MISSOULA — The Rapid Antigen Ellume COVID-19 Home Test has been recalled by the U.S. Food & Drug Administration due to a manufacturing error. The tests have given users higher than normal false positive results.
From the FDA website:
The U.S. Food and Drug Administration (FDA) is alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. Negative results do not appear to be affected by the manufacturing issue. The FDA is working closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.
The Missoula City-County Health Department is notifying people about the recall.
“It is just a completely not accurate testing kit,” said Cindy Farr, the county's COVID incident response commander.
Farr says PCR tests are our best bet on getting an accurate test result.
“The problem is that a lot of these over-the-counter tests that you can buy for home testing kits that manufactured pretty quickly and now some of them are starting to see flaws where they're either getting false negatives or they're getting false positives," said Farr.
One of the appeals to home tests is how quickly you can get results. However, at the health department’s Flynn Lane location, they use a local lab to get process test results, with a turn-around time of 24 hours.
“While we saw some delays a couple of months ago, now that we're using a local lap to process results we're getting those 24-hour turnaround," Farr told MTN News. "So definitely, fast and easy way to get tested.”
The health department is making a change to notifying people of their test results starting on Monday, Oct. 25.
They will be making a switch to a more automated process. So instead of getting a call, the contact tracers will be sending out text messages with a link provided to fill out the information they would normally ask over the phone.
Farr wants everyone to know that if they receive a text message with a link from the health department, it is not a scam.