Photo-Illustration: Intelligencer; Photo: Getty Images
On February 21, 2021 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 home COVID-19 tests for months, saying that allowing people to determine whether they’re infected without lining up at a clinic or waiting days for lab results could help turn the tide in the pandemic. As the Post reported, the White House was finally trying to make that a reality, awarding a nearly $232 million contract to help Ellume scale up production.
But as we enter a new year, at-home COVID tests are still scarce. Throughout the fall, home tests were frequently out of stock at pharmacies and online retailers. In late December, holiday plans and the emergence of the Omicron variant strained America’s COVID testing capabilities in general, and demand for home tests skyrocketed. In recent days, rapid antigen tests have been mostly unavailable from major online retailers and some local pharmacies jacked up prices on the tests they were able to stock. Just before Christmas, President Biden announced that the government will purchase 500 million at-home rapid tests and ship them out for free to anyone who requests one — but the tests won’t ship until late January.
So why are home COVID tests, which are cheap and widely available in other countries, still so hard to find in the U.S.? Can they detect the Omicron variant? Where can you buy a home test and what are your options? And when, if ever, will we Americans know the joy of jabbing a swab up their nose whenever they please? Here’s what you need to know.
COVID-19 tests fall into three categories:
- Antigen tests, which test for an active infection by detecting specific virus proteins. Most at-home tests and “rapid tests” performed by healthcare providers fall in this category.
- Molecular tests, which test for an active infection by amplifying genetic material from the virus. These are considered the “gold standard” for diagnosing COVID, as they are generally more accurate than antigen tests. The most familiar test from this category is the polymerase chain reaction (or PCR) test, which requires lab processing. The category also includes loop-mediated isothermal amplification (LAMP) tests, and clustered, regularly interspaced short palindromic repeat (CRISPR) tests. There are a handful of tests in the former two categories that can be performed at home, providing users with results in a matter of hours or minutes, as opposed to days with PCR.
- Antibody tests, which are blood tests that determine if the body has had an immune response to the virus. These tests are not used for diagnosing an active infection.
The FDA has issued emergency-use authorization for a variety of COVID-19 tests. At-home collection kits – which allow people to collect their own sample at home, mail their results to a lab, and get results within days – are available for each type of test. But when people lament the lack of at-home testing, they’re usually talking about rapid antigen tests that allow users to swab themselves and get a result in as little as 15 minutes, without any lab processing and without a prescription.
Antigen tests are more sensitive in people experiencing symptoms, and within the first week that symptoms emerge, as that’s when people have the highest viral load. Certain manufacturers recommend serial testing to boost accuracy, which is why some kits come with two tests. The CDC explains: “Performing serial tests, meaning two or more tests over several days with at least 24 hours between tests—with one test as close as possible to the event you will attend—improves the reliability of testing and reduces your risk of transmitting disease to others even further.”
The FDA has approved 13 fully at-home COVID antigen tests. These are the brands that are currently available from major U.S. retailers:
Note that “accuracy” refers to data the manufacturers submitted in applications to the FDA. The figures reflect the findings of tests that were performed on varying numbers of subjects, some symptomatic and some asymptomatic, at different points during the pandemic. The figures give a general sense of each test’s performance but should not be interpreted as a head-to-head comparison of the various brands.
Cost: $19.88 to $23.99 for two tests.
Sold at: Abbott’s website sells the tests directly, and online at CVS, Walmart, Rite Aid, Sam’s Club, and Walgreens. As of this writing they were not in stock at any of these stores online.
Accuracy: The test correctly gave a positive result 84.6 percent of the time, compared to a PCR test, and correctly gave a negative result 98.5 percent of the time, according to data submitted to the FDA.
Quidel QuickVue At-Home COVID-19 Test
Cost: $23.99 for two tests.
Where to purchase: Amazon, CVS, HEB Pharmacy, Hy-Vee, Optum, Pharmacy and Wellness Center, Simply Medical, Tops, Walmart, Walgreens. As of this writing, the tests were in stock at CVS.
