More innovative testing strategies
If COVID-19 testing is to play a more game-changing role in combating the pandemic, health policy leaders and administrators must face reality. Current levels of coronavirus testing are nowhere near enough to help manage or control the outbreak. Americans are taking roughly 750,000 tests per day according to The Associated Press, down slightly from a few weeks ago. The AP also reported the average number of positive testsrunning at around 60,000 per day, down from 70,000 in late July, and that while some states have plenty of testing center capacity, residents aren’t taking advantage due to the wait time for results in some cases.
Tests are expensive to fabricate and time-consuming for labs to process, and while supply chains are currently keeping up with demand in some areas of the country, they are by no means keeping pace with actual transmission rates. The Centers for Disease Control and Prevention said this summer that the actual case numbers in the U.S. could be as much as 10 times higher than the number of people who test positive.
Researchers at several top universities including Harvard and Stanford have proposed a different approach.
They advocate the development of faster tests that could provide a positive or negative indication within minutes. Such tests would trade some accuracy for expediency, but scientists contend that production could scale into the millions and compensate for the lack of precision with sheer quantity.
It’s a compelling argument. This strategy could allow businesses and schools to reopen more safely and provide a stronger safety net for the country’s most vulnerable populations: nursing homes.
Currently, there are no tests with quick turnarounds that can be self-administered. Federal regulators at the Food and Drug Administration require at least 80% accuracy for new COVID-19 tests. Rapid tests could only be as accurate as 50% or lower, depending on how much of the virus is present. The FDA’s coolness toward less-accurate tests has discouraged companies from attempting to develop them.
But experts contend the widespread, repeated availability of rapid tests makes up for their lack of precision and that they are most sensitive to people with large viral loads. These are likely the people at greatest risk of unknowingly spreading the virus.
Researchers at the Massachusetts Institute of Technology are working with the company 3M to develop a rapid test. The FDA’s caution is understandable, but it is impeding a potentially valuable tool for combating the coronavirus. The administration should work with researchers to authorize a scaled trial.
Even testing with only 50% accuracy is better than not testing at all. Detractors might argue that the risks of false negatives could be more damaging than continuing the current testing strategy, but the point to rapid tests would be to check for infectious levels of the virus regularly, perhaps multiple times per week, thus increasing their efficacy.
The FDA recently authorized a saliva-based test developed by a team at Yale that uses inexpensive, easily sourced chemical reagents. The test is thought to be as effective as nasal swab testing and if scaled up would likely alleviate some of the pressure on supply chains for current testing. Still, it is not a rapid test and requires laboratory processing.
Whenever a vaccine appears, the virus will not disappear overnight. The coronavirus response must be one of managing risk, and a faster test provides another method of assessing that risk. The FDA should explore approving faster, cheaper testing on a trial basis.