The FDA just made cheap, rapid, at-home Covid-19 testing even easier to get

prioritization of testing will smooth the road for this larger and more proactive role in stopping and monitoring the spread of the virus.

“We have, at each step, let the pandemic get ahead of us,” Quick said. “So at this point, it’s really critical that we stay ahead of it. That’s the key role that these tests play.”

The FDA recently made it easier and faster for rapid tests designed to screen individuals multiple times over several days to receive emergency use authorization. Many experts feel these sorts of frequent, rapid tests are necessary to, for instance, safely reopen schools (or at least provide enough reassurance to parents and teachers), workplaces, and large events. The Biden administration also recently issued guidance that insurers should cover the cost of tests even for screening purposes, so people don’t have to have symptoms or have been in contact with someone who has the coronavirus in order to have their test costs covered.

That said, experts warn that testing by itself still isn’t a magic bullet.

“Sometimes people wave technologies like they’re this shiny object that’s going to solve all of our problems,” Nuzzo said. “And it’s never usually the case that a single technology solves all of our problems. It may solve a few, but it could also create some if we’re not smart about it.”

But I got vaccinated, so I’m free! I never have to get tested again, right?

Wrong. We already know that no vaccine has 100 percent guaranteed immunity, especially with new variants that vaccines might not have as much protection against. So if you feel sick — even if you’ve been vaccinated — get tested.

And we’re still finding out if vaccinated people can transmit the virus to others, even if they don’t get sick themselves. That’s why the CDC still recommends that vaccinated people exercise caution in public spaces (masks, social distancing) and when interacting with many people who are not vaccinated.

already preparing for this). Continuous testing and monitoring of emerging variants will help us determine what those boosters should protect against.

“Vaccine manufacturers need to know what variants are there, because I believe that it’s going to be critical,” said Mara Aspinall, professor and co-founder of the Biomedical Diagnostics program at Arizona State University. “We are likely to need an annual booster vaccine, similar to flu.”

So, while being vaccinated certainly has its advantages and should provide for a welcome sense of relief and relative safety, your days of Covid-19 tests are not over.

I don’t want to wait days to get test results, but I heard antigen tests aren’t accurate. Which test should I get?

How much time do you have? If you’ve got a few days to quarantine as you wait for results and want the so-called “gold standard” for accurate results, then go with the RT-PCR. If quarantining for days is not feasible (for example, it means you can’t work at a job that doesn’t offer paid sick leave), well, that’s time you may not have.

Proponents of rapid antigen tests believe that while the tests aren’t as sensitive to lower levels of the virus as RT-PCR tests and will miss more people who have some virus in their system, they are pretty good at detecting people when they have the highest levels of virus and are the most infectious (which typically starts even before symptoms). And these tests can let people know essentially immediately so they reduce the number of others they might infect.

There are some important nuances and big unknowns, however. For example, we don’t yet know what specific level of virus makes a person contagious or not.

“We need to think about antigen tests differently,” Aspinall said. “They were designed to be fast and frequent.”

Getting two rapid tests a day apart should increase your confidence that the result is accurate, and experts recommend continuing to wear a mask and social distance even if you test negative. If you have symptoms but test negative, the CDC recommends confirming the results with an RT-PCR test.

Why can’t I just grab a Covid-19 test from the drugstore, do it at home, and get results quickly? Where is my pregnancy test, but for Covid-19?

Good news! You may soon be able to do just that. The FDA has now authorized several over-the-counter at-home rapid tests. No prescription needed, no doctor visit necessary. And there are likely more authorizations of other such tests coming.

Bad news: You won’t find them on shelves just yet, and it could be a while before they’re widely available.

“The real game changer is fully at-home self-tests, or do-it-yourself tests,” Aspinall said. “That’s when the power shifts to the individual. … Now we need to have enough capacity at the right price, which does not exist yet.”

The first over-the-counter rapid test to be authorized by the FDA comes from an Australian company called Ellume. Its CEO and founder, Dr. Sean Parsons, told Recode that the company hopes to produce up to 15 million tests a month once its American factory is up and running in the second half of 2021. But Ellume’s test costs about $30, partly because it requires the use of a mobile app to guide users through administering and running the test to reduce errors and maximize accuracy, as well as report results back to public health authorities. Parsons said a cheaper version of the test without an app could be produced, but the increased risk of user error and inaccurate results was too great to do it.

Michael M. Santiago/Getty Images

Parsons hopes that once Ellume scales up test production — a $231.8 million payment from the Biden administration for 8.5 million tests will allow the company to build its American plant and automate some of its production — it’ll be able to cut the price a bit. Parsons says we should start seeing some tests available for retail purchase next month (he wouldn’t say how many or where), but the test won’t be widely available until the second half of the year.

Another FDA-authorized over-the-counter test, from Cue Health, also uses a mobile app. Cue’s test was initially authorized as a point-of-care test, and the Trump administration gave a $481 million contract to the company to produce 6 million tests, which the company says will be used in schools, doctor’s offices, and nursing homes. The company hasn’t shared details yet about pricing and availability for retail sales.

On March 31, the FDA authorized over-the-counter at-home tests from Quidel and Abbott that may be even easier and cheaper than Ellume’s or Cue’s. Testing proponents have for months been calling for simple paper strip tests for Covid-19, and they are, unsurprisingly, thrilled.

Abbott told Recode that its tests should be available “in the coming weeks.” The company expects to sell them to retailers at less than $10 per test, with the retailers then choosing how much to charge consumers. Quidel says its tests will be available “soon” but the pricing has “yet to be determined.”

While testing is still important, we’ve also seen how ineffective it can be if programs aren’t deployed and managed properly. It’s not just about which tests we have or how many there are — it’s about incorporating them all where and when they’re most needed.

“I’m so adamant that what we need is a strategy above all,” Nuzzo, from Johns Hopkins, said. “You figure out which technology will give you information to be able to take that action. Sometimes it’s going to be a lab test; sometimes it’s going to be a rapid test. But we need to figure it out. We’ve never really done that.”

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