THE US COULD have prevented the surge of COVID-19 cases this winter that killed hundreds of thousands of people if only the FDA had approved methods for at-home rapid testing and made the tests widely available. That is the argument made by Dr. Michael Mina, assistant professor of epidemiology at Harvard’s T.H. Chan School of Public Health, one of the country’s strongest proponents for the use of at-home rapid COVID-19 tests.
“Had the regulatory barriers been broken down in the summer last year, and the companies that could produce these were actually allowed to produce them at scale…we could have seen the surges of the fall and winter that happened and killed hundreds of thousands of Americans, those could have largely been prevented,” Mina said on The Codcast.
Mina explained that if government gave every household a supply of at-home tests in September, and people were testing themselves twice weekly, that could have vastly reduced the rate of virus transmission. “It’s the thing about epidemics: They either grow exponentially or they fall exponentially, and it’s a razor thin line between the two,” Mina said.
Rapid tests are technology that Mina describes as similar to an at-home pregnancy test. While the exact methodology varies based on the test, the general idea is you take saliva or a nasal swab, put it into a tube, dip a paper strip into the tube, and the strip reveals whether someone is positive or negative in about 10 minutes.
Some countries, like Slovakia, have experimented with widespread use of rapid antigen testing, with generally positive results. But it has been controversial. As the United Kingdom prepared to roll out rapid antigen testing, for example, some scientists worried that the tests would miss a large portion of infections, and those people would be falsely reassured and spread the virus.
Unlike a PCR test, which is the current gold standard for COVID testing, a rapid test generally cannot tell if someone has only a small amount of the virus – for example, if they were sick several days ago. But if someone is at the infectious stage of the disease, rapid tests will detect it at least 90 to 95 percent of the time, Mina said.
In the US, a handful of rapid tests have been approved. But under FDA regulations, they still require a doctor’s prescription. That policy, Mina said, makes the tests more expensive and adds a layer of unnecessary complexity and barriers to access.
“There is absolutely no reason in the United States right now why a COVID test should require a physician’s prescription,” Mina said. “The FDA is not helping public health here.”
A state can potentially get around that by ordering a “standing prescription” allowing anyone to get one. But Mina called that an “abuse of the purpose of a medical prescription.” He added: “I should not be forced to write a prescription for 100,000 people who I don’t know, just so that they can have a test.”
In Massachusetts, the state has purchased a stock of Abbott BinaxNOW rapid tests from the federal government and sent them to schools. They can be used, for example, to aid in pooled testing. If a PCR test of pooled samples turns up positive, rapid tests can be given to every student whose sample was in the pool to determine who is positive. Rapid tests have also been deployed in nursing homes, where the facility can operate under a blanket prescription.
Even as more people are getting vaccines, Mina said rapid tests could remain important if variants circulate, if cases rise in the fall, or if people – particularly the elderly – lose immunity.
Mina estimates that deploying rapid tests nationwide would cost $20 billion. “Twenty billion dollars is essentially what this country has purged every single day as a result of this virus since last year,” he said.