COVID-19 cases, hospitalizations, and deaths have been climbing. On Thursday, the United States recorded more than 150,000 new cases, a record-breaking number. To stay abreast of this fast-moving virus, government will have to adopt new strategies. The good news? All it would take is 15 minutes and a decision by the Food and Drug Administration.
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Last winter, the FDA's approach to COVID-19 testing left us blind to the rapid spread and struggling to keep up with the wave of infections, hospitalizations, and deaths. This time around, the agency could (and should) give us the tools to get ahead of the virus by approving rapid self-testing kits for COVID-19.
If it doesn’t, we face a repeat of last winter’s disaster, with millions of infected people unaware of their condition and unknowingly spreading the disease.
The first case of COVID-19 in America was confirmed on Jan. 15. But the FDA made only one type of test kit available (a test from the Centers for Disease Control and Prevention that turned out to be faulty) until March. All that time, the virus was spreading like wildfire, without us being able to detect it.
The initial dearth of COVID-19 tests was solved by allowing private labs and medical device manufacturers to make and use alternative test kits. As a result, we are routinely breaking testing records as a nation and are now averaging more than 1 million tests per day. But there are still regulatory restrictions on how these tests may be administered—and those restrictions severely hamper our fight against this deadly disease.
For example, tests are authorized for administration only by certified lab personnel. What’s needed to keep pace with the disease are tests with near-instant results that can be done by laypersons.
This would represent a break from the public health mindset we’ve followed so far—a mindset that can’t get beyond lockdowns, social distancing, and mask-wearing. Those policies are premised on lack of knowledge. They assume that we can’t know who (including ourselves) is infected and thus require that we treat everyone (including ourselves) as disease carriers. We shut ourselves inside because we don’t know others’ COVID-19 status, and we wear masks and socially distance because we don’t know our own.
While such precautions may be sensible, we can make better-informed decisions if we know our own status and can be reasonably sure others know theirs. Massive distribution of rapid self-tests for use in homes, schools, offices, and other public places can broadly screen the population on a daily basis, replacing ignorance with knowledge.
The FDA recently authorized a COVID-19 test that is cheap, easy to use, is independent of complex laboratory equipment, and can turn around a result in 15 minutes. In other words, these are effective screening tests.
The Trump administration has purchased 150 million of these tests, which is a good start. But there’s a hitch. The FDA authorization requires these tests to be administered by certified lab personnel. Even though the test can be performed anywhere without need for laboratory equipment, it’s still tied to a laboratory certificate, which severely limits the potential for such a test.
This restriction would be understandable if the test requires a sample that is difficult to collect, but this test requires a sample from the front nostrils, an area easily accessed by anyone.
The FDA should amend its emergency use authorization for these tests to allow laypersons to administer these simple tests. Moreover, the Department of Health and Human Services should assess whether funding is available to provide a sufficient quantity of these tests. If it determines more money is needed, it should ask Congress to provide it.
Additionally, the FDA should approve rapid saliva tests, which are even less intrusive than the front-of-the-nose swab tests.
America, like Europe, has entered a season of rising cases, one that has already reached unprecedented caseload levels. Policies currently in place leave us no way to determine, on a rapid and widespread basis, who may have the infection and may be spreading it to others. People are either bunkering down or throwing precautions to the wind.
A simple test can go a long way toward enabling us to make smart decisions, if only the FDA would let it happen.
This piece originally appeared in the Washington Examiner