Updated December 10, 2021 - "On February 21, the Washington Post published a story titled, 'A fast, at-home coronavirus test will be available to Americans this year.' At the time, public-health officials had been calling for fast, widely available at-home COVID-19 tests for months.... As the Post reported, the White House was finally making that a reality.... But as we approach the end of 2021, pharmacy shelves in the U.S. still aren’t teeming with COVID tests, even though President Biden announced in a televised September 9 address that he was making at-home testing a major element of his plan to manage the pandemic and using the Defense Production Act to increase test availability.... So why are these at-home COVID tests still sometimes hard to find — even if you’re willing to pay the full retail price?...
"In many Asian and European countries, at-home COVID-19 tests are cheap and easy to find in stores. CBS News reported that home antigen tests are now used routinely in the U.K., where they are free and 'readily available at pretty much every pharmacy in the country.' The situation is drastically different here.... While some foreign governments moved quickly to encourage screening and subsidize the cost of at-home tests, the Food and Drug Administration’s approval process moved much more slowly. The FDA said it needed to ensure that the tests were accurate, but many scientists countered that the agency was letting the perfect be the enemy of the good. Rapid tests can quickly identify around 98 percent of infectious COVID cases; they’re not as sensitive as PCR tests, which can catch even noninfectious cases but need to be sent to a lab for processing....
"Harvard epidemiologist Michael Mina, who has been one of the most vocal proponents for mass testing throughout the pandemic, argued that U.S. officials focused too much on the accuracy of rapid antigen tests versus PCR tests, which obscured the former’s tremendous value. 'If the target is infectious people — which is really the most important public-health target — then these [rapid antigen] tests become extremely accurate,” 'Mina told Intelligencer in December 2020. “And that’s the issue — we shouldn’t be using a medical target, we should be using a public-health target. If they are being used for medical diagnostic purposes, they might not be as accurate as you would like, but as a public-health tool, they’re very accurate.'
"Due to these regulatory and messaging hurdles, the market for at-home antigen tests has been slow to develop in the U.S. For much of the last year, Americans couldn’t obtain the pricey tests, and their diagnostic value wasn’t clear to the public. Demand for the tests dropped even further in the spring of 2021, when ... the CDC said vaccinated people did not need to get tested if they were asymptomatic, even if they’d been exposed to someone who was COVID-positive.... Thus, when the Delta variant, breakthrough cases, and people returning to work and school drove up demand for at-home testing ... the U.S. was unprepared, and stores couldn’t keep the tests in stock....
"In September, the Biden administration responded with a new push toward making rapid tests more accessible and affordable, saying it would invoke the Defense Production Act and spend another $2 billion on about 280 million rapid tests.... However, the tests remained in short supply over the coming weeks, prompting the White House to announce on October 1 that it would invest an additional $1.2 billion to obtain millions more rapid tests from Abbott and Celltrion. In addition to ramping up production of tests already on the market, the government is also working to speed up the approval process. On ... October 25, the Department of Health and Human Services announced that the FDA will streamline its authorization process, and the National Institutes of Health will spend $70 million on a new program to 'establish an accelerated pathway' to aid test makers seeking approval for their products....
"In early December, President Biden announced plans to ramp up at-home testing by ensuring that the tests will be essentially free for Americans with health insurance, as part of a broader plan to combat emerging variants. (The Department of Health and Human Services will release formal guidance by January 15.) 'More than 150 million Americans on private health insurance will be able to submit receipts for at-home tests directly to their health insurance plans,' Jeff Zients, the White House COVID-19 coordinator, said. 'They can go to their local pharmacy, they can order online and then get reimbursed.' For those who don’t have health insurance, there will ostensibly be 'thousands of locations' such as clinics, health centers, and pharmacies where COVID-19 test kits are available for pickup.
"When White House Press Secretary Jen Psaki was asked at a press briefing on December 6 about why they administration chose such a complicated route for making free at-home tests more widely available, she gave a glib response, asking 'Should we just send one to every American?' In other, albeit much smaller, countries the government does mail out free tests. An anonymous HHS official also offered Politico an illogical answer on whether there’s much demand in America for at-home rapid tests. 'The primary channel people are getting tested isn’t at home,' the HHS spokesperson said. 'Samples are taken primarily at pharmacies and health care providers... [A]nother anonymous senior administration official offered a defensive response on why the U.S. does not have a clearer and more consistently available testing system.... 'Our pathway is multiple paths for people to get free tests. It’s less of the single, easy-to-grasp solution that people on Twitter like to hold up as a model'....
"Zients said the Biden administration’s latest $1.2 billion investment would quadruple the number of rapid tests available in the U.S. in the following weeks. That means that sometime in December, American consumers should have access to 200 million rapid at-home tests per month.... Still, in the U.S., at-home COVID testing may never be as cheap or as widespread as it is in places like the U.K. Dr. Michael Mina told NPR in October that while he’s happy to see the Biden administration devoting more resources toward rapid testing, 'it’s not enough, and it’s not fast enough. America is so far behind our peer nations.'"
Read more: https://nymag.com/intelligencer/article/at-home-covid-tests-accuracy-supply-issues.html
Photo: Decky, UK Covid home testing kit, 2020. CC BY-SA 4.0, Wikimedia Commons.
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