Concerns about the tests’ reliability, how consumers might react to their results and how public health departments will track them have slowed development.
Fast at-home coronavirus tests could help bring the United States’ surging outbreak under control — if companies developing the tests can convince regulators that the public can be trusted to use them correctly. Several firms are vying to be the first to market a test that Americans could buy over the counter with results delivered in minutes at a bedside or a breakfast table. That could allow people to screen themselves before heading to the office or school, relieving pressure on overburdened testing laboratories and quickly identifying new infections. But concerns about the tests’ reliability, how consumers might react to their results and how public health departments will track them have slowed their development. Companies formulating such tests say they won’t seek emergency authorization from the Food and Drug Administration until later this year or early next — in part because the agency wants them to prove that adults of different ages, education levels and English proficiency can successfully use their products. Public health experts say FDA’s caution is warranted, because a test that’s unreliable or hard to use could help the virus spread. There is also a risk that many people will interpret a negative result as an all-clear; in reality, even the best test will produce some false negatives. And even a true negative does not guarantee that a person is not in the early stages of infection. “If this was a disease that only impacted the individual, then it wouldn’t be such a problem,” said Georges Benjamin, executive director of the American Public Health Association. “The problem is that there will be a cohort of people who will take the test, find out that they are presumably negative, but they really weren’t, and go out and infect other people.” A false negative result could be especially dangerous if “people use it to decide whether to go to parties,” said Heather Pierce, senior director for science policy at the Association of American Medical Colleges. “You’ve got infected people feeling like they have a passport to not engage in the other public health measures that we need to suppress the virus.” False positive results are also a concern, because some people could isolate for up to two weeks, missing work or school for no reason. But that risk could be lowered with follow-up lab-based testing, and pales in comparison to at-home tests’ potential to prevent Covid-19 spread, said HHS testing czar Brett Giroir. There is little precedent for at-home infectious disease testing.