Accuracy: For people with symptoms, the test gave an accurate positive result 83.5 percent of the time and an accurate negative result 99.2 percent of the time, compared to PCR, according to data submitted to the FDA.
Ellume COVID-19 Home Test
Cost: $26.10 for one test.
Where to purchase: Ellume’s website says the test is sold at Amazon, CVS, Everlywell, Target, and Walmart. As of this writing, it was out of stock at all of these stores.
Accuracy: The company says that the data it submitted to the FDA “demonstrated 96 percent accuracy, with an overall sensitivity of 95 percent (positive percent agreement) and specificity of 97 percent (negative percent agreement) when compared to an emergency use-authorized RT-PCR laboratory test.” On October 5, the company recalled hundreds of thousands of its test kits after finding that there was a higher-than-expected potential for false positives due to a manufacturing issue.
On/Go COVID-19 Antigen Self-Tests
Cost: $23.99 to $34.98 for two tests.
Where to purchase: Amazon, MDMaxx.com, Walgreens, Walmart, Ro, and directly from On/Go. It was in stock at Amazon, On/Go, and Ro as of this writing.
Accuracy: The test correctly identified 87 percent of positive samples and 98 percent of negative samples, compared to PCR, according to data submitted to the FDA.
iHealth COVID-19 Antigen Rapid Test
Cost: $13.98 to $21.99 for two tests.
Where to purchase: Amazon, Sunline Supply, 360 Health Services, MDmaxx.com, HPFY, and directly from iHealth. It was in stock at Amazon, HPFY, and iHealth as of this writing.
Accuracy: In a clinical test involving symptomatic patients, the iHealth test correctly identified 94.3 percent of positive samples and 98.1 percent of negative samples compared to PCR, according to information submitted to the FDA.
Flowflex COVID-19 Antigen Home Test
Cost: $9.99 for one test.
Where to purchase: CVS, RiteAid, and Walgreens. It is currently only in stock online at CVS.
Accuracy: In a study of symptomatic and asymptomatic patients, the Flowflex test correctly identified 93 percent of positive cases and 100 percent of negative cases compared to PCR, according to data submitted to the FDA.
InteliSwab COVID-19 Rapid Antigen Home Test
Cost: $19.97 to $23.99 for two tests.
Where to purchase: Walgreens and Walmart. As of this writing the test was out of stock online at both stores.
Accuracy: In a clinical study of symptomatic patients, the InteliSwab test correctly identified 84 percent of the positive cases and 98 percent of negative cases, compared to PCR, according to data submitted to the FDA.
Access Bio Carestart COVID-19 Antigen Home Test
Cost: $32.99 for two tests
Where to purchase: MDmaxx.com.
Accuracy: In a clinical study of asymptomatic and symptomatic patients, the Carestart test correctly identified 87 percent of positive cases and 98 percent of negative cases, compared to PCR, according to data submitted to the FDA.
In addition to antigen tests, a few fully at-home molecular tests are available to U.S. consumers at (sort-of) affordable prices. Cue, Detect, and Lucira are now selling home molecular tests in the U.S., without a prescription. All three, which received emergency use authorization from the FDA, are billed as having “PCR quality results,” though each uses a molecular process that is slightly different from the PCR method. Some foreign nations accept results from LAMP tests for travel, if they are performed under the observation of a medical professional.
These are the costs and features of each at-home molecular test:
Cue COVID-19 Test
Accuracy: Information the company submitted to the FDA said that in a clinical study involving 273 subject, Cue correctly identified 97 percent of positive samples and 99 percent of negative samples, compared to a PCR test.
Cost and where to buy: CueHealth.com sells a Cue Reader for $249 and a pack of three tests for $225. A bundle including one reader and three tests costs $474 and a bundle including one reader and ten tests costs $949.05. The company also offers a membership program for $49.99 or $89.99 a month that offers product discounts, in-app access to primary care doctors, and supervised tests.
How to perform the test: Cue’s test involves a four step process: insert a cartridge into the small square reader, swab both nostrils, insert the swab into the cartridge, and get results on the Cue Health app in 20 minutes.
