AUSTIN, Texas — Editor's note: Ellume has issued a voluntary recall of specific lots of their at-home COVID-19 test.
More people are looking to buy at-home COVID-19 tests.
For some, the tests bring peace of mind, but they aren't perfect. Here's what researchers know so far about over-the-counter COVID-19 antigen tests.
Let's look at the three most common tests found in stores:
These three tests have a lot in common.
All three received "Emergency Use Authorization" from the FDA, which means they aren't fully approved yet. They are "rapid antigen tests," meaning they can detect certain proteins in the virus. They can use a nasal swab to collect a sample, and all three tests return results in 10 to 15 minutes.
But how accurate are these take-home tests?
Abbott BinaxNOW costs about $20 to $25 for a box of two tests. In a clinical study, the company said the test is about 84% accurate at detecting positive cases and 98% accurate at detecting negative cases.
Quidel QuickVue costs about $25 per test. In a clinical study, the company says the test was about 83% accurate at detecting positive cases and 99% accurate at detecting negative cases.
The Ellume COVID-19 Home Test costs about $40 per test. A clinical study looked at symptomatic and asymptomatic participants. The test was about 96% accurate for those who had symptoms and 91% accurate for people who did not have symptoms.
Ellume issued a recall on Oct. 1 for specific lots of the COVID-19 Home Test because "there is an increased chance that tests from the affected lot numbers may give a false positive result." The affected Ellume tests were distributed to retailers and distributors from April 2021 through August 2021. If you have bought the test, check Ellume's website to see if the lot number on your product falls under the recall list.
"The voluntary recall is being taken after specific product lots reported false-positive test result rates higher than was observed in clinical testing," the company said on its website. "Ellume has investigated the issue, identified the root cause, implemented additional controls and we are continuing to work on resolving the issue that led to this recall. Distribution of Ellume COVID-19 Home Tests to retail and distribution partners has recommenced."
Again, research on these tests is limited, but one thing experts agree on is that rapid antigen tests are better at detecting COVID-19 when someone is showing symptoms compared to someone who is asymptomatic.
Your doctor might recommend a PCR test that takes longer to give you your results but is more accurate.
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