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Where are the tests?
2021-09-21 00:00:00.0     芝加哥论坛报-国家与世界     原网页

       

       Your daughter wakes up with a scratchy throat, and you can’t decide whether she should go to school.

       You can’t shake a runny nose and start wondering whether it’s really because of allergies.

       You’re planning a family gathering, but you are nervous about your aging parents being there.

       Millions of Americans are grappling with situations like these, and there is a straightforward solution to all of them. But that solution is not widely available in the United States, even though the technology exists and is being used in much of Western Europe.

       The solution is rapid testing.

       Rapid testing — more formally known as antigen testing — allows people to learn within minutes whether they are carrying enough of the COVID-19 virus to be contagious. With this knowledge, infectious people can stay home and quarantine before they infect others. Everybody else can carry on with life.

       ‘Incomprehensible’

       In Britain, France and Germany, rapid testing is widely available and inexpensive, thanks to government subsidies. People can visit testing sites, like tents outside pharmacies in France or abandoned nightclubs in Germany, and get tested at no charge. Many people also keep tests in their homes and self-administer them. “It’s been a way to put people’s minds at ease,” Melissa Eddy, a New York Times correspondent in Berlin, told my colleague Claire Moses.

       In the U.S., by contrast, people usually take a different kind of test — known as a PCR test — which must be processed by a laboratory and sometimes does not return results for more than 24 hours. During that time, a person with COVID can spread it to others.

       The shortage of testing in the U.S. may be contributing to the virus’s spread. Recent outbreaks have been worse here than in Europe, even though Europe’s vaccination rate is only modestly higher.

       Stefanie Friedhoff, a professor at Brown University’s School of Public Health, recently returned from a visit to Germany and wrote on Twitter about the many benefits of rapid testing that she had seen. A friend’s husband has Parkinson’s disease, and the friend leaves a batch of tests in her hallway for people to take before they enter the home. The day care center where Friedhoff’s sister works has stayed open throughout the pandemic, because the staff and children take frequent tests.

       “Imagine what ubiquitous cheap testing could do in the U.S.,” Friedhoff wrote. “It is incomprehensible how the U.S. has failed on testing.”

       Frequency Over Sensitivity

       Other experts are also criticizing the Biden administration for its failure to expand rapid testing. Even as President Joe Biden has followed a COVID policy much better aligned with scientific evidence than Donald Trump’s, Biden has not broken through some of the bureaucratic rigidity that has hampered the U.S. virus response.

       In the case of rapid tests, the FDA has loosened its rules somewhat over the past year, allowing the sale of some antigen tests (which often cost about $12 each). But drugstores, Amazon and other sellers have now largely run out of them. I tried to buy rapid tests this weekend and couldn’t find any.

       The FDA’s process for approving rapid tests is “onerous” and “inappropriate,” Daniel Oran and Dr. Eric Topol of Scripps Research wrote in Stat News.

       For the most part, the FDA still uses the same cumbersome process for approving COVID tests that it uses for high-tech medical devices. To survive that process, the rapid tests must demonstrate that they are nearly as sensitive as PCR tests, which they are not.

       But rapid tests do not need to be so sensitive to be effective, experts point out. PCR tests often identify small amounts of the COVID virus in people who had been infected weeks earlier and are no longer contagious. Rapid tests can miss these cases while still identifying about 98% of cases in which a person is infectious, according to Dr. Michael Mina, a Harvard public health researcher who has been advocating for more testing.

       Identifying anywhere close to 98% of infectious cases would sharply curb COVID’s spread. An analysis in the journal Science Advances found that test frequency matters more for reducing COVID cases than test sensitivity.

       Biden’s new COVID action plan, announced this month, calls for an expansion of rapid testing, although it seems unlikely to be big enough to make rapid tests widely available. “The recognition by the president that this is a tool we haven’t been using yet, and we should be using, is a massive step forward,” Mina told me. But, he added, “It’s woefully inadequate.”

       Elizabeth Stuart, a vice dean at the Johns Hopkins Bloomberg School of Public Health, recently wrote: “I am more and more convinced we need to dramatically increase access and affordability of at-home rapid antigen COVID-19 tests.” Zo? McLaren, a health economist at the University of Maryland, Baltimore County, added: “So many preventable deaths are on the line.”

       Several experts have called on Biden to issue an executive order reclassifying rapid tests as a public health tool rather than a medical device. If that happened, the companies selling many tests in Europe, like Abbott and Roche, would quickly flood the U.S. market, experts say. The tests would not be free but would likely be substantially cheaper than they are now.

       White House officials told me that they expect rapid tests to become more widely available and less expensive soon. The administration awarded contracts on Monday that will lead to the delivery of 120 million at-home tests, starting next month. But the tests are not likely to become anywhere near as available as they are in much of Western Europe. The Biden administration wants to continue to defer to the FDA about what kind of test is rigorous enough to offer the public.

       France and Germany, for their part, will be ending universal free rapid testing this fall, in an attempt to encourage vaccination. People with symptoms will still receive free tests, but many others will have to pay.

       A Return to Normal

       COVID isn’t disappearing anytime soon. So long as it continues to circulate and cause both serious illness and anxiety, rapid testing is arguably the only way society can return to something that resembles normal life.

       Widespread testing can allow families to hold weddings, quincea?eras, bar and bat mitzvahs and other celebrations without worrying that they are putting grandparents at risk. Testing can allow shops, restaurants and schools to function normally. It can allow parents to send their children to school confidently.

       “Testing,” Mina said, “is how we end this pandemic without disrupting society.”

       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.

       c.2021 The New York Times Company

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