Detect COVID-19 Test
Accuracy: The instructions posted on FDA.gov say that when compared to a PCR test, the Detect test correctly identified 90.9 percent of positive cases and correctly identified 97.5 percent of negative cases. The company notes: “Both apparent false positives were due to subject’s misinterpreting the test result; the Detect App has since been modified to significantly reduce the frequency of this user error.”
Cost and where to buy: Detect.com sells a starter kit for $75 (currently discounted from $88) that includes one COVID-19 tests and a reusable Detect Hub. Additional COVID-19 tests cost $49 and additional Hubs cost $39. A video observation of the test, so it can be used for travel, costs an additional $20. The tests sold out at the end of December but will be back in stock at 12 noon EST on Monday, January 10th.
How to perform the test: After a sample is collected it needs to process in the Hub for 55 minutes. Then the tube must be inserted into a reader along with a liquid, which will show results in 10 minutes. In addition to the test and hub, users must download a free smartphone app.
Lucira Check It COVID-19 Test
Accuracy: Lucira’s website says that in two studies involving symptomatic and asymptomatic individuals, Lucira’s test identified 97 of positive cases and 98 percent of negative cases compared to PCR, “excluding samples with very low levels of virus that possibly no longer reflected active infection.” When the 10 samples with very low viral loads were included the test had 92 percent positive agreement and 98 percent negative agreement.
Cost and where to buy: LuciraHealth.com sells a single-use test kit for $75 (the list price is $89, but it is currently discounted). Amazon sells the kit for $89. You can also buy one test with a video observation for traveling to Hawaii through Azova.com for $89.
How to perform the test: Lucira’s website says you can see “results in as fast as 11 minutes for a positive result and 30 minutes for a negative result.”
When the Omicron variant first emerged, the companies that manufacture several of home antigen tests – including Abbott BinaxNow, Quidel QuickVue, and Ellume – said the mutations in the variant did not appear to affect test performance. The tests were designed to target a part of the virus that doesn’t change much, so they should show a positive for people infected with any version of COVID-19 (no home tests, and not even most lab tests, will tell you which specific variant you have).
However, the FDA said on December 28, “early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity,” suggesting that with Omicron some tests could be more likely to return false negatives. This finding is based on early research backed by the National Institutes of Health involving certain brands of antigen test, and studies are ongoing.
The FDA added that, as it has advised all along, “if a person tests negative with an antigen test but is suspected of having COVID-19, such as experiencing symptoms or have a high likelihood of infection due to exposure, follow-up molecular testing is important for determining a COVID-19 infection.”
Some experts criticized the FDA, which did not divulge which test brands were studied or exactly how much the test sensitivity is reduced, for presenting vague findings that may be misinterpreted by the public. Dr. Michael Mina said in a Twitter thread, “What the study identified is not that rapid tests are less sensitive – but simply that Omicron is more infectious.”
Federal health officials are still encouraging people to use rapid tests, despite the FDA’s warning on sensitivity.
“The tests are still worthwhile. Don’t let anybody think that the FDA was saying that tests are no longer good. They say they’re less sensitive now. They never were 100 percent sensitive,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases told CNN’s Michael Smerconish.
“What the FDA is saying today is that when you look at Omicron and its ability to detect Omicron, some of the tests have a diminution, further, of the sensitivity, but they still say the tests are useful and should be used.”
Starting January 19, Americans will be able to order free at-home rapid COVID tests from the government at COVIDTests.gov — but the tests likely won’t be shipped out until 7 to 12 days after the order is made, Biden administration officials told the New York Times.
Each American household will be able to order a total of four tests and will not need to pay for shipping or submit any kind of payment information. The tests will be shipped using first-class mail via the U.S. Postal Service. The Biden administration previously said that the tests could be ordered by telephone as well, but it’s not yet clear what that telephone number will be. Officials told the Times that free tests would also be available at community health centers, rural clinics, and federal testing sites, but it’s not yet clear how Americans can find out which ones.
