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COVID-19

Will Congress Fix the Testing Debacle?

12.7.20

 

Image by Unsplash. 


 

Image by Unsplash. 

As Congress raced to craft a coronavirus stimulus bill in the second week of December, the question foremost on epidemiologist Michael Mina’s mind was whether funding for accelerated production of rapid tests—$1 paper tests that can be used in the home to quickly determine whether someone is actively infected with the coronavirus—would be included in the bill. Mina, an assistant professor of epidemiology at both Harvard Medical School and the Harvard T.H. Chan School of Public Health, has been publicly advocating for approval and large-scale deployment of rapid, inexpensive, frequent coronavirus tests since the summer. 

Mina told reporters in a conference call Friday, December 4, that he has been hard at work trying to get support to have rapid testing included in the stimulus bill. “If it is a trillion-dollar bill, if they can set aside one thousandth of that”—$1 billion—toward developing the manufacturing capacity of the several small companies that have created such tests, he said, that would jumpstart efforts to make these paper-based test strips widely available.

Because rapid tests give results in under 30 minutes, they can be used to break chains of transmission in ways that current tests cannot, because of days-long delays to get results, or inadequate reach among asymptomatic individuals who are spreading the virus unknowingly. If individuals who learn that they are actively infected change their behavior as a result, perhaps isolating for the average six-day period of infectiousness characteristic of SARS-CoV-2, that would act as a barrier to transmission, causing outbreaks to die out. Mina estimates that another $5 billion to $10 billion would be required to produce a sufficient number of tests during 2021. Given Harvard scholars’ October estimate that the pandemic is imposing a $16-trillion penalty on the United States, the testing costs Mina cites are minute, and the public-health and economic return on such an investment could be astronomical.

People want these rapid tests, Mina emphasized, because “they desperately want to know, can I safely see my loved ones….Public health is also about the mental health of people—it’s keeping our society healthy as a whole….We can’t just keep saying lock yourself indoors for the next seven months [until vaccination is widespread]. It’s just not appropriate.” And while “vaccines are coming,” Mina noted, they will not be available to the average person for many more months—during which hundreds of thousands more Americans could die. 

Mina says rapid testing has bipartisan support in the House, Senate, and among state governors, but that support needs to be broad-based in order to secure passage. And crucially, it remains an open question whether funds will be earmarked specifically for the development of these inexpensive antigen tests.

There is still no effective testing infrastructure for the general public, Mina asserted. PCR (polymerase chain reaction) tests for SARS-CoV-2, which are typically used for diagnosis in hospital settings, “should never have been a public-health testing tool,” he said, because the results take days to receive, and are thus essentially useless for preventing spread of the disease. “By the time people get their results, most people have finished most of their infectivity period.” Such tests can also be outrageously expensive, he pointed out, noting that his fiancée’s grandmother in rural Ohio had been charged $400 for a PCR test. Given such fees, “there is a lot of incentive for these labs to just keep doing what they are doing.”

Evidence has been accumulating that rapid testing, on the other hand, is effective. In the Commonwealth of Massachusetts, says Mina, a partnership between the governor’s office and the state’s department of public health has found that combining mask-wearing and rapid testing works “magnificently.” Research from Boston’s Children’s Hospital also supports the effectiveness of such tests.

 Mina, who has no financial stake in rapid-testing technology, says he has been helping to connect regulators with the small companies that can manufacture rapid tests in order to smooth the way for approval. “The FDA [Food and Drug Administration],” he said, “is generally very supportive of the idea of getting them out,” and is “absolutely willing” to explain to companies what metrics they will use to decide whether to approve these products for sale. 

“I'm trying to now act somewhat as a matchmaker, I suppose…[working] with the CEOs of the companies and the FDA to try to…bring them to the table together and create dialogue…[and] more of an accelerated partnership, rather than a business-as-usual application” for regulatory review and approval.

Mina concluded by noting that transmission could continue even when vaccines are available: because no vaccine is 100 percent effective, some people will remain infectious. Mask-wearing and testing complement vaccination—all three are critical public-health measures against the coronavirus—and will continue to be necessary to bring COVID-19 under control. “I feel extremely strongly that…we need all of these to work synergistically. With vaccines and masks and tests, we can really tackle this, [but] we need a strategy. And we absolutely have to keep frequent testing. If you’re vaccinated and still use these tests, that will catch 99 percent of new cases that might potentially transmit. So it just makes sense.”

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