Breaking: FDA authorizes 1st over-the-counter COVID-19 test

Finally. The biggest hole in the US response to the COVID-19 pandemic has been rapid testing. It takes days in some cases to get results back from clinic tests, rendering them all but useless unless recipients isolate while waiting for the results.

Now, however, people can find out whether they have the virus within 20 minutes — and can perform the test themselves:

The FDA has authorized the first at-home COVID-19 test that doesn’t require a prescription and provides results within 20 minutes.

The Ellume COVID-19 Home Test is an antigen test that detects fragments of proteins from the SARS-CoV-2 virus on a nasal swab and then reports results to your phone. …

The test “correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms,” the FDA said. “In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.”

That’s amazing, especially in an OTC test administered by patients themselves, and a great example of innovation in a crisis. One well-known epidemiologist declared it a “game changer”:

There’s a catch, though:

Ellume expects to produce more than three million tests in January 2021.

That’s a lot of tests in terms of numbers, but it’s a drop in the bucket in terms of scope. To compare, we have had something north of 15 million diagnosed cases of COVID-19 in the US so far, and a daily number of over 150,000 over the past month or so. Everyone who comes in contact with those cases will want a test, which will put tremendous market pressure on three million tests in a month. Even if only two people associated with each diagnosed case wants to buy a test, we’d run through Ellume’s output of tests in ten days. And that doesn’t count the people who want to test themselves even without knowing contact with a carrier in order to plan for family meetings, travel, and so on. Not to mention the fact that many of those will want more than one test over the next few weeks, too.

So yes, this is very good news, but it’s not exactly a game changer … at least for now. Ellume can’t produce enough to effect isn’t going to help loosen things up or prevent retransmissions. When they can and other such tests come to market, that might truly have an impact while we move toward herd immunity.  But the true game-changer came last week and earlier this morning — the vaccines. The US plans to vaccinate 20 million people in December and perhaps 50 million or more in January, and hundreds of millions by the spring. That will make the Ellume test and all like it moot, assuming we can keep up the pace on vaccinations.

This is no knock on Ellume, which has done excellent work. However, the issue is that this effort should have been highly resourced from the very beginning in the US, and given just as much priority as the vaccines in Operation Warp Speed. If we had given testing that kind of resourcing, we might have had this in place a few months ago in much greater supply, which could have pushed off this second wave of rapid community transmissions. Testing has always been our Achilles heel, and it’s now almost too late for it to matter much. Every little bit helps, but this isn’t the game changer. The vaccines have already changed the game — and that’s great news.