The Food and Drug Administration (FDA) of the United States recalls more than 2 million at-home COVID-19 tests manufactured by the Australian company Ellume and distributed in the United States. The FDA classifies it as a Class I recall, which is the “most serious type.”
According to the FDA, the rapid-test recall is the result of a manufacturing defect that may result in false positives, telling people they are positive for the SARS-CoV-2 virus when they are not. The flaw does not appear to cause false negatives.
The Ellume tests in question were manufactured between February 24 and August 11, 2021. If you have an Ellume test in your cabinet, check the company’s website to see if your batch was affected. The lot number on the side of the carton will be required. If you’ve already used the test, they can check your app result screen or email to see if it was affected.
Ellume first informed the FDA about the flaws in October, prompting the FDA to issue its first recall of more than 200,000 tests, as previously reported by SELF. Since then, the FDA has discovered additional defective lots of the tests. The FDA had received 35 reports of false positives from these tests at the time of publication jobs and businesses were asked to remove the affected lots from their shelves.
The Ellume COVID-19 Home Test detects proteins from the SARS-CoV-2 virus using a nasal sample. It’s an example of a rapid antigen test, which can provide results in as little as 15 to 30 minutes. This type of test is typically inexpensive and, because it can be performed at home without a prescription, very convenient.
However, as previously reported by SELF, rapid antigen tests are not as precise as polymerase chain reaction (PCR) tests, which are considered the gold standard. In a Cochrane review of 64 studies and over 24,000 testing samples, rapid antigen tests only detected COVID-19 in 72 percent of people with symptoms and 58 percent of people without symptoms. PCR tests are often estimated to be around 98 percent accurate at detecting COVID-19 infections when used correctly.
Rapid antigen tests can be useful in the fight against COVID-19, but they aren’t the be-all and end-all of COVID-19 testing, especially when they have manufacturing flaws.
Source: SELF Magazine