What’s Driving the COVID Rapid Test Shortage?

When the COVID-19 pandemic hit, Leo Friedman pivoted his corporate gifting company, iPromo, to help provide his clients with needed products like masks and gloves.

Now that many of those clients have their employees returning to offices, companies want to provide them with rapid tests to protect against in-office transmission.

Friedman has been trying to fill those rapid test orders, but he can’t meet demand. When he does find a new batch of product, prices are inflated because they’re being resold.

“Most of the time, you go on Amazon and search BinaxNOW, and there’s nothing there,” Friedman told MedPage Today. “When there is supply, they get bought up by bots, and end up being resold.”

For several weeks now, rapid tests have been in short supply, for several reasons. There’s new demand from employers returning to in-office work. At the same time, manufacturers bet against the need for testing as cases took a nosedive last spring (Abbott notably destroyed several batches of its rapid tests over the summer). Then, there are concerns about the FDA authorization process being too strict, asking manufacturers to meet what some consider an unnecessarily high bar before being allowed on the market.

Experts are saying that the tests can provide a helpful means of controlling spread, especially in offices, schools, long-term care facilities, prisons, and other crowded settings. The White House seems to recognize that value, as it has recently pumped billions into several initiatives aimed at bolstering rapid testing.

Market analysts have said it will likely be weeks to months before supply can finally catch up with demand — and that’s worrisome as the cooler weather is already bringing more people indoors.

The Marketplace

Currently, FDA has authorized eight over-the-counter rapid antigen at-home tests:

  • Abbott BinaxNOW
  • Access Bio CareStart
  • ACON Flowflex
  • BD Veritor
  • Celltrion DiaTrust
  • Ellume Home Test
  • OraSure InteliSwab
  • Quidel QuickVue

All are at various stages and levels of production and distribution.

BinaxNOW is the market leader, with 75% of the market share, Abbott CEO Robert Ford said during the company’s latest earnings report call. Ford noted that the company had 90% of market share before dropping to 60% in September, which fell “just because of supply,” apparently acknowledging the summer purge.

Abbott recently re-opened an Illinois manufacturing plant it had shuttered when it bet that demand for rapid testing would fall, according to Reuters. Ford said during the earnings call that the company can now make more than 100 million tests per month — but still a far cry from what a nation of 330 million people could use.

While initially governments were its best clients for rapid tests, Ford pointed out that Abbott has now seen a rush of requests from companies and employers.

“In the beginning of the pandemic, most of our sales were focused to governments, whether international governments, federal government here in the U.S., state governments also. And that continues to be pretty strong,” he said. “But what we’ve seen now grow pretty significantly, and I think it’s aligned to the screening pieces, the private side of the market, whether it’s OTC, cash pay, whether it’s a lot of companies. We’ve seen a lot of companies, in the last couple of months here, signed contracts with us to ensure that they’ve got rapid testing to be able to give to their employees.”

Similarly, Quidel CEO Doug Bryant told Reuters, “Employer demand has gone crazy. We won’t be able to meet all the requests that we’re having.”

While the supply side struggles to catch up with demand, some experts have also raised concerns that FDA’s regulation of rapid tests may be too stringent.

In an op-ed for STAT, Daniel Oran, MA, of the digital medicine group at Scripps Research Translational Institute in La Jolla, California, argued that FDA shouldn’t classify rapid tests as medical devices. Instead, they should be considered public health screening tools and evaluated on their ability “to identify and isolate infectious individuals on a timely basis.”

Tinglong Dai, PhD, of Johns Hopkins Carey Business School in Baltimore, agreed that “FDA has been conservative and slow-moving in terms of approving rapid tests.”

Generally, he said, rapid tests have to prove their accuracy by being tested against gold-standard PCR testing — but that’s not necessarily the right comparison for tests that aim to pick up the most infectious cases that are most likely to spread. PCR, on the other hand, may turn up positive even when an individual is no longer infectious.

Dai noted that the European Union has authorized more than 100 different rapid tests, which has helped make them nearly ubiquitous there and allowed them to play a key role in helping to stop the spread of the virus.

What Happened to $5 Tests?

Several times in the last week, this reporter tried to purchase an Abbott BinaxNOW on Amazon. In most instances, there were none available.

Finally, on Tuesday morning, a positive result: a BinaxNOW was available for $14. The kit, which includes two tests, was placed into the virtual cart, ordered, and is supposed to be delivered between October 28 and November 4.

A few hours later, however, no more of the Abbott tests were available on Amazon.

In its place, a rapid antigen test called On/Go, made by Intrivo Diagnostics, was served up for $34.99.

That pricing is more in line with iPromo’s pricing, which ranges from $26 to $35 for a single box with two tests, the result of having to buy from middle-men, Friedman said.

The tests are supposed to be available at large retailers like CVS and Walgreens, but they have also been reported to be in short supply in these locations.

While the BinaxNOW was on sale at Walmart.com for $14, it was out of stock. It was, however, available online at both CVS and Walgreens, but for $23.99.

Dai noted that these prices are so much higher than what public health experts had initially hoped for.

“Originally we thought these tests could cost $5 each, we had a lot of hope for that,” Dai told MedPage Today. “At CVS and Walgreens they cost more than $20 apiece. That’s crazy.”

Dai, who reviewed the Abbott earnings call, lamented its focus on revenue and profit around testing: “I find it bizarre that there’s very little concern for public health.”

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    Kristina Fiore leads MedPage’s enterprise & investigative reporting team. She’s been a medical journalist for more than a decade and her work has been recognized by Barlett & Steele, AHCJ, SABEW, and others. Send story tips to k.fiore@medpagetoday.com. Follow

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