Why Have U.S. Policymakers Failed in Getting Rapid-Result Antigen Tests to Market?

Why Have U.S. Policymakers Failed in Getting Rapid-Result Antigen Tests to Market?

A Washington Examiner article questions why the “rapid-result antigen tests, which detect pieces of the SARS-CoV-2 virus’s proteins – that can slow the spread of infections” is an “underused mitigation tool.”

“The problem is regulatory ineptitude and an unwillingness or inability on the part of policymakers to address it” writes The Examiner. It is particularly baffling because rapid-result antigen tests are inexpensive and have been readily available in Europe.

The test, which is a self-administered initial screening tool individuals could use before going “into situations where they might come into contact with vulnerable people.” As the article title clearly points out, why did “Regulators blow the rapid antigen test opportunity”?

How is it possible the tests have not flooded the U.S. market? The article states, “they have come late to the U.S. market in large numbers because they have been treated as a highly regulated medical device rather than a public health tool.”

Regulators have compared them to lab-run PCR tests, which are more accurate over the entire course of an illness but not necessarily much better during the period of maximum contagiousness, and thus deemed them inferior. By limiting their supposed applicability, regulators have suppressed demand, and prices remain high in the United States, about $7-$12 each.

There are obvious flaws in the regulators’ logic.

First, relatively few people now opt to be tested if they don’t have symptoms. They thereby become spreaders as the virus replicates during the asymptomatic period. Second, even if a person is PCR-tested, the results take days to be reported, and an infected person is a spreader during that time. Third, even if the rapid antigen tests miss a few positives, it’s better to have most of those who self-screen and test positive remain at home than not to stop anybody at all.

In other words, the rapid antigen test achieves the most important goal: limiting the number of person-days that asymptomatic but contagious people are at large, infecting others.

The Biden administration seems finally to have awakened to the importance of these tests. In an effort to increase availability, the White House earlier this month allocated $1 billion to purchase millions of tests over the next year, encouraging manufacturers to ramp up production. But it’s very little, very late.


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