Health

Beyond ‘vaccinopia’: Employ rapid tests to fight Covid-19 – STAT

America is suffering from a serious case of vaccinopia: an inability to look beyond shots in arms when considering how to manage the pandemic. This was made clear by President Biden’s new Covid-19 plan, which emphasizes vaccine mandates while providing insufficient support for rapid tests, which we believe to be the most promising — and most underused — tool in the armamentarium against the coronavirus.

We are strong proponents of the Covid-19 vaccines, which have proven to be impressively effective and safe. In an ideal world, every eligible American would have been vaccinated by now. But we do not live in an ideal world. Covid-19 vaccination has become so politicized that a broad, societal consensus on its merits seems all but impossible. As many as one in five eligible Americans may continue to decline vaccination.

Vaccine mandates could change that, but their immediate impact will be blunted by the inevitable legal challenges and the months-long process of delivering millions of vaccinations and waiting for sufficient immunity to develop. In addition, 48 million children under 12 are not yet eligible for vaccination.

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Beginning in January 2020, just weeks after a novel coronavirus had begun to wreak havoc in Wuhan, China, public health experts in the U.S. were advocating for the development of rapid tests. Within a few months, effective ones began appearing on the market. Germany and other countries approved a large number of rapid tests and widely deployed them. In the U.S., bureaucratic and political obstacles delayed their arrival. With a new administration in Washington in January 2021, it seemed that rapid tests would at last get the attention and support they deserved. But the Biden team ultimately continued with the vaccine-centric strategy pursued by its predecessor.

Rapid tests could help us get the pandemic under control in the near term. And over the long run, they could become an essential tactic for reducing the spread of SARS-CoV-2 to low levels, so Covid-19 becomes more a nuisance than remaining a national emergency.

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In the early months of the pandemic, before the emergence of rapid tests, the main way to detect the presence of SARS-CoV-2 was via laboratory-based testing, which requires expensive equipment and trained technicians. Such testing is exquisitely sensitive, because it uses the polymerase chain reaction (PCR) to detect and amplify tiny amounts of genetic material from the coronavirus. But the results from PCR tests are often not available for several days — too late to prevent infected individuals from spreading the virus.

Rapid antigen tests, which provide results in about 15 minutes, look for viral proteins instead. This makes the process much faster. And unlike the deeply probing nasal swab typically used in PCR tests, a much less invasive swipe of a swab in the front of the nose is sufficient. (Antigen tests should not be confused with antibody tests, which require a few drops of blood, often from a finger stick, and look for signs of previous infection.)

If SARS-CoV-2 could be said to have a superpower — a unique feature that contributes greatly to its unchecked spread — that might be its ability to make infected people who are symptom free highly contagious. For days before the onset of symptoms, infected individuals can pass the virus to others, sometimes dozens of people at a time, as has been seen in the many superspreading events that have been documented over the last 18 months.

PCR tests are poorly suited for identifying and containing presymptomatic spread of the virus, which has been estimated to account for about half of all new infections. And because PCR tests are so sensitive, they often yield positive results after infected individuals are no longer contagious.

In contrast, rapid tests are ideally suited for spotting infectious individuals. Considering the growing number of breakthrough infections during the Delta wave, widespread use of rapid tests could be a powerful tactic for breaking viral transmission chains and quelling outbreaks.

In many countries, rapid tests are provided free of charge. In some parts of Europe, they can be purchased in retail stores for less than one dollar each. In parts of Asia, they are widely available in vending machines for a nominal price. Ideally, they should be provided free to all households to encourage their use on a frequent basis.

Rapid tests can be used in different settings for different purposes. At home, rapid tests could help parents keep sick children out of classrooms, allowing schools to stay open. In offices, rapid tests could give employers the confidence to reopen workplaces and their employees the confidence to return to them. And with testing required for entry, the travel and hospitality industries could use rapid tests to assure customers that airports and hotels are safe.

To be sure, there are challenging logistics regarding rapid tests. In an airport, for example, screening hundreds of passengers per hour would not be easy. But as we learned about security after 9/11, if there is sufficient demand, innovative organizations and start-ups will supply solutions.

Biden’s new Covid-19 plan does acknowledge a role for rapid tests. But it proposes to purchase only 280 million of them at a cost of around $7 each — about six times more than what they cost in European retail stores. This is far too few for far too much.

Instead, the U.S. should plan for a several-month surge of rapid testing, aiming to test a substantial proportion of the population at least twice a week. That would require around one billion tests a month. And the goal should be to get the price per test much closer to one dollar.

A key obstacle to achieving these goals is the onerous — and we believe inappropriate — criteria the FDA has set for authorizing rapid tests. Because the agency requires that rapid tests return results that are comparable to PCR tests, only a handful are now available for home use. In our opinion, the FDA is mistaken in classifying rapid tests as medical diagnostic devices. Instead, they should be deemed to be public health screening tools and evaluated solely on their ability to identify and isolate infectious individuals on a timely basis.

The European Union has recognized more than 135 rapid tests that provide accurate results. We urge President Biden to consider issuing an executive order that would break the FDA logjam and immediately make available in the U.S. suitable rapid tests developed here and around the world.

We know that rapid tests are not a panacea. In parallel with new testing efforts, the U.S. must press on with the difficult project of vaccinating a greater proportion of the population. But focusing primarily on vaccines and overlooking a valuable tactic like rapid testing is a dangerous kind of myopia that the country should avoid.

Daniel P. Oran is a member of the digital medicine group at Scripps Research Translational Institute. Eric J. Topol is the institute’s founder and director.



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