The Daily - The State of Testing

Episode Date: April 28, 2020

Across the United States, governors are weighing the difficult question of when, and how, to begin to lift lockdown restrictions. Without federal coordination, some are looking abroad to see what has worked in countries like New Zealand, Australia and South Korea, which have effectively controlled the spread of the virus. The answer? Widespread testing. Guest: Katie Thomas, a business reporter covering the health care industry for The Times. For more information on today’s episode, visit nytimes.com/thedaily. Background reading: How flawed diagnostic tests, scarce supplies and limited access to screening have hurt the United States’ ability to monitor Covid-19.Antibody tests have been hailed as a way to identify a person’s immunity to the virus and reopen the economy. But when a team of scientists worked around the clock to evaluate 14 antibody tests, only a few worked as advertised.

Everybody wants to reopen. So how do you actually do that intelligently? Well, you have to test. From The New York Times, I'm Michael Barbaro. This is The Daily. Today, as governors across the country debate when and how to reopen their economies. We are nowhere near where we need to be with testing supplies.

Yeah, look, we're nowhere near where we need to be on testing. Let's just be straight with folks. No, our testing is increasing, but it's not increasing nearly fast enough. They say that the single biggest impediment is their inability to measure and monitor infection rates in their communities. We've been fighting for testing. We need to be doing robust testing in order to really assess when and how it's safe to resume life. Katie Thomas on the state of testing. It's Tuesday, April 28th. Katie, when state officials talk about testing as a decisive factor in whether and when to reopen their economies, what do they mean?

Well, for the governors, this is really an essential tool. It's what they are going to need to rely on if they're going to reopen their economy and their communities. I mean, think of it like a fire department that doesn't have an essential tool like hoses. They can't put out fires. And the governors, if they can't have consistent and widespread testing throughout their states, then, you know, they can't see when a new hotspot is popping up or infections are rising and whether they're successfully beating the virus or not. And exactly what kind of testing are we talking about here? Well, there's two kinds of tests.

The first one is the one that many of us have been talking about for a while, the diagnostic testing, which actually tests for pieces of the actual virus. And that will tell you and your doctors whether you are actively infected with the virus and whether you have it. whether you are actively infected with the virus and whether you have it. Then the second group of testing, which is really kind of just getting underway right now, is called antibody testing. That's the idea that after you have had the virus and you've recovered, your body has developed antibodies which help fight off the virus. Generally, we don't know for sure.

Science still doesn't know. But people are pretty much operating on the assumption that if you have these antibodies in your system, then you are immune, at least for now, from getting infected again from this coronavirus. Gotcha. So one of these tests says you've got the virus. The other says you've had the virus. Let's start with the diagnostic test, right? Because that is the test that people talk to us about when they talk about flattening the curve and limiting the spread. So where do things stand with that test? So as you probably remember, things got off to a pretty bad start in the U.S. with diagnostic

testing back in January. The CDC, whose job it is to initially get things rolling with developing a test and then sending it out to all the public health labs around the country so that they can start testing, encountered basically a manufacturing problem as they were scaling up the tests and mailing them out. As they mailed out that first batch to the public health labs around the country and the labs started testing them to make sure that they were correct, they quickly realized that they had a problem. And what happened is some contamination got into the tests that basically made it so that they

revealed an invalid result. And so they couldn't be relied upon. So this set back testing in the country significantly and for weeks because basically those public health labs then couldn't do the testing that they had planned on doing. And almost all of the testing in the country for the month of February was only done through the CDC lab. Right. Creating a huge bottleneck at a crucial moment when the virus is spreading all over the country. Exactly. And while the CDC was scrambling to fix the problem, to fix the problem, this whole other system of private labs, university and hospital labs that were ready and who wanted to develop their own tests, they were slowed down, they said,

