![]() “The whiplash demand scenario for test kits is really difficult for manufacturers to manage,” said Thomas Goldsby, a logistics professor at the University of Tennessee. An SEC filing from Quidel warned that “inventory levels may fluctuate due to supply chain variability in conjunction with larger and more frequent customer orders” and of “delays” of “raw materials and components.” Company operations are based on factors that “cannot be predicted, including the duration of the Covid-19 outbreak, the severity and continuation of outbreak surges, actions to contain the spread of the virus such as mask wearing, social distancing and vaccination efforts globally, and the impact of these and other factors on testing demand,” it continues. That uncertainty has made it hard for testing companies to figure out how many to make. ![]() Make too many and you’ll be left with excess supply and falling demand, and expiring portions of products must be destroyed unsold, as Abbott Labs did with its Binax Now devices in May, when Covid rates were falling and interest in home tests was low. Undershoot demand and you’ll have shortages. Until now, each company had been left to make their own bets on how many tests to make. In September and October, the White House also announced $3 billion in investments to purchase test kits, secured agreements from manufacturers to speed production, and promised to streamline regulatory approvals needed to bring new tests to market. Some states and cities have already been offering free test kits. This week the administration announced it will purchase 500 million test kits that will be distributed free through a website. However, that will only benefit those with private insurance and won’t apply to any tests bought before then. 15, people would be able to get reimbursed by their insurers for Covid test kits. Recently, the Biden administration overhauled the Trump administration’s approach, saying that starting Jan. The patient typically adds a reactive liquid to a test card, swabs their nostrils, then inserts the swab into the kit and waits for “positive” or “negative.” Most are “lateral flow” tests, which have a liquid sample running along the surface of a pad embedded with a reactive molecule, just like a home pregnancy test. They include iHealth, InBios, Celltrion DiaTrust, ACON Flowflex, Abbott Labs BinaxNow, OraSure InteliSwab, Ellume Home Test, BD Veritor, and Quidel QuickVue. That made it far more difficult for companies to take on the early risks of creating and selling testing kits.Īs the pandemic took off, about a dozen different testing companies entered the competitive market space of the rapid at-home test market with products approved under FDA emergency use authorization, usually costing $18 to $100 for a two-pack. In the initial response to the pandemic, the Trump administration decided early on that relying on the free market was the best way to solve Covid-related supply issues, as Vanity Fair reported in September 2020. That increase hasn’t been enough to meet demand, not just from consumers but employers and state governments who have been outbidding one another for the limited supply to stock up for mandatory testing of unvaccinated employees and Covid surveillance programs.Īspinall projects capacity to rise to 305 million per month in March, a little less than would be needed to test every person over the age of 11 once per month. production of the rapid self-care home tests has risen to 216 million in December from 81 million a month in November, according to estimates by Mara Aspinall, a health professor at Arizona State University who has been tracking the trends. Rapid test kits are widely available in countries like the U.K., some European countries and South Korea, thanks to government purchases offering them at steep discounts or free to any one who wants them.īut until now that has not been the case in many parts of the United States, where a run on shelves has Amazon, CVS and Walgreens rationing purchases. The company is now also running production lines 24/7 and investing in automation, he said. Despite public health guidance over the summer that caused the market for rapid testing to plummet, we never stopped making tests.” “And we’re sending them out as fast as we can make them. “We’re seeing unprecedented demand,” said John Koval, Abbott’s director of public affairs for rapid diagnostics. Ellume says it will start making 15 million more tests a month, after production launches at its new facility in Frederick, Maryland, in January. Access Bio says it’s targeting 25 million tests for December and plans to produce an additional 40 million in the coming months. Abbott, makers of BinaxNow, says it’s increasing capacity to 70 million tests per month from 50 million, and Quidel is also increasing its production of the QuickVue test, to the same amount.
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