Rapid antigen COVID tests are cheap to produce, easy to use, and can report results in a matter of minutes. They’re a powerful tool for stopping the spread of COVID because they allow people to test frequently and, if results are positive, quarantine immediately rather than waiting one to five days for a PCR test result. So why hasn’t the U.S. embraced rapid antigen tests more fully? Michael Mina argues that the country has overlooked the power of rapid antigen tests because we’ve been consumed by a singular focus: vaccines.
On Friday’s episode of What Next: TBD, I spoke with Michael Mina, who teaches at the Harvard T.H. Chan School of Public Health and 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 for less than $1 per test, we could break the chain of transmission. So what’s stopping us?
Lizzie O’Leary: Let’s break down the universe of COVID testing in the US 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 correct?
Michael Mina: It’s not, because accuracy is entirely dependent on what your objective is. The conversation has been 100 percent dominated by physicians and clinical laboratory directors who are completely focused on medical diagnostics. And in a 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?”
But if our goal is instead to identify people who are currently transmitting the virus to other people, then actually the rapid test is much more accurate. The important thing is they’re specific, meaning they are only going to turn positive when you’re actually actively transmitting the virus. If the goal is to detect infectious people, then a rapid test is actually much more accurate, not less.
Why are we all so into to PCR tests, then?
We have so devalued and underfunded public health that we literally don’t have a regulatory framework or laws to even ask the question, what is a public health test? 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. I think the only reason we’re so infatuated with the PCR test is because it’s a founder effect. It was the first tool that got started for COVID.
OK. So let’s say you, Michael Mina, are like the COVID boss of everything. You’re the COVID czar. What does a day in the life look like if your kid’s got a runny nose?
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. If my kid had a runny nose today and I thought, “Oh, maybe they were exposed at school yesterday,” I would go and pull out a rapid test. In 15 minutes from start to finish, I would have an answer. And I would feel good about saying, “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.” So it’s simple.
So what does it look like at scale, if a school-system-worth of parents is using rapid tests or a workplace or a county?
One of the most simple examples of how these tests can be used at scale is this test to state program. I’m really tired of seeing schools close down. 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 instead of quarantining the 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.
If everyone starts testing themselves at home, will that make it harder for public health authorities to have an accurate sense of positivity rates and community spread?
I would forego having the data if it meant that the outbreaks disappear. That’s our number one goal: 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 eMed. eMed actually worked with the CDC to actually allow you to take a rapid test at home, but with a proctor who’s actually like watching you do it, over your phone or over your computer. So they just watch you swab your nose. If you’re an adult, they ask you to see your ID, so they can actually give you a real laboratory report. And they report out to the public health officials in all 50 states.
Currently only a handful of home antigen tests have emergency use authorization from the FDA. How is that impacting our access to these tests?
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. It’s driven costs of the actual test down. 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 because of how we define these tests.
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 met that requirement and could get emergency use authorization for their tests. Other companies have the technology but not the authorization.
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. Can you help us? It just feels like the FDA is like changing the goal posts on us at every time.”
There’s a push to reclassify these tests as a public health tool and not a medical device, what would that take?
I’ve tried for over a year to get the FDA to evaluate these differently than a medical device. It’s been essentially an immutable wall. So what that would take is for, I think, an executive action from the president, which would state 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, then 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 U.K. and Germany, and any test 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.” 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.
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 Walmart and Kroger to offer antigen tests at cost. What was your reaction to this plan?
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 eighty million, it 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 vaccinate or test part of it is going to massively drive demand for tests.
That just pushes people toward testing.
Exactly. So we’re about to see a crisis, because we don’t actually have an increased scale. He did talk about invoking the Defense Productions Act. But actually that’s not the problem. The companies that we do have evaluated and authorized in the U.S. are pretty much at their maximum of scaling anyway. We’re going to see a problem where we’re going to continue having empty shelves of rapid tests.
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 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.
You have been beating this 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?
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 the heck’s he talking about?” And what’s changing is now that people are seeing this and feeling it. The public is frustrated that they go to CVS and they see empty shelves.
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 this system? 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. The virus is the problem. The only solution we have for a public health problem like this is the public. And rapid, at-home tests 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.