Manufacturers of rapid at-home Covid tests scramble to meet growing demand as consumers brace for holiday gatherings and testing is suddenly scarce amid yet another wave of coronavirus.

Representatives of the dozen companies with emergency use clearance from the FDA for the tests say they are already operating at full capacity, producing tens of millions of tests per month and further ramping up production, hiring more workers, adding shifts, and bringing in subcontractors for manufacturing assistance.

Abbott, maker of BinaxNow, says it is increasing its capacity from 50 million to 70 million tests per month, and Quidel is also increasing its production of the QuickVue test, by the same amount. Access Bio says it is targeting 25 million tests by December and plans to produce an additional 40 million in the coming months. Ellume says it will begin performing an additional 15 million tests per month, after production begins at its new factory in Frederick, Md., In January.

“We are seeing unprecedented demand,” said John Koval, Abbott’s director of public affairs for rapid diagnostics. “And we’re sending them out as quickly as possible. Despite the summer’s public health advice that knocked the market for rapid tests down, we never stopped testing. ”

The company now also operates 24/7 production lines and invests in automation, he said.

The rapid test kits are widely available in countries like the UK, some European countries, and South Korea, thanks to government purchases offering them at big discounts or free to anyone who wants them.

But so far, that hasn’t been the case in many parts of the United States, where a run on the shelves has seen Amazon, CVS and Walgreens ration purchases. U.S. output of rapid home self-care tests rose to 216 million in December from 81 million per month in November, according to estimates from Mara Aspinall, an Arizona State University health professor who has been tracking the trends.

This increase has not been sufficient to meet demand, not only from consumers, but also from employers and state governments that have been outbid each other for the limited supply to be sourced for mandatory unvaccinated employee testing and Covid surveillance programs.

Aspinall predicts capacity will increase to 305 million per month in March, slightly less than what would be needed to test every person over 11 once a month.

Start-up delays

In the initial response to the pandemic, the Trump administration decided early on that relying on the open market was the best way to address the supply issues related to Covid, because Vanity Fair reported in September 2020. This has made it much more difficult for companies to take the early risks of creating and selling test kits.

“If instead of making companies take risks and venture capital and go in stages, if the government had given money to labs like us for expansion, it could have gone faster,” said Bob Terbrueggen , CEO of DxTerity, which makes a Covid Home Collection Test Kit. “On the other hand, there are many opportunities for laboratories ready to invest. “

When the pandemic took off, a dozen different testing companies entered the competitive space of the rapid home testing market with products approved under the FDA’s Emergency Use Clearance, typically costing $ 18 to $ 100 for a two-pack. They include iHealth, InBios, Celltrion DiaTrust, ACON Flowflex, Abbott Labs BinaxNow, OraSure InteliSwab, Ellume Home Test, BD Veritor, and Quidel QuickVue.

Most are “lateral flow” tests, which involve a sample of fluid flowing along the surface of a pad encrusted with a reactive molecule, much like a home pregnancy test. The patient usually adds a reagent liquid to a test card, swabs their nostrils, then inserts the swab into the kit and waits for “positive” or “negative”.

Recently, the Biden administration revised the Trump administration’s approach, saying that starting January 15, people could be reimbursed by their insurers for Covid test kits. However, this will only benefit those with private insurance and will not apply to any test purchased before that date. This week, the administration announced that it will purchase 500 million test kits which will be distributed for free through a website. Some states and cities already offer free test kits. In September and October, the White House also announced $ 3 billion in investments to purchase test kits, secured deals with manufacturers to speed up production, and promised to streamline the regulatory approvals needed to put new tests on the Marlet.

Unpredictable demand

Until now, each company had to make its own bets on how many tests to perform. Under-exceed demand and you will have shortages. Overdo it and you will end up with oversupply and falling demand, and expired parts of the products must be destroyed unsold, as Abbott Labs did with its Binax Now devices in May, as Covid rates were dropping and interest in home testing was low.

This uncertainty has made it difficult for testing companies to determine how much to make. A Quidel’s SEC filing warnsnoted that “inventory levels can fluctuate due to supply chain variability in conjunction with larger and more frequent customer orders” and “delays” of “raw materials and components.” The company’s operations are based on factors that “cannot be predicted, including the duration of the Covid-19 outbreak, the severity and continuation of outbreaks, actions aimed at containing the spread of the virus such as mask wear, social distancing and vaccination efforts around the world, and the impact of these and other factors on the demand for testing, ”he continues.

“The whiplash demand scenario for test kits is really difficult for manufacturers to manage,” said Thomas Goldsby, professor of logistics at the University of Tennessee. “When there is demand, there are huge pushes, but of course production doesn’t work that way. Production requires long, steady cycles with a lot of setup time to get quality where it needs to be. Running large production batches leaves manufacturers with a limited shelf life, ranging from 6 to 12 months, depending on the type of test.

Changing market

But companies that predicted an increase in Covid cases appear to be in better shape. Ron Gutman, co-CEO of Intrivo, says his company has “tens of millions” of rapid Covid tests and the capacity to scale up production even further.

“When other companies closed factories, laid off thousands of workers and destroyed huge amounts of inventory, we doubled our production, doubled our technology,” said Gutman. “Because we looked at the data. We looked at the trajectory of the virus and said there is no way in the world that it is happening. “

Gutman says his tests are in stock on the company’s website or online at major online retailers like Amazon and Walmart, with no limit on the number of products that can be purchased. The company plans to deploy capacity in some major cities to make testing available even faster. And this is the announcement of a new service that will allow organizers of events or gatherings to organize the sending of tests to each guest.

“That wave that you’re seeing right now in the tests is also that people really want to see their family, really want to see their loved ones and want to do it safely,” he said.

But statements of increased production at many of the larger test kit companies won’t come soon enough for families unsure whether they will be able to get tested in time before the holiday gatherings.

Although his family is fully vaccinated, Will Swarts, a 52-year-old public relations officer in Brooklyn, is worried about meeting people with compromised immune systems while on vacation. Five times in a row, he checked store websites and called ahead to verify they had test kits in stock, only to drive in and find them sold out. Eventually he found some at a nearby Walgreens and rushed off.

“Everyone is a little excited and nervous,” Swarts said. “There is an element of hypervigilance at work here, but the problem with this highly transmissible variant is still very real.”

Those who were able to buy in advance are thankful that they’ve already got their hands on a cache of tests, and wish it wasn’t up to them.

“I refueled on Halloween because even before omicron you could have predicted a winter surge, especially in the northeast, which public officials and test company executives should have predicted as well,” he said. said David Harrington, co-director of Brooklyn nonprofit.

“I’m not trying to be conceited,” he said. “It shouldn’t be for ordinary people to figure this out. “