Medical Examiner

Why It’s Still So Difficult to Get a Rapid Test Anywhere

A sign from the Los Angeles Unified School District reads "COVID-19 Testing" with an arrow. A note pasted below reads "Walk Ins."
A sign for COVID-19 testing is seen at a public school in Los Angeles on Wednesday. The United States reported more than one million new Covid-19 cases on January 4 after the long New Year’s weekend, according to data from Johns Hopkins University, as the Omicron variant spread at a blistering pace. (Photo by Robyn Beck / AFP) (Photo by ROBYN BECK/AFP via Getty Images) Robyn Beck/AFP via Getty Images

If you need a COVID test right now, what is your strategy? Maybe you plan to go wait in line for one of those PCR tests that will get shipped off to a lab. Maybe you’ve got a stash of at home tests squirreled away in your bathroom. Or maybe, like a lot of folks, you’re hoping you’re not going to need a test. On Thursday’s episode of What Next, I spoke with Lydia DePillis, who writes about COVID testing over at ProPublica, about why it’s still so hard to get your hands on a COVID test, three years into this pandemic. Our conversation has been edited and condensed for clarity.

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Mary Harris: The shortages in tests that we’re noticing now—especially for those at-home kits, which some call “lateral flow tests”—are actually a trickle-down symptom of all kinds of other shortages. And that’s what makes fixing this problem so hard.

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Lydia DePillis: Yes. It’s not just ordering up a bunch of tests. It’s also saying, “OK, we have factories that need to produce the nitrous cellulose strips that go into lateral flow tests, we need to make sure there’s capacity for producing swabs.” Swabs are a huge bottleneck. This production should have happened right out of the gate, and instead there was a hope and a prayer that vaccines would make this all sort of unnecessary. We now know how that played out.

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In the fall, you interviewed a health care consultant about at-home COVID testing, and it was so interesting because this person basically predicted where we were going to end up. They told you that the possibility of new variants were still unknown and that it’s not like you could flip a switch with the Defense Production Act and magically get more tests. You need to have these tests building for a while. You need to have existing infrastructure. I wonder if you look back on that conversation and are just like, Wow, we really knew this would happen and didn’t do anything.

So many public health experts had been saying that variants will continue to arise until the world is vaccinated, or until we have some other type of herd immunity. So it was basically an inevitability.

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And for months, officials like Anthony Fauci and Surgeon General Vivek Murthy have advocated for expanded availability of COVID tests, especially home tests. And other countries, like the U.K., have made testing into a national priority.

The U.K. authorized a good number of tests fairly quickly so that there were enough on the market to compete down the costs. So you can buy these, and buy them privately, for a few dollars. It also bought millions and millions of tests for free distribution.

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So they basically just committed to testing.

They did, and I think they did that in part because the U.K. didn’t have as quick access to vaccines as the U.S. did. It was a more necessary part of the COVID response strategy. And also, the U.K., like many countries in Europe, has a national health system. So there is the infrastructure to deliver tests in a more universal way.

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In an ideal world, how should at-home testing be working? How often should we be testing ourselves?

It really depends on your situation. Tests should definitely be freely available to use as often as you need, but you’re going to need them more often in different situations—for example, if you have an underlying health condition and getting COVID would be extremely dangerous for you, or if you live with someone who has such a condition.

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Part of the reason getting your hands on a test is so hard in the United States is because there are just not as many kinds available. In the EU there are almost 40 different rapid tests on the market. Stateside, there are only about 12. That’s because the approval process, spearheaded by the FDA, has been moving at a glacial pace from the very beginning. You’ve told the story of one test maker, a woman named Irene Bosch, and her experience with the FDA, which explains a little bit about how we got to this place, where at-home tests are still hard to find. She developed an at-home test for COVID really fast, within the first few weeks of the pandemic.

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So Dr. Bosch is a microbiologist, and she had started a company in 2018 to commercialize rapid antigen tests that she and the head of a lab at MIT had developed and published about—these tests would detect tropical diseases like Zika and chikungunya and dengue. In February 2020, the company realized that the new coronavirus didn’t behave all that differently. They could pick detect the antigens on the surface of the coronavirus and then make lateral flow tests like the ones you see today. They’ve been around for other types of conditions—even pregnancy tests are basically lateral flow tests. So made up a quick prototype and validated it in her lab in March. Preliminary data showed that it could detect the virus when it was at its highest loads.

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What did the FDA say?

The FDA said, Thank you for this, but we’re going to need you to do clinical trials to make sure that it works in real people.

Did that surprise her?

I mean, it’s a reasonable ask, but I think that did surprise her because it wasn’t being requested of all the PCR tests at that time. And it was an emergency, right?

She found that her test was a little less accurate than PCRs. What did she say to the FDA ,and what did the FDA say to her?

She was trying to make the argument to the FDA that her test is very accurate at detecting people with very high viral loads within three to seven days of contracting the disease. And if you use it frequently, it becomes very, very accurate in detecting anyone who has the disease. The FDA doesn’t accept data that is broken out by how much viral load people have because it thinks the way we measure those loads is not uniform across devices, and it also did not accept the argument that a test could be packaged or authorized on the condition that it is used frequently in certain contexts.

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Someone who was at the FDA during this time told me, At a time when we thought the virus was something that could be stamped out, we really wanted to make sure we got every single infection. So it might make sense to insist on having only tests that will pick up every single infection. But once you realize that COVID is going to be endemic and the important thing is to slow the spread and protect vulnerable people, you really need a different type of tool in the box. But again, this is a time when there were no rapid antigen tests on the market at all, and you have to ask the question, Could this test have been useful in certain contexts? It’s important, the circumstances under which a test is authorized, and that was what the FDA was sort of unwilling to see through all of 2020.

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When I look at the story you’re telling about testing and how we got to where we are right now, I see a few things happening at once and I’m hoping we can go through them one by one. There’s a paternalism at work, this idea that Americans can’t understand how to test right, as well as the idea that you need a mediator between you and these tests. Can you explain that?

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The FDA has long been hesitant about authorizing tests for use at home. This started in the ’80s when there were home tests for HIV available. There was concern from different parts of the medical community that if we allow people to just figure out whether they have HIV on their own, we don’t know what they might do, because there was so much stigma associated with the disease that they wouldn’t be under the watchful eye of health care provider to say, like, this is what this means, here’s how you can get treatment. So home tests for HIV were banned for a long time, and were only recently authorized.

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There’s something else, too: It sounds like there was an idea from the government that, well, we don’t need testing as much, and you shouldn’t need to test because you should be vaccinated. Can you explain how things changed after the vaccines came out?

The White House very clearly banked on vaccines as a way to end the pandemic, and they might have been a way to end the pandemic if we had gotten everyone vaccinated, but we didn’t. But even if we’d vaccinated everyone in the U.S., there are still billions upon billions of people unvaccinated the rest of the world, and public health experts and medical doctors were warning this circumstance would create new variants. So I think there was a bit of wishful thinking on the part of the White House. I also think that it was part of their carrot approach to getting people vaccinated. It quickly started to become apparent when the delta variant created breakthrough infections that it we couldn’t move to a world without testing. Testing was going to be needed in conjunction with all of these other public health measures. By that time, however, we just didn’t have the capacity in the U.S. to produce them in the volumes that would be necessary.

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