How to bring at-home COVID testing in the U.S. up to speed

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·Senior Editor
·5 min read
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  • Joe Biden
    Joe Biden
    46th and current president of the United States

“The 360” shows you diverse perspectives on the day’s top stories and debates.

What’s happening

Rapid at-home COVID tests are widely viewed by health experts as a key element of any comprehensive strategy to contain the pandemic. As far back as a year ago, when the first rapid test was approved for sale in the United States, disease modelers have been arguing that regular at-home testing could stifle the spread of coronavirus and — with the aid of vaccinations — end the pandemic entirely.

“We should be literally flooding the system with easily accessible, cheap, not needing a prescription, point of care, highly sensitive and highly specific [tests],” Dr. Anthony Fauci said in March.

A number of countries around the world have embraced that strategy, making major investments to ensure their citizens have easy access to tests at little or no cost. In the United Kingdom, for example, anyone who can’t take a free test at work or school can order a pack of seven tests from the National Health Service free of charge. In the U.S., on the other hand, rapid tests are often hard to find in stores and too expensive for many Americans to be able to test themselves as regularly as most models say is necessary.

Earlier this month, President Biden unveiled a new plan to help guide the country through the winter that called for a major expansion of rapid tests. To accomplish this, Biden's plan will require health insurance companies to reimburse their customers who pay out-of-pocket for rapid tests. The government will also provide 50 million free tests to health clinics for the uninsured.

Why there’s debate

Biden’s rapid-testing plan sparked a wave of criticism from a number of health experts who argue it’s not nearly enough to ramp up testing to the level that’s needed to make a dent in the pandemic. The most pointed critiques were aimed at the decision to put insurance companies at the center of the plan, rather than simply having the government provide the testing.

Others say ramping up America's rapid testing capacity will take more than federal funding. Another important step, they say, is for the FDA to change its approval process so more companies can bring tests to the market — which would improve availability and lower prices.

These logistical fixes must also be accompanied by a messaging campaign to change the public’s view of testing, some experts add, since the tests are only useful if people actually make them a part of their regular routine.

What’s next

The ease and speed of rapid testing could become even more critical in the near future if antiviral COVID-19 pills currently under development are approved by the FDA. The pharmaceutical giant Pfizer says its pill could be nearly 90 percent effective at preventing hospitalization and death in COVID-positive patients, but only if taken early within a few days of the onset of symptoms.

Perspectives

Ramping up rapid testing should be treated as a national emergency

“The Trump Administration’s Operation Warp Speed for vaccines was successful because the U.S. government recognized early that it had a central catalytic role in harnessing the formidable R&D, manufacturing, commercial expertise and innovation of the private sector. …

Now we’re at a similar crossroad for rapid testing and we need a U.S. government-led solution that does not rely mainly on market forces to drive COVID-19 policy.” — Michael Mina and Steven Phillips, Time

The FDA needs to abandon its excessively high approval standards

“During a crisis, governments sometimes face a choice between following their normal bureaucratic procedures and taking a new approach. In the case of rapid testing, the scientific and economic evidence seems to call for a change. For now, though, the bureaucracy’s status quo is winning.” — David Leonhardt, New York Times

The U.S. rapid testing program is doomed as long as insurers are involved

“Biden’s current plan for testing requires insurers to reimburse people for kits, but going through insurance — especially having to apply for reimbursement — adds too much friction in the process of getting tested and might discourage people from doing it altogether because it’s too much of a hassle. And the obvious problem with relying on insurers is that far too many people are uninsured.” — Editorial, Boston Globe

Regular testing must become a social norm

“Showing that you are free from COVID-19 at the time of an unmasked gathering is something we should be able to normalize. … In fact, since monitoring our own symptoms is insufficient, testing is the only way that even we can know if we’re safe to be around others. And we should certainly want to know if we’re safe to be around others.” — Dorry Segev, The Hill

The public’s perception of testing as means of exclusion needs to be changed

“Testing continues to be treated and talked about mainly as a means of limiting access, which is a tremendous misstep for the pandemic at this stage. … Set against the powerful backdrop of progress, testing should be reframed as a tool to allow people to more confidently gather in a world in which risks are still considerable.” — Amy Lauren Fairchild and Samuel S. Malloy, Stat

Widespread rapid testing isn’t the game changer proponents make it out to be

“Rapid COVID testing—at least as it’s been practiced in Germany, the U.K., and other countries—hasn’t really quashed anything. ​​That’s not because the tests are failing as a diagnostic tool for individuals and high-risk groups. Rather, we don’t have compelling real-world evidence that using them on a massive scale would change the course of the pandemic.” — Benjamin Mazer, The Atlantic

Lowering approval standards may be too risky

“The problem is that the FDA has been here before when it tried last year to expedite emergency approval of molecular rapid tests, which are more costly than antigen tests. It significantly reduced the review process requirements, only to later find that for two-thirds of scores of submitted products, internal quality control measures were flawed. If a test for a viral infection is unreliable, it's worse than useless. It's dangerous.” — Editorial, USA Today

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