White House press secretary Jen Psaki was asked on December 6 why the administration was leaning on health insurers to make the tests more affordable, as it’s a relatively complicated strategy. 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.) Two weeks later, President Biden announced that the federal government would do just that, making 500 million at-home rapid tests available to Americans who request them. On January 13, Biden announced that the government would purchase another 500 million tests for distribution.
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 because U.S. health officials focused on getting people vaccinated against COVID-19 and never leaned into asymptomatic testing as a strategy to fight the pandemic. 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 agency issued its first approval for a fully at-home antigen test, Ellume’s, in December 2020, and it took some time for it to become available to the public.
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 are better at catching 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 was 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 COVID cases plummeted and 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. This summer, there was so little interest in rapid antigen tests that Abbott Laboratories, by then the nation’s biggest producer of the tests, shut down one of its factories, laid off workers, and destroyed testing components, according to a New York Times report. (The company claimed the materials had a limited shelf life and couldn’t be donated overseas.)
Thus, when the Delta variant, breakthrough cases, and people returning to work and school drove up demand for at-home testing in the fall, the U.S. was unprepared, and stores couldn’t keep the tests in stock. Omicron and people gathering for the holidays exacerbated the situation.
On his first full day in office, President Biden signed an executive order instructing government agencies to use the Defense Production Act to increase the availability of various items needed to fight the pandemic. Materials for rapid antigen tests were among the many items on the list — along with N95 masks, surgical gowns, gloves, needles, and syringes — but at the time, lab testing delays were a more pressing concern.
By late August, PCR testing was widely available with nearly 2 million tests being performed daily in the U.S. But with the emergence of the Delta variant and schools and workplaces looking to make regular screening part of their reopening plans, attention turned to the lack of at-home antigen tests. 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 would invoke the Defense Production Act again to make them more available. Biden said Walmart, Amazon, and Kroger would sell the tests at cost for three months. (The retailers followed through, though home antigen tests were often unavailable at Amazon during this period. In early January, Walmart and Kroger said they would raise prices again since the deal has expired. The tests are still out of stock at Amazon.)
Biden also said his administration would spend $2 billion on about 280 million rapid tests that would be distributed to places like community health centers, food banks, and schools. However, 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 said it was also working to speed up the approval process. The Department of Health and Human Services announced on October 25 that the FDA would streamline its authorization process, and the National Institutes of Health would spend $70 million on a new program to “establish an accelerated pathway” to aid test makers seeking approval for their products.
The Biden administration announced this week that starting on Saturday, January 15, private health insurers will be required to cover the cost of home COVID tests. Customers will not need to visit a doctor or obtain a prescription before purchasing the tests, and they won’t be subject to copays or deductibles. Insurers will be required to pay for eight tests per covered individual per month. So, for example, a family of four could be reimbursed for 32 tests per month. There is no limit if the test is ordered or administered by a doctor.
The Biden administration is encouraging insurance companies to set up a network of preferred retailers, as the Wall Street Journal explains, which would allow customers to get free test for no cost up front. If people go outside the network, insurers would only have to cover $12 per test. The policy is not retroactive, so tests purchased before the 15th are not eligible for reimbursement.
While the tests will soon be more affordable for people with private health insurance, that doesn’t necessarily mean they’ll be more available. Kim Keck, CEO of the Blue Cross Blue Shield Association, told CNN, “We are concerned that the policy does not solve for the limited supply of tests in the country and could cause additional consumer friction as insurers stand up a program in just four days’ time.”
The new policy, which Biden first announced in December, does not apply to Medicare, which overs more than 60 million seniors. Medicaid and the Children’s Health Insurance Program already cover home COVID tests.
The White House said in early December that “we are on track to quadruple the supply of rapid at-home tests that we had in late-summer.” But despite the administration’s efforts it’s unclear if that will be enough to meet the skyrocketing demand for tests during this winter’s massive COVID surge.
Dr. Anthony Fauci said on December 26 that “obviously” the U.S. needs to make home COVID tests more widely available. “I think things will improve greatly as we get into January, but that doesn’t help us today and tomorrow.”
The reality is, 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.”
This post has been updated throughout.