 people. The United States has tested close to 80,000. But private companies here in America are now ramping up and making tests - lots of them.
JOHN GERACE: I mean, we have a 100,000-square-foot manufacturing facility here in Southern California, and that's all we do - is, you know, develop and manufacture molecular diagnostic kits.
DUFFIN: That is John Gerace. He's the president of DiaSorin Molecular. He's based in Southern California, but it is an Italian company, so they are painfully aware of how this can spread. And DiaSorin and had been ready to help, actually, for a long time before they got the go-ahead.
GERACE: Our R & D scientists in Italy, they had design and assay right - you know, very, very shortly after the outbreak was announced.
DUFFIN: Assay - remember the chemical part of the test?
GERACE: We are ramping up very quickly. We're implementing multiple shifts, and we plan to have, you know, full - we're ramping up to full production to where, you know, we can satisfy the demands, particularly in the U.S. and in Italy.
DUFFIN: And in the past week, the FDA has allowed several other private companies to start helping out with the tests. And actually, in just the last day or so, as we were finalizing this episode, President Trump announced that he will introduce new policies that will relax the FDA approval process even more. And this is the thing about crises. When the world turns into a place that you no longer recognize, all of those rules and big ideals spelled out so meticulously when times were good will probably have to change.
I see - because it's just so widespread. It has to just, like - you have to let go a little bit, it sounds like. Everyone in this situation has had to let go a little bit.
WROBLEWSKI: Yeah. Everybody has had to let go. That's a great way to describe it.
DUFFIN: Seems necessary but a little scary, especially in the moment of crisis.
WROBLEWSKI: Yes.
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DUFFIN: Please feel free to reach out. We want to hear how you're doing, what questions you have that we can help answer for you. You can email us - planetmoney@npr.org - or you can always find us on Facebook, Twitter or Instagram. We're @PlanetMoney. Our show today was produced by Darian Woods and Nick Fountain. Our supervising producer is Alex Goldmark. Bryant Urstadt edits the show. Special thanks to Daniel Olson, Irene Song, Daniel Wang and Luciana Borio. We really, really hope you're all staying safe, healthy and sane out there. I'm Karen Duffin. This is NPR. Thanks for listening.
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