Regulators blow the rapid antigen test opportunity

Regulators blow the rapid antigen test opportunity

Whether it was flip-flops on the effectiveness of masks, seemingly inane restrictions on certain activities, or crass politicization of the use of ineffective drugs, the past 20 months have provided numerous reasons to question what we were told. Significant numbers of people are resisting employer mandates to get the COVID-19 vaccine and thereby jeopardizing their jobs.

Still, there is a useful but misunderstood and underused mitigation tool — rapid-result antigen tests , which detect pieces of the SARS-CoV-2 virus’s proteins — that can slow the spread of infections.

The problem is regulatory ineptitude and an unwillingness or inability on the part of policymakers to address it. The rapid-result antigen tests, which have been inexpensive and readily available in Europe, are a self-administered initial screening tool for individuals to use before they venture into situations where they might come into contact with vulnerable people.

These tests are focused on identifying individuals who are in their three-to-five-day period of maximum contagiousness, mostly before they are symptomatic. The tests generally involve putting a nasal swab and some reagent drops on a test card or test cassette that quickly displays two lines for positive or one for negative. Results are available in 10-30 minutes, in contrast to the slightly more accurate PCR tests, which measure viral RNA and take days to report results.

In simple terms, the rapid antigen test enables you to be pretty sure you are not at risk to others before you leave for any get-together, movie, indoor sporting event, trip to a crowded store, and so on. It would also be useful for schoolchildren or teachers exposed to a case of COVID-19 by converting “test and quarantine” while awaiting the results of the PCR test to “test and stay” if the test is negative. The rapid antigen test is crucial yet simple to use, requiring little more than remembering to brush your teeth before going out.

So, where are these tests?

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. This is discussed clearly and persuasively by Harvard epidemiologist Michael Mina in this video , starting about 33 minutes in.

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.

Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. Andrew I. Fillat spent his career at technology venture capital and information technology companies. He is also the co-inventor of relational databases. They were undergraduates together at MIT.

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