A number of firms have developed cheap, paper-strip tests for coronavirus that report results at-home in about 15 minutes but they have yet to be approved for use by the FDA because the FDA appears to be demanding that all tests reach accuracy levels similar to the PCR test. This is another deadly FDA mistake.
NPR: Highly accurate at-home tests are probably many months away. But Mina argues they could be here sooner if the FDA would not demand that tests for the coronavirus meet really high accuracy standards of 80 percent or better.
A Massachusetts-based startup called E25Bio has developed this sort of rapid test. Founder and Chief Technology Officer Irene Bosch says her firm has field-tested it in hospitals. “What we learned is that the test is able to be very efficient for people who have a lot of virus,” she says.
The PCR tests can discover virus at significantly lower concentration levels than the cheap tests but that extra sensitivity doesn’t matter much in practice. Why not? First, at the lowest levels that the PCR test can detect, the person tested probably isn’t infectious. The cheap test is better at telling whether you are infectious than whether you are infected but the former is what we need to know to open schools and workplaces. Second, the virus grows so quickly that the time period in which the PCR tests outperforms the cheap test is as little as a day or two. Third, the PCR tests are taking days or even a week or more to report which means the results are significantly outdated and less actionable by the time they are reported.
The fundamental issue is this: if a test is cheap and fast we shouldn’t compare it head to head against the PCR test. Instead, we should compare test regimes. A strip test could cost $5 which means you can do one per day for the same price as a PCR test (say $35). Thus, the right comparison is seven cheap tests with one PCR test. So considered a stylized example. If a person gets infected on Sunday and is tested on Sunday then both tests will likely show negative. With the PCR test the infected person then goes to work, infecting other people throughout the week before being the person is tested again next Sunday. With the cheap test the person gets tested again on Monday and again comes up negative and they go to work but probably aren’t infectious. They are then tested again on Tuesday and this time there is enough virus in the person’s system to show positive so on Tuesday the infected person stops going to work and doesn’t infect anyone else. Score one for cheap tests. Now consider what happens if the person gets tested on another day, say Tuesday? In this case, both tests will show positive but the person doesn’t get the results of the PCR test until next Tuesday and so again goes to work and infects other people throughout the week. With the cheap test the infected person learns they are infected and again stops going to work and infecting other people. Score two for cheap tests.
Indeed, when you compare testing regimes it’s hard to come up with a scenario in which infrequent, slow, and expensive but very sensitive is better than frequent, fast, and cheap but less sensitive.
More details in this paper.