by the Food and Drug Administration, which they felt wasn't moving quickly enough to allow them to develop their own tests. And so not only did you have the CDC suddenly unable to disperse its tests to public health labs around the country, you also almost had this backup system that also couldn't get going initially. And so that was basically the story for the whole month of February, is that the state public health labs couldn't do their testing, and neither could the hospitals and the academic medical centers that also wanted to get in the game and start testing. So catch us up from that original sin in the diagnostic testing in the U.S. At this point, how much diagnostic testing is underway in the U.S. and how does that compare to where

everybody wants it to be? Yeah. So things have picked up significantly since then. I mean, the whole month of March, finally, the FDA, you know, they did make a policy change that allowed all of these labs to start developing and doing their own tests. Another thing that happened in the month of March is that these big testing companies that make these huge, high-capacity testing machines that enable labs to do thousands of coronavirus tests a day, they also completed their work on their tests and started selling them. And so there was a very big ramp up in the capacity for these labs to start doing the tests. But then, you know, as these labs started doing all these tests, they started to run into new problems. Like what?

Well, we started to see shortages of all kinds of different things. All of the supplies that you need in order to do these tests, suddenly they came under strain. you need in order to do these tests, suddenly they came under strain. The best example is probably the swabs that you need to conduct a test. It's this very long, skinny swab that almost looks like a Q-tip, but it's a very specialized swab that you stick all the way back into your nose to where your nose meets your throat. And those swabs are in demand globally because obviously this isn't just happening in the U.S., this is happening around the world. Of course. One of the biggest company that makes these swabs is actually an Italian company that is based in Northern Italy, and that's where their factory is as well. And of course, Northern Italy is where there was a giant

outbreak of the virus. That's right. So yeah, so in addition to the swabs, everything else started going into short supply as well. There were the chemical reagents that are needed to do the tests. There's the liquid that you insert the swab in to transport it to the lab. That started becoming short. Containers, the little vials that you stick the swab into, those started to become short. And then in addition, the little vials that you stick the swab into, those started to become short. And then in addition, the shortage of masks and other personal protective equipment that we've all heard about with hospitals and medical providers, the person who's doing the test also needs to have that protective wear. And so those shortages also started to affect the number of tests that providers could do. You know, if they didn't have masks, then they couldn't do a test.

And if they didn't have enough swabs, then they couldn't do a test. So it turns out there's this kind of like unseen chain of items required to do testing. And even if you have plenty of tests, you can't do the tests without each and every one of them. That's right. So at this point, how many diagnostic tests are being done in the U.S.? Well, the number is luckily going up. In the last couple of days, it's gone up significantly. You know, no one knows for sure exactly how many tests are being done. But the best estimates are that, you know, in the last several days, the U.S. has been doing about 250,000 tests a day.

Now, Katie, is that a lot or a little, given that we are a nation of nearly 300 million people? It sounds like a lot of tests, but actually experts say that we'll have to do many times that in order to really reopen the country. Some say we may need to be doing a million or more in order to really know what we're dealing with and to get a handle on the virus. tests, right? The Trump administration says at these daily news briefings, capacity has grown significantly. There is sufficient testing. So how does that square with what you're describing? Right. And that's the issue, is that there's a big disconnect right now between the labs and what they theoretically could do in a day if they were sent X amount of tests. And the number of tests that hospitals that are actually testing the patients can do in a single day,

given these ongoing shortages of everything from swabs to masks to the vials to send the swabs in. So the White House is accurate when it says a lot more testing is possible. The only problem is that possible is not the same as having everything you need to do all the tests. That's right. weapon in telling governors, public health officials, how many people have the virus. Once this major bottleneck at the CDC got solved, then testing has really expanded, in part because the private sector was allowed to get involved. But there's still a major problem with the supply chain that basically means there isn't nearly as much testing done

as everybody wants there to be done and thinks there needs to be done. That's right. We've come very far from where we were. And the picture is changing by the day. We're still not anywhere close to where most people feel like we need to be in order to really reopen the country. And it's right in the midst of that, of still ramping up these diagnostic tests, that we're now kind of shifting our attention and focus toward this other big category of tests, which is the antibody test. The test that tells you if you've already had the virus. The test of whether you've had the virus. That's correct. And how, Katie, is that test going? Oh, that is proving to be

