LP Vol. 27 - The State of Rapid Testing in America
Nearly a year ago, I lamented the lack of national attention on building an overwhelmingly fast, cheap and convenient testing capability to stop the spread of covid:
If we want any sense of normalcy in 2021, our cities and states will need to develop robust infrastructure and policies to encourage the gradual return of social and economic activity as well as isolation for those who test positive.
I am hopeful that in the new year America will take a more serious approach to both funding and enforcing efforts for testing and isolation, but for now, private companies are forced to blaze their own trail.
A few weeks ago, a ProPublica reporter decided to test his kids for COVID-19. They had the sniffles, and with a grandparent set to visit he wanted to minimize the risk that they were infectious. This was the problem that quick, cheap COVID-19 tests were supposed to help fix. No need to go to a clinic or wait days for results. Just pick up a pack of tests at a local pharmacy whenever you want, swab your nose and learn within 15 minutes if you’re likely to pass the virus along. So the ProPublican went to his neighborhood CVS, hoping to buy the required pack of two for $23.99. They were out of stock. Then he went to Rite Aid. They didn’t have the tests either. Then Walgreens, then another CVS. All out of stock. The only supplier with a few tests to offer was his sister, who happened to have a few tucked away.
So why are at-home tests still so pricey and hard to find in the United States?
Problem 1 - Regulatory Pain Is Limiting Testing Supply
The FDA asked manufacturers to submit their rapid tests for approval last year, but has been slow to approve new tests. Average approval times jumped from roughly 30 days in April of 2020 to nearly 100 by November of 2020. As of November 2021, Europe has authorized 39 unique rapid tests for at-home use, whereas the FDA has authorized 12, only 9 of which can be used at home.
Letting the FDA manage test certification has turned out to be a consequential decision, as their mandate requires them to evaluate diagnostic tests as medical devices rather than as public health tools. The agency has been evaluating tests on a standard that minimizes false negatives rather than false positives. That is, it is much more important to the FDA that any approved test for sale in the US be able to tell someone who has COVID they definitely have it rather than accidentally telling someone who is healthy they may be infectious.
Rapid tests, which can be administered at home and provide results within 15-minutes, have been shown to be 98% effective at detecting actively infectious individuals, whereas the gold standard PCR test, which must be run in a lab and can take days for results, is able to detect COVID in both infectious and pre-infectious individuals. For non-infectious individuals, rapid tests have been found to be closer to 80% accurate at detecting COVID as a one-off test, but the effectiveness rises back into the high-90s when a second test is given within 2 days). Until very recently, rapid tests for sale in the US have only been available in 2-packs and not single use for this reason.
Problem 2 - Vaccines Have Slowed, but Haven't (Yet) Stopped the Spread
Demand for testing dropped like a rock in the spring as the first wave of jabs in arms started spreading across the country and it looked like Hot Vaxx Summer was everyone's great salvation. Then vaccination rates stalled, the way more infectious Delta variant ruined everyone's summer, and parents of young children everywhere started having panic attacks at the realization school may never go back to normal until the vaccines were approved for humans under 12 (better late than never I guess).
In the last 6-8 weeks, it's finally dawned on the people in charge that endemic covid may be here in some form forever. Delta was personally terrifying as the combination of a much more transmissable variant + waning immunity meant I could possibly once again be a transmission vector for my kids. The looming cultural and political buzzsaw of vaccine mandate challenges combined with a global manufacturing challenge to keep formulating boosters for future mutations mean vaccines alone will be insufficient to quell the COVID danger.
And so, like everything else in 2021, having a sufficient quantity of affordable and available rapid tests is a regulatory and physical supply chain problem. As one of the first providers to win FDA approval, last August Abbott touted their rapid test as being a $5, it's still close to 5x that price (if you can find them):
Part of the reason we don't have tests right now is because there was no Operation Warp Speed to guarantee manufacturers a willing buyer a year ago. The FDA itself has made the point that nothing has stopped the government from buying massive quantities of the tests already approved for domestic use:
The UK spent billions of dollars on free and pervasive rapid tests, relying on the tests to allow schools to drop mask requirements for students. Germany also provided hundreds of millions of to its population for free. The Biden Admin has been trying to catch-up:
The FDA approved the FlowFlex test from ACON Labs in October, which plans to ramp to 100m tests per month by early next year
Two weeks ago they announced the FDA and NIH were streamlining their test authorization processes to ease the regulatory burden on manufacturers
These efforts are welcome, but they are late and we should have been pushing for cheap and abundant tests months ago in order to protect and ease a return to normalcy.
What Comes Next for Testing?
The two voices that have been beating the testing drum the earliest and most consistently have been Paul Romer and Michael Mina. Both were on a panel last December discussing the value of rapid tests:
Dr. Paul Romer: I think it’s useful to think of setting a target rate of spread of the virus. So set a target for this reproduction number R, or its rate of growth. Then ask, if we do more testing and then we reduce other things that are restricting R to keep R the same, what’s the net effect?
If you knew who was infected, you could put in restrictions only on the people who were infected. And then you don’t have to suffer the enormous costs that we’re bearing when everybody has to be restricted.
And what the calculations show is that each dollar you spend on test and isolate would let you remove restrictions that are costing us at least $10, maybe as much as $100, in wasted output.
So, the way to think about, well, what else would change? Just pick whatever R you want, probably one that’s well below one, so we’re going on a declining path for the virus. But then as you scale up more testing, you can remove all of these extremely costly restrictions on everybody
I think the other thing to keep in mind is that the strategy so far has been “Let’s restrict the activities of everybody because we don’t know who’s infected,” even though we know that the fraction of the population that’s infected is in low-single-digit percentages, at best
Now, if you knew who was infected, you could put in restrictions only on the people who were infected. And then you don’t have to suffer the enormous costs that we’re bearing when everybody has to be restricted
And then, that tells you why you want tests. If you just know who’s infected, you can focus your efforts on them and get them to stop spreading the virus. You don’t have to interfere with the activities of anybody else.
Mina recently appeared on an episode of the Lex Friedman podcast, specifically talking about the regulatory issues with keeping the FDA in charge of certification and the power of testing to cut through the politicized vaccine environment. This is on my shortlist as one of the most important podcasts of 2021, as I think this issue will continue to be culturally salient as the economy lurches back towards a post-pandemic normal:
In particular, I found the discussion at around 48:30 (of the youtube version) describing a recent conference that required rapid testing with certified testing from a self-administered test via telemedicine a great example of marrying the best of technology and public health requirements. The subsequent discussion on the need for testing privacy and balancing the needs of individuals versus the needs of the state was pragmatic and refreshing.
Demand for tests is likely to spike over the Holidays and into early 2022 given the upcoming OSHA vaccine mandate:
The Biden administration says workers at companies with at least 100 employees will need to get vaccinated or produce a negative Covid-19 test weekly. The administration estimates the rule will cover 84 million workers. It has separately required vaccinations for federal employees and federal contractors. More than 17 million workers must get vaccinated under a federal requirement for workers in health facilities that get Medicare and Medicaid reimbursement.
Fines on employers start at $14k per infraction, and employers are not responsible for covering the cost of testing. Adding to the challenge? The mandate requires independent confirmation of test results, which won't allow for self-reported at-home use.
We are going to need solutions like Mina and Romer outline to coexist with present and future variants until some combination of vaccination rates, herd immunity and other weapons of modern science make COVID a thing of the past.
It’s time to get testing.
Man oh man, that’s just a whole bunch of depressing COVID-related takes, so enjoy this palate-cleanser of birds with arms:
Until next week,
W