Where are the rapid tests?

Count on David Leonhardt to get to the bottom of it.  Also, I have to say, he doesn’t get much credit, but, Leonhardt has been as smart on the key aspects of this pandemic as just about anybody out there.  Anyway:

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 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 P.C.R. 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

Other experts are also criticizing the Biden administration for its failure to expand rapid testing. Even as President 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 F.D.A. 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 F.D.A.’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 F.D.A. 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 P.C.R. tests, which they are not.

But rapid tests do not need to be so sensitive to be effective, experts point out. [emphases mine] P.C.R. 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 percent of cases in which a person is infectious, according to Dr. Michael Mina, a Harvard epidemiologist who has been advocating for more testing

Identifying anywhere close to 98 percent 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.

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.” Zoë 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.

So, there you have it.  Our over-priced, under-available rapid tests are a policy choice– we’ve made the wrong one.  We want an FDA to be cautious of course.  But, I would strenuously argue that the FDA has been excessively cautious, rather than appropriately cautious.  They seemingly focus only on the costs of action and making a wrong call while ignoring the costs of inaction, in this case the inaction of more appropriately classifying the rapid test.  Our failure to properly use this amazing tool is not as bad as our failure to get better uptake on the vaccines, but certainly one of our society’s most frustrating and discouraing failures of the pandemic.  

About Steve Greene
Professor of Political Science at NC State http://faculty.chass.ncsu.edu/shgreene

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