just as complicated and problematic, maybe, as the diagnostic tests were. We'll be right back. Katie, what do we need to know about this second test, the antibody test? Yeah, well, we really need this new category of tests, the antibody tests, as we move forward and communities think about reopening. And that's for a number of reasons. One is just to get a feel for how far has the virus spread in your community? How many people have gotten it? Unlike the diagnostic tests, which are kind of a moment in time, the antibody test tells you, have you ever had it? Which is a valuable and slightly different piece of information. The other piece of this is if we can accurately identify who has had it and who hasn't, it might help us figure out, you know, which healthcare workers can safely go back to work

and who can kind of rejoin our community. Right. And of course, which parts of the economy can reopen. We talked to our colleague Donald McNeil about this. This is the test that would help us distinguish the immune from the still susceptible. And the immune, if this test works, they become a very privileged class of people who get to do almost everything. Right. I mean, theoretically, that's the idea. And so where are we in the development of that test? the idea. And so where are we in the development of that test? So the FDA and the federal government took a completely different approach when it came to the antibody tests. The FDA came under criticism for having been too slow to allow the development of the diagnostic tests. And so when

it came to the antibody tests, they almost overcorrected and they went in the other direction. And they went to all of the testing companies and basically said, if you want to develop an antibody test, go ahead, go for it. And rather than coming to us for approval before you can sell it, we are going to let you develop the tests, do your own validating, make sure that you are comfortable that your test works. And then once you are comfortable that it works, you can start selling the test. You don't need approval from us. And so, you know, the FDA has said that they're now aware of dozens of companies that are selling or developing these antibody tests. And it's really become almost like a wild, wild west of testing. So after having kind of held up the private sector when it came to the diagnostic test, this time they are supercharging the private sector

on the antibody test and putting a huge amount of trust in these corporations to do this and do it right. Yes, that's right. And so how has it gone? It's been a really mixed bag. There's just a huge variety of tests that are out there and a huge variety of accuracy. In fact, there is a study that just came out by independent researchers that took a look at 14 of these tests. And it found that out of those 14 tests that they examined, only three delivered consistently reliable results. Wow. Three of 14 tests that are on the market already. That's right. Yeah. And some of the tests, a group of the tests,

produced what's known as a false positive rate up to 16% of the time. And explain that. What does a false positive mean when it comes to an antibody test for the coronavirus? Sure. So a false positive would be when the test incorrectly identifies somebody as having had the antibodies for the coronavirus when they didn't really have it, when they had never had the virus. And a 16% false positive rate, correct me if I'm wrong, that sounds really bad for a test. Yeah. I mean, it means that, you know, if you have 100 people, 16 of those people could be incorrectly identified as having had the virus and having antibodies to the virus. And that, of course, would be quite dangerous because a false positive for the antibodies is basically the false understanding that you may be immune to the virus and would act accordingly, go out to the world, return to work, maybe not wear a mask.

That's right. That's right. It also would mean that, you know, if you're the mayor or the governor or, you know, a public health leader, you also just don't have a very good picture of what's going on in your community and how many people have had the virus. And that could really be bad in a community where there aren't a lot of people that truly have the virus, because it could lead that community to think that they're at a different stage in this outbreak than they truly are. And it could lead them to make decisions about how to reopen and how to move forward in a way that really doesn't accurately reflect what their risks truly are. Right. I'm thinking about places in rural America, for example,

where if suddenly an antibody test were given to everyone in that community and infection rates were really low, in reality, a high false positive rate test might make everyone think, oh, wow, we've come out the other side of this epidemic and a lot of us are okay when, in fact, the virus just hasn't really washed over that community yet. That's right, when, in fact, it's really an issue about the accuracy of the test versus the reality on the ground.

