At-home COVID-19 tests: FDA says kits may be less sensitive to omicron. What to know today

COVID-19 home testing kit

Demand for at-home COVID-19 testing kits has skyrocketed as the omicron variant surges across the US.

Stephen Shankland/CNET

For the most up-to-date news and information about the coronavirus pandemic, visit the WHO and CDC websites.

As the omicron variant of COVID-19 continues to spread during the year-end holiday season, the Food and Drug Administration said on Tuesday at-home test kits may not be as good at detecting the mutated strain of the virus. “Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity,” the FDA said.

Concern about omicron has led to a shortage of test kits and raised costs of testing programs in many states. In response, manufacturers have increased production, and the Food and Drug Administration has been approving new tests at an unprecedented speed: Acon Laboratories says it will be able to produce more than 100 million Flowflex COVID-19 Home Test kits per month by the end of 2021, and more than 200 million by February.

We’ll share what we know now, and will continue to update this story as we learn more details, including when the federal reimbursement program starts and exactly how it will work. Also, get the latest on the Pfizer COVID-19 pill Paxlovid, updates on mask mandates and how to choose a booster shot.

Read more: Clever COVID-19 booster shot trick: Text this number for free rides, easy appointments

How effective are at-home test kits in detecting omicron?

At-home test kits are less effective at detecting COVID-19 infections than PCR (polymerase chain reaction) tests, the FDA said, but the home antigen tests “may have reduced sensitivity” to the omicron variant.

Anthony Fauci, the chief medical adviser to President Joe Biden, said during a White House briefing on Wednesday the kits are still an important tool in checking the spread of the virus. “The fact that the sensitivity is diminished somewhat does not obviate the importance of the advantage and usefulness of these tests under different circumstances,” Fauci said, pointing to testing for family gatherings and at schools.

When will free at-home COVID-19 tests be available?

Starting early next year, over-the-counter COVID-19 test kits will be available for free to everyone: Under a plan announced by President Joe Biden, health insurance companies will be required to reimburse Americans for home antigen tests, which can cost more than $25 each.

Those who don’t have health insurance will also have access to free kits at health centers and other community sites. The Biden administration has pledged to make 50 million tests available at such locations.

The White House has said it will issue reimbursement guidelines to health insurers by January 15 and companies are expected to start refunding the costs of at-home testing shortly after. The plan is not expected to be retroactive, however, so kits purchased before then will not likely be covered. 

Some states, including Vermont, have mandated insurers to start paying for at-home kits now. Others, including Washington, New Hampshire and New Jersey, have started issuing free test kits to their states’ residents. Massachusetts plans to distribute 2.1 million free test kits to 100 municipalities. On Monday, Connecticut Gov. Ned Lamont announced a new plan to deliver 3 million at-home tests and 6 million N95 masks to state residents starting Dec. 30.

If you don’t live in one of those states you may want to check with your employer, as some private companies have begun offering reimbursement options for at-home tests.

Once the White House plan does take effect, anyone with insurance will be able to submit a receipt or other proof of payment for reimbursement after buying a test. The process is similar to visiting an on-site testing facility and submitting your bill to a health insurance provider.

What if I don’t have health insurance?

For those without insurance, Biden says there will be “thousands of locations” available to pick up COVID-19 test kits. You’ll be able to take the kit home to test in private, rather than get swabbed in a drive-thru clinic.

In its announcement on Dec. 2, the Biden administration promised to distribute at least 50 million free tests to community health centers and other organizations.

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Where can I get an at-home COVID-19 test?

At-home rapid COVID-19 tests are available at pharmacies like Walgreens, CVS and Walmart. You can also buy them online at Amazon or at the websites of the pharmacies. It’s unclear at this time if you can still claim them on your insurance when you buy online. Each box typically comes with two tests, unless you buy in bulk.

How much do at-home COVID-19 tests cost?

The FDA has authorized 13 different rapid at-home COVID-19 tests and 61 different at-home collection tests. Rapid antigen tests are generally much cheaper than home collection tests. Costs vary from brand to brand, but the rapid tests generally run about $10 to $12 apiece.

Both Walgreens and CVS are selling Abbott’s BinaxNow and Quedel’s QuickVue tests — two of the first authorized — for $24 for a pack of two. Acon’s FlowFlex rapid test usually runs slightly less — currently $10 for one test at both Walgreens and CVS.

Home collection tests — where a nasal swab or saliva sample is sent to a lab — cost much more than the rapid antigen tests. CVS and Walgreens are selling Labcorp’s Pixel home-collection test for $125.

Buying in bulk seems like a way to cut down the cost of individual tests, but that hasn’t happened in reality yet. Amazon is selling a two-pack of Intrivo’s On/Go rapid test for $24.49 ($12.45 a piece), but the price for 40, at $499, is slightly more per test: $12.48 apiece.

Unfortunately, almost all of the tests mentioned are out of stock for online purchase due to the December rush. We’ll continue to update this section as the availability of tests changes.

Should I use a rapid at-home test or go in for a PCR test?

The two main types of COVID-19 tests are rapid antigen tests and PCR (polymerase chain reaction) tests. Antigen tests can be taken at home and return results in about 15 minutes. PCR tests require lab work and generally provide results in 12 hours to 5 days.

Both types of tests mostly use nasal swab samples. PCR tests administered by a professional may require a nasopharyngeal sample that involves a much deeper nostril swab. Rapid antigen tests usually require swirling a swab in the nostril less than an inch deep.

PCR tests amplify genetic material from the collected sample up to a billion times to detect even the slightest amount of COVID-19 genes, making them highly accurate. They’re also more expensive, usually costing more than $100 a piece.

Rapid antigen tests simply detect the presence of antigens — the substances that prompt your immune system to create antibodies — and work much like home pregnancy tests. If your sample contains COVID-19 antigens, the thin line of SARS-CoV-2 antibodies on the test strip will change color.

Because rapid tests are simply looking for the existence of antigens, they work best when someone is symptomatic. Rapid antigen tests are less successful with early infections and asymptomatic cases. The risk of a false negative is much higher with a rapid test than a false positive.

The type of test to choose will mostly depend on your situation. Do you need results right now, with less accuracy? Then rapid antigen fits your bill. If you want closer to 100% accuracy and don’t need instant results, the “gold standard” PCR is your choice.

What should I do if my at-home test shows positive for COVID-19?

If you take an at-home test and it says you’re positive for COVID-19, it’s recommended that you turn your results in to your health care provider. You should stay home and isolate for at least 5 days or longer if you’re symptomatic, according to new recommendations from the CDC.

Though the risk of false positive results from rapid tests is low, most medical experts and health officials still recommend confirming a positive at-home test with a subsequent PCR test.

For more information, here’s the latest on the federal vaccine mandate and everything you need to know about the Moderna booster shot.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.