Why FDA Has Expanded Its Recall of Ellume COVID-19 At-Home Test Kits

The Food and Drug Administration (FDA)Trusted Source has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results.

More than 2 million tests made by the company that were distributed between April 13, 2021, and Aug. 26, 2021, are now targeted.

“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these tests may cause serious adverse health consequences or death,” agency officials stated.

The COVID-19 home test by Ellume is a form of antigen test that can be used to detect the coronavirus that causes COVID-19 in people ages 2 and older.

It’s available without a prescription and uses a nasal swab to detect if the coronavirus is present. The FDATrusted Source approved the tests for use under an emergency use authorization in December 2020.

Certain batches of the Ellume tests have a higher than acceptable false-positive rate, but the FDA says negative test results aren’t affected.

Why incorrect results are a concern
Dr. William Schaffner, an infectious disease expert at Vanderbilt University in Tennessee, says it’s possible to have incorrect results due to the nature of the tests.

“The simpler at-home tests are not nearly as complicated,” Schaffner told Healthline. “They just detect the virus that’s present, but if there is only a small amount of virus, it may not trigger a positive result. These rapid antigen tests have great utility if the result is positive, but if it’s negative, there is a chance it could be a false-negative result and the person tested is not truly negative but has small amounts of virus.”

“In this circumstance, we’re talking about the other side of the coin where the test registered positive falsely. That’s also troublesome. You can have troubles on both sides,” he added.

As of Nov. 10, the FDA had 35 reportsTrusted Source of a false-positive results using the Ellume tests.

The agency says a false positive can be problematic, as it may lead to a delay in a correct diagnosis of the actual cause of a person’s illness.

A false positive can also lead to unnecessary COVID-19 treatments, unnecessary isolation for the person and their close contacts, and the potential for COVID-19 to spread if people who are presumed positive are grouped together on the basis of an incorrect test result.

“The false positive will set you down a separate trail, namely if you were an older person or a person with underlying illnesses, you would wish to immediately present yourself for treatment with monoclonal antibodies now and perhaps those antiviral drugs in the near future,” Schaffner said.

The need for testing
Despite the Ellume recall, Schaffner argues more testing should be done in the United States.

“Here in the U.S., we need to do much more testing, more like what’s available in Europe. We haven’t used testing very much as an intervention in order to help us control COVID-19 here in the States, but there’s increasing desire to do that both in private and public circumstances,” he said.

Ellume is one of many companies that have received FDA approval for at home COVID-19 tests. Since March 2020, the FDA has approved more than 400 testsTrusted Source for COVID-19 and sample collection devices. This includes rapid at-home tests that can be purchased over the counter without a prescription.

“We believe at-home diagnostic tests play a critical role in the fight against COVID-19. We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans,” Dr. Jeffrey E. Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statementTrusted Source in October.

How to use the tests
Schaffner says as well as using the at-home tests when experiencing symptoms of COVID-19, there are other circumstances where the at-home tests could be useful. But he notes that following the instructions is important.

“If you think you’re somehow exposed (to COVID-19), then you’ll have to read the instructions carefully because if you do the test the day after you’re exposed, you can’t expect it to be positive. It’s too soon, so you’ll have to wait several days before you do it in order to get a more reliable result,” he said.

“Another circumstance… is if there’s going to be a family gathering and there are people who are coming together who are at high risk of serious disease,” Schaffner added.

“If everyone had a negative test, that would reduce the risk of introducing the virus into that circumstance. In Europe, they’re using these tests in order to control admission to a number of entertainment and other venues, and that’s a reasonable thing to do also. So, there are any number of circumstances where these tests might be used.”

If consumers are worried they have a faulty at home COVID-19 test, they can check the product lot number found on a sticker on the side of the Ellume test carton. A list of the affected lot numbers can be found at the Medical Device Recall Database Entry.

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