Hmm. So this government plan to avoid the problems of the diagnostic test rollout by taking a really hands-off approach and relying on private companies, that doesn't seem to have worked out very well. In fact, it seems to a certain degree to have backfired. It has. I mean, you know, if you are a governor

or a public health official in a community, you now have the job of trying to figure out, you know, which test you want to use and try and learn for yourself kind of whether it works or not. Are any of the tests highly reliable? Do any of the tests have very low false positive rates? Yes, there are some tests that experts said

are good and are accurate. And some of the really big testing companies, Abbott is one example, have recently come out with their own antibody tests. And the feeling is that these tests are measurably better than some of the other ones that have come on the market. But it feels like overall, just to establish exactly where we are at this moment when it comes to testing, There are still significant problems with diagnostic tests because of the supply chain issues you talked about earlier. And we don't have anywhere near as reliable a set of antibody tests as everybody thinks we need. That's right. I mean,

we basically haven't mastered either one of these tests. Katie, is testing just really hard in a public health emergency like the coronavirus? Or do we just keep screwing this up kind of uniquely in the U.S.? Because now we have two examples, the diagnostic and the antibody test, where we can't quite seem to get it right when we very much need to get it right. can't quite seem to get it right when we very much need to get it right. Yeah, I think some of this goes to the bigger picture of where we are at as a country with our health care system. Even before the pandemic, and even so more so now that we are in a pandemic, the truth is, is that our health care system is a huge jumble.

There's the federal government. There's all of the states, there are for-profit hospitals, there are non-profit hospitals, there's people who are covered by Medicare, by Medicaid, by insurance through their employer. It's all a big mix and some would say a big mess. And this is all playing into testing and who is testing and what company do we use and how do we get our supplies? So just to give you an example, say you're a patient and you're in the hospital and your doctor wants to give you a coronavirus test. They open up their computer and there's an electronic system that they use. And when they hit

click to order a test, that test order will go out to the company that they happen to have a relationship with, say it's LabCorp. Now, if LabCorp at that moment of the crisis, has a week-long backlog, it's not so easy for that hospital to quickly pivot to a different lab that might have capacity. So, you know, it's very hard, for example, for that doctor then to get on the phone and maybe call 10 other labs in the area to check and see how quickly that they can process their test. And I can give you an example on the other side of that equation, which is I know of a lab director who has all of that excess capacity. He could be processing hundreds more tests a day than he is, and yet he's not getting calls from hospitals for their tests. You're describing a situation in which the lack of any kind of centralized system in U.S. healthcare is really hampering our ability to test.

Right. I mean, in a pandemic, you really need to be able to move quickly and decisively. And, you know, I think we've long known that our health care system is very fragmented, but we're really seeing that play out in the example of testing, whether it's the supply chain issues or getting antibody testing out there and accurate. It's showing all of the kind of little ways that this system that we have is not quite up to the task and is slowing us down. Right. And the price of that is that it will take much longer for governors around the country and for local health officials to really get a grasp on where the virus is and to reopen our economy. I think, unfortunately, that's right. and to reopen our economy. I think, unfortunately, that's right. Katie, thank you very much.

Thanks for having me. On Monday, the White House released new national guidelines on testing that put much of the burden on states rather than the federal government. Testing, the plan said, would be state-managed and locally executed. The federal government, the guidelines said, would be a, quote, supplier of last resort. We'll be right back. Here's what else you need to know today. On Monday, the U.S. Centers for Disease Control and Prevention named six new symptoms of the coronavirus in a move that reflects the unpredictable ways

that the virus can affect individual patients. Previously, the CDC listed just three symptoms, fever, cough, and shortness of breath. It has now included chills, repeated shaking with chills, muscle pain, headache, sore throat, and loss of taste or smell. And New York State has canceled its presidential primary, saying that with Bernie

Sanders out of the race, the June 23rd election would be purely symbolic and would detract from the state's response to the pandemic. Supporters of Sanders, whose name would have remained on the New York ballot, had pushed for the primary to be held, hoping to win more delegates that would give them greater influence over the party's platform at the Democratic National Convention. That's it for The Daily. I'm Michael Barbaro. See you tomorrow.